Improving mental health and reducing antipsychotic use in people with dementia in care homes: the WHELD research programme including two RCTs

Article history

The research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0608-10133. The contractual start date was in April 2010. The final report began editorial review in September 2018 and was accepted for publication in January 2020. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR 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

Clive Ballard reports grants from Novo Nordisk (Bagsværd, Denmark); grants and personal fees from Acadia Pharmaceuticals (San Diego, CA, USA) and from Lundbeck Pharmaceuticals (Copenhagen, Denmark); and personal fees from Pfizer Inc. (New York, NY, USA), Roche Holding AG (Basel, Switzerland), Eli Lilly and Company (Indianapolis, IN, USA), Heptares Therapeutics (Hertford, UK), Otsuka Pharmaceutical (Tokyo Japan), Novartis (Basel, Switzerland) and Allergan (Dublin, Ireland), outside the submitted work. Esme Moniz-Cook held National Institute for Health Research (NIHR) funding for a programme grant during this period (RP-PG-0606-106). Anne Corbett reports personal fees from Lundbeck Pharmaceuticals, Novartis, Bial (Trofa, Portugal) and Acadia Pharmaceuticals, outside the submitted work, and a NIHR Programme Development Grant held during the study period (RP-DG-1212-10004). Dag Aarsland has received research support and/or honoraria from AstraZeneca (Cambridge, UK), Lundbeck Pharmaceuticals, Novartis and GE Healthcare (Chicago, IL, USA), and serves as a paid consultant for Lundbeck Pharmaceuticals and Axovant Gene Therapies (Hamilton, Bermuda), outside the submitted work. Zoe Hoare reports associate membership of the Health Services and Delivery Research programme board (2016–20). Jane Fossey reports a grant from the Alzheimer’s Society (London, UK) outside the submitted work.

Copyright statement

© Queen’s Printer and Controller of HMSO 2020. This work was produced by Ballard 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.

2020 Queen’s Printer and Controller of HMSO

Background

Dementia is characterised by the progressive loss of cogition and function, leading to the loss of independence and communication ability, and eventually to death. Dementia exerts an enormous impact on the individuals affected and their families, many of whom provide informal care for long periods of time. In the context of an ageing population, dementia is also a critical public health issue with considerable financial implications at a societal level. There are 46 million people with dementia worldwide, including 850,000 people in the UK, of whom an estimated 250,000 live in care homes. 1,2 In the USA, 64% of people receiving Medicare in nursing homes have dementia. 3 Care homes provide full-time residential and nursing care, and represent a unique challenge for health care. There is an increasing focus in research and policy on the improvement of institutionalised care and the need for evidence-based interventions for people with dementia that are tailored to this setting.

Dementia in health-care provision and policy

Dementia has a vast impact on health and social care services in the UK. The direct cost of dementia is £42B per year,1 which is higher than the cost of stroke, heart disease and cancer combined. This was the basis of the UK’s national dementia strategy for England, developed by the Department of Health and Social Care in partnership with stakeholder organisations, such as the Alzheimer’s Society (London, UK). 4,5 The strategy laid out a unique vision for people with dementia and provided a 5-year plan for building health and social services for people with dementia that are fit for the 21st century. 4

The strategy included two key objectives with particular relevance to care home settings, with strategies to achieve them. ‘Improving the quality of care for people with dementia in care homes’ (Contains public sector information licensed under the Open Government Licence v3.0)⁴ – objective 11 – involved a government directive to include specialist mental health teams in dementia care within a range of other measures. ‘The development of an informed and effective workforce for people with dementia’ (Contains public sector information licensed under the Open Government Licence v3.0)⁴ – objective 13 – aimed to provide training and skills for health and social care staff to enable them to deliver the best possible care.

The importance of providing high-quality care for people with dementia who are living in residential and nursing homes received less attention in the subsequent Prime Minister’s Challenge on Dementia 20205 and the related implementation plan. 6 However, the value of an adequately trained workforce and the provision of evidence-based training was highlighted, and the focus on minimising unnecessary prescribing of antipsychotic medications to people with dementia was maintained,6 in line with international recommendations. 7 A subsequent report from The King’s Fund, Social Care for Older People: Home Truths,8 has shown the substantial pressures facing the care home sector and the urgent need to use limited resources more effectively to achieve high-quality care.

People with dementia have complex care needs, particularly those residing in care homes. The majority of these individuals have moderate or severe dementia and their care needs are influenced by a combination of cognitive, functional and communication impairments, and medical comorbidities, and a high frequency of behavioural and psychological symptoms of dementia (BPSD). 3,7,9 The NHS provides for these complex health needs largely through primary care and specialist service consultancy. Some specialist teams have introduced more proactive liaison services, but these are not widespread. An effective solution is needed to enable consistent and effective NHS support for people with dementia and staff, particularly in care home settings where specialist staff are rarely available. Such an NHS service would need to improve the general quality of care, the skill base of care staff and the availability of non-pharmacological interventions and reduce the frequency of potentially harmful antipsychotic prescribing to improve health and quality of life (QoL) for people with dementia in care homes.

The Well-being and Health for people with Dementia (WHELD) programme grant was run in parallel with the national dementia strategy for England and the Prime Minister’s challenge on dementia implementation activities, and within the context of a national drive to improve health-care service provision and care home services for people with dementia. The programme represents an important example of the development of a robust evidence-base for dementia care and the improvement of services in care homes.

Behavioural and psyschological symptoms in dementia

Neuropsychiatric symptoms, often referred to by consensus as BPSD, include aggression, agitation and restlessness, psychosis, depression, anxiety, elation, disinhibition, sleep disturbance and apathy. BPSD affect 90% of people with dementia at some point during the course of their condition. 10 These BPSD are critical indicators of QoL and well-being, and have clinically significant effects on the individual and their caregivers. They present a substantial challenge for health and care professionals, as there are limited treatment options. 10

Current best practice guidelines promote non-pharmacological interventions as the first-line approach for the treatment of BPSD, and there is a growing evidence base to support the value of this approach. 11 However, there is little guidance on how to implement non-drug treatments and no structured framework for their widespread use in practice.

