Enhanced Care for Patients With Complex Multimorbidity in Primary Care (MM600-DK)

Effectiveness of an Adaptive, Complex Intervention to Enhance Care for Patients With Complex Multimorbidity in General Practice - a Pragmatic Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Multimorbidity
• Intervention / Treatment: Other: Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements

• Study Type: Interventional
• Enrollment (Actual): 117000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2700
    • General practices in all of Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Other: 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)
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment burden (MMQ1-TB) - PROM	Under validation. The PROM consists of six domains with response categories from 0-3. a high score means high burden (negative)	2 years
Patient-perceived patient-centeredness of consultations (PCC-GP) -PROM	Under validation, The PROM consists of eight domains with response categories from 0-3. a high score means high patient-centeredness (positive)	2 years
Mortality - registry-based	Number of deaths in each group per patient-years at risk	2 years
Hospitalizations - registry-based	Number of hospitalizations in each group in total and per patient-years at risk. Any admittance to the hospital counts regardless if it is planned or unplanned and regardless the duration.	2 years
Nursing home placement registry-based	Number of nursing home placements in each group in total and per patient year at risk	2 years
number of prescription medicines - registry-based	Number of prescription medicines per patient in each group (as a count regardless indication)	2 years
Polypharmacy - registry-based	Number of patients with polypharmacy (more than 5 prescription drugs) in each group	2 years
GP work satisfaction related to care for patients with multimorbidity - questionnaire	We have developed six items regarding work satisfaction/burden in relation to working with patients with MM in general practice. A clinically significant difference between the groups in at least one of the items will be considered a success.	2 years
GP burn-out - questionnaire	If we get access to the national GP burnout questionnaire data, we will use the data to report this outcome. But the outcome depends on the questionnaire being distributed at an appropriate time which is not currently yet planned.	2 years
Use of health services in general practice registry-based	This outcome combines all use of health services in general practice regardless contact form. It will be measured as number of contacts	2 years
Use of other primary care health services (such as private specialists and out-of-hours care) registry-based.	All contacts in primary care will be combined and the number of contacts compared between groups	2 years
Use of outpatient and other planned health services in secondary care (including new referrals), registry-based	All contacts in secondary care will be combined and the number of contacts compared between groups	2 years
Health service use in the municipalities - registry-based	All contacts in the municipalities regarding health and rehabilitation will be combined and the number of contacts compared between groups	2 years

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Research Unit for General Practice, Aarhus University; Aalborg University; Slagelse Hospital; Research Unit of General Practice, Odense

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): October 29, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Factors; Comorbidity; Multimorbidity
• Other Study ID Numbers: UCopenhagen-MM600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No