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Medicines and SocIal Prescribing to aDdress pAtient priorities in multimorbidity (MIDAS): A multi-arm definitive cluster randomised trial in Irish general practice

BACKGROUND
Multimorbidity is recognised as a key challenge facing patients and health systems, requiring clinically-effective and cost-effective interventions to improve health outcomes. We have conducted two separate pilot trials, one supporting GPs to manage polypharmacy in patients with multimorbidity (MyComrade), and the other providing link workers to deliver social prescribing for patients with multimorbidity (LinkMM). Both interventions have the capacity to be integrated into Ireland’s new Chronic Disease Management (CDM) Programme. AIM
The MIDAS trial aims to evaluate the clinical and cost-effectiveness of both the MyComrade intervention and the LinkMM intervention. Clinical effectiveness for MyCOMRADE will be determined by changes in medicines and for LinkMM will be based on changes in patient capability
METHODS
We will conduct a multi-arm definitive cluster randomised controlled trial in Irish general practices participating in CDM. The trial will include three arms: (1) MyComrade, (2) LinkMM, and (3) usual CDM care, acting as an efficient shared control arm for both interventions. Recruited from 48 general practices (clusters), participants will be 672 adult patients with multimorbidity, defined as having at least two chronic conditions, and who are taking 10 or more regular medicines. Outcome data will be collected for all patients in all trial arms at baseline and after six . The primary outcome for MyComrade will be the number of medicines per patient, and for LinkMM it will be the ICECAP-A, a measure of patient capability and well-being. Shared secondary outcomes will include medicines and mental health outcomes, patient experience of care, patient activation, self-rated health, health related quality of life, mortality and healthcare utilisation. All aspects of the research will be guided by our PPI panel and the appropriate CONSORT guidance for multi-arm cluster trials. We will also conduct parallel process and health economic evaluations. CONCLUSIONS
This multi-arm trial will evaluate the clinical and cost-effectiveness of two separate interventions that have potential to improve current multimorbidity management and patient outcomes. Its linkage with the existing national CDM Programme provides a unique opportunity and pathway for system-wide implementation of interventions that can improve health outcomes patients with multimorbidity.