Development of the Community-based complex Interventions to sustain Independence in Older People (CII-OP) typology: a qualitative synthesis of interventions in randomised controlled trials.

INTRODUCTION: Community-based services to sustain independence for older people have varying configurations. A typology of these interventions would improve service provision and research by providing conceptual clarity and enabling the identification of effective configurations. We aimed to produce such a typology. METHOD: We developed our typology by qualitatively synthesising community-based complex interventions to sustain independence in older people, evaluated in randomised controlled trials (RCTs), in four stages: (i) systematically identifying relevant RCTs; (ii) extracting descriptions of interventions (including control) using the Template for Intervention Description and Replication; (iii) generating categories of key intervention features and (iv) grouping the interventions based on these categories. PROSPERO registration: CRD42019162195. RESULTS: Our search identified 129 RCTs involving 266 intervention arms. The Community-based complex Interventions to sustain Independence in Older People (CII-OP) typology comprises 14 action components and 5 tailoring components. Action components include procedures for treating patients or otherwise intended to directly improve their outcomes; regular examples include formal homecare; physical exercise; health education; activities of daily living training; providing aids and adaptations and nutritional support. Tailoring components involve a process that may result in care planning, with multiple action components being planned, recommended or prescribed. Multifactorial action from care planning was the most common tailoring component. It involves individualised, multidomain assessment and management, as in comprehensive geriatric assessment. Sixty-three different intervention types (combinations) were identified. CONCLUSIONS: Our typology provides an empirical basis for service planning and evidence synthesis. We recommend better reporting about organisational aspects of interventions and usual care.

Study protocol for a systems evaluation of an infant mental health service: Integration of 'Little Minds Matter' into the early years system.

Infant Mental Health relates to how well a child develops socially and emotionally from birth to age three. There is a well-established link between parent-infant relationship quality, Infant Mental Health, and longer-term social and emotional development there is a lack of evidence-based interventions that support the parent-infant relationship and/or protect against poor Infant Mental Health. Little Minds Matter is a specialist Infant Mental Health service developed in Bradford (UK) to support parent-infant relationships by providing training and consultation for professionals and direct clinical work to families. The successful implementation of this intervention depends upon how well it becomes embedded within, or integrated into, the early years system. For the purposes of this study, the early years system includes health, social and education services that support child health and development from conception to primary school entry at age five. This study protocol aims to apply a systems approach to evaluate this service and provide a perspective on the process of embedding a complex service within a healthcare system. Multiple methods will be used to investigate embeddedness within the wider early years system. Routinely collected quantitative data about the service will be used to develop a system map showing interaction with related services. Qualitative data will be collected at two time points through interviews with individuals involved in the design and provision of the service, and professionals working within the early years system. Framework analysis will be used to analyse the data inductively and deductively within a systems approach. The findings from this study will provide evidence to inform the ongoing implementation of the service for providers and commissioning bodies. Exploring the application of a systems approach in this clinical context will have application more broadly for researchers evaluating complex interventions and services within a wider system.

Community based complex interventions to sustain independence in older people: systematic review and network meta-analysis.

