scholarly journals A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Ruth Stow ◽  
Natalie Ives ◽  
Christina Smith ◽  
Caroline Rick ◽  
Alison Rushton
Keyword(s):  
Care Home ◽  
Feasibility Trial ◽  
Nutritional Interventions ◽  
Cluster Randomised

scholarly journals Care home resident and staff perceptions of the acceptability of nutrition intervention trial procedures: a qualitative study embedded within a cluster randomised feasibility trial

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022307
Author(s):  
Ruth Elizabeth Stow ◽  
Christina H Smith ◽  
Alison B Rushton
Keyword(s):  
Focus Groups ◽  
Care Home ◽  
Nutrition Intervention ◽  
Nutrition Support ◽  
Feasibility Trial ◽  
Trial Participation ◽  
Staff Perceptions ◽  
Nutritional Interventions ◽  
Cluster Randomised ◽  
Care Home Resident

ObjectivesTo examine care home resident and staff perceptions of the acceptability of participating in a feasibility trial evaluating nutritional interventions in the treatment of malnutrition.DesignExploratory qualitative methodology was used to gather descriptions of resident and staff perceptions of trial procedures, using semi-structured interviews with residents and focus groups with staff. The interviews were used to explore individual perceptions of the acceptability of the assigned intervention and the outcomes measured. Focus groups were used to explore staff experiences of trial participation and perspectives of nutritional support interventions.SettingThe study was embedded within a cluster randomised feasibility trial, which randomised six care homes to provide standard care (SC), food-based (FB) intervention or oral nutritional supplement (ONS) intervention to residents with, or at risk of, malnutrition.ParticipantsResidents in the trial with capacity to consent (n=7) formed the sampling frame for inclusion. Four agreed to be approached by the researcher and to take part in the individual interviews. All were women, representing two arms of the trial (ONS and SC). Twelve staff participated in six focus groups, one at each care home. All participants were women, representing all three arms of the trial.ResultsMajor themes that emerged from both interviews and focus groups included the perceived acceptability of trial involvement, the value of residents completing participant-reported outcome measures and the challenges associated with outcomes measurement in this setting. Themes that emerged from the focus groups alone, included the importance of individualising an intervention, and the perceived value of FB and ONS interventions and dietetic input.ConclusionsResidents and staff perceived involvement in a trial evaluating nutritional interventions to be acceptable, although the challenges associated with research in this setting were acknowledged. Resident preferences were highlighted by staff as an important consideration when implementing a nutrition support plan.Trial registration numberISRCTN38047922

scholarly journals Strategies to enhance routine physical activity in care home residents: the REACH research programme including a cluster feasibility RCT

2021 ◽  
Vol 9 (9) ◽  
pp. 1-314
Author(s):  
Anne Forster ◽  
Mary Godfrey ◽  
John Green ◽  
Nicola McMaster ◽  
Jennifer Airlie ◽  
...  
Keyword(s):  
Physical Activity ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Care Home ◽  
Intervention Mapping ◽  
Research Programme ◽  
Care Homes ◽  
Feasibility Trial ◽  
Daily Routines ◽  
Cluster Randomised

Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5). Setting The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK. Participants The participants were elderly residents, carers, managers and staff of care homes. Intervention The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines. Main outcome measures The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5). Results Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and support the movement of residents in their daily routines. Workstream 5 – 12 care homes and 153 residents were recruited to the cluster randomised feasibility trial. Recruitment in the care homes varied (40–89%). Five care homes were randomised to the intervention and seven were randomised to usual care. Predetermined progression criteria were recruitment of care homes and residents (green); intervention delivery (amber); and data collection and follow-up – 52% of residents provided usable accelerometer data at 9 months (red), > 75% of residents had reported outcomes at 9 months (green, but self-reported resident outcomes were red), 26% loss of residents to follow-up at 9 months [just missing green criterion (no greater than 25%)] and safety concerns (green). Limitations Observations of residents’ movements were not conducted in private spaces. Working with care home residents to identify appropriate outcome measures was challenging. Take-up of the intervention was suboptimal in some sites. It was not possible to make a reliably informed decision on the most appropriate physical activity end point(s) for future use in a definitive trial. Conclusions A whole-home intervention was developed that was owned and delivered by staff and was informed by residents and staff. The feasibility of conducting a cluster randomised controlled trial was successfully tested: the target numbers of care homes and residents were recruited, demonstrating that it is possible to recruit care home residents to a cluster randomised trial, although this process was time-consuming and resource heavy. A large data set was collected, which provided a comprehensive picture of the environment, residents and staff in care homes. Extensive quantitative and qualitative work comprehensively explored a neglected area of health and social care research. Completion of ethnographic work in a range of settings enabled the production of an in-depth picture of life in care homes that will be helpful for other researchers considering organisational change in this setting. Future work The content and delivery of the intervention requires optimisation and the outcome measurement requires further refinement prior to undertaking a full trial evaluation. Consideration could be given to a recommended, simplified, core outcome set, which would facilitate data collection in this population. Trial registration Current Controlled Trials ISRCTN16076575. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grant for Applied Research programme and will be published in full in Programme Grant for Applied Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

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

2020 ◽  
Vol 49 (5) ◽  
pp. 821-828
Author(s):  
Liz Graham ◽  
Alison Ellwood ◽  
Karen Hull ◽  
Jill Fisher ◽  
Bonnie Cundill ◽  
...  
Keyword(s):  
Data Collection ◽  
Care Home ◽  
Well Being ◽  
Care Staff ◽  
Feasibility Trial ◽  
Training Package ◽  
Cluster Randomised ◽  
Mobility Training ◽  
Randomised Controlled ◽  
Intervention Uptake

Abstract 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.

scholarly journals Longer-term health and social care strategies for stroke survivors and their carers: the LoTS2Care research programme including cluster feasibility RCT

2021 ◽  
Vol 9 (3) ◽  
pp. 1-268
Author(s):  
Anne Forster ◽  
Seline Ozer ◽  
Thomas F Crocker ◽  
Allan House ◽  
Jenny Hewison ◽  
...  
Keyword(s):  
Usual Care ◽  
Unmet Needs ◽  
Social Care ◽  
Feasibility Trial ◽  
Stroke Survivors ◽  
Post Stroke ◽  
Cluster Randomised ◽  
Health And Social Care ◽  
Stroke Services ◽  
Randomised Controlled

Background It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration Current Controlled Trials ISRCTN38920246. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.

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