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)
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...
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| Format: | Article |
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BMJ Publishing Group
2024-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/2/e077441.full |
| _version_ | 1827324927004377088 |
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| author | 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 |
| author_facet | 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 |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T14:09:54Z |
| format | Article |
| id | doaj.art-8aad408a96b9438fb2bc86a103ff16ac |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-07T14:09:54Z |
| publishDate | 2024-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-8aad408a96b9438fb2bc86a103ff16ac2024-03-06T16:55:07ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2023-077441Effectiveness 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) 0Per KallestrupAnne FrølichFrans Boch Waldorff1Susanne Reventlow2Volkert Siersma3Anne MøllerDagný Rós NicolaisdóttirJanus Laust ThomsenTora Grauers Willadsen4Jesper Bo NielsenLine Bjørnskov PedersenHenrik LarsenAnne Holm5Anders Prior6Ann Dorrit GuassoraMette Bech RisørJohn Brandt Brodersen7Anders StockmarrAnna Bernhardt Lyhnebeck8Maarten Rozing9Sussi Friis Buhl10Ann-Kathrin Lindahl Christiansen11Jette Kristensen12John Sahl Andersen13Barbara Ann BarrettCamilla MerrildFrans WaldorffIben Charlotte AamannJens SøndergårdJette Kolding KristensenKatrine Tranberg JensenKristine BissenbakkerMads Toft KristensenMaria Haahr NielsenMarius Brostrøm KousgaardSanne Lykke LundstrømSidsel BöcherSofie Rosenlund LauSolvej Skriver HansenZaza Kamper-Jørgensen1Section Sports Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South AfricaResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkResearch Unit for General Practice, Aarhus University, Aarhus, DenmarkCentre of Research & Education in General Practice Primary Health Care Research Unit, Zealand Region, University of Copenhagen, Copenhagen, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkResearch Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkThe Center for General Practice, Aalborg University, Aalborg, DenmarkResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, DenmarkIntroduction 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.https://bmjopen.bmj.com/content/14/2/e077441.full |
| spellingShingle | 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 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/2/e077441.full |
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