The use of antipsychotics in people with dementia

Current best practice guidance limits the use of antipsychotics to short-term prescription (up to 12 weeks) of risperidone (Risperdal^®, Janssen Pharmaceutica, Beerse, Belgium) in intractable cases that are causing risk to the person or others.

Non-pharmacological treatments for behavioural and psychological symptoms of dementia

All best practice guidance for the management of BPSD recommend the first-line use of non-pharmacological approaches unless the symptoms are so severe that they are causing great distress or risk. 11 Although more severe and challenging agitation and aggression often require pharmacological intervention, this level of BPSD does also respond to intense psychological approaches when tailored to the individual.

Rationale for the WHELD programme

Key NHS priorities include improving mental health and the treatment of mental health problems to further reduce antipsychotic use and improve the QoL for people with dementia in care home settings. There is strong evidence that a number of specific person-centred care interventions confer some benefit, but no single intervention has achieved both an improvement of mental health and a reduction in psychotropic drug use in people with dementia. Furthermore, none of the interventions evaluated prior to this programme conferred a direct benefit to the QoL for people with dementia who were living in care homes. Most importantly, none of these interventions had achieved widespread implementation in a clinical or care setting as part of routine NHS practice.

Further research is, therefore, urgently needed to address these key issues. Such research will need to develop an optimised therapy that combines the most effective elements of the currently available evidence-based interventions to maximise the breadth of benefit. The intervention needs to be conceptually integrated, practical to implement in an NHS and care home setting and be cost-effective.

Achieving these objectives will require an integrated programme of research. We tackled this using the Medical Research Council (MRC)’s framework for complex interventions to model, develop, adapt, evaluate and disseminate the intervention.

The final stage of the MRC pathway, overcoming the barriers to enable widespread implementation, is also a major challenge, which cannot be overstated, as this has never been achieved for any therapy in a care home setting. Research is needed to tailor an optimised therapy to the needs of NHS staff, care home staff and people with dementia who are living in care homes and their families. In addition, research is also imperative to understand and overcome the potential obstacles to implementation and to refine the intervention model through an extensive period of testing in the field. Although much is known about the effectiveness of interventions, which benefit specific aspects of health and mental health, any intervention is of limited value unless it is practical and can be implemented routinely in clinical practice. A comprehensive programme of research is essential to overcome these barriers and to develop and implement an effective intervention that can be rolled out nationally as an NHS service to people with dementia in care homes, conferring the benefits to real people in everyday care settings. This is the basis for the design and delivery of the WHELD programme, which was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme in 2012.

Aims and objectives

The overarching aim of the WHELD programme was to improve mental health and reduce the prescription of antipsychotic drugs for people with dementia living in care homes, by developing and evaluating an optimised intervention that is based on the most effective currently available therapies that can provide a broad range of benefits and can be routinely implemented as part of NHS care. We will also determine whether or not the intervention improves QoL.

To achieve these aims, the specific obectives for the WHELD programme were to:

• update current systematic reviews regarding the most effective interventions to reduce BPSD experienced by people with dementia in care homes

• optimise the most promising interventions and adapt them for an NHS and care home context through expert consenus and consultation with health and care professionals

• determine the specific benefits of the interventions in incremental evaluation studies

• develop an optimised intervention that is supported by an operationalised manual, with the specific aim of maximising the breadth of benefit while remaining practical and cost-effective

• evaluate the optimised intervention and determie the cost-effectiveness in a well-powered, cluster RCT

• understand the factors that contribute to feasible implementation and sustainability through consultation with study participants, and to field test the intervention to customise it as a practical NHS intervention

• proactively disseminate the findings and intervention to enable widespread implementation.

In addition, the WHELD programme aimed to support capacity development within dementia reserach by providing research training to postdoctoral researchers to enable them to develop careers as independent researchers, and to build skills and knowledge among NHS care staff through study participation.

Guiding principles for the design of the WHELD programme

The design and approach taken for the WHELD programme followed a number of guiding principles to maximise the impact and relevance of the reserach to current practice and evidence. These guiding principles were as follows:

• Development of interventions – it would have been inefficient and unneccesary to develop new interventions to promote mental health from basic principles, as effective interventions already existed at the commencement of the programme. However, these interventions required adaption for a UK NHS and care home setting and optimisation to improve the breadth of benefit.

• Evaluation of QoL – previous trials had not been able to demonstrate improvement of care home residents’ QoL. The WHELD programme was, therefore, adequately designed and powered for such an effect to be demonstrated.

• Meaningful evaluation of interventions – prior to a large RCT, incremental evaluation was prioritised as a means of determining the effective elements within the overall WHELD programme intervention, how these elements improve the breadth of benefits and which of these key elements deliver value for money.

• Importance of field testing – it was deemed essential to undertake an extensive period of field testing to ensure that the WHELD programme intervention was fully tailored to the needs of the NHS and the care home sector, and that an intervention was delivered that could be a nationally implemented cornerstone of NHS treatment for people with dementia who are residing in care homes. This was particularly important, as it has not previously been possible to achieve widespread implementation of any intervention in a care home setting.

• Dovetailing with national strategy and ongoing research – the WHELD programme recognises the need to work within the dynamic climate in UK health-care provision and alongside ongoing complementary research. The programme was designed to address the priorities published in the national dementia strategy for England and dovetails with studies examining specialist approaches for the psychological and pharmacological management of BPSD and other physical and mental health problems.

Work plan

The WHELD programme followed a pathway through modelling, feasibility, evaluation, dissemination and implementation, as illustrated in the MRC framework for complex interventions. The programme, which involved six work packages (WPs), is summarised in Figure 1.

FIGURE 1.

Research pathway diagram.