OBJECTIVE: To synthesise evidence of the effectiveness of community based complex interventions, grouped according to their intervention components, to sustain independence for older people. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Medline, Embase, CINAHL, PsycINFO, CENTRAL, clinicaltrials.gov, and International Clinical Trials Registry Platform from inception to 9 August 2021 and reference lists of included studies. ELIGIBILITY CRITERIA: Randomised controlled trials or cluster randomised controlled trials with ≥24 weeks' follow-up studying community based complex interventions for sustaining independence in older people (mean age ≥65 years) living at home, with usual care, placebo, or another complex intervention as comparators. MAIN OUTCOMES: Living at home, activities of daily living (personal/instrumental), care home placement, and service/economic outcomes at 12 months. DATA SYNTHESIS: Interventions were grouped according to a specifically developed typology. Random effects network meta-analysis estimated comparative effects; Cochrane's revised tool (RoB 2) structured risk of bias assessment. Grading of recommendations assessment, development and evaluation (GRADE) network meta-analysis structured certainty assessment. RESULTS: The review included 129 studies (74 946 participants). Nineteen intervention components, including "multifactorial action from individualised care planning" (a process of multidomain assessment and management leading to tailored actions), were identified in 63 combinations. For living at home, compared with no intervention/placebo, evidence favoured multifactorial action from individualised care planning including medication review and regular follow-ups (routine review) (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty); multifactorial action from individualised care planning including medication review without regular follow-ups (2.55, 0.61 to 10.60; low certainty); combined cognitive training, medication review, nutritional support, and exercise (1.93, 0.79 to 4.77; low certainty); and combined activities of daily living training, nutritional support, and exercise (1.79, 0.67 to 4.76; low certainty). Risk screening or the addition of education and self-management strategies to multifactorial action from individualised care planning and routine review with medication review may reduce odds of living at home. For instrumental activities of daily living, evidence favoured multifactorial action from individualised care planning and routine review with medication review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living: combined activities of daily living training, aids, and exercise; and combined activities of daily living training, aids, education, exercise, and multifactorial action from individualised care planning and routine review with medication review and self-management strategies. For personal activities of daily living, evidence favoured combined exercise, multifactorial action from individualised care planning, and routine review with medication review and self-management strategies (0.16, -0.51 to 0.82; low certainty). For homecare recipients, evidence favoured addition of multifactorial action from individualised care planning and routine review with medication review (0.60, 0.32 to 0.88; low certainty). High risk of bias and imprecise estimates meant that most evidence was low or very low certainty. Few studies contributed to each comparison, impeding evaluation of inconsistency and frailty. CONCLUSIONS: The intervention most likely to sustain independence is individualised care planning including medicines optimisation and regular follow-up reviews resulting in multifactorial action. Homecare recipients may particularly benefit from this intervention. Unexpectedly, some combinations may reduce independence. Further research is needed to investigate which combinations of interventions work best for different participants and contexts. REGISTRATION: PROSPERO CRD42019162195.

Mapping review of pain management programmes and psychological therapies for community-dwelling older people living with pain.

PURPOSE: Persistent pain is common in older people and people living with frailty. Pain or the impact of pain on everyday life is potentially modifiable. We sought to map research evidence and information from randomised controlled trials (RCTs) of pain management programmes and psychological therapies targeting community-dwelling older people, and explore appropriate strategies and interventions for managing or reducing the negative impact of pain for older people, particularly those with frailty. METHOD: A mapping review of pain management programmes and psychological therapies for community-dwelling older people living with chronic pain. We searched for systematic reviews of randomised controlled trials and for individual randomised controlled trials and extracted data from eligible studies. RESULTS: Searches resulted in 3419 systematic review records and 746 RCT records from which there were 33 eligible interventions identified in 31 eligible RCTs (48 reports). Broad aims of the interventions were to: improve physical, psychological, or social functioning; adjust the effects or sensation of pain psychologically; enhance self-care with self-management skills or knowledge. Common mechanisms of change proposed were self-efficacy enhanced by self-management tasks and skills, using positive psychological skills or refocusing attention to improve responses to pain, and practising physical exercises to improve physiological well-being and reduce restrictions from pain. Content of interventions included: skills training and activity management, education, and physical exercise. Interventions were delivered in person or remotely to individuals or in groups, typically in 1-2 sessions weekly over 5-12 weeks. CONCLUSION: All the evaluated interventions appeared to show potential to provide some benefits to older people. None of the included studies assessed frailty. However, some of the included interventions appear appropriate for community-dwelling older people living with both frailty and pain.

Psychological and Social Factors Associated with Coexisting Frailty and Cognitive Impairment: A Systematic Review.

