Clinical trial NCT05676541: Enhanced Care for Patients With Complex Multimorbidity in Primary Care
Official title: Effectiveness of an Adaptive, Complex Intervention to Enhance Care for Patients With Complex Multimorbidity in General Practice - a Pragmatic Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multimorbidity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Research Unit of General Practice, Odense
name: Research Unit for General Practice, Aarhus University
name: Slagelse Hospital
name: Aalborg University
First posted: 2023-01-09
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Needs-based quality of life measured with MMQ1 - PROM
timeFrame: 2 years
Secondary outcomes:
measure: Treatment burden (MMQ1-TB) - PROM
timeFrame: 2 years
measure: Patient-perceived patient-centeredness of consultations (PCC-GP) -PROM
timeFrame: 2 years
measure: Mortality - registry-based
timeFrame: 2 years
measure: Hospitalizations - registry-based
timeFrame: 2 years
measure: Nursing home placement registry-based
timeFrame: 2 years
measure: number of prescription medicines - registry-based
timeFrame: 2 years
measure: Polypharmacy - registry-based
timeFrame: 2 years
measure: GP work satisfaction related to care for patients with multimorbidity - questionnaire
timeFrame: 2 years
measure: GP burn-out - questionnaire
timeFrame: 2 years
measure: Use of health services in general practice registry-based
timeFrame: 2 years
measure: Use of other primary care health services (such as private specialists and out-of-hours care) registry-based.
timeFrame: 2 years
measure: Use of outpatient and other planned health services in secondary care (including new referrals), registry-based
timeFrame: 2 years
measure: Health service use in the municipalities - registry-based
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: General practices in all of Denmark
Study officials:
References: