Effectiveness of an Adaptive, Complex Intervention to Enhance Care for Patients With Complex Multimorbidity in General Practice - a Pragmatic Cluster Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 117,000
- Locations
- 1
- Primary Endpoint
- Needs-based quality of life measured with MMQ1 - PROM
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Prescribed at least five prescription drugs
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention
Intervention: Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements (Other)
Control
Outcomes
Primary Outcomes
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
- Treatment burden (MMQ1-TB) - PROM(2 years)
- Patient-perceived patient-centeredness of consultations (PCC-GP) -PROM(2 years)
- Mortality - registry-based(2 years)
- GP work satisfaction related to care for patients with multimorbidity - questionnaire(2 years)
- GP burn-out - questionnaire(2 years)
- Use of outpatient and other planned health services in secondary care (including new referrals), registry-based(2 years)
- Nursing home placement registry-based(2 years)
- Use of other primary care health services (such as private specialists and out-of-hours care) registry-based.(2 years)
- Hospitalizations - registry-based(2 years)
- Use of health services in general practice registry-based(2 years)
- Health service use in the municipalities - registry-based(2 years)
- number of prescription medicines - registry-based(2 years)
- Polypharmacy - registry-based(2 years)