Navigating uncharted territory with a borrowed map: lessons from setting up the BATH-OUT-2 randomised controlled trial in adult social care and housing services in English local authorities.

Populations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services.Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service (NHS). However, adult social care and local authorities are relatively uncharted territory for trials. BATH-OUT-2 is one of the first clinical trials currently underway within adult social care and housing adaptations services in six English local authorities. It provides an opportunity to explore how the clinical trial road map fares in these settings.Whilst setting up BATH-OUT-2, we encountered challenges with securing funding for the trial, lack of non-NHS intervention costs, using research and support costs as intended, gaining approvals, identifying additional trial sites, and including people who lack the mental capacity to provide informed consent. Overall, our experience has been like navigating uncharted territory with a borrowed map. In the UK, the clinical trial road map was developed for medical settings. Its key features are integrated within the NHS landscape but have been largely absent, unfamiliar, inaccessible, or irrelevant in social care and wider local authority terrain. Navigating the set-up of a clinical trial outside the NHS has been a complicated and disorientating journey.BATH-OUT-2 highlights how local authorities generally and adult social care specifically are a relatively new and certainly different type of setting for trials. Whilst this poses a challenge for conducting trials, it also presents an opportunity to question longstanding assumptions within trials practices, reimagine the conventional clinical trial road map, and take it in new directions. As the UK research landscape moves forward and becomes better primed for randomised evaluations in local authorities, we propose several suggestions for building on recent progress and advancing trials within adult social care and across health and care systems.

Bathing Adaptations in the Homes of Older Adults (BATH-OUT-2): study protocol for a randomised controlled trial, economic evaluation and process evaluation.

BACKGROUND: The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is housing adaptation, but there are often lengthy waiting times for statutory provision. In this randomised controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of bathing adaptations compared to no adaptations and to explore the factors associated with routine and expedited implementation of bathing adaptations. METHODS: BATH-OUT-2 is a multicentre, two-arm, parallel-group RCT. Adults aged 60 and over who are referred to their local authority for an accessible level access shower will be randomised, using pairwise randomisation, 1:1, to receive either an expedited provision of an accessible shower via the local authority or a usual care control waiting list. Participants will be followed up for a maximum of 12 months and will receive up to four follow-ups in this duration. The primary outcome will be the participant's physical well-being, assessed by the Physical Component Summary score of the Short Form-36 (SF-36), 4 weeks after the intervention group receives the accessible shower. The secondary outcomes include the Mental Component Summary score of the SF-36, self-reported falls, health and social care resource use, health-related quality of life (EQ-5D-5L), social care-related quality of life (Adult Social Care Outcomes Toolkit (ASCOT)), fear of falling (Short Falls Efficacy Scale), independence in bathing (Barthel Index bathing question), independence in daily activities (Barthel Index) and perceived difficulty in bathing (0-100 scale). A mixed-methods process evaluation will comprise interviews with stakeholders and a survey of local authorities with social care responsibilities in England. DISCUSSION: The BATH-OUT-2 trial is designed so that the findings will inform future decisions regarding the provision of bathing adaptations for older adults. This trial has the potential to highlight, and then reduce, health inequalities associated with waiting times for bathing adaptations and to influence policies for older adults. TRIAL REGISTRATION: ISRCTN Registry ISRCTN48563324. Prospectively registered on 09/04/2021.

Normative puzzles for local government: Managing the introduction of single-handed care in England.

A crisis in social care is apparent across the developed world as ageing populations put unprecedented demand on understaffed social care workforces. A recent popular response to this 'care crisis' within the UK involves the 'innovation' of single-handed care (SHC). SHC involves a care package with two or more homecare workers being reduced to one worker using advanced equipment and new moving and handling techniques. In this article, we explore how SHC is rendered in 245 documents from 52 local authorities in England. Using Actor Network Theory as an interpretative lens, we suggest documents attempt to satisfy three 'duties of care': to the individual wellbeing of citizens, morally and fiscally to the collective and to innovation. Each appeal to different stakeholder groups necessary for SHC to work, but the combination of duties can pose problems in enabling coherent stories of SHC. Duties can be kept apart in different documents, but at times they must be brought together in certain textual spaces to enact SHC as a coherent enterprise. Here, the potential tensions that emerge are routinely orientated to as (merely) problems of process that can and should be managed in and through a more refined approach to change management.

