A New Organisation of Clinic for Multimorbidity and Polypharmacy

Not Applicable

Not yet recruiting

• Conditions: Multimorbidity

• Registration Number: NCT06735339
• Lead Sponsor: Central Jutland Regional Hospital

Brief Summary

The purpose of this study is to investigate:

1) the implementation and 2) the effects of an outpatient program for patients with complex multimorbidity. The investigators intend to integrate care from various health professionals across medical specialties and sectors, promote person-centered care, and ensure a holistic approach. Specifically, the investigators have redesigned the existing clinic, the Clinic for Multimorbidity, which has been operational since 2012 without any protocol-based evaluation. The new version introduces differentiated care options based on general practitioners needs for support.

Multimorbidity, defined as the presence of two or more chronic diseases in an individual, poses a significant challenge for healthcare systems globally. There is an urgent need for targeted interventions for those with high complexity, such as due to interacting diseases and polypharmacy, particularly in light of an aging population, where on-fourth has multimorbid. Although the care for individuals with multimorbidity often may be perceived as fragmented, there is limited evidence on how to best organize the care. Effective, evidence-based strategies to ensure integration are lacking.

The population will consist of adults with complex multimorbidity from the Central Denmark Region, referred to the Clinic for Multimorbidity from general practice. Using a stepped wedge randomized controlled design, the project will encompass two studies.

1. The implementation study will be based on implementation outcomes by Proctor et al: acceptability, adoption, appropriateness, feasibility, fidelity, and penetration. Data will be collected through interviews with patients and general practitioners, as well as measurements related to referral practices, costs, and feasibility.

2. The effectiveness study will include outcome measures such as questionnaire-based patient experiences regarding health-related quality of life, treatment burden, depression, and anxiety. Additionally, the investigators will assess effects on inappropriate medication, symptoms, mortality, treatment continuity, healthcare utilization, and the initiation of health-promoting initiatives.

The investigators anticipate demonstrating that multimorbid patients will benefit from an interdisciplinary, cross-sector collaborative model. Furthermore, the investigators expect that this new organization will support general practitioners, municipalities, and hospitals in their management of these patients, addressing differentiated treatment needs in accordance with the recommendations of the Danish Health Structure Commission.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2025-01-05
• Primary Completion: 2026-09-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Aged18 years or older
• Multimorbidity: = 2 chronic conditions (minimum 6 months' duration per condition)
• Polypharmacy (= 5 medications)
• Complexity: Complex multimorbidity refers to the patient suffering from multiple concurrent, chronic diseases/conditions creating additional challenges. Complexity can be of physical, mental, social character and due to medication, high treatment burden, frailty, frequent healthcare visits or a special need for joint healthcare collaboration.

Exclusion criteria:

Diagnostically unresolved conditions and patients whose primary issues require focused management of chronic pain, psychiatric disorders, alcohol misuse, and other addiction-related challenges.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Need-based quality of life (MMQ-1 questionnaire)	From enrollment to 3 months after have undergone a trajectory at Clinic for Multimorbidity	Will be assessed using the MultiMorbidity Questionnaire MMQ-1 measuring needs-based QoL: physical ability (6 items), worries (6 items), limitations in everyday life (10 items), social life (6 items), self-image (6 items), and personal finances (3 items). -in total 31 items.; The questionnaire was deveoped by Bissenbakker et al. and has been validated in Danish settings for patients living with multimorbidity: the MMQ1 is a condition-specific PROM with adequate psychometric properties designed to measure needs-based QoL.

Trial Locations

Locations (1)

Clinic for Multimorbidity, Medical Diagnostic Centre, Central Denmark Region, Denmark; 🇩🇰 Silkeborg, Denmark