A description of each WP is as follows:

• WP1 – update and publish a systematic review to show the service models and interventions for people with dementia living in care homes with the best available evidence base.

• WP2 – model and adapt exisiting effective interventions to a UK NHS context.

• WP3 – evaluate the breadth of benefits in an incremental design to establish the most effective and cost-effective combination of intervention elements (factorial study).

• WP4 – develop an optimised intervention (WHELD), ‘welding together’ the most effective elements of the best available interventions, and develop a standardised manual and training programme for care staff.

• WP5 – evaluate the full breadth of benefit conferred by the intervention through a large cluster RCT with parallel cost-effectiveness and process evaluations.

• WP6 – disseminate the findings and the WHELD programme to enable widespread national implementation.

Limitations in design

In designing the study, we were mindful of the challenges of measuring QoL in people with moderate to severe dementia and, therefore, relied predominantly on a proxy measure. Within any RCT of a non-pharmacological intervention, it is a difficult decision whether to opt for treatment as usual or for an active control in the comparision arm. We used an active control (person-centred care) in WP3, which involved 16 care homes, but opted for a treatment as usual control in WP5, as a result of the scale of the study in 69 care homes. This may have inflated the magnitude of observed benefits with the WHELD programme in WP5.

The training and supervision in the intervention was delivered directly to care staff, who participated in qualitative work. However, we recognise that residents with dementia who received the intervention that was delivered by the staff were not included in the qualitative studies and could provide a valuable perspective.

The details of each WP are discussed in the following sections.

Abstract

Objectives: WP1 sought to ask two specific research questions: (1) what is the evidence supporting the use of psychosocial interventions for BPSD? and (2) what is the quality and efficacy of existing psychosocial interventions and staff training programmes in person-centred care in improving BPSD and antipsychotic use?

Methods: Two systematic reviews were conducted. One examined publications relating to psychosocial interventions and the other conducted a search to identify person-centred care training manuals. Quality criteria were applied and the efficacy of manuals was considered.

Results: The systematic review of psychosocial interventions identified 40 studies and highlighted the evidence supporting the use of reminiscence therapy (ES 0.33), personalised pleasant activities (ES 0.46) and training in person-centred care. The modest number of adequately powered RCTs was highlighted. The efficacy and quality review identified 30 manuals meeting the quality criteria, of which only four were supported by RCT evidence. The studies reported benefit to agitation, depression, overall BPSD and antipsychotic use.

Conclusions: The reviews showed the limitations of the evidence base related to person-centred care training, but the combined reviews indicate that there are some benefits in the use of psychosocial interventions for people with dementia living in care homes.

Background

Behavioural and psychological symptoms of dementia represent a major challenge to dementia care and are associated with important clinical outcomes. 14,47 There is a high level of unmet need, particularly for individuals living in care homes. 2

A major element of dementia care is the development of safe, effective psychosocial interventions that improve residents’ care, reduce behavioural and psychological symptoms in people with dementia and offer an alternative to antipsychotic medication. There is a growing focus on a personalised approach to these interventions. Another element of dementia care is the need for high-quality training, in addition to effective support for clinicians. These requirements are highlighted in government directives worldwide. 7,17,48

As the starting point for the WHELD programme, WP1 aimed to synthesise the landscape of non-pharmacological treatment approaches and the resources that are currently available. This work directly informed decisions regarding the design and delivery of the WHELD programme.

Aim and objectives

The aim was to address and update gaps in the evidence base to inform the development of the WHELD programme.

The two major objectives were to:

1. update a systematic review highlighting service models and interventions for people with dementia living in care homes

2. conduct a two-pronged systematic review of quality and efficacy of existing person-centred care interventions, with a focus on the impact on BPSD and antipsychotic use.

Systematic review of psychosocial interventions to address behavioural and psychological symptoms experienced by people with dementia living in care homes

Implications for delivery of the WHELD programme

This review demonstrated valuable differential effects between different personalised psychosocial interventions that could have implications for the tailoring of care packages according to symptoms. It showed the importance of person-centred care interventions, pleasant activities for the treatment of agitation and the use of reminiscence therapy for mood. These findings were pulled through to WP2 and directly informed the development of the WHELD programme.

In addition, the review indicated areas of need for the design of the WHELD programme and protocol, including the need to focus on health economics, to improve the understanding of the impact of duration and frequency of specific interventions on ES and to develop a more detailed understanding of the impact of the conceptual frameworks on the outcome, and whether or not this can be used to optimise interventions. The review also emphasised the importance of understanding the level of care staff education that is needed to deliver specific interventions effectively, as well as the effect of the care environment and leadership on implementation.

The review was conducted based on a literature search up to December 2012, as part of the WHELD programme and to inform therapy development. A rapid updating search in October 2019 and citation tracking from out-published papers did not identify any relevant new studies that would change our conclusions.

Systematic review of person-centred interventions and training manuals for care home staff working with people with dementia

Implications for delivery of the WHELD programme

This review showed the major disconnect between the interventions that are routinely available and commissioned and the evidence base. This added further weight to the overall rationale of the WHELD programme.

The review provided key indicators of elements that are required for a successful person-centred intervention, including the importance of consistent, long-term support for staff. It indicated the need to evaluate effectiveness on psychosis, depression and QoL, in addition to agitation and antipsychotic use.

The limited number of available training manuals without direct clinical trial evidence of benefit for people with dementia is alarming, and emphasises the importance of a feasible, effective training programme.

Concluding remarks from work package 1

Work package 1 successfully delivered the objective of updating the current evidence base with systematic reviews. It highlighted pleasant activities and social intervention as priority areas for addressing agitation, and reinforced our view that augmentation of existing interventions is needed to deliver comprehensive benefit and improve QoL.

Finally, WP1 identified an alarming number of available training manuals that are not evidence based, and strongly emphasised the need for an evidence-based manual. These findings were taken forward by the Therapy Development Group (TDG) in WP2.

