Non-traditional support workers delivering a brief psychosocial intervention for older people with anxiety and depression: the NOTEPAD feasibility study

Article history

The research reported in this issue of the journal was funded by the HS&DR programme or one of its preceding programmes as project number 13/54/34. The contractual start date was in September 2015. The final report began editorial review in January 2018 and was accepted for publication in November 2018. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HS&DR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Peter Bullock is Chief Executive of Age UK North Staffordshire and reports that a contract between Keele University and Age UK was set up to enable Age UK support workers to deliver the intervention during the study. Carolyn A Chew-Graham, Simon Gilbody and Peter Bower are and have been in receipt of funding from the National Institute for Health Research outside the submitted work. Simon Gilbody is a member of the Health Technology Assessment (HTA) Commissioning Board, HTA Efficient Study Designs, HTA End of Life Care and Add-on Studies and HTA Funding Boards Policy Group.

Copyright statement

© Queen’s Printer and Controller of HMSO 2019. This work was produced by Burroughs et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

2019 Queen’s Printer and Controller of HMSO

Definitions and epidemiology

Depression is a major global public health burden, and by 2030 depressive disorders are predicted to be the second leading cause of disease burden and disability worldwide. 1 Anxiety and depression often coexist and are prevalent among older people, with up to 20% of older people reporting symptoms of depression. 2,3

Should the prevalence rates for these mental health problems remain stable in the future, we are still likely to witness an increase in the total number of older people with mental health problems owing to demographic changes (i.e. an ageing population). This will lead to an increased demand for treatment and an increased burden on health and social care. 4 Untreated anxiety and depression present a particular challenge and lead to increased health and social care utilisation and mortality. 5

Living with comorbidities (the presence of one or more additional conditions) is a common occurrence in later life: 36% of people aged 65–74 years and 47% of people aged ≥ 75 years experience a limiting chronic condition, and comorbidities present a significant risk to mental health. 6 The presence of long-term physical conditions increases the prevalence of depression and anxiety; for example, up to 30% of people with diabetes experience depression and up to 25% of people with chronic obstructive pulmonary disease (COPD) experience anxiety. 7 The presence of two or more long-term physical conditions increases the likelihood of depression by as much as seven times. 8

For older people with undetected depression, longer-term prognosis is poorer than for those whose depression is known by their general practitioner (GP). 9

Older adults face adversity in the areas of health, bereavement and loss, which is associated with depression. Isolation, loneliness and loss may be important contributors to anxiety and depression. This has clinical relevance for psychological interventions for older adults to consider social context and social support. 10

Depression and anxiety in older people are poorly detected and can be poorly managed in primary care,11 particularly in people with chronic physical ill health. 12 One impediment to detection is that older people may not present to their GP with depression because of the stigma they perceive about mental health problems. 13 Older people with chronic physical illness may normalise their depression, or view it as a ‘justifiable’ cause of low mood. 12–14 As a result, older people may hold negative views about help seeking. 15 Diagnosis and treatment led by a narrow biomedical model may overlook important social and contextual factors of mental health that can inform management. 16 One way around this is to treat people with mild to moderate depression and anxiety in a way that underserved individuals, such as older people, find non-stigmatising.

Management of anxiety and depression in older adults

The National Service Framework for Older People17 made specific references for the improvement of health-care services in England. The framework suggested that older adults who have mental health problems should have access to specialist older people’s mental health services with integrated social service elements, provided by the NHS and local councils, to ensure effective diagnosis, treatment and support. This framework was followed by a new older people’s mental health service development guide from the Department of Health and Social Care, Everybody’s Business,18 which made it clear that older people’s mental health spans health and social care, physical and mental health and mainstream and specialist services. The strategy document No Health Without Mental Health19 emphasises the importance of improving outcomes for people with mental health problems through high-quality services, for people of all ages, that are accessible to all.

A total of 90% of people with mental health problems are managed in primary care, and the population of older adults is no exception, with most older people with GP-recognised anxiety and/or depression being managed solely in primary care. In addition, older adults are under-represented in referrals to Improving Access to Psychological Therapies (IAPT). 20–22

The National Institute for Health and Care Excellence (NICE)’s guidelines for depression23 and anxiety24 advocate a stepped care approach in the management of depression and anxiety, as outlined in Figures 1 and 2.

FIGURE 1.

The NICE stepped care model for depression. 23 © NICE 2009 Depression: Treatment and Management of Depression in Adults. Clinical Guideline 90. Available from www.nice.org.uk/guidance/cg90 All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this publication.

The NICE stepped care model for depression. 23 © NICE 2009 Depression: Treatment and Management of Depression in Adults. Clinical Guideline 90. Available from www.nice.org.uk/guidance/cg90 All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this publication.

FIGURE 2.

The NICE stepped care model for anxiety. 24 CBT, cognitive–behavioural therapy; GAD, generalised anxiety disorder. © NICE 2011 Generalised Anxiety Disorder and Panic Disorder in Adults: Management. Clinical Guideline 113. Available from www.nice.org.uk/guidance/cg113 All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this publication.

The NICE stepped care model for anxiety. 24 CBT, cognitive–behavioural therapy; GAD, generalised anxiety disorder. © NICE 2011 Generalised Anxiety Disorder and Panic Disorder in Adults: Management. Clinical Guideline 113. Available from www.nice.org.uk/guidance/cg113 All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this publication.

The NICE guidelines advocate that mild to moderate ‘cases’ of anxiety and depression are offered, at steps 1 and 2, advice about lifestyle by GPs and low-intensity interventions, respectively, which may include provision by non-statutory or third-sector bodies. There is limited evidence of the effectiveness of such providers in improving patient outcomes.

The NICE guidelines for common mental disorders25 emphasises the need to promote access to services for people with common mental health disorders from a range of socially excluded groups including older people, with suggestions, such as using different explanatory models of common mental health disorders, interventions in the person’s home or other residential settings or assistance with travel, and signposting to self-help and support groups.

Evidence base for the management of depression in older adults

A range of individual treatments has been shown to be effective in older people, including antidepressants and psychosocial interventions. 26 Antidepressants may not be an acceptable option for older people and, therefore, concordance is likely to be poor. 15 In addition, evidence repeatedly suggests that older people are not referred for ‘talking treatments’. 22 There is evidence that befriending (a one-to-one intervention) is effective in reducing depression in older people. 27 Befriending has been defined as ‘a relationship between two or more individuals which is initiated and supported and monitored by an agency that has defined one or more parties as likely to benefit. Ideally the relationship is non-judgemental, mutual, and purposeful, and there is a commitment over time’. 28

Lester et al. 29 suggest that befriending provides older people with desired opportunities to develop social ties that they perceive as reciprocal, to share intimacies and establish trust. Moriarty and Manthorpe30 emphasise the need for further research to evaluate the effectiveness of befriending-type interventions.

Other literature, however, suggests that a one-to-one intervention for older people with depression is insufficient: according to a systematic review of interventions for isolated and depressed older people,31 9 out of the 10 effective interventions included were group activities with an educational or support input, whereas six of the eight ineffective interventions provided one-to-one social support, advice and information or health-needs assessment. Therefore, befriending alone is unlikely to achieve a lasting effect, and the practitioner delivering the intervention needs to encourage change in behaviour and activity in the older person.

We attempted to conduct a systematic review32 into the effectiveness of psychosocial interventions for treating depression and anxiety in older people to evaluate which interventions are effective. The aim was to identify which components of psychosocial interventions are most effective in reducing the symptoms of depression and anxiety in older people, which was to inform the NOTEPAD (NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression) intervention. However, the studies identified in the search were too heterogeneous for a metasynthesis, with divergent statistical tests and reporting, follow-up periods, depression scales and control conditions (see Appendix 1). Nine of the interventions were group-based activities and a major difficulty is disentangling the effectiveness of the activity from the effectiveness of being part of a group regardless of the activity that is taking place. Collaborative care as a framework for delivery or complex multicomponent interventions seem to be the most effective. Individual components such as cognitive–behavioural therapy (CBT) and group reminiscence are also promising. However, the study reporting the effectiveness of group reminiscence did not differentiate the reminiscence therapy from socialising as part of a group.

Loneliness and isolation are risk factors for developing depression and anxiety10 and, because increasing age is associated with loneliness and isolation, new methods of treatment of depression and anxiety among older people should focus on addressing loneliness. Kharicha et al. 33 suggested that older people experiencing, or at risk of, loneliness may not consider that primary care has a role in alleviating this. In addition, they reported that older people with characteristics of loneliness generally know about local resources but do not consider services advertised as being for ‘lonely older people’ to be desirable or helpful. Participants in their qualitative study reported that group-based activities with a shared interest are preferred to one-to-one support or social groups.

Behavioural activation (BA) is a short-term CBT-based intervention known to be effective in the management of depression, which can be delivered by practitioners who do not have specialist mental health training. 34 BA focuses on activity scheduling to encourage participants to approach activities that they may have previously enjoyed but are currently avoiding owing to increasing life changes (e.g. loss of spouse), or to develop new activities, and on analysing the function of cognitive processes (e.g. rumination) that serve as a form of avoidance. Participants are thus refocused on their goals and valued directions in life. The main advantage of BA-oriented interventions over traditional CBT for depression is that it may be easier to train non-clinical staff to deliver the intervention. 34 BA within a collaborative care model forms the cornerstone of trials35–39 in which the intervention is delivered by psychological well-being practitioners. 30,35–37 In addition, behavioural therapies have been shown to be effective in older people. 40,41 BA is therefore likely to be effective in older adults with anxiety and depression.

In the CASPER plus (CollAborative care for Screen-Positive EldeRs with major depression) trial,42–44 the BA intervention was acceptable for many of the older adults with depression and could readily be delivered over the telephone, following a face-to-face meeting. This approach may be able to reduce the stigma of the label of mental illness and resolve misconceptions around antidepressant medication prescribed by GPs. 29,30 However, some participants reported that the intervention was intrusive, and felt that talking and thinking about their symptoms made them feel uncomfortable.

An observation among all trials of people with depression has been the failure to integrate these effective elements of care into routine primary care services. 31,44

Collaboration with the third sector

The argument for working with the third sector, specifically Age UK, is based on previous collaborations with Age UK, and that older adults may find third-sector services less stigmatising.

Age UK has funded previous evaluations such as ‘Fit as a fiddle’45 and ‘Call me’. 46 Fit as a fiddle was a £15.1M portfolio of activities funded by the Big Lottery Fund and delivered across the nine English regions between 2007 and 2009. The aim was to increase the opportunities for older people to undertake physical activities and improve their eating habits, contributing to an overall improvement in mental health. The evaluation demonstrated a significant improvement in physical and mental well-being and an increase in volunteering capacity. The model has been accepted by Age Action Alliance as the preferred model for delivering healthy ageing services. Findings from the Call me project demonstrated that tailoring activities to a participant’s interests increases engagement in social activities and participant satisfaction and encourages sustainability.