'Single-handed care' initiatives and reviews of double-handed homecare packages: A survey of practices in English local authorities with adult social care responsibilities.

International health and social care systems are experiencing unprecedented pressure and demand. 'Single-handed care' initiatives seek to identify whether all or part of a homecare package involving more than one care worker can be safely reduced to a single worker. Little is known about these initiatives across local authorities. The aim of this study was to identify, describe and explain current processes and practices for single-handed care initiatives and double-handed homecare reviews. An electronic survey link was sent to each local authority with social care responsibilities in England. The questions covered a range of areas in relation to single-handed care processes and included a combination of pre-coded and free-text responses. Responses were received from 76 (50%) local authorities. Findings were that over 12,000 reviews were reported within a year with a median of 141 (IQR 45-280) from 53 authorities that provided figures. Reviews were usually led by a local authority occupational therapist. On average, 540 min was spent per review, including conducting and organising the review, documentation, and travel. In nearly half the authorities, double handed care remained at least partially in place following at least 80% of the reviews and remained wholly in place following at least 60%. Local authorities also reported some resistance from homecare providers when implementing single-handed care. The findings have confirmed anecdotal evidence that reviews of double-handed homecare packages are common practice within local authorities. Given the amount of time taken with these reviews, and paucity of evidence on outcomes for people receiving them, further research should evaluate this.

Bathing adaptations in the homes of older adults and their carers (BATH-OUT): a qualitative extended follow-up study with concurrent nested outcome assessments.

OBJECTIVE: We previously completed a nested qualitative interview study, as part of a feasibility randomised controlled trial with 21 older adults and five carers who had an accessible shower installed in their home. The objective of this study was to follow-up the participants approximately 24 months on. DESIGN: This was an extended follow-up study comprising semi-structured interviews to explore the longer-term experiences of the older adults. To elaborate and add breadth to the findings these were supplemented with concurrent nested outcome assessment measures. SETTING: The study was conducted within one local authority City Council housing adaptations service. PARTICIPANTS: Thirteen older adults (mean age: 76; SD: 6.87) and three carers from the original study completed the extended follow-up study. INTERVENTIONS: The intervention in the original study was the provision of an accessible showering facility either by immediate provision or routine 4-month wait. RESULTS: Findings were presented thematically with three themes identified: environment, autonomy with personal care and wider occupation. Improvements in the physical and social environment combined with greater autonomy in personal care were reported to impact more widely on older adults' occupations including other self-care activities and leisure. These are consistent with domains underpinning social care related quality of life particularly personal safety, cleanliness and occupation. The results of the outcome assessments support the qualitative themes demonstrating sustained improvements in quality of life, independence in daily living and reduced fear of falling. CONCLUSION: This research suggests the positive lived experiences reported immediately after the installation of the accessible shower are still evident up to 28 months later in this cohort of older adults. Future research should investigate medium to longer-term outcomes with a more diverse sample. TRIAL REGISTRATION: ISRCTN14876332; Post-results.

Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study.

OBJECTIVE: To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors. DESIGN: Feasibility randomised controlled study with nested qualitative interview study. SETTING: The intervention was delivered in the community in either a group or one-to-one format. SUBJECTS: Carers and stroke survivors within one year of stroke onset. INTERVENTIONS: A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention. MAIN OUTCOME: Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation). RESULTS: Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups. CONCLUSIONS: Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs.

The lived experience of bathing adaptations in the homes of older adults and their carers (BATH-OUT): A qualitative interview study.

