Enhanced Care for Patients With Complex Multimorbidity in Primary Care
- Conditions
- Multimorbidity
- Interventions
- Other: Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements
- Registration Number
- NCT05676541
- Lead Sponsor
- University of Copenhagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50000
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements -
- Primary Outcome Measures
Name Time Method Needs-based quality of life measured with MMQ1 - PROM 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 Outcome Measures
Name Time Method Treatment burden (MMQ1-TB) - PROM 2 years Under validation. The PROM consists of six domains with response categories from 0-3.
a high score means high burden (negative)Patient-perceived patient-centeredness of consultations (PCC-GP) -PROM 2 years Under validation, The PROM consists of eight domains with response categories from 0-3. a high score means high patient-centeredness (positive)
Mortality - registry-based 2 years Number of deaths in each group per patient-years at risk
GP work satisfaction related to care for patients with multimorbidity - questionnaire 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.
GP burn-out - questionnaire 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.
Use of outpatient and other planned health services in secondary care (including new referrals), registry-based 2 years All contacts in secondary care will be combined and the number of contacts compared between groups
Nursing home placement registry-based 2 years Number of nursing home placements in each group in total and per patient year at risk
Use of other primary care health services (such as private specialists and out-of-hours care) registry-based. 2 years All contacts in primary care will be combined and the number of contacts compared between groups
Hospitalizations - registry-based 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.
Use of health services in general practice registry-based 2 years This outcome combines all use of health services in general practice regardless contact form. It will be measured as number of contacts
Health service use in the municipalities - registry-based 2 years All contacts in the municipalities regarding health and rehabilitation will be combined and the number of contacts compared between groups
number of prescription medicines - registry-based 2 years Number of prescription medicines per patient in each group (as a count regardless indication)
Polypharmacy - registry-based 2 years Number of patients with polypharmacy (more than 5 prescription drugs) in each group
Trial Locations
- Locations (1)
General practices in all of Denmark
🇩🇰Copenhagen, Denmark