Rationale for the NOTEPAD study

There is a need to improve the quality of care for older people with anxiety and depression. Improving quality of care means addressing not only the effectiveness of interventions but also the issue of limited access to acceptable care.

Older adults are a vulnerable and underserved group, often experiencing difficulty in accessing mental health care. 47 This is compounded by social isolation, loneliness and economic deprivation. 36,48 Given the ageing population and the public health implications of depression in older people, it is clear that acceptable community interventions focused on older people with anxiety and depression are needed. 49

Previous studies, such as Dowrick et al. ,50 explored ways to improve access for particular patient groups with limited access to care (e.g. older people). In the AMP (Access to Mental Health in Primary Care) study,50 psychological well-being practitioners (seconded from local IAPT services) delivered a brief psychosocial intervention to older people, which participants found to be acceptable. 51 In the same programme,50 third-sector workers were trained to deliver a similar intervention to South Asian women. Delivery by therapists or mental health practitioners is costly, which makes an intervention less likely to be commissioned in the NHS. Whether or not third-sector workers can deliver such an intervention to older people, and whether or not it is acceptable to patients and effective in improving outcomes, is unknown.

A further argument for increasing social participation is that loneliness and depression are strongly associated in older people52 and loneliness is an independent risk factor for depression. 48 Evidence from the USA53 suggests that for lonely older people there is a potential benefit from a social group or educational activities. Thus, it is reasonable to postulate that group activity might be a useful adjunct to treatment for mild to moderate depression.

Further evidence from a systematic review of social interventions targeting loneliness in older people54 suggests that the most successful interventions for loneliness, measured by improvement in the domains of physical, mental and social health, tend to be group based and participatory and offer some activity. 55–58 Such community-based interventions have been shown to have additional benefits in terms of social inclusion and social cohesion. 59–61

It has been argued that creativity plays an important role in later life and has positive implications for health and well-being and the maintenance of social networks by older people. 62–65 Creative activity has also been shown to provide therapeutic benefits,66 further evidenced by the rise in community-based ‘art for health’ across the UK. 67

A report from the Baring Foundation68 argues that the arts are an effective way to tackle loneliness, offering opportunities to connect and contribute, and to develop friendships and a sense of being valued, so that resilience is enhanced. It also notes that they are often overlooked by older people’s services. Despite the growing call for a diverse range of support for older people, there remains a paucity of evidence on what works best and Dickens et al. 54 suggest that there is a need for more studies to add to the evidence base.

From the literature, it is likely that the ideal intervention would be a tailor-made, flexible combination of elements, with some individual psychological therapy if necessary, followed by a group-based social activity that the participant might find enjoyable and/or meaningful.

In this older population, however, there are likely to be barriers to recipients of BA resuming previously enjoyed activities, such as difficulties with transport or lack of confidence. One solution would be for support workers (SWs) to initially accompany participants to activities to support their attendance.

The proposed intervention was supported by a wide theoretical basis, including social identity theory69 and self-concept theory,70 which examine how a person’s self-concept is affected by membership of social groups, and self-efficacy theory,65 which is highly relevant to health behaviours and posits that self-efficacy can be directly influenced by modelling or social persuasion within groups. These theories indicate how group interventions might help to foster good mental health framed within a critical gerontology approach. Critical gerontology challenges traditional notions of ageing as problematic and burdensome, and argues for older people to be seen as assets and contributors to the societies in which they live. This approach emphasises diversity and the need to take account of the wide range of issues that profoundly structure the experience of ageing, including life-course, sex, health and disability, socioeconomic status, ethnicity, sexual orientation and the physical environment. 71

Whether or not third-sector workers can deliver such an intervention to older people, and whether or not it is acceptable to patients and effective in improving outcomes, is unknown.

Summary

The overall aim of the NOTEPAD study was to explore whether SWs from the third-sector organisation Age UK North Staffordshire can deliver a non-stigmatising psychosocial intervention to support and manage older people with anxiety and depression recruited from primary care.

Research aims and objectives

This was a study composed of three phases, each informed by a patient and public involvement and engagement (PPIE) group:

• phase 1 – qualitative work with older people and third-sector providers, plus a consensus group to refine the intervention, training, SW manuals and patient participant materials

• phase 2 – recruitment and training of SWs

• phase 3 – feasibility study to test recruitment procedures and assess fidelity of delivery of the intervention; interviews with study participants, SWs and GPs to assess acceptability of the intervention and impact on routine care.

Objectives

Phase 1: to refine a psychosocial intervention to be delivered by third-sector NTPs/SWs to older people with anxiety and/or depression.

Phase 2: to assess feasibility of recruiting and training NTPs/SWs to participate in the study and to assess fidelity of delivery of the psychosocial intervention to older people with anxiety and/or depression.

Phase 3: to answer the questions below.

• Feasibility:

  • Can we recruit general practices to participate in a study to evaluate the feasibility of this approach?

  • Can we recruit and retain older adult participants in a randomised study, including the completion of follow-up questionnaires?

  • Can the NTPs/SWs deliver a psychosocial intervention to older people with anxiety and/or depression?

  • Can this intervention be implemented in routine NHS service delivery?

• Process evaluation:

  • Do older people find working with an Age UK SW, and joining groups, acceptable?

  • What are the perspectives of the SWs about training, support to deliver the intervention, and how did they find working with older people in a more structured way?

  • Were the manuals developed to support training and delivery of the psychosocial intervention acceptable and useful to SWs?

  • What did participating primary care clinicians understand by the study and how did it impact on their work?

Figure 3 illustrates how the three phases link together.

FIGURE 3.

Model of the NOTEPAD study phases. TAU, treatment as usual.

Aims and objectives

The objective of phase 1 of the NOTEPAD study was to inform the refinement of the psychosocial intervention to be delivered by SWs recruited from the third sector to older people with anxiety and/or depression. Based on the previous work of the research team, and on the existing literature, it was anticipated that the intervention would comprise a two-stage process of one-to-one contact, utilising BA, based on the principles of CBT, and including the option of signposting to a group activity.

In addition, an objective of phase 1 was to contribute to the development of training for the SWs, including the development of manuals for the SWs and for patient participants.

Design and setting

Ethics approval was obtained from the Keele University Ethical Review Panel on 23 September 2015.

Patient and public involvement and engagement

A PPIE group was established to support the development of the whole NOTEPAD study. The group helped to create the NOTEPAD logo and strapline ‘Supporting Mental Strength’.

The PPIE group suggested that the term ‘non-traditional providers’ used in the application for funding was unlikely to be acceptable to older people, and suggested that the term ‘support workers’ would be more appropriate.

The PPIE group suggested that the terms ‘depression’ and ‘anxiety’ may not be acceptable to older adults owing to stigma and could limit engagement with the study. Alternative terms ‘low mood’ and ‘stress’ were suggested by the PPIE group members and used thereafter. The term ‘stress’ is not clinically equivalent to anxiety; however, the research team accepted that there is sufficient overlap between these terms to support exploration in the qualitative interviews.

The PPIE group provided advice on the design of participant-facing documents (e.g. participant information sheet, consent forms), on the language and terminology used and on the layout of documents.

Towards the end of the qualitative study, the results of the emerging analysis were presented to the PPIE group, and they contributed to the development of a model that mapped the perspectives of older adults and third-sector workers on older adult responses to loss, which informed the intervention (Figure 4).

FIGURE 4.

Older people’s and third-sector service responses to distress and loss in later life. Reproduced from Kingstone et al. 49 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Methods

Qualitative methods were used to explore older people’s experiences of, and perspectives on, low mood and stress, and third-sector workers’ perspectives on working with people suffering from mental health problems. In addition, the views of participants on how to manage low mood and stress were sought, along with what an intervention delivered by third-sector workers to older people might look like.

Semistructured interviews were used to generate data.

The approach to sampling was purposive. We sought to recruit older adults (aged ≥ 65 years) living in the community and interested in sharing their views about experiencing low mood and/or stress in old age. We also sought to recruit individuals who were either in paid employment or volunteering with third-sector organisations and involved in the provision of community-based support for older people who may or may not experience low mood and stress.

Results

Discussion

Strengths and limitations

Summary

This phase of the study identified the central role of loss in later life as a potential contributing factor in mental health problems; the findings have important implications for the proposed feasibility study, training of third-sector workers delivering the intervention and clinical practice. Third-sector workers reported regular contact with older people presenting apparent mental health problems and needs related to the community; typically, such contact occurred at group activities and services not designed to respond to mental health needs nor with staff or volunteers appropriately trained. Phase 1 affirmed that, with appropriate training, third-sector workers could be well placed to deliver a low-intensity psychosocial intervention to older people, as recommended in the stepped care approach in NICE guidelines for anxiety and depression, and would provide both older people and primary care professionals with choice for management. The analysis contributed to the refinement of the NOTEPAD intervention and the development of the SW training, SW manual, and the resources intended for study participants. This will be discussed in Chapter 3.

Aims

The aims of phase 2 of the NOTEPAD study were to:

• identify the effective components of an intervention that aims to improve the management of depression and anxiety, reduce social isolation, increase participation and promote good mental health in older people

• develop, refine and integrate interventions that respond to patients’ self-reported difficulties and may include lifestyle and activity advice, psychoeducation, BA techniques (a simple CBT-based intervention) and referral to existing third-sector resources (which might include referral to a befriending service, patient or carers group, Age UK or other local groups) to reduce social isolation

• develop training for SWs from the third sector (Age UK) to enable them to conduct the assessment and deliver the psychosocial intervention

• develop a manual for the SWs to structure the intervention and support and supervise their work with study participants

• develop resources for study participants to use with a SWs’ support.

Refining the intervention

The intervention was built on the literature, the research team’s previous experience39,42,76 and consensus achieved in an expert group.

The evidence base underpinning the NOTEPAD study is outlined in Chapter 1. The systematic review (see Appendix 1) confirmed the premise of the application; that the ideal intervention would be a tailor made combination of individual psychological support and subsequent group-based social activity that the participant might find enjoyable and/or meaningful. Our review suggested that reminiscence therapy might be useful but that the effects were not well differentiated from the effects of merely socialising as part of a group.

The research team drew on previous interventions that incorporated BA that they had been responsible for developing and delivering within trials. 39,42,76 BA is a structured programme of reducing the frequency of negatively reinforced avoidant behaviours in parallel with increasing the frequency of positively reinforcing behaviours to improve functioning and mood. The intervention for this study was to include signposting to local agencies and activities, when acceptable to the study participants, and the SWs were encouraged to accompany the study participants to a first visit to a group. The intervention was designed to be delivered by SWs recruited from Age UK North Staffordshire.