The onset of disability in bathing may be followed by disability in other daily activities for older adults. A bathing adaptation usually involves the removal of a bath or inaccessible shower and replacement with a level, easy access shower. The purpose is to remove the physical environmental barriers and restore older adults' ability to bathe safely and/or independently. The aim of this study was to explore the views and experiences of older adults and their carers who had received a bathing adaptation in order to examine how the adaptation had affected them and identify mechanisms of impact and outcomes from their perspectives. The study was nested within a feasibility Randomised Controlled Trial (RCT) (BATH-OUT) conducted within one local authority housing adaptations service in England. Semi-structured interviews were completed between 21 December 2016 and 19 August 2017 with 21 older adults and five carer participants of the feasibility RCT. Interview participants were purposively sampled on living arrangement and gender. Interviews were audio-recorded, transcribed verbatim and analysed in seven stages using framework analysis. Findings were presented thematically. Five themes were identified: ease of use; feeling safe; feeling clean; independence, choice and control; and confidence and quality of life. The removal of the physical barriers in the bathroom led to older adults re-mastering the activity of bathing, having an improved sense of physical functioning which gave a sense of 'freedom'. This appeared to impact a range of areas contributing to a wider sense of increased confidence consistent with constructs underpinning social care-related quality of life. We suggest that future research should examine housing adaptations from a person-environment fit approach, and that timely restoration of bathing ability is especially important as it can affect confidence and perceived competence in other areas of daily living.

Bathing adaptations in the homes of older adults (BATH-OUT): results of a feasibility randomised controlled trial (RCT).

BACKGROUND: Housing adaptations have been identified as an important environmental and prevention intervention for older adults, which may improve health and quality of life. The onset of disability in bathing can act as a warning for further disability in other activities and may therefore be a judicious time-point for intervention. The aim of this study was to determine the feasibility of conducting a Randomised Controlled Trial (RCT) of bathing adaptations, to evaluate whether they improve older adults' perceived health status and quality of life, prevent further functional deterioration, and reduce the use of other health and social care resources. This study was conducted in preparation for a powered RCT. METHOD: Eligibility criteria were aged > 65 and referred to local authority housing adaptations service for an accessible flush-floor shower. Participants were randomised to either usual adaptations (3-4 month wait) or immediate adaptations (no wait). Outcomes were assessed at 3, 6 and 9 months and included perceived physical and mental health status, health and social care related quality of life, independence in activities of daily living (ADL) and bathing, and falls. Data on costs and the use of health and social care resources were collected during follow-up in order to inform a definitive health economic evaluation. RESULTS: Sixty participants were recruited and randomised, 31 to immediate adaptations and 29 to waiting list control. Mean age was 77(SD8), 58% women and 58% living alone. Follow-ups were completed with 90, 85 and 72% at 3, 6 and 9 months respectively. Adaptations were delivered to 65% of participants within the requisite timescales as there were delays with some privately owned properties. There were improvements from baseline in both groups on all outcome measures following the completion of the adaptations. CONCLUSIONS: This is the first RCT of housing adaptations in the UK. We demonstrated the feasibility of using a waiting list control, subject to minor alterations to the timescales for privately owned properties. A powered trial would evaluate the impact on older adults' quality of life and investigate the impact of waiting times on functional outcomes and health and care resource use. TRIAL REGISTRATION: ISRCTN14876332 Registered 12 July 2016.

Interventions to reduce dependency in bathing in community dwelling older adults: a systematic review.

BACKGROUND: The onset of bathing disability for older adults has been found to be an indicator and potential precursor of further disability. Thus interventions targeting bathing may prevent or delay further disability and the use of health and social care services. The aim of this systematic review was to identify interventions targeted at reducing dependency in bathing for community dwelling older adults, and determine their content and effectiveness in maintaining or improving function and quality of life. METHODS: We conducted a systematic search of electronic databases including: The Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; AMED; CINAHL; PsycINFO and OTSeeker. The search took place on 18 October 2016. We included randomised controlled trials, nonrandomised controlled trials, and controlled before and after studies that evaluated an intervention designed to reduce dependency in bathing. Articles were screened for inclusion by two independent reviewers; risk of bias was assessed using quality assessment tools; and data extracted using pre-prepared forms. Disagreements were resolved by discussion and inclusion of a third reviewer. RESULTS: The search process identified one study for inclusion in the review. This study evaluated a bathing intervention delivered by an occupational therapist following discharge from hospital. Overall, the findings suggest modest improvements in functional ability in favour of the intervention group although the results should be interpreted with caution. CONCLUSION: Despite evidence suggesting the importance of addressing bathing difficulties as a means of possible prevention of disability in the ageing process, there is a dearth of evaluative or interventional research studies. Further robust research is warranted, including studies of randomised and controlled design.

