Effectiveness of an adaptive, multifaceted intervention to enhance care for patients with complex multimorbidity in general practice: protocol for a pragmatic cluster randomised controlled trial (the MM600 trial)
,
Per Kallestrup,
Anne Frølich,
Frans Boch Waldorff,
Susanne Reventlow,
Volkert Siersma,
Anne Møller,
Dagný Rós Nicolaisdóttir,
Janus Laust Thomsen,
Tora Grauers Willadsen,
Jesper Bo Nielsen,
Line Bjørnskov Pedersen,
Henrik Larsen,
Anne Holm,
Anders Prior,
Ann Dorrit Guassora,
Mette Bech Risør,
John Brandt Brodersen,
Anders Stockmarr,
Anna Bernhardt Lyhnebeck,
Maarten Rozing,
Sussi Friis Buhl,
Ann-Kathrin Lindahl Christiansen,
Jette Kristensen,
John Sahl Andersen,
Barbara Ann Barrett,
Camilla Merrild,
Frans Waldorff,
Iben Charlotte Aamann,
Jens Søndergård,
Jette Kolding Kristensen,
Katrine Tranberg Jensen,
Kristine Bissenbakker,
Mads Toft Kristensen,
Maria Haahr Nielsen,
Marius Brostrøm Kousgaard,
Sanne Lykke Lundstrøm,
Sidsel Böcher,
Sofie Rosenlund Lau,
Solvej Skriver Hansen,
Zaza Kamper-Jørgensen
Affiliations
1Section Sports Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa
Per Kallestrup
Anne Frølich
Frans Boch Waldorff
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Susanne Reventlow
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Volkert Siersma
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Anne Møller
Dagný Rós Nicolaisdóttir
Janus Laust Thomsen
Tora Grauers Willadsen
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Jesper Bo Nielsen
Line Bjørnskov Pedersen
Henrik Larsen
Anne Holm
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Anders Prior
Research Unit for General Practice, Aarhus University, Aarhus, Denmark
Ann Dorrit Guassora
Mette Bech Risør
John Brandt Brodersen
Centre of Research & Education in General Practice Primary Health Care Research Unit, Zealand Region, University of Copenhagen, Copenhagen, Denmark
Anders Stockmarr
Anna Bernhardt Lyhnebeck
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Maarten Rozing
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Sussi Friis Buhl
Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark
Ann-Kathrin Lindahl Christiansen
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Jette Kristensen
The Center for General Practice, Aalborg University, Aalborg, Denmark
John Sahl Andersen
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
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.