Enhanced Care for Patients With Complex Multimorbidity in Primary Care

NCT05676541 | Completed DMC

• 1 other identifier: UCopenhagen-MM600
• Study Type: interventional
• Target: 117,000
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction Patients living with a chronic disease often have more than one chronic condition, which is referred to as multimorbidity. Multimorbidity is associated with decreased quality of life, functional decline, polypharmacy, and increased healthcare utilization. Patients with multimorbidity often have a high symptom- and treatment burden, and have to attend multiple appointments, often at numerous locations, and comply with complex or even conflicting advice and drug regimens, resulting in an increased risk of depression and low quality of life. In Denmark, general practice is the key organizational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centered care. However, caring for patients with multimorbidity is a complex and time-consuming task and the organization of chronic care in general practice is organized around individual conditions. 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.

Conditions

Multimorbidity

Outcome Measures

Primary Outcomes (1)

• Needs-based quality of life measured with MMQ1 - PROM

  The primary outcome is needs-based quality of life measured with MMQ1 (unpublished at present). The outcome consist of six unidimensional domains; physical capacity, worries, limitations in daily activities, social life, self-image and economy with a scale from 0-3 per item (sum scores differ due to differences in the number f items) We expect our intervention to be able to affect the three domains; worries, limitations in daily life and social life. We will consider a clinically significant improvement in at least one domain as a success.

  2 years

Secondary Outcomes (13)

• Treatment burden (MMQ1-TB) - PROM

  2 years

• Patient-perceived patient-centeredness of consultations (PCC-GP) -PROM

  2 years

• Mortality - registry-based

  2 years

• Hospitalizations - registry-based

  2 years

• Nursing home placement registry-based

  2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements

Control

NO INTERVENTION

Interventions

Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements OTHER

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)

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years or older) patients listed at participating GPs living in their own home with
• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Research Unit of General Practice, Odense: collaborator
• Research Unit for General Practice, Aarhus University: collaborator
• Slagelse Hospital: collaborator
• Aalborg University: collaborator

Study Sites (1)

General practices in all of Denmark

Copenhagen, 2700, Denmark

Location

Related Publications (4)

• Larsen HH, Willadsen TG, Prior A, Lyhnebeck AB, Waldorff FB, Holm A. Methods and baseline results of the Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice in Denmark (CHRONIC-GP). BMJ Open. 2025 Nov 26;15(11):e103807. doi: 10.1136/bmjopen-2025-103807.

  PMID: 41298265 DERIVED

• 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.

  PMID: 40819910 DERIVED

• 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.

  PMID: 39780227 DERIVED

• 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.

  PMID: 38309759 DERIVED

MeSH Terms

Interventions

Multimorbidity

Intervention Hierarchy (Ancestors)

Comorbidity; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 9, 2023
• Study Start: March 1, 2023
• Primary Completion: October 29, 2025
• Study Completion: December 31, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)