The research team considered that adaptations would need to be made to the information gathered at the initial session by the SW. Older adults are more likely to experience long-term health problems and a reduced level of functioning, with their psychological status often closely linked to their physical functioning. 77 Additional questions regarding health conditions and their impact were therefore thought to be needed as part of the initial assessment by the SW. The team considered that the SWs should adopt a person-centred approach. Depression in older adults is associated with impaired social support;78 therefore, additional questions regarding social contacts and family were felt to be important, especially as we anticipated that signposting to local groups to reduce social isolation should be an integral part of the intervention. The team felt that the risk assessment in the intervention and the suicide ideation protocol in the feasibility study – available on the project webpage [see www.journalslibrary.nihr.ac.uk/programmes/hsdr/135434/#/ (accessed 20 March 2019)] – should be adapted to enquire about past passive and past active suicide ideation as well as current plans and preparations, as past suicidality is a risk factor for current suicidal behaviour. 79

The qualitative study conducted in phase 1 (see Chapter 2) highlighted important areas for inclusion in the intervention for the NOTEPAD feasibility study: the need for an empathic relationship and the development of trust, acknowledgement of loss, the importance of self-management as an integral part of the intervention, maintenance of participant engagement, and the need for adequate support for the SWs delivering the intervention.

At the PPIE meetings in January and September 2016, participants were presented with results of the qualitative study and an outline of the proposed intervention. Comments from the group were also sought on examples of patient manuals used in previous trials39,42,76 and views taken to present and discuss further at the consensus group. Members of the PPIE group particularly commented on the size (A4) of the example materials, which they felt were not convenient for carrying or storing. In addition, the group felt that the manuals used in the previous trials39,42,76 contained too much jargon and that the text needed breaking up with more illustrations and pictures. The PPIE group also strongly felt that the term ‘non-traditional provider’ would not be appealing or understandable to older adults and suggested that the term ‘support workers’ should be used.

The consensus expert group was held in January 2016 to draw together the evidence base, views from the PPIE group and findings from the qualitative study. The group comprised clinicians (GPs, psychiatrists, IAPT practitioners), academics and researchers with knowledge and expertise about the management of older people’s mental health. During development of the funding application, it had been agreed that the intervention would use the principles of BA plus signposting to existing third-sector resources. The group members were tasked with responding to outstanding questions posed by the research team and achieving consensus by the end of the day in the following areas:

• What intervention for anxiety?

• How many sessions in the intervention?

• Should we use a measure/assessment of mood within the NTP/SW–study participant consultations?

• How should the participant manual look?

• What are the implications of phase 1 for the SW training?

The group discussion resulted in a consensus as presented in Table 4 and Box 1.

The SW manual needs to fit with the patient manual; the SWs should feel comfortable working with the study participants and in supporting them to use the participant manual.

The NOTEPAD materials can be found on the project web page [see www.journalslibrary.nihr.ac.uk/programmes/hsdr/135434/#/ (accessed 20 March 2019)].

The final NOTEPAD intervention

At a PPIE meeting in February 2016 the NOTEPAD intervention, as agreed at the consensus meeting, was presented to the group and supported by members.

The final intervention is outlined against the Template for Intervention Description and Replication (TIDieR) checklist80 in Table 5.

The NOTEPAD participant resources

Support worker manual

The SW manual was developed by members of the training team (CC-G, HB, KL, DB and LG), with input from co-investigator Peter Bullock from Age UK North Staffordshire. The manual supported the SW training and complemented the participant resources. The manual included suggestions to the SWs about how to introduce aspects of the NOTEPAD intervention, for example establishing the problem, and included a section on risk assessment, which was covered in the SW training.

The SW manual can be found on the project web page [see www.journalslibrary.nihr.ac.uk/programmes/hsdr/135434/#/ (accessed 20 March 2019)].

Recruitment of support workers

Support workers were recruited from Age UK North Staffordshire via a job advertisement giving extensive information about the NOTEPAD study. This was devised by Peter Bullock (Chief Executive, Age UK North Staffordshire) and Heather Burroughs. Peter Bullock personally drew the attention of suitable workers to the advertisement, answered any questions that they had and encouraged them to apply by submitting a written application. The applicants were then shortlisted and selected for interview. Peter Bullock and Heather Burroughs interviewed the applicants, and six of the eight applicants were appointed. At the suggestion of the NOTEPAD study steering committee (SSC), a seventh, substitute worker was also recruited to ensure that we had enough SWs should any of them drop out.

Delivering the support worker training

The NOTEPAD training was developed from training used in previous trials,37,39,42,76 modified in line with suggestions made at the consensus group meeting (see Table 4 and Box 1).

The training was delivered over 3 days at Keele University in May 2016 by the training team (CC-G, HB, KL, DB and LG). The training was supported by a set of slides and the SW manual. Skills practice was facilitated by the use of simulated patients (SPs) recruited from the pool used for educational events at Keele University School of Medicine.

The training included a description of the role of the SW in the NOTEPAD study, discussion and revision of the risk assessment and safeguarding policies for Age UK, advice regarding note keeping about study participants and details required for the feasibility study. In addition, the requirement for recording the first two sessions with each study participant was reinforced, with training on how to use the recorder and transfer recordings to the study team. Arrangements for supervision were given during the training.

A ‘refresher’ training event, again with skills practice using SPs, was held in August 2016 owing to a delay in recruitment to the feasibility study.

All training materials can be found on the project web page [see www.journalslibrary.nihr.ac.uk/programmes/hsdr/135434/#/ (accessed 20 March 2019)].

Evaluation of the training

Questionnaires were completed by the SWs before the first session and following the third session of training to assess usefulness of the training. The results are shown in Tables 7 and 8. The shift in scores to the right suggest that the training achieved what was intended. One SW indicated that they were still ‘not sure’ about how to use BA as a technique and were ‘not sure’ about how to manage people with anxiety symptoms. A different SW was ‘not sure’ about how to work with the study participants using the NOTEPAD file (patient participant resources). These items were covered in the refresher training.

Feedback from the SPs was encouraging: it suggested that the SWs had understood the training; the SPs felt more comfortable with each of the SWs during role play on the third day of training and seemed very confident in the refresher training.

Support worker supervision

Supervision for the SWs was offered in two ways:

1. Group meetings (with refreshments) at Keele University with Carolyn A Chew-Graham and Heather Burroughs to discuss practicalities of the NOTEPAD feasibility study (including the documentation and how to use the digital recorder) and to share experiences and accumulated knowledge of local resources.

2. One-to-one supervision, either face to face or by telephone, between Carolyn A Chew-Graham and the individual SWs, at intervals to suit the SWs. The SWs were asked to complete a form to prepare for supervision. Carolyn A Chew-Graham documented each supervision session. SWs also received usual and on-going support for their work with Age UK North Staffordshire from their nominated manager at Age UK.

SWs were encouraged to claim the costs of their time and travel to attend both group meetings and individual supervision sessions.

Summary

This section has outlined phase 2 of the NOTEPAD study: refining the psychosocial intervention, developing and delivering the training for SWs and finalising the manual for use by NOTEPAD study participants. Chapter 4 describes the methods for the feasibility study within which this intervention was tested.

Aim

The aim of phase 3 of the NOTEPAD study was to determine whether or not it is feasible to recruit and randomise participants to the study, to test procedures and to conduct a process evaluation to provide essential information and data to inform a future application for a full randomised trial. The objectives were to assess feasibility in terms of recruitment of general practices and patient participants, retention, delivery of intervention, acceptability of intervention to participants, SWs and GPs, and questionnaire completion rates in both intervention and usual-care arms.

To determine feasibility, findings will be assessed against the following criteria:

• Engage GP practices – at least six practices to participate.

• Recruit, train and retain SWs – at least six SWs to be retained.

• High response rates to the screening questionnaire – receive useable responses from at least 40% of those mailed.

• Recruitment – at least two out of five individuals eligible from the screening questionnaire randomised to the trial at a rate of at least one individual per practice per week.

• High response rates to a follow-up questionnaire – at least 75% for the primary outcome.

• Adherence to intervention – data to be drawn from SW notes and recordings of sessions. A participant will have at least one contact with a SW. This will be investigated in more detail with the in-depth qualitative interviews with the participants, SWs and GPs to determine the barriers to, and facilitators of, intervention delivery/reception.

• Acceptability of the intervention – to be explored using qualitative interviews.

• Fidelity checking.

Study methods and design

Study design

The NOTEPAD study was organised into three phases as presented in Figure 3. Phases 1 and 2 are described in Chapters 5 and 6, respectively. The protocol described here relates to phase 3, the feasibility study.

The feasibility study aimed to assess whether or not it is possible to recruit and randomise patients, deliver a psychosocial intervention to older people and conduct a process evaluation. We conducted a process evaluation to explore whether or not this intervention was acceptable to participants and SWs, and to GPs. The study was conducted within primary and community care in Stoke and North Staffordshire Clinical Commissioning Groups (CCGs). This included a range of geographical areas (inner city, urban and rural) so the patient populations had a range of characteristics.

The process of phase 3 is presented in Figure 5; each stage is described in the sections that follow.

FIGURE 5.

Diagram of the NOTEPAD phase 3 processes. CASP-12, Control, Autonomy, Self-realisation and Pleasure-12 items; CIS-R, Clinical Interview Schedule-Revised; EQ-5D-5L, EuroQol-5 Dimensions, five-level version; GAD-7, Generalised Anxiety Disorder-7 items; PHQ-9, Patient Health Questionnaire-9 items; RN, research nurse.

Process evaluation

The aim of the process evaluation was to determine whether or not Age UK SWs can deliver the NOTEPAD psychosocial intervention to older people with sufficient fidelity to the training. The process evaluation explored whether or not the one-to-one intervention, delivered by SWs, is acceptable to older adult participants and whether or not the intervention affected GPs in participating practices. Interviews were used to explore whether or not the intervention made sense to the study SWs and whether or not the training, support materials and supervision were acceptable.

Data management

All information and documentation relating to this study is stored securely on password-protected computers or filed in locked cabinets in Keele CTU. In accordance with Keele CTU standardised operating procedures (SOPs), data have been anonymised, are held securely (in locked cabinets and/or on secure servers) and will be archived for at least 5 years after the grant has ended. Keele CTU is legally obliged to store research data securely and this has been done by removing all personally identifiable information from all sources at an appropriate stage of the study. Paper-based consent records that are personally identifiable are stored separately from research data. The processing of data (in line with the Data Protection Act 1998)92 will occur within Keele CTU. Once personal data have been processed and are not required for contact with the participant, they are destroyed and research databases are anonymised using a unique code ID allocated to each participant. All questionnaires completed by/with participants are identified by the participant’s unique code and are therefore anonymised.