Abstract

Objectives: WP2 sought to identify the factors that influence implementation of psychosocial interventions in care home settings and to develop the WHELD programme for evaluation, based on the outputs and findings from WP1.

Methods: A metasynthesis approach was used to conduct a review of studies that examine the implementation of psychosocial interventions in care homes. Data were analysed by thematic analysis using an interpretive method of metadata synthesis, grouping themes where they had the greatest explanatory power. These findings and WP1 results were used by a TDG to create and protocolise a WHELD programme package.

Results: The meta-analysis revealed key issues in promoting the use of interventions in care homes, including the core involvement of staff, buy-in by family members, flexibility of care home working arrangements, training, supervision and support for staff and the need for cultural change. These findings, combined with WP1, informed development of the intervention. The WHELD programme involved four key elements: person-centred care training that was based on adapted versions of published manuals, antipsychotic review by general practitioners (GPs) that was based on national best practice guidelines, social interaction and exercise, both of which were adapted from published interventions.

Conclusions: The work completed in WP2 follows a clear pathway, from theoretical basis to conceptual framework to a tangible operational intervention. The WHELD programme represents a synthesis of knowledge that was drawn from clinical trial data, existing resources and qualitative analysis, and was collated for use by a broad expert consensus process.

Background and rationale

Work package 1 illustrated the strength of evidence for several psychosocial interventions and manualised person-centred care programmes that confer benefit on mental health and antipsychotic medication use for people with dementia living in care homes. Promising interventions were identified, including staff training, person-centred care and structured social interaction approaches and exercise. Importantly, none of the interventions directly improved QoL for care home residents or achieved widespread implementation as part of routine care practice. WP1 also showed the lack of evidence-based training programmes and the importance of an integrated approach to ongoing support for care staff.

The work carried out in WP1 pointed towards the need for a whole-systems approach to improve person-centredness in care homes with integration of the most effective individual interventions, and to develop an understanding of the factors that influence implementation.

Therefore, WP2 encompassed a further review to gather qualitative data on aspects of psychosocial intervention design, followed by a series of therapy development steps to adapt and combine the key components of established effective interventions.

Aim and objectives

The overall aim of WP2 was to create a conceptually integrated evidence-based intervention that was practical to implement in UK care home settings.

The objectives of WP2 were to conduct a:

1. systematic review and metasynthesis of qualitative research to identify factors that influence the implementation of psychosocial interventions.

2. series of expert panel and TDG sessions to develop a person-centred care intervention by combining the best elements of existing interventions in a way that is both conceptually integrated and practical.

Implementation of psychosocial interventions: systematic review and meta-analysis

Implications for the WHELD programme

The recommendations outlined above were taken forward to the intervention development phase of WP2 (described below). The identification of key elements of successful interventions, combined with the outputs of the review in WP1, indicated the need for incremental evaluation of individual elements of psychosocial interventions to enable an examination of the breadth of their benefits.

The WHELD therapy development

Concluding remarks for work package 2

Work package 2 successfully collated evidence from different sources, including systematic reviews, qualitative reviews, expert consensus and existing operationalised interventions, to prioritise interventions for the new WHELD programme. The large consensus process gives additional validation to the final intervention, which was taken forward for evaluation in WP3.

Major outputs of work package 2

Abstract

Objectives: To establish the feasibility, effectiveness and cost-effectiveness of person-centred care training for care staff alone and in combination with antipsychotic review, social interaction and exercise.

Methods: A 9-month, cluster, factorial RCT of the WHELD programme in 16 care homes. All care homes received person-centred care. Eight care homes were randomly assigned to receive antipsychotic review, social interaction or exercise. The primary outcome measure was antipsychotic use. Secondary outcome measures were BPSD and mortality. The costs of care were defined and cost-effectiveness was analysed using the Client Service Receipt Inventory (CSRI). Focus group discussions with staff talked about their expectations.

Results: Antipsychotic review reduced antipsychotic use by 50% [odds ratio (OR) 0.17, 95% CI 0.05 to 0.6]. Antipsychotic review plus social interaction significantly reduced mortality but increased BPSD compared with receiving neither antipsychotic review nor social interaction (score difference 7.37, 95% CI 1.53 to 13.22). This detrimental impact was mitigated by concurrent delivery of social interaction (–0.44, 95% CI –4.39 to 3.52). The exercise intervention significantly improved neuropsychiatric symptoms (–3.58 symptoms, 95% CI –7.08 to –0.09 symptoms) but not depression (–1.21, 95% CI –4.35 to 1.93). The focus groups emphasised that successful training must acknowledge and respond to ‘whole-home’ issues.

Conclusions: Person-centred care, antipsychotic review and social interaction showed benefit to QoL, antipsychotic use and mortality and have indications of cost-effectiveness.

Background and rationale

The work that was completed in WPs 1 and 2 of the WHELD programme builds on a growing body of literature. 32 Our meta-analysis showed the benefit conferred by social interaction and pleasant activities on both BPSD and antipsychotic use,43 and of physical activity through personalised exercise on mood. 31 This suggested that augmented person-centred care with social interaction, pleasant activities and physical activity would be effective.

Until 2008, cohort studies and audits in the USA and Europe reported that 40% of people with dementia in care homes were receiving an antipsychotic drug. 148–150 In recent years, the concerted effort to reduce unnecessary prescribing has led to a 15–50% reduction in prescriptions of antipsychotic drugs across the USA and Europe. 23–25 Although recent randomised antipsychotic discontinuation studies have reported benefits following the withdrawal of antipsychotics,16 there have been no randomised trials of rigorous antipsychotic review.

Working papers detailing the work plan and analysis plan are in Appendix 1.

Aim and objectives

Work package 3 reports a factorial evaluation of the WHELD programme, to evaluate the effectiveness of person-centred care training for care staff alone and in combination with antipsychotic review, social interaction and exercise interventions.