Those living with coexistent frailty and cognitive impairment are at risk of poorer health outcomes. Research often focuses on identifying biological factors. This review sought to identify the association psychological and social factors have with coexisting physical and cognitive decline. Six databases were systematically searched in July 2020. Studies included individuals aged 60 years or older identified as being both frail and cognitively impaired. A narrative synthesis examined patterns within the data. Nine studies were included, most employed a cross-sectional design. Depression was investigated by all nine studies, those with coexistent frailty and cognitive impairment had higher levels of depressive symptoms than peers. Findings were mixed on social factors, although broadly indicate lower education, living alone and lower material wealth were more frequent in those living with coexistent decline. Further research is needed to explore potentially modifiable psychological and social factors which could lead to the development of supportive interventions.

An intervention to increase physical activity in care home residents: results of a cluster-randomised, controlled feasibility trial (the REACH trial).

BACKGROUND: Care home (CH) residents are mainly inactive, leading to increased dependency and low mood. Strategies to improve activity are required. DESIGN AND SETTING: Cluster randomised controlled feasibility trial with embedded process and health economic evaluations. Twelve residential CHs in Yorkshire, United Kingdom, were randomised to the MoveMore intervention plus usual care (UC) (n = 5) or UC only (n = 7). PARTICIPANTS: Permanent residents aged ≥65 years. INTERVENTION: MoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents. OBJECTIVES AND MEASUREMENTS: Feasibility objectives relating to recruitment, intervention delivery, data collection and follow-up and safety concerns informed the feasibility of progression to a definitive trial. Data collection at baseline, 3, 6 and 9 months included: participants' physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation. RESULTS: 300 residents were screened; 153 were registered (62 MoveMore; 91 UC). Average cluster size: MoveMore: 12.4 CHs; UC: 13.0 CHs. There were no CH/resident withdrawals. Forty (26.1%) participants were unavailable for follow-up: 28 died (12 MoveMore; 16 UC); 12 moved from the CH. Staff informant/proxy data collection for participants was >80%; data collection from participants was <75%; at 9 months, 65.6% of residents provided valid accelerometer data; two CHs fully, two partially and one failed to implement the intervention. There were no safety concerns. CONCLUSIONS: Recruiting CHs and residents was feasible. Intervention implementation and data collection methods need refinement before a definitive trial. There were no safety concerns.

Maintaining and improving mouth care for care home residents: A participatory research project.

BACKGROUND: Many people residing in nursing or residential care homes (also called long-term care facilities) live with physical or cognitive difficulties. Staff working in these environments often help residents (particularly those with more advanced dementia) with their personal care needs, including maintaining mouth care and health. Poor oral health is associated with many difficulties, including increased risk of respiratory problems, pain and discomfort. Yet, concerns have been raised that staff may not have the knowledge and skills to effectively support residents with oral care and health. There is therefore an important gap between what is known about the importance of maintaining oral health (scientific evidence) and daily practice in long-term care environments. OBJECTIVES: To work with care home staff: (1) to create a learning culture to address how to promote mouth care for residents, particularly when a resident resists support with this aspect of care; and (2) to effect mouth care practice changes (if required) using participatory and inclusive research cycles. METHODS AND RESULTS: We conducted a participatory research project to address this important area of care. Four participatory research 'cycles' were conducted. Cycle one explored existing literature to develop accessible guidance on strategies that staff could use to support residents to maintain and improve oral care, particularly when a resident may resist such care. Cycle two built on this review to determine knowledge levels within the care team. This highlighted deficiencies in staff knowledge, skills and competence for providing mouth care and their need for training to address this. Cycle three identified evidence-based strategies to develop staff understanding and knowledge. Cycle four brought together experts from nursing, dentistry, behaviour change, systematic reviews and care homes research to develop a grant application to progress this work further. CONCLUSION: This paper provides an example of the processes undertaken in a participatory research project, bringing together science and practice to improve an essential area of care. IMPLICATIONS FOR PRACTICE: Using participatory research approaches in this setting can allow the effective translation of uncertainties in care and practice into questions that can be addressed by research, leading to meaningful outcomes for those living and working in care homes.