The computerised CIS-R data were kept on an encrypted Universal Serial Bus (USB) stick and this was used to move the data from the laptop. The RN then uploaded the data directly from the USB stick into the CTU secure server using a CTU file transfer protocol.

All sensitive data sets are retained on a secure server and access is restricted dependent on study team role at Keele CTU. Access to all research data sets is controlled by password protection and additional permissions to access folders pertaining to the data.

Study and participant information from the qualitative interviews as part of the process evaluation is stored and processed securely (as above). Any identifying information provided to the study team has been dealt with in the strictest confidence under the terms of the Keele University Code of Research Conduct.

Data analysis

The data collected in this study include sequential quantitative and qualitative types owing to the mixed methods being applied.

Ethics considerations

Participant burden

The burden of taking part in this study included the completion of questionnaires delivered by the RN, and participants randomised to the intervention arm were asked to participate in up to six consultations with the SW, a qualitative interview (subsample only) and audio recording of up to two of their consultations with the SW.

The baseline visit was anticipated to take approximately 90 minutes to complete, and the follow-up interview up to 45 minutes to complete.

Study management and safety reporting procedures are reported in Appendix 5.

Patient and public involvement and engagement

Because a key study objective was to develop an intervention that was person-centred, it was particularly important to incorporate a large PPIE component within the study.

As described in Chapter 2, our PPIE group played an integral part in the development of the NOTEPAD study. The group’s input to the feasibility study included advising that the term ‘non-traditional provider’ would not be acceptable to older people and that we should use the term ‘support worker’. The PPIE group contributed to the logo used for the study and the strapline ‘Supporting Mental Strength’ (Figure 6).

FIGURE 6.

The NOTEPAD logo.

The PPIE group contributed to the refinement of the NOTEPAD intervention and patient materials, which was fed into the consensus group meeting (see Chapter 3), and advised on patient-facing documents for participant recruitment as part of the ethics approval.

The group met in May 2017 to discuss recruitment and contributed to discussion of findings towards the end of the study.

The PPIE members were reimbursed for their time (£12 per hour, paid in vouchers), with an average meeting length of 2–3 hours plus preparation time, and travel expenses and had refreshments provided. Two members of the PPIE group were also members of the SSC (see Table 10).

Summary

This section has outlined the methods for the NOTEPAD feasibility study. The results are presented in Chapter 5.

Quantitative results

Patient recruitment

The searches of practice records identified 3822 people aged ≥ 65 years. Of these, 60 met the study exclusion criteria so were excluded by GPs.

Information packs and screening questionnaires were mailed to 3762 people. The flow of participants in the feasibility study is shown as a Consolidated Standards of Reporting Trials (CONSORT) flow diagram in Figure 7.

FIGURE 7.

The CONSORT recruitment flow diagram for NOTEPAD phase 3.

Notably, out of 113 potentially eligible people identified, 38 were randomised. Ten people were not contactable by the RN and 54 declined to participate in the study. The RN documented reasons for declining and these included ‘not wanting to take part’ (19 people). One person directly said that anxiety or depression was not a problem, and five people described having mood problems but felt that they were sufficiently supported by family, friends or their GP.

As outlined in Chapter 4, an ethics amendment was obtained to enable the research team to contact people declining to participate at this stage, to explore reasons for declining. Analysis of data generated by these telephone calls is given in Process evaluation results, Analysis of qualitiative data, Findings, and Decliners.

Process evaluation results

This section outlines the findings of the process evaluation. We begin with feedback from study participants on the burden of completing the questionnaires; comments from RNs on completion of assessment are also included.

Contact times between SWs and study participants are tabulated in this section; details of supervision times and a description of topics covered in supervision are provided.

The bulk of this section focuses on the analysis of the qualitative interviews, conducted with study participants, SWs and GPs.

Analysis of qualitative data

Analysis of the data was conducted both independently and subsequently collectively by three members of the qualitative research team (HB, BB and CCG). Transcripts were read and re-read, themes arising during analysis and data collection were discussed within the team and the topic guides were modified as data collection and analysis progressed. The qualitative research team met regularly to discuss and agree coding, revisiting the data from each dataset in an iterative manner to verify coding and themes generated from these codes. This process was repeated until it was agreed that each dataset had reached saturation. Analysis was initially conducted within each data set, then comparison carried out across the data sets. NVivo 10 was used to store and manage data and aid analysis.

Study participants

In this section, we outline the key findings from the interviews with patient participants. Of the 18 people who were allocated to the intervention group, two people did not complete the intervention. These are denoted as ‘dropouts’. We also interviewed SWs (n = 6) and GPs (n = 12). A total of 17 older people in the intervention arm were interviewed.

The mean duration of interviews was 23 minutes for patients (range 12–68 minutes), 37 minutes for SWs (range 30–51 minutes) and 23 minutes for the GPs (range 11–28 minutes).

Tables 28–30 provide details of the participants.

TABLE 28 - Baseline characteristics of the interview participants (n = 17)

Participant ID	Characteristic
	Age (years)	Sex	Ethnic group	Employment status	Marital status	Living situation	General health	Taking medication for low mood or stress	Long-standing illness/disability	Completer/dropout
P11	76	Male	White British	Retired	Married	Lives with more than one other person	Poor	No	Yes	Completer
P145	67	Male	White British	Retired	Divorced or separated	Lives with another person	Poor	Yes	Yes	Completer
P441	84	Male	White British	Carer	Married	Lives with another person	Fair	No	Yes	Completer
P467	80	Male	White British	Missing	Married	Lives with another person	Fair	No	Yes	Completer
P589	67	Female	White British	Retired	Divorced or separated	Lives alone	Poor	No	Yes	Completer
P1061	76	Female	White British	Retired	Widowed	Lives alone	Poor	No	Yes	Dropout
P1093	74	Female	White British	Retired	Married	Lives with more than one other person	Poor	Yes	Yes	Completer
P2427	79	Female	White British	Retired	Widowed	Lives alone	Very good	Yes	Yes	Completer
P2589	73	Female	White British	Retired	Widowed	Lives alone	Fair	No	Yes	Completer
P2662	85	Female	White British	Missing	Widowed	Lives with another person	Poor	No	Yes	Completer
P2777	78	Male	White British	Retired	Married	Lives with another person	Poor	Yes	Yes	Completer
P2945	72	Female	White British	Retired	Married	Lives with another person	Excellent	Yes	No	Completer
P2977	66	Male	White British	Retired	Married	Lives with another person	Good	Yes	Yes	Completer
P3009	73	Female	White British	Retired	Co-habiting (living as married)	Lives with another person	Poor	Yes	Yes	Completer
P3060	71	Male	White British	Missing	Married	Lives with another person	Very good	No	Yes	Dropout
P3512	70	Male	White British	Retired	Married	Lives with more than one other person	Very good	No	No	Completer
P3560	69	Female	White British	Retired	Widowed	Lives alone	Good	Yes	Yes	Completer

TABLE 29 - General practitioner interviewees

F, female; M, male.

General practice	List size	Number of interviewees	Sex
Practice 1	4648	2	2M
Practice 2	7028	3	2M, 1F
Practice 3	7255	1	M
Practice 4	10,978	4	2M, 2F
Practice 5	5545	2	2M

TABLE 30 - Support worker interviewees (n = 6)

Characteristic	n
Female	5
Male	1
Age (years)
45–50	2
55–60	2
60–65	1
65–70	1

General practitioners at practice 4 had agreed to participate in the study, recruiting older people, but, owing to lack of capacity in CTU and CRN, the final two practices identified were not used for recruitment. Four GPs did agree to be interviewed at the end of a practice meeting to discuss the management of depression in older people and their reasons for agreeing to participate in the NOTEPAD study.

Limited data are given about the SWs to ensure anonymity is preserved.

Findings

Perspectives of patient participants

A number of key, interlinked themes emerged from the patient interview data: recognising depression and the long-standing nature of mental health problems, comorbid physical and mental health problems, loneliness, support received and views and reflections on the NOTEPAD intervention. Data will be provided to support each of the themes presented, with participant IDs (which include ‘dropout’ for the two participants who did not complete the intervention but agreed to be interviewed).

Recognising depression and the long-standing nature of mental health problems

Participants recognised that they were suffering from depression, and that it was currently, and had previously, caused difficulties in their lives:

I’ve been up and down, I mean I’ve had it 50 years to tell you the truth so I had it in my 20s yeah. . . . the first time I was depressed in [my] early 20s.

P3512

I’ve had this depression and anxiety for about 7 years now, but my last 4 years has been horrendous.

P145

Linked to the long-standing nature of their problems, people reported diverse experiences of treatments ranging from interventions by GPs and counselling services to psychologists and psychiatrists. These included both psychological and pharmaceutical approaches:

I’ve been treated for depression since – when was it – 1998. I’m still on tablets now for depression. I’ve been to see, talk to somebody, like a psychiatrist . . . It weren’t a psychiatrist, it was . . . [trails off].

A psychologist?

Something like that.

Multiple and complex problems

Reflecting on answering the postal questionnaires and completing the questionnaires with the RNs, the older people interviewed reported multiple illnesses:

Yes, yes, I’ve got it all. You name it, if it’s free I have it. Now I’ve got, what is it? Cholesterol, COPD, diabetes two, blood pressure. I’ve just been up and had blood taken this morning. Mmm, I’ve got ‘em all.

P11

So, as well as the cancer, you mentioned you’ve got arthritis as well?

Yeah . . . you know, I can’t run, I can’t kneel, I can’t stoop, I have to do anything like tying shoelaces I have to sit on the floor, things like that . . . well, it affects everything in every way.

Right OK, and do you – does it affect your sleep?

Yes.

And do you have a lot of pain with it?

Oh yes, yeah . . . I’m on morphine patches at the moment. I’ve got a heart condition as well.

In addition to physical health problems, some participants’ experiences were compounded by difficulties with their families:

I’ve had depression in the past, severe depression and there’s a family history of depression and I’ve had episodes of depression. So the depression comes and goes a bit. You know, there some times when I’m feeling really low, and other times when I’m not too bad mood-wise . . . but it’s all what’s happening within the family and what’s happening within my physical health is all, is all sort of jumbled up together. So if I’m having a good day one day, there’s quite a few things that can make it not so good the next day.

P589

There are currently, and there has been for about 18 years, quite severe family problems and they’re getting worse as well with certain, certain parts of the family. And that’s causing a lot of stress and distress.

