A New Organisation of Clinic for Multimorbidity and Polypharmacy

NCT06735339 | Not Yet Recruiting

• 1 other identifier: 1-16-02-342-24
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Multimorbidity

Keywords

multimorbidity; continuity of care; patient pathway; Denmark; outpatient care; multidisciplinary; MDT; appropriate medicine; comorbidity

Outcome Measures

Primary Outcomes (1)

• Need-based quality of life (MMQ-1 questionnaire)

  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.

  From enrollment to 3 months after have undergone a trajectory at Clinic for Multimorbidity

Study Arms (1)

Clinic for multimorbidity

EXPERIMENTAL

All participants will be assigned to the intervention but at different times according to the stepped wedge design. There are 6 clusters, to be assigned at different times.

Other: Clinic for Multimorbidity

Interventions

Clinic for Multimorbidity OTHER

The patient is assigned a healthcare coordinator. A review of the patient's medication history and a medication review are conducted. A functional assessment is performed, along with relevant measurements, and the patient consults with a specialist physician. A multidisciplinary team (MDT) conference is held with selected specialists, depending on the patient's needs. This may include a cardiologist, endocrinologist, pulmonologist, gastroenterologist, rheumatologist, nephrologist, geriatrician, clinical pharmacologist, psychiatrist, pain nurse, physiotherapist, occupational therapist, and the patient's GP. The handover of information to the GP is agreed upon at the time of referral and can be carried out in writing, through virtual MDT participation, or by telephone. In agreement with the patient, the clinic may initiate follow-up actions, such as counseling on medication or disease management. Additionally, the clinic may facilitate cross-sectoral activities, such as therapy.

Clinic for multimorbidity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Clinic for Multimorbidity, Medical Diagnostic Centre, Central Denmark Region, Denmark

Silkeborg, 8600, Denmark

Location

Related Links

• Related Info

MeSH Terms

Interventions

Ambulatory Care Facilities; Multimorbidity

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services; Comorbidity; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Cathrine Bell, PhD., cand.scient.san

CONTACT

004578417884; catbel@rm.dk

Charlotte W Appel, PhD, cand.scient.san

CONTACT

004578417821; charlotte.appel@midt.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge randomised design including 6 hospital clusters of general practitioners in the Central Denmark Region.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 16, 2024
• Study Start: January 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)