Inter-rater reliability of care home staff's proxy judgements with residents' assessments of their own health-related quality of life: an analysis of the PATCH trial EQ-5D data.

OBJECTIVES: to compare care staff proxies with care home residents' self-assessment of their health-related quality of life (HRQoL). METHODS: we assessed the degree of inter-rater reliability between residents and care staff proxies for the EQ-5D-5L index, domains and EQ Visual Analogue Scale at baseline, 3 months and 6 months, collected as part of the PATCH trial. We calculated kappa scores. Interpreted as <0 no agreement, 0-0.2 slight, 0.21-0.60 fair to moderate and >0.6 substantial to almost perfect agreement. Qualitative interviews with care staff and researchers explored the challenges of completing these questions. RESULTS: over 50% of the HRQoL data from residents was missing at baseline compared with a 100% completion rate by care staff proxies. A fair-to-moderate level of agreement was found for the EQ-5D-5L index. A higher level of agreement was achieved for the EQ-5D-5L domains of mobility and pain. Resident 'non-completers' were more likely to: be older, have stayed a longer duration in the care home, have lower Barthel Index and Physical Activity and Mobility in Residential Care (PAM-RC) scores, a greater number of co-morbidities and have joined the trial through consultee agreement. Interviews with staff and researchers indicated that it was easier to rate residents' mobility levels than other domains, but in general it was difficult to obtain data from residents or to make an accurate proxy judgement for those with dementia. CONCLUSIONS: whilst assessing HRQoL by care staff proxy completion provides a more complete dataset, uncertainty remains as to how representative these values are for different groups of residents within care homes.

A posture and mobility training package for care home staff: results of a cluster randomised controlled feasibility trial (the PATCH trial).

BACKGROUND: provision of care for care home residents with complex needs is challenging. Physiotherapy and activity interventions can improve well-being but are often time-limited and resource intensive. A sustainable approach is to enhance the confidence and skills of staff who provide care. This trial assessed the feasibility of undertaking a definitive evaluation of a posture and mobility training programme for care staff. DESIGN AND SETTING: a cluster randomised controlled feasibility trial with embedded process evaluation. Ten care homes in Yorkshire, United Kingdom, were randomised (1:1) to the skilful care training package (SCTP) or usual care (UC). PARTICIPANTS: residents who were not independently mobile. INTERVENTION: SCTP-delivered by physiotherapists to care staff. OBJECTIVES AND MEASUREMENTS: key objectives informed progression to a definitive trial. Recruitment, retention and intervention uptake were monitored. Data, collected by a blinded researcher, included pain, posture, mobility, hospitalisations and falls. This informed data collection feasibility and participant safety. RESULTS: a total of 348 residents were screened; 146 were registered (71 UC, 75 SCTP). Forty two were lost by 6 months, largely due to deaths. While data collection from proxy informants was good (>95% expected data), attrition meant that data completion rates did not meet target. Data collection from residents was poor due to high levels of dementia. Intervention uptake was variable-staff attendance at all sessions ranged from 12.5 to 65.8%. There were no safety concerns. CONCLUSION: care home and resident recruitment are feasible, but refinement of data collection approaches and intervention delivery are needed for this trial and care home research more widely.

Recruiting care homes to a randomised controlled trial.

