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.

scholarly journals An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Kathryn A. Radford ◽  
Kristelle Craven ◽  
Vicki McLellan ◽  
Tracey H. Sach ◽  
Richard Brindle ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Return To Work ◽  
Vocational Rehabilitation ◽  
Usual Care ◽  
Economic Forecast ◽  
Stroke Survivors ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
To Receive ◽  
Roll Out

Abstract Background Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) is more clinically and cost-effective for supporting post-stroke RTW, than UC alone. Methods Seven hundred sixty stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants’ homes or workplaces, and outpatient/inpatient therapy settings, via telephone, email, or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 h/week). Secondary outcomes will include mood, function, participation, health-related quality of life, confidence, intervention compliance, health and social care resource use, and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out. Discussion This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings. Trial registration ISRCTN, ISRCTN12464275. Registered on 26 February 2018.

scholarly journals The older prisoner health and social care assessment and plan (OHSCAP) versus treatment as usual: a randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Katrina Forsyth ◽  
Roger T. Webb ◽  
Laura Archer Power ◽  
Richard Emsley ◽  
Jane Senior ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Unmet Needs ◽  
Social Care ◽  
Controlled Trial ◽  
Care Needs ◽  
Treatment As Usual ◽  
Prisoner Health ◽  
Care Assessment ◽  
Health And Social Care ◽  
Randomised Controlled

Abstract Background Older people are the fastest-growing demographic group among prisoners in England and Wales and they have complex health and social care needs. Their care is frequently ad hoc and uncoordinated. No previous research has explored how to identify and appropriately address the needs of older adults in prison. We hypothesised that the Older prisoner Health and Social Care Assessment and Plan (OHSCAP) would significantly increase the proportion of met health and social care needs 3 months after prison entry, compared to treatment as usual (TAU). Methods The study was a parallel randomised controlled trial (RCT) recruiting male prisoners aged 50 and over from 10 prisons in northern England. Participants received the OHSCAP or TAU. A clinical trials unit used minimisation with a random element as the allocation procedure. Data analysis was conducted blind to allocation status. The intervention group had their needs assessed using the OHSCAP tool and care plans were devised; processes that lasted approximately 30 min in total per prisoner. TAU included the standard prison health assessment and care. The intention to treat principle was followed. The trial was registered with the UK Clinical Research Network Portfolio (ISRCTN ID: 11841493) and was closed on 30 November 2016. Results Data were collected between 28 January 2014 and 06 April 2016. Two hundred and forty nine older prisoners were assigned TAU of which 32 transferred prison; 12 were released; 2 withdrew and 1 was deemed unsafe to interview. Two hundred and fifty three 3 prisoners were assigned the OHSCAP of which 33 transferred prison; 11 were released; 6 withdrew and 1 was deemed unsafe to interview. Consequently, data from 202 participants were analysed in each of the two groups. There were no significant differences in the number of unmet needs as measured by the Camberwell Assessment of Needs – Forensic Short Version (CANFOR-S). The mean number of unmet needs for the OHSCAP group at follow-up was 2.03 (SD = 2.07) and 2.06 (SD = 2.11) for the TAU group (mean difference = 0.088; 95% CI − 0.276 to 0.449, p = 0.621). No adverse events were reported. Conclusion The OHSCAP was fundamentally not implemented as planned, partly due to the national prison staffing crisis that ensued during the study period. Therefore, those receiving the OHSCAP did not experience improved outcomes compared to those who received TAU. Trial registration Current Controlled Trials: ISRCTN11841493, 25/10/2012.

scholarly journals Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care

2015 ◽  
Vol 3 (1) ◽  
pp. 1-602 ◽  
Author(s):  
Lois H Thomas ◽  
Beverley French ◽  
Christopher J Sutton ◽  
Denise Forshaw ◽  
Michael J Leathley ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Usual Care ◽  
Evidence Synthesis ◽  
Randomised Trial ◽  
Research Programme ◽  
Post Stroke ◽  
Cluster Randomised ◽  
Systematic Voiding Programme ◽  
Randomised Controlled