P589

Other participants were busy with caring responsibilities:

I was at a stage where I was running backwards and forwards to my mother and then when my mother died I suppose it made it easier because then it was only my husband but I mean he got, I had to take him [to] the toilet, in other words it was full on. I had to wash him, dress him, everything.

P3650

Some participants reported financial difficulties thay they felt affected their health:

The disability living allowance, it’s, it’s gone to PIP [Personal Independence Payment] now and I had my assessment . . . but I’m just waiting to hear from that now, to, you know, know whether I’m going to keep me car and that. It’s just – because I’d be lost without the car because . . . I can’t walk and get buses now, I can’t even sit on a bus, so I’m worried sick about that because I don’t know what I’d do if I – do you know what I mean?

P145

Loneliness

Some study participants expressed feelings of loneliness and isolation, acknowledging that loneliness exacerbated their feelings of anxiety and depression:

I do suffer from anxiety and depression and I worry a lot. I worry tremendously. I never used to worry this much but I do now and I think it’s because . . . I think it’s because I’m on my own . . . every little thing . . . and when I draw the curtains at night I’m thinking, ‘oh gosh what’s that’ and it’s probably absolutely nothing. Just a car passing.

P2427

Respondents who were lonely described their families as living far away or busy with work or their own family commitments:

I’ve got two sons who try very hard to be supportive but are quite some distance away, work 7 days a week, have family of their own, so are not as available.

P589

Other respondents reported that they were not lonely or isolated, but despite this, still suffered from depression:

You know people with [. . .] anxiety and depression and, that’s one thing I’ve suffered for a lot of, great many years, off and on like . . . I mean I’m not lonely because I’m very busy, I’ve got three daughters so I’m not lonely.

P3512

Support received

The GPs were seen as an important source of support for the variety and complexity of described problems, particularly physical. However, a number of patients reported that the treatment offered by their GP for low mood had been ineffective in the past, particularly where a pharmaceutical approach was taken, as P1093 describes:

OK, have you spoken to your GP about it or . . . ?

I have done, yeah, but they just give you tablets.

Right, so have you taken tablets?

Yeah, I do, yeah.

You do? For your mood?

Yeah, yeah.

Yeah, and do you find that helps or not?

Not really, no.

Moreover, patients had little expectation that their GP could offer any alternative owing to time constraints on the length of consultations:

I know, having worked with GPs, you know, their time is so short it’s very difficult to deal with any problems but particularly mood and depression. It’s very hard for them to deal in the surgery with how people are feeling because, you know, it’s not a 5- or 10-minute thing, is it?

P2977

Experiencing the NOTEPAD intervention

All of the patients who completed the intervention suggested that it was acceptable, even though some were initially uncertain about what it might involve:

At first I wasn’t quite sure what it was about, I couldn’t quite grasp what it was about . . . and then as time went on a bit I started to realise you were really trying to find out what elderly people want and what their needs are really. And then it sort of got a bit more interesting to me and I thought, ‘oh, somebody actually asking me [what you want]’ . . . I just felt that my answers mattered because I feel as if I’m just one in millions as just feel the same.

P2427

The patients reported that the empathic approach of the SWs and the time available to be listened to by the SWs were valuable experiences, regardless of whether or not they considered themselves lonely. The personal qualities of the SWs were particularly commented upon:

She actually listened, which a lot of people don’t do . . . she very quickly seemed to grasp the struggle I was having.

P2589

I thought she was quite professional; she was empathetic and I felt she was listening to me.

P3009

Patients also reported that the practical support offered by the SWs was helpful and reported receiving help with claiming benefits and filling in forms, in addition to signposting to local groups and activities:

She gave me a lot of contact information about organisations that could help with bereavement, for instance, and benefits, finance things, and she also found me a support group called [name of local group].

P589

And he found out other interests or other things I could do in [the] area . . . he found indoor bowling as well, down the leisure centre. Then I go swimming occasionally as well. It’s different groups I didn’t know about in [the area], community groups where you can go. Just like to play dominoes or a book club or things like that.

P2977

In helping older people identify their goals, respondents suggested that the SWs also went beyond simply mentioning possible activities:

And she said, ‘Do you want me to come with you?’ And I said, ‘Yes, that would be nice’. So she came with me the first time. She didn’t stay for the whole session but she said, before we went in, she said, ‘Let me know if you feel at any time that you’re OK and that you don’t need me there,’ sort of thing. And so she went halfway through. She went by our agreement.

P589

Some patients reported attending groups to be helpful:

It’s quite a positive thing. Everybody sits around and talks about what sort of day or week they’ve had and things come out, you know? Like I was struggling about my dad, and about some other family issues, and the rest of the group all sort of say, you know, they sort of give you encouragement. Like saying, you know, ‘Well, you’ve done really well to do this and do that’. So it was good and I think I will go again.

P3009

Other people reported that they did not want to attend social or activity groups, even when they acknowledged that the SWs seemed to have tried hard to find a group to match their interests and help to overcome psychological and/or practical barriers to attending. Those people who did not find attending social or activity groups appealing did not feel themselves to be lonely or in need of company or activity. They lived with spouses or other family members or were busy with caring responsibilities:

She [the SW] desperately wanted me to go to, erm, places that I haven’t been to before like there’s a leisure place in [local town] where they do various clubs. I didn’t want to go. I really didn’t want to meet people I didn’t know.

P1061 [dropout]

But the more I thought of it, I didn’t really want that ‘cause I aren’t on me own, I’ve got me family and me wife here. I thought it was more for people on their own sort of thing, you know, no company or anything like that. So I was quite happy myself.

P3060 [dropout]

Participants reported that they valued activity that they felt to be personally meaningful and were not interested in groups that did not contribute in that way:

Yes, well, it didn’t help but he [the SW] was helpful. Helpful in the list of things. He did try to get me to go to Men in Sheds and all that. I just didn’t fancy driving all that way to sit and drink tea. But I don’t drink tea and so I just couldn’t see a future for me there of any kind.

P11

However, those who engaged with the intervention but did not want to attend groups still reported that the time spent with the SW, being listened to, was beneficial to them:

You see, I don’t want to go out to these groups as I’ve explained cos I can’t . . . but having somebody coming to talk to you relaxes you and all that, it’s great.

P1093

Most participants reported that they felt better having met with the SW, such as P441, who was the main carer for his wife and attributed this change to the SW visiting:

We’re working better now than it has done in the past. She [the SW] has done wonders. I’ve got [my wife] used to the routine and I’m on a routine which we can cope with, I can cope with well. And I think if anything [my wife’s] better than she has been, she’s yeah, she is, she’s better.

P441

The SW intervention prompted P3009 to visit their GP for a change in medication:

I mean, one thing because of talking to [name of SW] is I finally did go to the GP and I’m on a different antidepressant.

P3009

The following model (Figure 8) illustrates how the distinction between loneliness and depression is an important one. Those who were lonely needed supportive listening as well as help to access meaningful group activity. The group who would characterise themselves as ‘not lonely’ because they have supportive family nearby did not want to attend groups but still wanted and valued being listened to. This model was checked out with the study PPIE group. We debated the idea that the ‘GP is not helpful’, and considered alternative ways of expressing this, but the group felt that this phrase represented the data from both study participant and GP data sets.

FIGURE 8.

Conceptual model.

Decliners

Potential participants who were eligible to participate in the NOTEPAD study but had declined to take part at the point of the RN telephone call without making an appointment for a visit by the RN were considered to be ‘decliners’. Thirty-seven people were telephoned by Heather Burroughs or Bernadette Bartlam to attempt to explore their reasons in more detail. These telephone calls were very brief, with older people apparently not wishing to discuss this, or justify their decision, further. Where people did give a reason for declining to participate, this was noted and Table 31 lists the reasons given for declining to take part (some people gave more than one reason).

TABLE 31 - Reasons for declining to participate

Reason for declining	n
Could not be contacted	5
Declined to discuss	4
Ill health	8
Carer	5
Too busy	7
Does not do surveys	5
Does not want anyone to visit	4
Does not want to take part/study is not for me	7
Does not feel depressed	6

Perspectives of support workers

The interviews with the SWs focused on the training, supervision, delivery of the intervention, and suggestions for refining the intervention. Data will be provided, with participant IDs, to support each of the themes presented.

Recruitment to the study

The SWs all reported that they found the idea of the study novel and interesting:

I was looking for, you know, a bit of a new challenge really. Because my son’s gone off to university and, and I just thought, ‘Oh, do something a bit different’, that I’m interested in, you know? Because I’m quite interested in helping people, really. I’ve always been in the caring profession really, so. It just sounded interesting, really.

SW1

I mean, overall, I think it was – it’s been really good to be involved. I thought kind of the initial information we got about what and why, you know, I thought was really well sort of researched and it seemed like it was a really good idea.

SW3

The above data reflect the detailed information given about the study by Peter Bullock and the research team during the recruitment process.

Prior experience

The SWs described a wealth of prior professional experience and some had done courses in counselling:

I’d been a teacher in a former life and then became a trainer in the voluntary sector . . . I did some study, it was just a year’s psychology for everyday life and I’d done psychology for my degree years ago anyway.

SW 6

My first degree is sociology so my interest is across the board . . . I’ve managed community centres . . . I’ve also managed a drugs and alcohol rehab and I’ve written alcohol counselling training nationally . . . I’ve lectured in universities and college.

SW2

I did counselling courses when I was young, maybe about 10 years ago now, so I have a bit of a basic foundation of one-to-one interaction with people.

SW4

Thus, the SWs recruited from Age UK had broad knowledge and skills on which the NOTEPAD training could build on.

Experiences of training

The SWs all spoke of experiencing anxiety prior to and during the training:

We were all scared, we were all really scared. I mean, we were very well supported on the training and, to be kind of, doing the skills practice and have people sitting there observing, was initially very scary.

SW6

I mean overall, I think it was – it’s been really good to be involved. I thought kind of the initial information we got about what and why, you know, I thought was really well sort of researched and it seemed like it was a really good idea right. I think – yeah, the training was really good.

SW3

One SW, however, suggested that the theory included in the training was excessive:

[It needed to be] more experiential, more practical . . . That’s a big block to learning, that there’s too much here, once one of them [the SWs] said, ‘if I’d have known it was going to be like this’ . . . I just thought I was going to visit people and find out what they wanted to do . . . and I’m just wondering if you needed all that other stuff. You didn’t need a lecture in psychiatry.

SW1

All of the SWs reported that the training manual was essential:

In terms of the training manual, how useful did you find that?

Oh, very, very good actually, very good. Because it’s something to keep going back to if you’re not sure of things . . . Everything is in there that we could possibly need, you know. And I just sort of had started to sort of do a little check list for myself, you know, when I went out. Just a little card, just to remind me of, so I didn’t sort of forget anything.

