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The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evid...

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Autores principales: Hynes, Lisa, Murphy, Andrew W., Hart, Nigel, Kirwan, Collette, Mulligan, Sarah, Leathem, Claire, McQuillan, Laura, Maxwell, Marina, Carr, Emma, Walkin, Scott, McCarthy, Caroline, Bradley, Colin, Byrne, Molly, Smith, Susan M., Hughes, Carmel, Corry, Maura, Kearney, Patricia M., McCarthy, Geraldine, Cupples, Margaret, Gillespie, Paddy, Newell, John, Glynn, Liam, Alvarez-Iglesias, Alberto, Sinnott, Carol
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958932/
https://www.ncbi.nlm.nih.gov/pubmed/35346380
http://dx.doi.org/10.1186/s40814-022-01018-y
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author Hynes, Lisa
Murphy, Andrew W.
Hart, Nigel
Kirwan, Collette
Mulligan, Sarah
Leathem, Claire
McQuillan, Laura
Maxwell, Marina
Carr, Emma
Walkin, Scott
McCarthy, Caroline
Bradley, Colin
Byrne, Molly
Smith, Susan M.
Hughes, Carmel
Corry, Maura
Kearney, Patricia M.
McCarthy, Geraldine
Cupples, Margaret
Gillespie, Paddy
Newell, John
Glynn, Liam
Alvarez-Iglesias, Alberto
Sinnott, Carol
author_facet Hynes, Lisa
Murphy, Andrew W.
Hart, Nigel
Kirwan, Collette
Mulligan, Sarah
Leathem, Claire
McQuillan, Laura
Maxwell, Marina
Carr, Emma
Walkin, Scott
McCarthy, Caroline
Bradley, Colin
Byrne, Molly
Smith, Susan M.
Hughes, Carmel
Corry, Maura
Kearney, Patricia M.
McCarthy, Geraldine
Cupples, Margaret
Gillespie, Paddy
Newell, John
Glynn, Liam
Alvarez-Iglesias, Alberto
Sinnott, Carol
author_sort Hynes, Lisa
collection PubMed
description BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). METHODS: A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed. DISCUSSION: The findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN80017020. Date of confirmation is 4/11/2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01018-y.
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spelling pubmed-89589322022-03-29 The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial Hynes, Lisa Murphy, Andrew W. Hart, Nigel Kirwan, Collette Mulligan, Sarah Leathem, Claire McQuillan, Laura Maxwell, Marina Carr, Emma Walkin, Scott McCarthy, Caroline Bradley, Colin Byrne, Molly Smith, Susan M. Hughes, Carmel Corry, Maura Kearney, Patricia M. McCarthy, Geraldine Cupples, Margaret Gillespie, Paddy Newell, John Glynn, Liam Alvarez-Iglesias, Alberto Sinnott, Carol Pilot Feasibility Stud Study Protocol BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). METHODS: A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed. DISCUSSION: The findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN80017020. Date of confirmation is 4/11/2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01018-y. BioMed Central 2022-03-28 /pmc/articles/PMC8958932/ /pubmed/35346380 http://dx.doi.org/10.1186/s40814-022-01018-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Hynes, Lisa
Murphy, Andrew W.
Hart, Nigel
Kirwan, Collette
Mulligan, Sarah
Leathem, Claire
McQuillan, Laura
Maxwell, Marina
Carr, Emma
Walkin, Scott
McCarthy, Caroline
Bradley, Colin
Byrne, Molly
Smith, Susan M.
Hughes, Carmel
Corry, Maura
Kearney, Patricia M.
McCarthy, Geraldine
Cupples, Margaret
Gillespie, Paddy
Newell, John
Glynn, Liam
Alvarez-Iglesias, Alberto
Sinnott, Carol
The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial
title The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial
title_full The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial
title_fullStr The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial
title_full_unstemmed The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial
title_short The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial
title_sort multimorbidity collaborative medication review and decision making (mycomrade) study: a protocol for a cross-border pilot cluster randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958932/
https://www.ncbi.nlm.nih.gov/pubmed/35346380
http://dx.doi.org/10.1186/s40814-022-01018-y
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