Enhanced Care for Patients With Complex Multimorbidity in Primary Care
NCT ID: NCT05676541
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50000 participants
INTERVENTIONAL
2023-03-01
2025-12-31
Brief Summary
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Research question The objective of the study is to evaluate the effectiveness of a complex intervention consisting of a prolonged consultation and a strengthened cross-sectoral collaboration for patients with complex multimorbidity listed in participating practices on the patients' health-related quality of life, health and use of health-services.
Methods
Design:
A pragmatic, adaptive, cluster-randomized, non-blinded, parallel-group trial conducted in general practice in all regions in Denmark evaluating a complex intervention.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements
The intervention consists of 1) an extended overview consultation lasting 30-45 minutes in general practice, 2) access to cross-sectoral video conferences with secondary care specialists and 3) an instruction material for GPs on how to organize the intervention and 4) an adaptive toolbox to support elements in the intervention (not yet developed)
Control
No interventions assigned to this group
Interventions
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Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements
The intervention consists of 1) an extended overview consultation lasting 30-45 minutes in general practice, 2) access to cross-sectoral video conferences with secondary care specialists and 3) an instruction material for GPs on how to organize the intervention and 4) an adaptive toolbox to support elements in the intervention (not yet developed)
Eligibility Criteria
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Inclusion Criteria
* Two or more chronic conditions from two of ten diagnosis groups OR who were identified by the GP with complex multimorbidity (see box 1)
* At least one contact with secondary care in 2022 or 2023.
* Prescribed at least five prescription drugs
18 Years
ALL
No
Sponsors
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Research Unit of General Practice, Odense
OTHER
Research Unit for General Practice, Aarhus University
OTHER
Slagelse Hospital
OTHER
Aalborg University
OTHER
University of Copenhagen
OTHER
Responsible Party
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Locations
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General practices in all of Denmark
Copenhagen, , Denmark
Countries
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Facility Contacts
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Anne Holm
Role: primary
References
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Lyhnebeck AB, Holm A, Buhl SF, Bissenbakker KH, Kristensen JK, Moller A, Prior A, Kamper-Jorgensen Z, Bocher S, Kristensen M, Waagepetersen A, Dalsgaard AH, Siersma V, Brodersen JB; MM600 trial group. Measuring treatment burden related to general practice in patients with multimorbidity: development and validation of a PROM. Fam Med Community Health. 2025 Aug 17;13(3):e003378. doi: 10.1136/fmch-2025-003378.
Holm A, Lyhnebeck AB, Buhl SF, Bissenbakker K, Kristensen JK, Moller A, Prior A, Kamper-Jorgensen Z, Bocher S, Kristensen MAT, Waagepetersen A, Dalsgaard AH, Siersma V, Guassora AD, Brodersen JB; on behalf MM600 trial group. Development of a PROM to measure patient-centredness in chronic care consultations in primary care. Health Qual Life Outcomes. 2025 Jan 8;23(1):4. doi: 10.1186/s12955-024-02327-x.
Holm A, Lyhnebeck AB, Rozing M, Buhl SF, Willadsen TG, Prior A, Christiansen AL, Kristensen J, Andersen JS, Waldorff FB, Siersma V, Brodersen JB, Reventlow S; MM600 project team. 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. 2024 Feb 2;14(2):e077441. doi: 10.1136/bmjopen-2023-077441.
Other Identifiers
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UCopenhagen-MM600
Identifier Type: -
Identifier Source: org_study_id