SW1

It, it was very helpful. You know, it rejogs your memory, builds on the foundations that you had in, yeah. It refreshes you, and I found that I was reading, the session one, every time I was going into the person, and reading session two every time I was going in to see them, see them the second time and the third time and the familiarising myself with the mood thermometers, and explaining that to them.

SW4

Some of the SWs described how they had made their own summaries of the key messages in the manual, which were vital in the first couple of encounters, but eventually needed them less as they became more confident working with their clients:

I made my own prompt sheet because you feel a bit, like everything’s entering your head at once sort of thing. So, it was just sort of all the things. That was one of the most difficult things. There were all sorts of aspects that you had to include but, one of the tricky things was, how do I order this? Should I say, should I broach that part before that? Do I make the list before we go into this part? So, the prompt sheet was really useful for that.

SW5

As the SWs became more experienced, the manual was used less:

I did read, more or less read through that each time, you know, well I wouldn’t say before every contact, because the further I went on with contact and settled into it and could actually see, you know, see BA in practice and how actually, you were able to engage with somebody and it did, it did make sense, that gave me a bit more confidence and I felt I was internalising it, I wasn’t so focused on, oh you know, I’ve got all these things written down, how am I going to remember it all, because it was, it was making sense.

SW6

Delivering the intervention

Most of the SWs reported experiencing anxiety following the training and prior to visiting their first client and carrying out the intervention:

I felt completely overwhelmed by what I was hearing, I think it was far, far more [complex] than I had ever anticipated . . . because I was so nervous, throughout the first 10 minutes, my heart, you know, I could feel my heart was going like this, I could barely speak, because I was stuttering and I thought for goodnees sake, get a grip, get a grip of yourself . . . I felt this pressure . . . I felt quite a responsibility that, you know, we’d had this time invested, this knowledge given to us and I didn’t want to let anybody down.

SW6

The SWs reported that there were particular areas that they initially found difficult, such as doing the risk assessment, but which they became more confident in as they saw more clients:

I think you said it was the first client that you saw who had attempted suicide previously. More generally in terms of assessing risk, how comfortable or not where you in doing that?

I’m a lot more comfortable now after seeing six people than when I started. It’s just a shame he was the very first one, you see? It was like [a] baptism of fire really. But I managed to, broach the subject with everybody, and I was getting a lot better at it . . . So, yeah, I’m much more comfortable than I was at the start. But I found the training very useful.

SW5

Utilising existing knowledge

Because they were already employed by Age UK and were running activity groups, SWs felt they had a comprehensive knowledge about benefits and resources, services and support groups available in the local area:

Obviously I know about the Age UK and benefit type things and I use the internet a lot to find social groups and things that were available. And perhaps my local knowledge, because a lot of the, clients I got, because I think they were from [health centre], the last group. Because I run my befriending scheme in [town] I knew what was available there so that was useful.

SW5

Recruiting SWs with this local knowledge was key.

Dealing with complexity

The SWs found dealing with the complex needs of some clients challenging and requiring careful thought beyond simply delivering an intervention:

I’m thinking, ‘how am I going to help this man, how am I going to help him?’ But if I’d said, ‘oh well, you know, why don’t you ring [a group]’, that would have been completely inappropriate . . . And just thinking, you know, what, how, you know? I can’t wave a magic wand and make this go away, but it wasn’t about that, and then, you know, you come away and you make your notes and you reflect.

SW6

The SWs sometimes found that organised groups, of which they had prior knowledge, may not be appropriate for their clients, and finding alternatives required careful investigation, with often a number of suggestions offered to clients:

I’d kind of gently kept coming back to these groups and I thought, ‘Maybe this isn’t kind of what they want’. So I asked them, ‘Well,’ you know, ‘kind of what, what – where do you go? What, what do you do? What, what do you like doing?’ And they said, ‘Going to garden centres. He loves B&Q [B&Q plc, Eastleigh, UK]. Doing things around the house’. And I said, ‘Right, OK. It doesn’t have to be a bladder cancer support group,’ you know. ‘If, if that’s what you would like to go to,’ you know, ‘what about planning it?’

SW3

Achieving success

Reflecting on the challenges in working with clients with complex needs, SWs reported a sense of satisfaction when goals were achieved:

She did [go to the group], she did! Oh, it was, I kind of ran round the office going, ‘yes, yes’. It was great. I was just in the office with my colleague who runs these groups, and my colleague took a phone call and then my colleague said to me the lady’s name and she said, ‘well, she’s just phoned up to enquire about the computer groups and she’s going to come along on Thursday’. So that was thrilling. That was really, really thrilling.

SW6

We discussed different types of respite and after a while, he, this is another visit, he told me that he had decided that he and his wife were going to go together and have respite in this lovely residential facility. He said ‘it’s so posh’, and he told me all about it. It was marvellous [to hear] and they were booking in for 2 weeks and very, very excited about it. And they’d never done that before, so I’m hoping that just by, you know, prompting him to think about his own needs and maybe, you know, were there things they could do together that would give him respite? So that was a good thing.

SW6

The SWs also reported that they thought some clients had carried on attending groups after they had ended contact, which they felt indicated that they had made an impact:

I went up there and physically supported them by standing next to them, and I also passed on the information on paper, and as far as I know they went on and carried it forward themselves.

SW4

Sometimes improvements were reported by SWs to be more subtle, reflecting patients’ accounts of the importance of feeling heard:

You know, I was just going along and sitting down and saying, ‘tell me, tell me, you know, I’ve got time and I want to listen and you can be as honest with me as you want, just tell me because I care about what you’re going to say’. And I think that is such a simple thing, but it is absolutely key, because just the fact that somebody would want to do that and be genuinely interested, even if you can’t help them resolve it or maybe only a bit, because with that participant we did make some progress.

SW4

The SWs suggested that one of the main factors contributing to helping clients was the time they invested in people:

I think a lot of what was positive about this was, I think, the person visiting, just keeps showing that person that they are important and you do care about them and I think that was quite a motivating factor.

SW3

Reflecting on supervision

The SWs reported that the one-to-one supervision offered was helpful in dealing with their anxieties, particularly after the first visit to the first client:

The first supervision that I did on the phone was very, reassuring . . . just to, just to know that there was somebody else there who I could offload to myself, and that was welcomed.

SW4

[Supervision was] quite good really. They were all over the phone. I did think, I don’t know whether it was, we were supposed to some have supervision meetings. I initially thought that it would be a supervision session [right] somewhere. I didn’t think it would just be on the phone. But it was ok, you know, it was fine. But because I didn’t have any really major problems, it was just really talking about each case so, that was very useful I think.

SW5

Face-to-face meetings were held between the SWs and Carolyn A Chew-Graham and Heather Burroughs, but these were seen by the SWs more as group support meetings than as formal ‘supervision’ sessions.

What could be done differently?

Some SWs felt that the intervention could be improved by building in a follow-up session with clients a few months after the six sessions:

Hopefully that there would be an opportunity to engage over a longer time. I think also, some kind of follow-up could be built in, say at possibly a 3-month or 6-month point, perhaps a year or something like that.

SW6

Other SWs felt that the limited time of the intervention helped to motivate patients to make the most of the sessions:

More than one person said to me, ‘well, I’ve only got you for a short time, so I better make good use of you’, sort of thing, so, it spurred them in a way, really, they’re all, oh, I’ve only got like four or five sessions, or six sessions so, if I’m going to do something, I’ve got to do it now type of thing, without making them feel rushed in anyway, but, it took, sometimes took a few weeks to get to that stage but, no, I thought it was really good.

SW5

Thus, SWs recognised that people in the study had complex problems, and to meet this challenge required the support of their peers on the study, colleagues at Age UK and the opportunity to discuss at supervision. The knowledge and expertise that the SWs already had through previous training, and concurrent experience working with Age UK, were perceived as vital in suggesting local groups to study participants, being able to contact the group leaders and feeling comfortable accompanying people to groups.

Perspectives of general practitioners

Recruiting GPs to participate in interviews was challenging. GPs seemed reluctant to spare the time to be interviewed and those who were spoken to commented that they had not been affected by the NOTEPAD study. The researchers needed to be very flexible in organising interview times.

The interviews with GPs identified themes around working with patients with complex needs and GPs’ views on the study.

Older adults as a vulnerable group

GPs recognised that there is a group of older adults who may be depressed, or lonely or socially isolated (GPs used these terms interchangeably), and who may benefit from simply having a conversation with someone:

We used to have a receptionist here who was very astute, who would say, ‘do you realise, if I had a kettle, teapot and a packet of biscuits, half these people coming in to see you wouldn’t need to come in and see you?’

GP practice 3

Initially, I think more face-to-face chat and probably seeing them every week and just giving them a bit of support and listening to them and acknowledging what’s happening.

GP practice1

They reported, however, that they were personally unable to provide time to listen owing to a lack of capacity within the practice and the constraints of time-limited consultations:

I think all she came to do was talk to me and that’s fine, and might have been fine in general practice 20 years ago, 25 years ago. It ain’t any more. It’s too task orientated, it’s too problem orientated and there’s too much pressure as the hospital dump more and more long-term conditions on us to look after. We’ve just not got that . . . We’ve not got that capacity, we’ve not got that sort of pastoral effect we used to have. We’ve just not got time.

GP practice 2

The GPs reported that they often had difficulty in making a diagnosis of mental health problems in this group of patients with already complex needs, with mental health not being a priorty for the GP or the older adult. GPs also identified differences between consultations with older adults and younger populations:

We don’t diagnose that well because they have other conditions, like dementia . . . so we tend to forget about and it’s not probably screened. And also they don’t ask for support as much as the younger people do, and because older people actually they say, ‘it’s just anxiety, I’ll get over it’. Whereas younger people, they work, and their work stress and everything, they want to take some time off or they want a sick note, that sort of thing.

GP practice 4

Lack of services

The GPs all reflected on the poor provision of services for older adults, who they felt would benefit from further input, whether this was a result of loneliness, being isolated or having a depressive illness. Even if services were reported to be available, GPs noted that patients could not access them in a timely manner:

There’s huge delays for older people. It has improved a lot but it’s still not great.

GP practice 2

Some GPs reported knowledge of accessible and acceptable NHS-commissioned well-being services, and mentioned an awareness of third-sector organisations, such as Age UK, providing support. However, GPs were reluctant make a diagnosis of anxiety or depression without being certain that there were services available to support older adults:

I think the other thing we must consider is to find underlying depression and anxiety in elderly patients without making sure we’ve got adequate resources to cope with this. It will be a shame to diagnose depression in an elderly patient and then it would be a further shame that then there’s nothing to help them and possibly that will make them worse really.

