A randomised controlled trial evaluation of structured routine follow-up after a disabling stroke
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Status:
Completed. The results of the trial are currently in press and will be published in Age and Ageing in the autumn of 2009.
Purpose:
1. The primary research question is to determine if protocol driven, routine reviews of disabled stroke patients promote improved clinical and health economic outcomes (independence, mood, carer burden, secondary prevention compliance, service resources used)
2. The secondary question investigates the effects of stroke review clinic context by a comparison between two types of clinic structure
Interventions:
Review Clinic
receive existing care supplemented by a review clinic attendance at 5-6 months post-stroke onset
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Standard Medical Care
per the National Guidelines for Stroke.
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Location(s):
United Kingdom
Year Started:
2003
Year Finished:
2006
Design:
Randomised controlled trial
Inclusion Criteria
Patients with a new stroke associated with persisting disability and or language impairment at 4 months post-stroke onset. A persisting disability is defined as a Barthel Index score at 4 months lower than their pre-stroke score.
Exclusion Criteria
1. Patients without new disability
2. Patients whose main problem is vascular dementia
3. Patients considered to have a poor 6 month survival prognosis because of co-morbidity
Patient Involvement:
The control group will receive existing care arrangements including a service information pack and a structured discharge summary to general practitioners detailing secondary prevention, rehabilitation goals, expected community care services and a new recommendation to the primary health care team that the patient should be contacted at 6 months in accord with the National Service Framework requirement. The patients in the intervention group will receive existing care supplemented by a review clinic attendance at 5-6 months post-stroke onset (some flexibility is required for service operational reasons). Additional visits will be organised if indicated but the emphasis will be on co-ordination of inputs rather than frequent attendances. Two follow-up clinic approaches will be used:
1. An existing secondary care-based review clinic in Leeds. This clinic is medically-led, with some nursing support and established links to therapy and social care services.
2. Multidisciplinary review clinics in Bradford. These are being established in each of three Primary Care Trust, locality-based rehabilitation centres. A nurse (with some mental health training) and a therapist will jointly lead the clinics. Through joint working, it is anticipated that ‘new ways of working’ will evolve so the clinic will be truly ‘interdisciplinary’. Stroke consultant physician support will be available to the clinic through participation in post-clinic meetings, also attended by social service and relevant primary care staff.
Primary Outcome:
Patient: extended activities of daily living (Frenchay Activities Index)
Carer: Well-being (General Health Questionnaire-28)
Secondary Outcome:
Patient: disability (Barthel Index); mood (Hospital Anxiety and Depression Scale); health status (EQ-5D); service satisfaction (Homesat)
Carer: strain (Carer Strain Index)
Resource use: health, social and voluntary sector service use, and secondary prevention and psychotropic medication will be recorded using proforma questionnaires developed for our previous community stroke trials, supplemented by specific inquiry of service databases for high cost resources such as care home or hospital admissions
Results:
Independence at 12 months post-stroke was similar in both groups (Frenchay activities index, adjusted mean difference 0.64; 95% confidence interval -0.74-2.02). Emotional distress in carers was similar in both groups (general health questionnaire 28, mean difference 0.02; 95% confidence interval -0.95-1.00). Results for the secondary outcome measures and total mean costs were similar for both groups. The intervention group patients used 301 fewer hospital bed days and 1,631 fewer care home bed days. CONCLUSIONS: the structured, systematic re-assessment for patients and their carers was not associated with any clinically significant evidence of benefit at 12 months. Health and social care resource use and mean cost per patient were broadly similar in both groups.
Source of Information:
Controlled Trials
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Web Links and Publications:
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This information last updated on: 10/27/2009
Reviewed on: 10/19/2009.
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Trials
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