BackgroundUrinary incontinence (UI) following acute stroke is common, affecting between 40% and 60% of people in hospital, but is often poorly managed.AimTo develop, implement and evaluate the preliminary effectiveness and potential cost-effectiveness of a systematic voiding programme (SVP), with or without supported implementation, for the management of UI after stroke in secondary care.DesignStructured in line with the Medical Research Council framework for the evaluation of complex interventions, the programme comprised two phases: Phase I, evidence synthesis of combined approaches to manage UI post stroke, case study of the introduction of the SVP in one stroke service; Phase II, cluster randomised controlled exploratory trial incorporating a process evaluation and testing of health economic data collection methods.SettingOne English stroke service (case study) and 12 stroke services in England and Wales (randomised trial).ParticipantsCase study, 43 patients; randomised trial, 413 patients admitted to hospital with stroke and UI.InterventionsA SVP comprising assessment, individualised conservative interventions and weekly review. In the supported implementation trial arm, facilitation was used as an implementation strategy to support and enable people to change their practice.Main outcome measuresParticipant incontinence (presence/absence) at 12 weeks post stroke. Secondary outcomes were quality of life, frequency and severity of incontinence, urinary symptoms, activities of daily living and death, at discharge, 6, 12 and 52 weeks post stroke.ResultsThere was no suggestion of a beneficial effect on outcome at 12 weeks post stroke [intervention vs. usual care: odds ratio (OR) 1.02, 95% confidence interval (CI) 0.54 to 1.93; supported implementation vs. usual care: OR 1.06, 95% CI 0.54 to 2.09]. There was weak evidence of better outcomes on the Incontinence Impact Questionnaire in supported implementation (OR 1.22, 95% CI 0.72 to 2.08) but the CI is wide and includes both clinically relevant benefit and harm. Both intervention arms had a higher estimated odds of continence for patients with urge incontinence than usual care (intervention: OR 1.58, 95% CI 0.83 to 2.99; supported implementation: OR 1.73, 95% CI 0.88 to 3.43). The process evaluation showed that the SVP increased the visibility of continence management through greater evaluation of patients’ trajectories and outcomes, and closer attention to workload. In-hospital resource use had to be based on estimates provided by staff. The response rates for the postal questionnaires were 73% and 56% of eligible patients at 12 and 52 weeks respectively. Completion of individual data items varied between 67% and 100%.ConclusionsThe trial was exploratory and did not set out to establish effectiveness; however, there are indications the intervention may be effective in patients with urge and stress incontinence. A definitive trial is now warranted.Study registrationThis study is registered as ISRCTN08609907.Funding detailsThe National Institute for Health Research Programme Grants for Applied Research programme. Excess treatment costs and research support costs were funded by participating NHS trusts and health boards, Lancashire and Cumbria and East Anglia Comprehensive Local Research Networks and the Welsh National Institute for Social Care and Health Research.

scholarly journals An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

2020 ◽  
Author(s):  
Kathryn Radford ◽  
Kristelle King ◽  
Vicki McLellan ◽  
Tracey Sach ◽  
Richard Brindle ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Return To Work ◽  
Vocational Rehabilitation ◽  
Usual Care ◽  
Self Report ◽  
Economic Forecast ◽  
Stroke Survivors ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
To Receive

Abstract Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e., usual NHS rehabilitation) is more clinically and cost effective for supporting post-stroke RTW, than UC alone.Methods: 760 stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants’ homes or workplaces, outpatient/inpatient therapy settings, via telephone, email or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 hours/week). Secondary outcomes will include: mood; function; participation; health-related quality of life; confidence; intervention compliance; health and social care resource use; and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out.Discussion: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings.Trial registration: ISRCTN, ISRCTN12464275.Registered on 26th February 2018, http://www.isrctn.com/ISRCTN12464275.

scholarly journals The Older Prisoner Health and Social Care Assessment and Plan (OHSCAP) versus Treatment as Usual: A Randomised Controlled Trial

2020 ◽  
Author(s):  
Katrina Forsyth ◽  
Roger T Webb ◽  
Laura Archer Power ◽  
Richard Emsley ◽  
Jane Senior ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Unmet Needs ◽  
Social Care ◽  
Controlled Trial ◽  
Care Needs ◽  
Treatment As Usual ◽  
Prisoner Health ◽  
Care Assessment ◽  
Health And Social Care ◽  
Randomised Controlled