Factorial randomised controlled trial of the WHELD programme

Results

Discussion

The WHELD programme conferred a significant 50% reduction in antipsychotic use, even in a population with a baseline antipsychotic use < 20%. Exercise conferred significant benefits to overall BPSD. In addition, the group who received antipsychotic review in combination with social interaction had a significant reduction in mortality. Social interaction alone also conferred benefit to health-related QoL.

The detrimental affect of antipsychotic review on BPSD and health-related QoL was an important finding, which was probably explained by the changed landscape of antipsychotic prescribing. 17,23–25 The antipsychotic review intervention was based on guidance that was created before the substantial reductions in antipsychotic use over the last 5 years. 27 Although this has achieved significant benefits, it has meant that the severity of BPSD in people who are now receiving antipsychotics is probably much higher than it was previously.

The mortality figures also have important implications, particularly given that mortality risk has been a key driver in the campaign to reduce antipsychotic use. 15 Although antipsychotic review alone reduced mortality by > 30%, this became statistically significant only in combination with social interaction.

Implications for the WHELD programme

Work package 3 clearly demonstrated the feasibility of the WHELD programme to reduce antipsychotic use in people with dementia and suggested the potential for benefit in QoL.

Qualitative analysis: implementation of psychosocial interventions in care homes

Implications for the WHELD programme

Qualitative work conducted with care staff clearly demonstrated the need to involve the entire staff team in any new intervention to have complete ‘buy-in’, as well as ensuring that trainers fully acknowledge the cultural and resource challenges inherent in care home settings and strive to work with staff to overcome them.

Concluding remarks for work package 3

Work package 3 was successfully delivered and demonstrated an impact on QoL, antipsychotic use and mortality with the combination of person-centred care, social interaction and antipsychotic review. These, therefore, appeared to be the key components to integrate into a single optimised intervention in WP4.

The qualitative work provides clear insights into the needs for delivery of the intervention to support future implementation. In practical terms, this includes effective supervision and support for therapists to enable ‘on-the-job’ learning, and an understanding of the drivers for motivation and engagement among care home staff.

Based on qualitative feedback from this WP and WP4 (see Work package 4: evidence-based and user-driven optimisation of the WHELD programme for use in a real-world setting), the decision was made to develop a lower cost champion model for intervention delivery.

Abstract

Objectives: WP4 sought to optimise the WHELD programme through a series of review and consultation steps.

Methods: WP4 involved (1) review of the outcomes of WP3 with expert and governance groups, (2) review of the study materials and their usage with WHELD programme therapists and (3) focus group discussions with 41 care staff who were involved in the factorial trial in WP3 to understand their experience of involvement in research and use of the WHELD programme. The intervention was then refined according to the outputs.

Results: A number of key changes were made to the intervention. The optimised intervention consisted of person-centred care and social interaction, with activities elements from the exercise package and a cascade version of the antipsychotic review intervention in which staff prompted GPs for review. The delivery model was adapted for implementation and cost-effectiveness, replacing intensive therapist time with a champions model. The focus group discussions relating to both the overall research experience and the use of WHELD materials reported a generally positive experience for staff, and beneficial aspects of WP3 were identified. However, there were issues identified in relation to the extra burden of data collection for research and the perceived pressure of time to deliver the intervention alongside routine care activities.

Conclusions: The adaptations of the intervention and protocols ensured that the WHELD programme was fit for full evaluation in WP5.

Background and rationale

The factorial trial completed in WP3 provided robust, meaningful data regarding the value of the four elements of the WHELD programme, in addition to critical information regarding the most valuable outcome measures for a full evaluation and the importance of user involvement in intervention development.

This work was completed in the context of a considerable literature and academic consensus that supports the need and rationale for an intervention that draws together the best available interventions to create an optimised ‘real-life’ approach, which is both effective and feasible for implementation. WP3 provided key evidence of effectiveness, but showed the need to optimise the intervention further to ensure that it could be feasibly rolled out. A critical factor in this was the need to involve end users in the refinement process. Existing literature consistently reports the need for a collaborative approach that seeks the views of staff from the outset, provides positive feedback, does not judge past or present care practices and offers an effective method of engagement. 170

Cost-effectiveness is also a critical aspect in the prospective success of any health service intervention, particularly in the care sector, in which resources are limited and there is considerable competition for commissioning. This aspect was clearly shown in the cost–function analysis performed in WP3, which indicated the need to integrate meaningful cost-effectiveness measures into large-scale trials, as well as improving needs-based care for people with dementia.

Work package 4, therefore, collated the findings of the programme to date, and consisted of a collaborative final optimisation stage to create a final WHELD programme described in a manual for full evaluation in WP5.

Aim and objectives

The overall aim of WP4 was to optimise the overall WHELD programme for full RCT evaluation.

This was achieved through the following objectives:

• conduct a review of the materials used in WP3 and collate learning points from supervision conducted with WHELD therapists regarding feasibility of intervention delivery

• conduct a consultation with key groups (PMG and TDG) to agree on the requirements for adaptation of the WHELD programme

• conduct a series of focus group discussions with care staff, with the aim of ensuring a collaborative approach to the intervention optimisation

• adapt the intervention manuals to reflect the approved amendments.

Methods

Results

Discussion and implications for the WHELD programme

Work package 4 drew on consultations with a range of stakeholders who had been involved in WP3 to understand how best to adapt the intervention, delivery model and evaluation protocol. It was important to consider the overall experience of staff in the whole research process in recognition that these elements may have an indirect impact on staff motivation and effectiveness in engaging with the project. This approach proved helpful in triangulating information about which elements had been effective and which required revision, both from a process and a content perspective. The resulting adaptations of the intervention and protocols ensured that the WHELD programme was fit for full evaluation in WP5.

Concluding remarks for work package 4

This was a largely operational WP, combining consultation with key groups with a period of refinement and optimisation of the WHELD programme. The process followed by the investigator team resulted in a fit-for-purpose intervention portfolio and trial protocol. This fulfilled the stated objectives of the WP.

