TY - JOUR

T1 - Effectiveness of an adaptive, multifaceted intervention to enhance care for patients with complex multimorbidity in general practice

T2 - protocol for a pragmatic cluster randomised controlled trial (the MM600 trial)

AU - Holm, Anne

AU - Lyhnebeck, Anna Bernhardt

AU - Rozing, Maarten

AU - Buhl, Sussi Friis

AU - Willadsen, Tora Grauers

AU - Prior, Anders

AU - Christiansen, Ann-Kathrin Lindahl

AU - Kristensen, Jette

AU - Andersen, John Sahl

AU - Waldorff, Frans Boch

AU - Siersma, Volkert

AU - Brodersen, John Brandt

AU - Reventlow, Susanne

AU - MM600 project team

N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2024

Y1 - 2024

N2 - INTRODUCTION: Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.METHODS AND ANALYSIS: In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.ETHICS AND DISSEMINATION: The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.TRIAL REGISTRATION NUMBER: NCT05676541.

AB - INTRODUCTION: Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.METHODS AND ANALYSIS: In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.ETHICS AND DISSEMINATION: The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.TRIAL REGISTRATION NUMBER: NCT05676541.

KW - Adult

KW - Humans

KW - Chronic Disease

KW - General Practice

KW - Multimorbidity

KW - Patient-Centered Care

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Pragmatic Clinical Trials as Topic

U2 - 10.1136/bmjopen-2023-077441

DO - 10.1136/bmjopen-2023-077441

M3 - Journal article

C2 - 38309759

VL - 14

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 2

M1 - e077441

ER -