Biopsychosocial Intervention for Stroke Carers (BISC): protocol for a feasibility randomised controlled trial (RCT).

INTRODUCTION: Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT). METHODS AND ANALYSIS: Feasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life. ETHICS AND DISSEMINATION: Favourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN15643456; Pre-results.

Bathing adaptations in the homes of older adults (BATH-OUT): protocol for a feasibility randomised controlled trial (RCT).

INTRODUCTION: The Care Act 2014 has placed a responsibility on local authorities in England to provide services that prevent deterioration and minimise the use of other health and social care services. Housing adaptations have been identified as 1 of the 10 most promising prevention services for older adults, with bathing adaptations being the most requested. However, many local authorities have lengthy waiting times which may increase costs, reduce effectiveness and reduce the preventive effect. There is no robust evidence of the effect of these adaptations on: health, well-being and functional ability. METHODS AND ANALYSIS: This is a feasibility randomised controlled trial (RCT) with nested qualitative interview study. The RCT will recruit between 40 and 60 people who have been referred for an accessible showering facility, and their carers, from 1 local authority in England. They will be randomised to either usual adaptations (∼3-month wait) or immediate adaptations (no wait). The primary outcome is the feasibility of conducting a powered study. The outcomes assessed will be: health and social care-related quality of life, independence in activities of daily living and bathing, falls and use of health and social care services. Outcomes will be assessed at 3 and 6 months. Preliminary health economic feasibility will be established. ETHICS AND DISSEMINATION: Favourable ethical opinion was provided by the Social Care Research Ethics Committee (reference number 16/IEC08/0017). The results of this study will lay the foundations for a further powered study. This would investigate the effect of bathing adaptations on quality of life and whether increased waiting times are associated with poorer outcomes and increased costs. The results have further potential to inform trials of other housing or social care interventions using the novel waiting list control method. Dissemination will include peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN14876332; Pre-results.

Occupational Therapy in HomEcare Re-ablement Services (OTHERS): results of a feasibility randomised controlled trial.

OBJECTIVES: The objective of this study was to test the feasibility of conducting a randomised controlled trial (RCT) of an intervention targeted at activities of daily living (ADL), delivered by an occupational therapist, in homecare reablement. DESIGN: Feasibility parallel group RCT. SETTING: Single-site local authority homecare reablement service. PARTICIPANTS: People referred for homecare reablement with ability to consent. Exclusion criteria were as follows: inability to speak English, receiving other community therapy services, needing two or more to assist transfer and receiving end-of-life care. CONTROL: 'Usual care' was 6 weeks of homecare reablement delivered by social care workers (no routine health professional input). INTERVENTION: A targeted ADL programme, delivered by an occupational therapist incorporating goal setting, teaching/practising techniques, equipment/adaptations and provision of advice/support. This was in addition to usual care. OUTCOME MEASURES: Aspects of feasibility including eligibility, recruitment, intervention delivery, attrition and suitability and sensitivity of outcome measures. Participant outcomes were personal and extended ADL, quality of life, falls and use of health and social care services. RESULTS: 30 participants were recruited, 15 to each arm, which was 60% of those eligible. Data from 22 (73%) were analysed at 6 months. Of the 15 participants, 13 (86%) received the intervention and were able to set one or more ADL goals. There were improvements from baseline in both groups, although overall improvements were greater in the occupational therapy (OT) intervention group. The biggest threat to feasibility was a change in service configuration during the trial, involving additional occupational therapy input, affecting usual care and recruitment. CONCLUSIONS: Despite the service reconfiguration, it was feasible to recruit and retain participants, deliver the intervention and collect outcome data that were responsive to change. The choice of primary outcome measure remains unclear. A further powered study is feasible and warranted; however, the design will require careful consideration because of ongoing national changes in service configurations. TRIAL REGISTRATION NUMBER: ISRCTN21710246; Results.

Interventions to reduce dependency in personal activities of daily living in community dwelling adults who use homecare services: a systematic review.