Abstract Background Older adults are the fastest-growing subgroup among prisoners in England and Wales and have more health and social care needs than their younger counterparts and those the same age living in the community . We hypothesised that the Older prisoner Health and Social Care Assessment and Plan (OHSCAP) would significantly increase the proportion of met health and social care needs three months after prison entry, compared to treatment as usual (TAU).MethodsA parallel randomised controlled trial (RCT) was conducted at ten prisons in the North of England. Males aged 50 and over received the OHSCAP or TAU. The allocation procedure was minimisation with a random element. The OHSCAP process involved individuals having their needs assessed, care plans being created and reviewed. TAU encompassed the standard prison health assessment. The trial was registered with the UK Clinical Research Network Portfolio (ISRCTN ID: 11841493) and was closed on 30th November 2016.ResultsData were collected between 28th January 2014 and 06th April 2016. 249 older prisoners were assigned TAU of which 32 transferred prison; 12 were released; 2 withdrew and 1 was deemed unsafe to interview. 253 prisoners were assigned the OHSCAP of which 33 transferred prison; 11 were released; 6 withdrew and 1 was deemed unsafe to interview. Consequently, data from 202 participants were analysed in each of the two groups. There were no significant differences in the number of unmet needs as measured by the Camberwell Assessment of Needs – Forensic Short Version (CANFOR-S). The mean number of unmet needs for the OHSCAP group at follow-up was 2.03 (SD=2.07) and 2.06 (SD= 2.11) for the TAU group (RR = 0.088; 95% CI -0.276 to 0.449, p = 0.621). No adverse events were reported. Conclusion Those received the OHSCAP did not experience an improvement to the meeting of the needs in comparison to the TAU g. This was largely due to the OHSCAP not being implemented as planed due to a national prison crisis.The OHSCAP was fundamentally not implemented as planned, partly due to the national prison staffing crisis that ensued during the study period. Therefore, those receiving OHSCAP did not experience improved outcomes compared to those who received TAU. Trial RegistrationISRCTN11841493 25/10/2013Protocol available at: http://www.isrctn.com/ISRCTN11841493

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals Needs of patients with dementia and their caregivers in primary care: lessons learned from the Alzheimer plan of Quebec

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Vladimir Khanassov ◽  
Laura Rojas-Rozo ◽  
Rosa Sourial ◽  
Xin Qiang Yang ◽  
Isabelle Vedel
Keyword(s):  
Primary Care ◽  
Unmet Needs ◽  
Social Care ◽  
Phase 1 ◽  
Lessons Learned ◽  
Community Dwelling ◽  
Care Plan ◽  
Phase 2 ◽  
Care Needs ◽  
Health And Social Care

Abstract Background Persons living with dementia have various health and social care needs and expectations, some which are not fully met by health providers, including primary care clinicians. The Quebec Alzheimer plan, implemented in 2014, aimed to cover these needs, but there is no research on the effect this plan had on the needs and expectations of persons living with dementia. The objective of this study is to identify persons living with dementia and caregivers’ met and unmet needs and to describe their experience. Methods This is a sequential mixed methods explanatory design: Phase 1: cross-sectional study to describe the met and unmet health and social care needs of community-dwelling persons living with dementia using Camberwell Assessment of Need of the Elderly and Carers’ Assessment for Dementia tools. Phase 2: qualitative descriptive study to explore and understand the experiences of persons living with dementia and caregivers with the use of social and healthcare services, using semi-structured interviews. Data from phase 1 was analyzed with descriptive statistics, and from phase 2, with inductive thematic analysis. Results from phases 1 and 2 were compared, contrasted and interpreted together. Results The mean total number of needs reported by the patients was 5.03 (4.48 and 0.55 met and unmet needs, respectively). Caregivers had 0.52 met needs (3.16 unmet needs). The main needs for both were memory, physical health, eyesight/hearing/communication, medication, looking after home, money/budgeting. Three categories were mentioned by the participants: Persons living with dementia and caregiver’s attitude towards memory decline, their perception of community health services and of the family medicine practice. Conclusions Our study confirms the findings of other studies on the most common unmet needs of the patients and caregivers that are met partially or not at all. In addition, the participants were satisfied with access to care, and medical services in primary practices, being confident in their family. Our results indicate persons living with dementia and their caregivers need a contact person, a clear explanation of their dementia diagnosis, a care plan, written information on available services, and support for the caregivers.

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