Of note, this WP particularly benefited from user involvement and patient and public involvement (PPI) throughout, ensuring that the various discussions and alterations were directly informed by stakeholder feedback and opinion.

Abstract

Objectives: WP5 aimed to establish the clinical effectiveness and cost-effectiveness of the optimised WHELD programme and to determine factors influencing sustainability for use in UK care homes.

Methods: This was achieved through (1) a large RCT of the optimised intervention compared with usual care; (2) an integrated cost-effectiveness analysis of the optimised intervention; (3) a qualitative analysis of WHELD materials that were used by WHELD therapists and supervisors to determine factors that are associated with successful implementation; and (4) a qualitative analysis with care home staff to determine the sustainability of the WHELD programme.

Results: WP5 successfully delivered a robust and rigorous clinical evaluation of the optimised WHELD programme utilising a champion’s model. The intervention conferred a statistically significant improvement in QoL [DEMQoL – proxy z-score of 2.82, mean difference 2.54, standard error of measurement (SEM) 0.88, 95% CI 0.81 to 4.28, Cohen’s d ES of 0.24; p = 0.0042]. There were also statistically significant benefits on agitation (CMAI z-score of 2.68, mean difference –4.27, SEM 1.59, 95% CI –7.39 to –1.15, Cohen’s d ES of 0.23; p = 0.0076) and overall neuropsychiatric symptoms (NPI-NH z-score of 3.52, mean difference –4.55, SEM 1.28, 95% CI –7.07 to –2.02, Cohen’s d ES of 0.30; p < 0.001). Benefits were greatest in people with moderately severe dementia.

Conclusions: These findings suggest that the WHELD programme confers benefits to QoL, agitation and neuropsychiatric symptoms, albeit with relatively small ESs, as well as cost saving in a model that can readily be implemented into nursing homes. Future work should consider how to facilitate sustainability of the intervention in these settings.

Background and rationale

Work package 5 represents a culmination of extensive evaluation, consultation and optimisation work, leading to an optimised WHELD champion intervention.

Aim and objectives

Work package 5 aimed to establish the effectiveness and cost-effectiveness of the optimised WHELD programme and to determine which factors influence sustainability for use in UK care homes.

This was achieved through the following main objectives:

• A large RCT of the optimised intervention compared with usual care.

• An integrated cost-effectiveness analysis of the optimised intervention. To determine whether or not the intervention is cost-effective is an important factor in whether or not commissioners and private payers are likely to pay for the training.

• A qualitative analysis of WHELD materials used by WHELD therapists and supervisors to determine factors that are associated with successful implementation.

• A qualitative analysis with care home staff to determine the sustainability of the WHELD programme.

Randomised controlled trial of the optimised WHELD programme in care homes in the UK

The first phase of WP5 was a large-scale multicentre RCT of the optimised WHELD programme, as described in a published output. 180

Results

Discussion

The WHELD programme conferred a statistically significant improvement in QoL over 9 months. There was also a statistically significant benefit regarding agitation and overall neuropsychiatric symptoms, and a significant increase in the proportion of positive care interactions between care staff and residents with dementia. Importantly, the benefits were achieved in the context of cost saving with a model that can readily be implemented in nursing homes.

Although comparable to atypical antipsychotics, the standardised ESs of benefit are modest in the context of a clinical intervention. The benefits do, however, also include improvements in QoL, which have not been shown with pharmacological interventions or other person-centred care interventions. Although there is no established threshold for a clinically meaningful benefit in QoL or quality of care, any statistically significant benefit is important given the lack of any benefit in previous RCTs. In addition, the intervention was not just delivered to people with clinically significant neuropsychiatric symptoms, but conferred benefit among the broader population of people with dementia living in care homes and could, therefore, be considered as a health and well-being intervention rather than a clinical intervention per se. Although the ES would be considered marginal in terms of a clinically significant benefit, we do believe that the benefits to the broader population of people with dementia living in care homes make this a meaningful benefit in the quality of care. The benefits were also smaller than hypothesised.

Agitation is a frequent and distressing symptom for people with dementia. 191,192 The findings are favourable when compared with trials of antipsychotic medications, which show only very modest benefits over 12 weeks in the treatment of agitation in the context of significant harms. 13,16 Our results compare favourably with the small number of previous studies that focused on person-centred care, in which benefits in agitation are inconsistent and none of which has reported benefits in QoL. 28,30 In addition, this study shows cost advantages over usual care, which have not been demonstrated with any previous drug or non-drug intervention.

Recent studies have begun to suggest that other pharmacological therapies, such as citalopram (Cipramil, Lundbeck)193 and dextromethorphan (Neudexta, Avanir),194 may confer benefit for the treatment of agitation; however, further studies are needed.

Elements of the WHELD programme, such as social interaction and pleasant events, have previously been demonstrated to improve agitation in modest-sized RCTs. 49,195 Incorporating these elements within a coherent framework, such as WHELD, enables straightforward and affordable implementation.

In contrast to our previous factorial RCT of the WHELD programme, no significant reduction in antipsychotics prescriptions was achieved. This is probably attributable to a combination of a small number of baseline antipsychotic prescriptions and the more limited education programme for primary care physicians. It should also be noted that the ICCs were higher than the 0.03 that was identified from previous studies, which may have limited statistical power of the trial. Other limitations include the challenges of measuring QoL for people with moderately severe and severe dementia and the potential challenges of data analysis in the context of a frail group of individuals with high rates of mortality.