GP practice 5

Thus, although GPs recognised that older people were a vulnerable group, they suggested that they had little time to personally offer pastoral support to older people, and that there were limited resources to which to refer people to.

Engagement with the NOTEPAD study

Some GPs had difficulty recalling that their practice was taking part in the study:

I wasn’t aware about it [the NOTEPAD study] but I may have been told but I didn’t know about it.

GP practice 2

Some GPs were generally supportive of the concept behind the NOTEPAD study, recognising a need for such an intervention for older people, and recognising that primary care could not fulfil this role. Other GPs were vocal in their criticism of recent cuts in mental health services and suggested that using non-medical personnel to work patients with mental health problems was not appropriate, especially when the responsibility to assess suicide risk remained with the GP. This was felt particularly strongly in the context of cuts to secondary care psychiatric services in the local area (this was documented in field notes, summarising conversations recorded prior to an interview and a focus group).

Some GPs reported feeling annoyed by the NOTEPAD risk protocol, which required a member of the research team to notify them if one of their patients expressed suicidal ideation. Some GPs felt that risk was being raised unnecessarily, generating additional work:

I had contact with the [researcher] who was worried that the patient had suicidal thoughts. I think I’ve had two or three of those and the patient had to speak to me but that was just depressing thoughts they were having. The [researcher] was very worried but the patient wasn’t.

Did that annoy you at all?

Yeah, a bit . . . a lot, actually.

GP practice 2

Other than being contacted by researchers as part of the risk protocol, GPs did not feel that participating in the NOTEPAD study had affected their routine practice. They could not recall any contact with the SWs, and did not recollect any patients discussing participation in the NOTEPAD study with them in consultations. GPs were not able to suggest if or how the NOTEPAD intervention might be implemented in practice.

Introduction

The NOTEPAD study is the first study, to our knowledge, that attempted to train SWs from the third sector to deliver a psychosocial intervention to older people with anxiety and/or depression recruited from primary care. The study was conducted in collaboration with Age UK North Staffordshire.

As outlined in Chapter 1, the research aims and objectives of the NOTEPAD study were as follows.

Summary of main findings

In this study, we developed and evaluated a psychosocial intervention for delivery by Age UK SWs to older people with anxiety and/or depression recruited from primary care.

Comparison with previous studies

Pettit et al. 21 report that older adults are still under-represented in IAPT services, and the NICE guidelines on common mental disorders25 suggests the need to modify interventions to improve access. It is important to establish whether or not changes to service configuration, treatment options, and GP behaviour can increase referrals for middle-aged and older adults. In response to the knowledge that older people are one of the vulnerable groups for whom access to mental health services needs to improve, the AMP research programme50 developed a model to improve access and develop acceptable interventions. In the AMP study,94 one of the vulnerable groups in which a new model of care was evaluated was older people with depression, but the intervention was delivered by IAPT practitioners who worked closely with local groups offered by Age Concern (the group in Manchester preferred to be known as ‘Age Concern’ rather than ‘Age UK’). The NOTEPAD study was an attempt to increase access to care for people with anxiety and depression by developing and testing the acceptability of a less stigmatising intervention delivered by SWs from the third sector.

In the CASPER plus trial,43 older people reported the value of receiving the screening questionnaires and being invited to participate in a trial about depression. The study team suggested that this might facilitate an older person to disclose their feelings, name the problem and seek help. The NOTEPAD process evaluation suggests that some, although not all, older people found the screening questionnaires disconcerting and uncomfortable. The study participants in the CASPER plus trial43 were thought to be from areas of higher socioeconomic status, in contrast to the participants in the NOTEPAD study, who were recruited from deprived areas in Stoke-on-Trent.

In the CASPER plus trial,43 it was reported that offering older people an opportunity to talk outside the primary care consultation was valued by patients and GPs and that psychosocial intervention in the primary care setting may fill the gap in the care of older people with depression. Our findings confirm this.

In a service development evaluation in which practice nurses (PNs) delivered a psychosocial intervention to patients with long-term conditions,95 the patients valued the availability of PNs to listen to their concerns.

In the process evaluation in the COINCIDE trial (a trial of a psychological intervention for the management of depression in adults with diabetes and/or heart disease),37 it was reported that patients with long-term conditions and comorbid depression preferred a protected space to discuss mental health issues, and study participants in the NOTEPAD study alluded to their beliefs that they did not feel it was appropriate to discuss low mood or stress and distress with their GPs. The PNs and IAPT practitioners in the COINCIDE trial expressed a wish to maintain barriers around physical and mental health expertise. In our study, GPs suggested that they could not offer support to older people with anxiety and depression and lacked services to refer them to. The SW role might meet this need.

The GPs interviewed as part of the process evaluation suggested that the NOTEPAD study had only affected the practice when a call was received in relation to the risk protocol. The SWs had no contact with the practices from which study participants were recruited. Although a safe space perceived to be outside the primary care consultation was valued, it might have been better if we had achieved closer liaison between the SWs and practices, perhaps linking one SW with one practice. This was achieved in the DeepEnd initiative in Glasgow,96 where ‘community links practitioners’ (CLPs) were embedded in practices in Glasgow; these CLPs carried out one-to-one working with patients to support patients’ use of community services.

This study has improved our understanding of the link between depression and loneliness48 (see Chapter 2), people’s response to it and the potential role of the third sector in delivering a one-to-one intervention and signposting group activities. The qualitative study by Kharicha et al. 33 suggested that older people with characteristics of loneliness generally know about local resources but may not consider services that they perceive as being for ‘lonely older people’ as desirable, helpful or relevant to them. Our study suggests that groups can be acceptable to some people who perceive themselves to be lonely; group-based activities with a shared interest are preferred to social groups. Our study resonates with Kharicha’s findings that older people experiencing loneliness may not consider that primary care has a role in alleviating this.

Patient and public involvement and engagement

This study’s design and processes were informed by PPIE in accordance with INVOLVE’s recommendations [URL: www.invo.org.uk/resource-centre/resource-for-researchers/ (accessed on 10 October 2018)]. Participants at the meetings prior to submission of the funding application endorsed the concept of a ‘non-medicalised’ approach to the management of depression and anxiety in older people, and welcomed partnering with third-sector groups such as Age UK. PPIE members also supported the idea of a one-to-one intervention delivered by a worker from Age UK. Members of the group felt that most older people would be happy to talk to the SW and strongly supported the idea of tailoring activities to the older person’s interests. Many felt that older people might need some encouragement and reassurance to take part. They also felt strongly that barriers to participation, such as transport and lack of confidence, would need to be addressed. These factors were at the heart of the intervention.

In subsequent meetings, the PPIE group provided input on the patient information sheets, letters and participant resources for phases 1 and 3. The group contributed to the NOTEPAD logo and suggested the strapline ‘Supporting Mental Strength’, which was adopted by the research team.

The group met during the feasibility study and reflected on the slow recruitment. In particular, group members commented on the formality of the language used in public-facing documents (which had been modified with the group’s input) and how the stringent requirements of the regulatory procedures might negatively affect recruitment.

The group reflected on the results of the process evaluation, supporting the development of the model (see Figure 8).

Strengths and limitations of the methods

Conclusions

Although recruitment was lower than anticipated, it was feasible to recruit and randomise patients, to test procedures and to conduct a process evaluation to provide essential information and data to inform a future randomised trial. Workers in third-sector services have the potential to deliver non-stigmatising interventions to support and manage older people with anxiety and depression, which is potentially useful within a resource-poor NHS.

Implications for health and social care

We have demonstrated that SWs, recruited from staff employed by Age UK North Staffordshire, were capable of working with older adults with anxiety and depression and delivering the psychosocial intervention as intended. The NOTEPAD intervention was acceptable to older adults, the personal qualities of the SWs were valued and the intervention was perceived to be less stigmatising than statutory services. Signposting to group activities was not acceptable to all older adults; older males, particularly, did not want to be passive recipients of services and suggested a preference for more reciprocal relationships in any new activities they embarked on. This emphasises the need to be person-centred, assessing the likelihood of a patient accepting this approach prior to a referral for such an intervention.

The SWs recruited for the study reported broad experience and expertise of working with older adults. This expertise is currently under-recognised and underutilised and is a source of expertise that could be of benefit to primary care, particularly given that our qualitative study suggests that GPs have little time for, and do not prioritise, supporting older adults.

Supervision was perceived by the SWs to be necessary, with supervision duration varying between the four SWs in the study. If this intervention was commissioned as a service, supervision costed in would be limited, which may reduce the confidence of SWs from the third sector to deliver the intervention.

Depression in older adults is a common condition, with a prevalence of depressive symptoms of up to 20%. 2,3 At policy level, there is a need to increase access to psychological services98 for older adults with anxiety and depression to reduce disease burden and costs for the individual and the NHS. There is evidence that older people still do not access IAPT services. 21 An intervention, such as the NOTEPAD intervention, delivered by SWs from the third sector, might be less stigmatising and more acceptable to older adults. Assessment of cost-effectiveness of commissioning third-sector services, rather than facilitating recruitment of older people to existing IAPT services, is necessary.

We demonstrated a lack of engagement by GPs participating in the NOTEPAD study. GPs disclosed that they have little time to support vulnerable older adults. One option would be to locate the SWs in the practice, which would support liaison between the SW and the GP.

Research recommendations

1. Before a fully powered RCT to evaluate the clinical effectiveness and cost-effectiveness of a psychosocial intervention delivered by third-sector workers can be considered, further work is needed to refine procedures and intervention, focusing on older adults with physical long-term conditions already on antidepressants and people living alone. Assessment of cost-effectiveness would be required in a RCT.

2. The intervention might be improved by the inclusion of a structured liaison with primary care/co-location of SWs within practices.

3. Future work should explore partnership with a range of third-sector providers, across more geographical sites, to see if the SW intervention can be delivered at scale.

4. Future research using other existing primary care professionals to deliver the intervention, for example health care assistants and PNs, would be useful to explore integration in routine primary care.

5. A longitudinal implementation study using ethnographic methods would be useful to assess the contribution and long-term sustainability of third-sector organisations in the management of older people with anxiety and depression.

Contributions of authors

Heather Burroughs (Research Fellow, Keele University) was principal investigator. She contributed to the grant application and the training of SWs and was trial manager of the feasibility study. She made a major contribution to the final report.

Bernadette Bartlam (Senior Lecturer, Keele University) contributed to the grant application, qualitative work in phase 1 and the process evaluation in phase 3.

Peter Bullock (Chief Executive of Age UK North Staffordshire) contributed to the grant application and supported recruitment and retention of the SWs.

Karina Lovell (Professor of Mental Health, University of Manchester) contributed to the grant application and development of the intervention and training and delivered the training to the SWs.

