Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice
Background There is increasing awareness of the impact of living with multiple long-term conditions (referred to as multimorbidity) on patients and health systems. Managing multimorbidity remains a challenge for primary care providers; necessitating tailored interventions that are both clinically an...
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BMJ Publishing Group
2025-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/6/e101315.full |
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| author | Susan M Smith Fiona Boland Frank Moriarty Molly Byrne Farah Tahsin Barbara Clyne Paul Doody Laura O’Connor Paddy Gillespie Bridget Kiely Andrew W Murphy Eanna Kenny |
| author_facet | Susan M Smith Fiona Boland Frank Moriarty Molly Byrne Farah Tahsin Barbara Clyne Paul Doody Laura O’Connor Paddy Gillespie Bridget Kiely Andrew W Murphy Eanna Kenny |
| author_sort | Susan M Smith |
| collection | DOAJ |
| description | Background There is increasing awareness of the impact of living with multiple long-term conditions (referred to as multimorbidity) on patients and health systems. Managing multimorbidity remains a challenge for primary care providers; necessitating tailored interventions that are both clinically and cost effective. In the Irish health system, two pilot trials have demonstrated promising results for patients living with multimorbidity. The first, MultimorbiditY COllaborative Medication Review And DEcision making (MyComrade), involved pharmacists supporting the management of polypharmacy, and the second, Link MultiMorbidity (LinkMM), involved link workers delivering social prescribing. This definitive trial aims to evaluate the clinical and cost effectiveness of both these interventions, as well as conduct a process evaluation.Methods This is a pragmatic, multi-arm, definitive, cluster randomised controlled trial in Irish general practices. The trial will include three arms: (1) MyComrade; (2) LinkMM and (3) usual care, acting as an efficient shared control arm for both interventions. For this trial, 672 patients will be recruited from 48 general practices. The eligibility criteria for the patients will be: (1) over 18 years of age; (2) has two or more chronic conditions; (3) taking 10 or more regular medicines and (4) attending their general practice team for chronic disease management. Outcome data will be collected for all participants, across all trial arms at baseline and 6 months. Primary outcomes include the number of medicines (reflecting the MyComrade intervention) and patient capability (reflecting the LinkMM intervention). Secondary outcomes include proportions and types of potentially inappropriate medications, patient experience of care, patient activation, self-rated health, health-related quality of life, mortality and healthcare utilisation. Quantitative and qualitative data will be collected to inform the process evaluation. Additionally, an economic evaluation will be conducted to evaluate the cost-effectiveness of both interventions compared with the control arm.Ethics and dissemination The trial protocol was approved by the Irish College of General Practice (ICGP) Ethical Review Board (ref: ICGP_Rec_2023_016). A formal knowledge dissemination plan has been developed for the trial, which includes peer-reviewed publications, conference presentations and reports to healthcare professionals, commissioners and policymakers.Trial registration number ISRCTN11585238. |
| format | Article |
| id | doaj-art-a252ddc5479f4da1a81ed1a2b84b4f47 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-a252ddc5479f4da1a81ed1a2b84b4f472025-08-20T03:27:17ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2025-101315Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practiceSusan M Smith0Fiona Boland1Frank Moriarty2Molly Byrne3Farah Tahsin4Barbara Clyne5Paul Doody6Laura O’Connor7Paddy Gillespie8Bridget Kiely9Andrew W Murphy10Eanna Kenny11Discpline of Public Health and Primary Care, Trinity College Dublin, Dublin, IrelandData Science Centre, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, IrelandSchool of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, IrelandSchool of Psychology, University of Galway, Galway, IrelandDiscpline of Public Health and Primary Care, Trinity College Dublin, Dublin, IrelandDepartment of Public Health and Epidemiology, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, IrelandDiscpline of Public Health and Primary Care, Trinity College Dublin, Dublin, IrelandHRB Primary Care CTNI, Department of General Practice, University of Galway, Galway, IrelandHealth Economics & Policy Analysis Centre (HEPAC) at the J.E. Cairnes School of Business & Economics, University of Galway, Galway, IrelandDepartment of General Practice, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, IrelandHRB Primary Care CTNI, Department of General Practice, University of Galway, Galway, IrelandDiscpline of Public Health and Primary Care, Trinity College Dublin, Dublin, IrelandBackground There is increasing awareness of the impact of living with multiple long-term conditions (referred to as multimorbidity) on patients and health systems. Managing multimorbidity remains a challenge for primary care providers; necessitating tailored interventions that are both clinically and cost effective. In the Irish health system, two pilot trials have demonstrated promising results for patients living with multimorbidity. The first, MultimorbiditY COllaborative Medication Review And DEcision making (MyComrade), involved pharmacists supporting the management of polypharmacy, and the second, Link MultiMorbidity (LinkMM), involved link workers delivering social prescribing. This definitive trial aims to evaluate the clinical and cost effectiveness of both these interventions, as well as conduct a process evaluation.Methods This is a pragmatic, multi-arm, definitive, cluster randomised controlled trial in Irish general practices. The trial will include three arms: (1) MyComrade; (2) LinkMM and (3) usual care, acting as an efficient shared control arm for both interventions. For this trial, 672 patients will be recruited from 48 general practices. The eligibility criteria for the patients will be: (1) over 18 years of age; (2) has two or more chronic conditions; (3) taking 10 or more regular medicines and (4) attending their general practice team for chronic disease management. Outcome data will be collected for all participants, across all trial arms at baseline and 6 months. Primary outcomes include the number of medicines (reflecting the MyComrade intervention) and patient capability (reflecting the LinkMM intervention). Secondary outcomes include proportions and types of potentially inappropriate medications, patient experience of care, patient activation, self-rated health, health-related quality of life, mortality and healthcare utilisation. Quantitative and qualitative data will be collected to inform the process evaluation. Additionally, an economic evaluation will be conducted to evaluate the cost-effectiveness of both interventions compared with the control arm.Ethics and dissemination The trial protocol was approved by the Irish College of General Practice (ICGP) Ethical Review Board (ref: ICGP_Rec_2023_016). A formal knowledge dissemination plan has been developed for the trial, which includes peer-reviewed publications, conference presentations and reports to healthcare professionals, commissioners and policymakers.Trial registration number ISRCTN11585238.https://bmjopen.bmj.com/content/15/6/e101315.full |
| spellingShingle | Susan M Smith Fiona Boland Frank Moriarty Molly Byrne Farah Tahsin Barbara Clyne Paul Doody Laura O’Connor Paddy Gillespie Bridget Kiely Andrew W Murphy Eanna Kenny Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice BMJ Open |
| title | Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice |
| title_full | Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice |
| title_fullStr | Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice |
| title_full_unstemmed | Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice |
| title_short | Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice |
| title_sort | medicines support and social prescribing to address patient priorities in multimorbidity midas protocol for a definitive multi arm cluster randomised controlled trial in irish general practice |
| url | https://bmjopen.bmj.com/content/15/6/e101315.full |
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