OBJECTIVES: To identify interventions that aim to reduce dependency in activities of daily living (ADL) in homecare service users. To determine: content; effectiveness in improving ability to perform ADL; and whether delivery by qualified occupational therapists influences effectiveness. DATA SOURCES: The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, AMED, CINAHL, PsycINFO, OTseeker, PEDro, Web of Science, CIRRIE, and ASSIA. REVIEW METHODS: We included: randomised controlled trials, non-randomised controlled trials and controlled before and after studies. Two reviewers independently screened studies for inclusion, assessed risk of bias and extracted data. A narrative synthesis of the findings was conducted. RESULTS: Thirteen studies were included, totalling 4975 participants. Ten (77%) were judged to have risk of bias. Interventions were categorised as those termed 're-ablement' or 'restorative homecare' (n=5/13); and those involving separate components which were not described using this terminology (n=8/13). Content of the intervention and level of health professional input varied within and between studies. Effectiveness on ADL: eight studies included an ADL outcome, five favoured the intervention group, only two with statistical significance, both these were controlled before and after studies judged at high risk of bias. ADL outcome was reported using seven different measures. Occupational therapy: there was insufficient evidence to determine whether involvement of qualified occupational therapists influenced effectiveness. CONCLUSION: There is limited evidence that interventions targeted at personal ADL can reduce homecare service users' dependency with activities, the content of evaluated interventions varies greatly.

Occupational Therapy in HomEcare Re-ablement Services (OTHERS): study protocol for a randomized controlled trial.

BACKGROUND: Homecare re-ablement services have been developed by local authorities in England in response to the government agenda for health and social care. These services aim to optimize users' independence and ability to cope at home, and reduce the need for ongoing health and social care services. However, there is currently limited evidence and guidance regarding the optimum configuration and delivery of re-ablement services. In particular, the impact of occupational therapy input on service user outcomes has been highlighted as a specific research priority. METHODS/DESIGN: This feasibility randomized controlled trial (RCT) will recruit 50 people from one local authority led homecare re-ablement service in England. Those who provide informed consent will be randomized to receive either usual homecare re-ablement (without routine occupational therapy input) or usual homecare re-ablement plus an enhanced program targeted at activities of daily living (ADL), delivered by an occupational therapist. The primary aim of this study is to assess the feasibility of conducting a further, powered study. The participant outcomes assessed will be independence in personal and extended ADL, health and social care-related quality of life, number of care support hours, falls, acute and residential admissions and use of health and social care services. These will be assessed at two weeks, three months and six months post-discharge from the re-ablement service. DISCUSSION: To our knowledge, this is the first RCT of occupational therapy in homecare re-ablement services. The results of this study will lay the foundations for a further powered study. The findings will be relevant to researchers, clinicians, commissioners and users of adult social care services. TRIAL REGISTRATION: Current Controlled Trials registration number: ISRCTN21710246 (registered on 31March 2014).

Interventions to reduce dependency in personal activities of daily living in community-dwelling adults who use homecare services: protocol for a systematic review.

BACKGROUND: There is a growing demand for services whereby individuals receive assistance from care workers for personal care within the home. This has led to the development of re-ablement or restorative homecare services that provide time-limited input aimed at reducing dependency in personal activities of daily living, and preventing or delaying the need for further homecare support. However, little is currently known about how such interventions are configured, or how they may affect individuals' ability to carry out personal care independently. METHODS/DESIGN: We will seek to identify studies that compare an intervention designed to reduce dependency in personal activities of daily living with routine input or usual care as the control. We will include randomised controlled trials, nonrandomised controlled trials, and controlled before and after studies. We will also include interrupted time series studies. We shall search electronic databases in addition to searching for ongoing and unpublished studies, and where appropriate will contact key authors. Two reviewers will independently screen articles for inclusion; will assess risk of bias using quality assessment tools; and will carry out data extraction using pre-prepared forms. Any disagreements, at any stage, will be resolved by discussion and the involvement of a third reviewer if needed. We will produce a narrative summary of the results. A meta-analysis will be conducted if sufficient data are available of appropriate quality and comparability. DISCUSSION: The findings from this review will inform future practice within homecare re-ablement services; will inform policy decisions about the structure, organisation and content of such services; and will identify areas where further research is warranted. TRIAL REGISTRATION: This review protocol has been registered on the PROSPERO database (CRD42013004163).