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The OPTIMAL study: A randomized controlled trial and process evaluation of an OccuPaTIonal therapy led self MAnagement support programme for patients with muLtimorbidity in primary care.

Background
People with multiple chronic conditions or multimorbidity, are particularly vulnerable with poorer health outcomes, higher health service utilisation and costs. The Medical Research Council’s (MRC) Framework (2008) for complex interventions was used to develop and pilot “OPTIMAL” an occupational therapy led self-management programme for those with multimorbidity. Following on from the developmental work conducted, this study will use a randomised controlled trial (RCT) with a process evaluation in order to examine definitively the effectiveness of the “OPTIMAL” programme.
Aims
The overarching study aim is to evaluate definitively the effectiveness of the “OPTIMAL” programme for individuals with multimorbidity as per Stage III of the MRC framework. Design and methodology
The study will be conducted in primary care teams (PCT) in Dublin South Central and Dublin West. The approach selected is a RCT. Patients with multimorbidity interested in participating in the study will be identified prospectively during clinical encounters with any PCT member. Primary outcome measures will include EQ-5D (quality of life measure) and Frenchay Activities Index (activity participation). Secondary outcomes include the Stanford Chronic Disease Self-Efficacy Scale (self-efficacy), Canadian Occupational Performance Measure (occupational performance/satisfaction), the Nottingham Extended Activities of Daily Living (activity independence), the Hospital Anxiety and Depression Scale (anxiety and depression) and the Goal Attainment Scale. Those allocated to the intervention group will attend the six-week programme while control patients will continue to receive care as usual in their primary care setting. Follow-up data collection will take place immediately post-intervention and 6 months post-intervention.
A process evaluation will be used to examine the experience and views of patients who attend the programme, the health professionals who refer patients to the programme and the occupational therapists who deliver the programme. Qualitative data will be collected using focus groups with participants and healthcare providers immediately post-intervention using a qualitative descriptive approach.