The OPTIMAL study: A randomized controlled trial and process evaluation of an occupational therapy led self-management support programme for people with multimorbidity in primary care

Abstract

Title: The OPTIMAL study: A randomized controlled trial and process evaluation of an occupational therapy led self-management support programme for people with multimorbidity in primary care PhD candidate: Lynn O Toole 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. This PhD study aimed to evaluate the effectiveness of the OPTIMAL programme as per Stage III of the MRC framework. Methods: A pragmatic parallel randomised controlled trial including 149 participants recruited from primary care settings was conducted. Primary outcome measures were the EQ-5D (health related quality of life measure) and Frenchay Activities Index (activity participation). Those allocated to the intervention group attended the six-week group-based OPTIMAL programme while control participants were allocated to a waiting list to receive care as usual. Follow-up data collection took place immediately post-intervention. Intention to treat and per protocol analyses using multi-level linear regression models were performed. A process evaluation was also used to examine the experience and views of programme participants and the occupational therapists and other health professionals who referred to and delivered the programme. Results: In total 149 participants were recruited across eight HSE primary care team areas. At follow-up there was a significant improvement in health related quality of life for the intervention group (Adjusted MD=7.86; 95% CI=0.92 to 14.80) in comparison to controls. No significant differences were found between the two groups in frequency of activity participation. Sub-group analyses found a significant difference in both primary outcome measures in favour of the intervention group for participants aged <65 and those with &#8805;4 chronic conditions. Process evaluation results highlighted difficulties with recruitment and wide variation in referral sources by site. The group-based nature and goal-setting components of the programme were perceived as being important mechanisms of change. Barriers and facilitators to future implementation and effectiveness identified included managerial and collegial support, sufficient participant numbers, resources and caseload demands. Overall the intervention was well received by participants and health professionals who perceived the intervention to improve participants activity levels, emotional well-being and self-management skills. Conclusion: This study found that the OPTIMAL intervention was effective in improving health related quality of life but not frequency of activity participation. The process evaluation highlighted that while the intervention was acceptable to health professionals and participants, there were enablers and barriers to the routine implementation of the OPTIMAL programme in primary care.