Enhanced Care for Patients With Complex Multimorbidity in Primary Care

Multimorbidity Clinical Trial

— MM600-DK  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05676541
• Other study ID #: UCopenhagen-MM600
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multimorbidity

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)

Locations

Country	Name	City	State
Denmark	General practices in all of Denmark	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
University of Copenhagen	Research Unit for General Practice, Aarhus University, Research Unit of General Practice, Aalborg, Research Unit of General Practice, Odense, Slagelse Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mortality - registry-based	Number of deaths in each group per patient-years at risk	2 years
Secondary	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
Secondary	Nursing home placement registry-based	Number of nursing home placements in each group in total and per patient year at risk	2 years
Secondary	number of prescription medicines - registry-based	Number of prescription medicines per patient in each group (as a count regardless indication)	2 years
Secondary	Polypharmacy - registry-based	Number of patients with polypharmacy (more than 5 prescription drugs) in each group	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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