Pain was a prespecified secondary outcome for the WP5 WHELD RCT. Given that several members of our research group were particularly interested in pain in people with dementia, which we consider to be a key factor for health and well-being, we made these data available for a more detailed evaluation. This was an added value to the outputs from the programme and led to a secondary paper that focused on pain experienced by people with dementia. The baseline prevalence of pain was 35.3% among residents with dementia. Pain severity was significantly correlated with dementia severity, neuropsychiatric symptoms, depression, agitation and QoL at baseline and at 9 months. Regular treatment with analgesics was associated with reduced pain severity. Pain was significantly associated with more antipsychotic prescriptions and with all-cause mortality during follow-up (OR 1.48, 95% CI 1.18 to 1.85). See the published output for the full paper. 196

Field testing and implementation of the WHELD programme in care homes in the UK

Discussion

Discussion with care home staff represented a unique opportunity to explore their perceptions of the long-term impacts of the WHELD programme and the factors influencing its sustainability. The focus group discussions highlighted that the ethos of person-centred care and associated approaches can be embedded and that a number of the WHELD materials continue to be used after study involvement has ceased.

Concluding remarks from work package 5

Work package 5 successfully delivered a robust and rigorous clinical evaluation of the optimised WHELD programme utilising a champion’s model. Significant benefits were seen in the treatment of agitation, overall scores of neuropsychiatric symptoms and health-related QoL in individuals with agitation compared with TAU.

There are also economic benefits from a low-resource multicomponent intervention that is aimed at people with dementia living in a care home setting.

Feedback from therapists and staff involved in the trial also confirmed a positive and empowering experience.

Abstract

Objectives: WP6 sought to effectively disseminate the findings of the programme to impact on practice and maximise the output of the research.

Methods: A dedicated dissemination phase involved a series of tailored activities to maximise the impact of the WHELD programme. Work included academic publication and presentations, outreach to GPs, updating of national best practice guidelines and additional events for care homes.

Results: The dissemination activities were successfully completed. Key activities included regional workshops for GPs, which received excellent feedback and response, and the creation of an e-learning module for GPs with the British Medical Journal learning portal. The national guidelines on BPSD management were updated and endorsed by NHS England. Additional events and workshops were held with care home staff, and investigators presented the findings at numerous national and international conferences. All findings were prepared for publication in peer-reviewed journals.

Conclusions: WP6 constituted an integrated and broad approach to ensure that the outputs of the WHELD programme were effectively communicated in a targeted manner. WP6 exemplifies the success of the WHELD programme and highlights the importance of the key findings from the clinical evaluations that were conducted throughout the study. Involvement of key health-care professionals, particularly GPs and care home staff, was purposely selected to ensure that the learning from the programme informs future practice in a meaningful way.

Background and rationale

The WHELD programme consisted of a series of high-quality research elements that sought to understand the UK care home landscape, develop and optimise a complex care intervention, evaluate it in a real-world environment and fully understand its implications for care home residents and staff. Ultimately, the aim of this programme was to improve the care that is provided to people with dementia, with a focus on improving management of BPSD, increasing QoL and promoting the judicious use of antipsychotic medications.

Dissemination activity is an integral aspect of a successful research programme and an essential step in ensuring that research informs improvements to clinical and care practice. There was, therefore, a need to dedicate time and resources to the final adaptations of the intervention, inform peripheral resources to support ongoing implementation and move towards the roll-out of WHELD as an intervention.

Concluding remarks from work package 6

Work package 6 constituted an integrated and broad approach to ensure that the outputs of the WHELD programme were effectively communicated in a targeted manner. WP6 exemplifies the success of the WHELD programme and highlights the importance of the key findings from the clinical evaluations conducted throughout the study.

Furthermore, the involvement of key health-care professionals, particularly GPs and care home staff, was purposely selected to ensure that the learning from the programme informs future practice in a meaningful way.

Patient and public involvement in the WHELD programme: discussion and reflections on the programme by our patient and public involvement co-investigator

Investigator team discussion and reflections on the WHELD programme

The WHELD programme built on a series of systematic reviews to design and optimise a person-centred care training package by augmenting person-centred care with personalised pleasant activities/social interaction, exercise and antipsychotic review. This was evaluated in a factorial RCT that demonstrated tangible added benefits, including improvements in QoL and reduced mortality as well as a reduction in antipsychotic use. Further optimisation of the intervention developed a training approach that used a champion model to make the programme more pragmatic: an essential component for successful implementation. The definitive RCT of the WHELD champion intervention conducted in WP5 showed significant benefits in QoL and neuropsychiatric symptoms (including agitation) for people with dementia at a lower cost than usual care. This provides an evidence-based platform to enable effective implementation in care home settings for people with dementia.

Although the programme had a number of methodological strengths, there were also limitations. The qualitative work undertaken to inform the optimisation of the intervention was focused largely on the participating staff who were responsible for delivering the intervention, but we recognise that residents with dementia who received the intervention delivered by the staff were not included in the qualitative studies and could provide a valuable perspective. In designing the study, we carefully considered the challenges of measuring QoL in people with moderate to severe dementia and, therefore, relied predominantly on a proxy measure. In addition, we opted for a TAU control in WP5 because of the scale of the study (i.e. 69 care homes), but this may have inflated the magnitude of observed benefits.

The intervention in WP5 was optimised not just for efficacy, but to also to design an intervention that was more suitable for practical implementation in real-world settings. However, as part of the adaptation of the intervention there was a less proactive approach to GP education as part of antipsychotic review and the modified WHELD programme did not achieve an overall reduction in antipsychotic use in this RCT. The GP intervention has been developed as a British Medical Journal educational module and in practice it should, therefore, be possible to implement the WHELD programme directly in care homes and promote the GP educational component in parallel.

A key question is whether or not the benefits are meaningful. The standardised ESs of benefit for the WHELD programme were small in the context of a clinical intervention (Cohen’s d standardised ESs 0.23–0.3). However, the benefits included improvements in QoL, which have not been demonstrated with other pharmacological or non-pharmacological treatments. The benefit in QoL was modest but is important given the absence of any benefit in previous studies. The findings are particularly favourable when compared with those of trials of antipsychotic medications that show only modest benefits in treating agitation over 12 weeks and with the potential of significant harms.

