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OpenTrials
Completed

NCT Number: NCT05676541

Enhanced Care for Patients With Complex Multimorbidity in Primary Care

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.

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Key information

Conditions

Multimorbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General practices in all of Denmark

Copenhagen, 2700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Needs-based quality of life measured with MMQ1 - PROM

    Time frame: 2 years

    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.

Secondary outcomes

  1. Treatment burden (MMQ1-TB) - PROM

    Time frame: 2 years

    Under validation. The PROM consists of six domains with response categories from 0-3.

    a high score means high burden (negative)

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

    Time frame: 2 years

    Under validation, The PROM consists of eight domains with response categories from 0-3. a high score means high patient-centeredness (positive)

  3. Mortality - registry-based

    Time frame: 2 years

    Number of deaths in each group per patient-years at risk

  4. Hospitalizations - registry-based

    Time frame: 2 years

    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.

  5. Nursing home placement registry-based

    Time frame: 2 years

    Number of nursing home placements in each group in total and per patient year at risk

  6. number of prescription medicines - registry-based

    Time frame: 2 years

    Number of prescription medicines per patient in each group (as a count regardless indication)

  7. Polypharmacy - registry-based

    Time frame: 2 years

    Number of patients with polypharmacy (more than 5 prescription drugs) in each group

  8. GP work satisfaction related to care for patients with multimorbidity - questionnaire

    Time frame: 2 years

    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.

  9. GP burn-out - questionnaire

    Time frame: 2 years

    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.

  10. Use of health services in general practice registry-based

    Time frame: 2 years

    This outcome combines all use of health services in general practice regardless contact form. It will be measured as number of contacts

  11. Use of other primary care health services (such as private specialists and out-of-hours care) registry-based.

    Time frame: 2 years

    All contacts in primary care will be combined and the number of contacts compared between groups

  12. Use of outpatient and other planned health services in secondary care (including new referrals), registry-based

    Time frame: 2 years

    All contacts in secondary care will be combined and the number of contacts compared between groups

  13. Health service use in the municipalities - registry-based

    Time frame: 2 years

    All contacts in the municipalities regarding health and rehabilitation will be combined and the number of contacts compared between groups

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Aalborg University
  • Research Unit for General Practice, Aarhus University
  • Research Unit of General Practice, Odense
  • Slagelse Hospital

Registry information

Official study title

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

Acronym: MM600-DK

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2023
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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