Reuben Ogollah (Associate Professor of Medical Statistics, University of Nottingham) contributed to the grant application and developed the SAP.

Mo Ray (Professor of Health and Social Care Integration, University of Lincoln) contributed to the grant application and phase 1 of the study.

Peter Bower (Professor Health Sciences, University of Manchester) contributed to the grant application and development of the intervention and feasibility study.

Waquas Waheed (Professor of Primary Care Psychiatry, University of Manchester) contributed to the grant application and development of the intervention.

Simon Gilbody (Professor and Director of the Mental Health and Addictions Research Group, University of York) contributed to the grant application and development of the intervention and feasibility study.

Tom Kingstone (Research Associate, Mental Health, Keele University) contributed to the qualitative work in phase 1, the NOTEPAD protocol and the process evaluation papers.

Elaine Nicholls (Research Fellow, Biostatistics, Keele University) led the quantitative analysis in phase 3.

Carolyn A Chew-Graham (Professor of General Practice Research, Keele University) was chief investigator in this study, led the grant application, co-conceived and designed the study, led the research team, provided clinical input and was lead author on the following sections of the final report: Abstract, Plain English summary, Scientific summary, Chapter 1 and Chapters 3–6. She is the guarantor.

All authors contributed to the final report.

Publications

Kingstone T, Burroughs H, Bartlam B, Ray M, Proctor J, Shepherd T, et al. Developing a community-based psycho-social intervention with older people and third sector workers for anxiety and depression: a qualitative study. BMC Fam Pract 2017;18:77.

Burroughs H, Bartlam B, Ray M, Kingstone T, Shepherd T, Ogollah R, et al. The feasibility and acceptability of an intervention for older people with depression and anxiety delivered by third sector workers: the NOTEPAD feasibility study protocol. BMC Trials 2018;19:172.

Presentations

Bartlam B, Burroughs H, Kingstone T, Bullock P, Ray M, Chew-Graham CA. Lay Perspectives on Supporting Older People with Anxiety and Depression: A Qualitative Study to Develop a Community-Based Psychosocial Intervention Working with Non-Traditional Providers. Paper presented at the British Society of Gerontology, Stirling, July 2016.

Kingstone T, Bartlam B, Burroughs H, Bullock P, Ray M, Chew-Graham CA. Refining a Psychosocial Intervention for Older People with Anxiety and/or Depression to be Delivered by Third Sector Providers: a Qualitative Study. Paper presented at the Society for Academic Primary Care, Dublin, July 2016.

Burroughs H, Kingstone T, Bartlam B, Bullock P, Ray M, Chew-Graham CA. Development of a Psychosocial Intervention for Older People with Anxiety and Depression to be Delivered by Third Sector Practitioners: a Qualitative Study. Poster presented at the Royal College of General Practitioners’ annual conference, Glasgow, October 2016.

Burroughs H, Kingstone T, Bartlam B, Bullock P, Ray M, Chew-Graham CA. Refining a Community-Based Psychosocial Intervention, Delivered by Third Sector Practitioners, for Older People with Depression and Anxiety: Focus on Role of PPIE in Shaping a Feasibility Study. Poster presented at the Keele University ten-year anniversary PPIE event, Keele, Staffs, October 2016.

Kingstone T, Bartlam B, Burroughs H, Bullock P, Ray M, Chew-Graham CA. Exploring Views about Anxiety and Depression Among Older People in the Community in Order to Refine a Psychosocial Intervention Delivered by Third Sector Workers: A UK Qualitative Study. Paper presented at the North American Primary Care Research Group, Colorado Springs, CO, November 2016.

Burroughs H, Kingstone T, Bartlam B, Bullock P, Ray M, Chew-Graham CA. Developing a Community-Based Psychosocial Intervention for Anxiety and Depression: The Views of Older People and Third Sector Workers. Poster presented at the Health Service Research UK symposium, Nottingham, July 2017.

Burroughs H, Bartlam B, Kingstone T, Bullock P, Ray M, Lovell K, et al. The Acceptability of a Psychosocial Intervention Delivered by Age UK Support Workers to Older Adults with Anxiety and Depression: A Qualitative Analysis. Paper presented at Primary Care Mental Health Conference, Southampton, April 2018.

Chew-Graham CA, Kingstone T, Burroughs H, Bullock P, Gilbody S, Bower P, et al. Development and Evaluation of a Brief Psycho-Social Intervention for Delivery by Support Workers from Age UK North Staffordshire, to Support Older People with Anxiety and Depression: A Feasibility Study. Poster presented at the SAPC, London, July 2018.

Chew-Graham CA, Kingstone T, Burroughs H, Bullock P, Gilbody S, Bower P, et al. Development and Evaluation of a Psycho-Social Intervention for Delivery by Support Workers from Age UK North Staffordshire, to Support Older People with Anxiety and Depression: A Feasibility Study. Poster presented at Public Health England, Warwick, September 2018.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to available anonymised data may be granted following review.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Health and Social Care.

Keele University Research Project – AUNS Costings 2014 for 6 NTPs (Version 3)

NTP engagement with patients – agreed assumptions:

1. Patient group = 50

2. Each NTP – average caseload of 8.33 patients (= 6 NTPs)

3. Each patient will require ‘at least 4 contacts’ > ’5 to be budgeted’

4. NTP contact visit with a patient – each requires ‘3 hours’ including face-to-face visit, travel time, visit record keeping

—————————————————————————————————————————————

TRAVEL COSTS (paid at 45p/mile)

1. At an average of 8 miles/contact visit – 8.33 patients × 5 contact/visits × 8 miles each visit × 45p/mile = £150 per NTP

2. + £14.40 (i.e. 4 training/reflection days at 8 miles each day)

3. = £164.40 per NTP;

4. × 6 NTPs = £986.40

TIME/NTP (assuming 6 NTPs) – 155 hours per NTP

1. 8.33 patients × 5 contacts/patient × 3 hours/contact visit = 125 hours

2. + 28 hours training/reflection time (4 days × 7 hours)

3. + 2 hours Age UK 1 : 1 supervision (3 sessions during the project: 1 hour + 30 minutes + 30 minutes)

TOTAL COST of 6 NTPs

1. 930 hours in total

2. = £11,625 (@ £12.50/hour inclusive of management/supervision/organisational costs)

+ £250 – recruitment costs

+ £200 – DBS processing

Total: £13,061.40 for 6 NTPs (= £261/patient)

Safety reporting

This feasibility study did not involve any investigational medicinal products and was therefore a non-CTIMP (Clinical Trial of an Investigational Medicinal Product) trial. The following describes the safety reporting procedures for this study.

Insurance and indemnity

Keele University carries professional liability and medical malpractice insurance to indemnify it, subject to the terms and conditions of the policy, for its legal liability for claims or damages arising out of any bodily injury, mental injury, illness, disease or death of any participant caused by negligent act, error or omission committed by the university in the course of its business.

Age UK has full insurance cover for all those acting on their behalf (staff and volunteers) as well as public liability insurance to the value of £10M.

Feasibility study management

Management meetings and risk register

The NOTEPAD study team (chief investigator, principal investigator, study co-ordinator, statistician, administration lead, CRN research facilitator and co-investigators) held monthly meetings to discuss study progress. Identified risks were documented on the NOTEPAD ‘risk register’ and each item on the risk register was discussed in every study management meeting, relating to level of risk (low, medium or high) and the impact on the study (low, medium or high).

Monitoring and audit

The NOTEPAD study was monitored in line with the protocol and Keele CTU SOPs. The independent members of the SSC also monitored the progress of the study. Monitoring was also undertaken by the approving REC and HSDR in the format of progress reports.

Data preservation

All research staff involved in this study adhered to robust data security procedures and have explicit duties of confidentiality. All confidentiality arrangements adhered to relevant regulations and guidelines (Data Protection Act 1998,92 Caldicott, GMC, Medical Research Council, Research Governance Framework).

The transfer of audio files from the recording device to computer for transcription was carried out by the researcher conducting the interviews. Any transfer of personal information between the CRN staff/GP practice staff and the study team was via the NHSmail service (Accenture plc, Dublin, Ireland) and between NHSmail endpoints (from one NHS e-mail to another NHS e-mail address). The transfer of the CIS-R output file was carried out by the RN who used an encrypted USB drive to store the file on the CTU secure network.

The identification of, and invitation to, potentially eligible participants from general practice was supported by CRN staff. Patients’ identification details (e.g. names and addresses) were made available to the research team only once the patient had provided consent to take part in the study.

Specific consent was taken prior to the start of each qualitative interview to enable the research team to use anonymised direct quotes in future publications.

Anonymised paper copies of transcripts and questionnaires are stored in a locked filling cabinet at the Research Institute for Primary care and Health Sciences, Keele University. Consent forms are stored in a separate cabinet to the anonymised data.

All study and participant information is housed in the Keele CTU secure network, which is a secure virtual network, requiring two-factor authentication to access it. Roles and permissions are applied to users to restrict what data a user can access. The CTU secure network has been independently audited and achieved level one of the government-backed Cyber Essentials scheme.

The study data have been anonymised for analysis. All identifiable information was removed once the data collection was complete.

All research staff involved in this study work to robust data security procedures and have explicit duties of confidentiality, equivalent to the duty placed on NHS staff, written into their employment contracts. Access to patient identifiable data are highly restricted, using predefined roles and privileges, and views of the data are restricted so that authorised study team members see only the data that are required to carry out their role. Data access is fully auditable in this system.

Hardcopy data held by Keele CTU have been archived in the designated Keele CTU archive facility and site data and documents have been archived at the participating sites. Keele CTU will proceed to confidential destruction of the data 20 years after the grant expires. Electronic data from the study have had any identifiable information removed, and on this basis will be kept indefinitely, and may be used for future research (where the participant has given consent).

Dr Reuben Ogollah was the data custodian of the quantitative research data; this role has now been taken up by Dr Elaine Nicholls. Professor Carolyn A Chew-Graham is the data custodian of the process evaluation data.

Changes to study design

Amendments to the study design after the protocol were recorded and approved.

One important amendment was approved in May 2017, which we submitted for ethics approval on the advice of the SSC, following a meeting at which recruitment was discussed. It was noted that the conversion of ‘potentially eligible participants’ to people who agreed to be randomised was lower than expected (about 50%). Although the RNs had been asked to keep verbatim notes on reasons for people declining, the research team suggested it would be useful to try to interview people who declined to participate. The SSC supported this, so ethics approval was obtained to contact people who were were potentially eligible to participate in the NOTEPAD study but who had declined at the stage of the RN telephone call. Ethics approval was obtained for these people to be contacted by telephone and brief questions asked about reasons for declining.

First intervention

Second intervention