Discussion of implications for practice

First, with regard to antipsychotic use, the clinical trials in the programme provide evidence that advocates the continued judicious prescribing of antipsychotics that follows the changing landscape of their use in the UK and worldwide. Given the findings related to antipsychotic review, prescribers should balance the potential impacts of antipsychotic withdrawal and carefully balance the harm-to-benefit ratio associated with antipsychotics.

Second, the WHELD programme has clearly demonstrated the value of social interaction and individualised pleasant activities in the treatment and care of people with dementia. Clinicians and care staff should consider these approaches as part of usual care.

Furthermore, the qualitative work conducted in this programme has identified opportunities and challenges in implementation of psychosocial approaches in care homes.

Recommendations for future research

The WHELD investigator team would like to make recommendations for future research in this field.

First, there is a need to examine the sustainability of the WHELD programme in care homes. The programme has demonstrated effectiveness over 9 months and this raises the question of whether or not this impact would be translated to longer-term effects for residents.

Future research might also examine cost-effective models of delivery to achieve sustained benefit. A pilot is under way to develop an e-learning version of the WHELD programme and it will be important to evaluate the effectiveness of this approach for care staff and its impact on residents.

An interesting secondary outcome from the RCT in WP5 was the significant impact of the intervention on pain in people who had significant pain at baseline. Pain is a major health concern in people with dementia and is a common underlying factor in BPSD. Therefore, it will be interesting to consider the effectiveness of training and tailored non-drug interventions on this key clinical factor.

Contributions of authors

Clive Ballard (https://orcid.org/0000-0003-0022-5632) (Professor of Age-Related Diseases at the University of Exeter) was the chief investigator for this programme and was a member of the TDG and PMG.

Martin Orrell (https://orcid.org/0000-0002-1169-3530) (Director of the Institute of Mental Health at the University of Nottingham) co-led WP2 and was a centre lead for the RCT in WP5. He was a member of the TDG and PMG.

Esme Moniz-Cook (https://orcid.org/0000-0002-7232-4632) (Professor of Clinical Psychology at the University of Hull) co-led WP2 and the TDG, and was centre lead for the RCT in WP5. She was a member of the PMG.

Robert Woods (https://orcid.org/0000-0002-6781-651X) (Director of Dementia Service Development Centre) chaired the PMG.

Rhiannon Whitaker (https://orcid.org/0000-0003-4305-3236) (Senior Statistician at Bangor University and is CEO of Whitaker Research Ltd) led the statistics and statistical design of the programme and was a member of the PMG.

Anne Corbett (https://orcid.org/0000-0003-2015-0316) (Senior Lecturer in Dementia Research at the University of Exeter) led WP6.

Dag Aarsland (https://orcid.org/0000-0001-6314-216X) (Chairperson of Old Age Psychiatry at King’s College London) led work in WP1 and was a member of the TDG and PMG.

Joanna Murray (https://orcid.org/0000-0002-7348-7505) (Senior Lecturer in Qualitative Research at King’s College London) led the qualitative research analysis in WP3 and was a member of the PMG.

Vanessa Lawrence (https://orcid.org/0000-0001-7852-2018) (Lecturer in Qualitative Research at King’s College London) led the qualitative research work in WP2 and co-led WP3.

Ingelin Testad (https://orcid.org/0000-0002-0534-6575) [Director of SESAM (Centre for Age-related Medicine) at Stavanger University and Professor of Nursing at the University of Exeter] led recruitment to the RCTs in WP3 and WP5.

Martin Knapp (https://orcid.org/0000-0003-1427-0215) (Professor of Social Policy at the London School of Economics) led the health economics in WP3 and WP4 and was a member of the PMG.

Renee Romeo (https://orcid.org/0000-0003-3871-9697) (Senior Lecturer in Health Economics at King’s College London) managed the health economics analyses for data arising from WP3 and WP5.

Darshan Zala (https://orcid.org/0000-0001-5020-2354) (Research Associate at King’s College London) supported health economics data analysis from WP3 and WP5.

Jane Stafford (https://orcid.org/0000-0002-4964-075X) (Programme Manager at Oxford Health NHS Foundation Trust) was the programme manager for WHELD.

Zoe Hoare (https://orcid.org/0000-0003-1803-5482) is a Senior Statistician at NWORTH in the University of Bangor. She supported statistical analysis for WP5.

Lucy Garrod (https://orcid.org/0000-0003-4378-1372) (Research Therapist at Oxford Health NHS Foundation Trust) was a WHELD therapist in WP3 and therapy supervisor in WP5 and contributed to the qualitative evaluation in WP5.

Yongzhong Sun (https://orcid.org/0000-0003-0659-9811) (Statistician at NWORTH at Bangor University) performed statistical analysis for WPs 3 and 5.

Eddie McLaughlin (Director of Adult Mental Health Services at Oxford Health NHS Foundation Trust) was the NHS manager for the programme.

Barbara Woodward-Carlton (Research Network Volunteer at Alzheimer’s Society and a former carer of a person with dementia) provided a lay perspective throughout the programme.

Gareth Williams (Lead Bioinformatician, Wolfson Centre for Age Related Diseases, King’s College London) contributed to statistical analysis and interpretation and co-writing of WP5.

Jane Fossey (https://orcid.org/0000-0002-8533-3263) (Associate Director of Psychological Services at Oxford Health NHS Foundation Trust) led one of the systematic reviews in WP1, led WP3 and the qualitative work in WP5 and co-led WPs 2 and 4, supervised the programme manager, provided NHS management and was a member of the TDG and PMG.

Publications

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 and appropriate agreements being in place. Data from the RCT described in WP5 is in the Dryad repository (URL: https://datadryad.org/resource/doi:10.5061/dryad.75373; accessed 1 November 2019).

The authors will be happy to discuss potential collaborations regarding other data and will make anonymised data available on that basis.

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, CCF, NETSCC, PGfAR 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 PGfAR programme or the Department of Health and Social Care.

Agreed work plan

(PDF download)

Analysis plan

(PDF download)