BACKGROUND: There are more than a quarter of a million individuals aged ≥ 65 years who are resident in care homes in England and Wales. Care home residents have high levels of cognitive impairment, physical disability, multimorbidity and polypharmacy. Research is needed to ensure there are robust, evidence-based interventions to improve the quality of life of this frail group. However, there is a paucity of research studies in this area. Recruiting care homes and their residents to research is challenging. A feasibility, cluster randomised controlled trial was undertaken as part of a research programme to identify ways to develop and test methods to enhance the physical activity of care home residents. This paper describes two methods of recruiting care homes to the trial and draws out learning to inform future studies. METHODS: Eligible care homes met the following criteria: they were within a defined geographical area in the north of England; provided residential care for adults ≥ 65 years of age; had not previously been involved in the research programme; were not taking part in a conflicting study; were not recorded on the Care Quality Commission website as 'inadequate' or 'requiring improvements' in any area; and had ≥ 10 beds. Care homes were identified by a 'systematic approach' using the Care Quality Commission website database of care homes or a 'targeted approach' via a network of research-ready care homes. A standardised method was used to recruit care homes including eligibility screening; invitation letters; telephone contact; visits; formal letter of agreement. RESULTS: In the systematic approach, 377 care homes were screened, 230 (61%) were initially eligible and invited to participate, 11 were recruited (recruitment rate (RR) 4.8%). In the targeted approach, 15 care homes were invited to participate, two were recruited (RR 13.3%). Overall, 245 care homes were approached and 13 recruited (RR 5.3%). A variety of care homes were recruited to the trial in terms of size, location, ownership and care provision. CONCLUSIONS: Systematic recruitment of care homes to the study was time-consuming and resource-heavy but led to a variety of care homes being recruited. The targeted approach led to a higher recruitment rate. TRIAL REGISTRATION: ISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015.

PATCH: posture and mobility training for care staff versus usual care in care homes: study protocol for a randomised controlled trial.

BACKGROUND: Residents of care homes have high levels of disability and poor mobility, but the promotion of health and wellbeing within care homes is poorly realised. Residents spend the majority of their time sedentary which leads to increased dependency and, coupled with poor postural management, can have many adverse outcomes including pressure sores, pain and reduced social interaction. The intervention being tested in this project (the Skilful Care Training Package) aims to increase the awareness and skills of care staff in relation to poor posture in the older, less mobile adult and highlight the benefits of activity, and how to skilfully assist activity, in this group to enable mobility and reduce falls risk. Feasibility work will be undertaken to inform the design of a definitive cluster randomised controlled trial. METHODS: This is a cluster randomised controlled feasibility trial, aiming to recruit at least 12-15 residents at each of 10 care homes across Yorkshire. Care homes will be randomly allocated on a 1:1 basis to receive either the Skilful Care Training Package alongside usual care or to continue to provide usual care alone. Assessments will be undertaken by blinded researchers with participating residents at baseline (before care home randomisation) and at three and six months post randomisation. Data relating to changes in physical activity, mobility, posture, mood and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of NHS service usage will be collected to inform the economic analysis. An embedded process evaluation will explore intervention delivery and its acceptability to staff and residents. DISCUSSION: Participant uptake, engagement and retention are key feasibility outcomes. Exploration of barriers and facilitators to intervention delivery will inform intervention optimisation. Study results will inform progression to a definitive trial and add to the body of evidence for good practice in care home research. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN50080330 . Registered on 27 March 2017.

Research Exploring Physical Activity in Care Homes (REACH): study protocol for a randomised controlled trial.

BACKGROUND: As life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home setting spend most of their time sedentary, and this is one of the leading preventable causes of death. Encouraging residents to engage in more physical activity could deliver benefits in terms of physical and psychological health, and quality of life. This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity. METHODS/DESIGN: This is a cluster randomised feasibility trial, aiming to recruit at least 8-12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at baseline (prior to care home randomisation) and at 3, 6, and 9 months post-randomisation. Data relating to changes in physical activity, physical function, level of cognitive impairment, mood, perceived health and wellbeing, and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care, and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of National Health Service (NHS) usage will be collected to inform the economic analysis. An embedded process evaluation will obtain information to test out the theory of change underpinning the intervention and its acceptability to staff and residents. DISCUSSION: This feasibility trial with embedded process evaluation and collection of health economic data will allow us to undertake detailed feasibility work to inform a future large-scale trial. It will provide valuable information to inform research procedures in this important but challenging area. TRIAL REGISTRATION: ISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015.