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Not yet recruitingNCT06735339Updated Dec 16, 2024

A New Organisation of Clinic for Multimorbidity and Polypharmacy

An interventional study of Clinic for Multimorbidity in Multimorbidity, sponsored by Central Jutland Regional Hospital. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Central Jutland Regional Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multimorbidity

Keywords

  • multimorbidity
  • continuity of care
  • patient pathway
  • Denmark
  • outpatient care
  • multidisciplinary
  • MDT
  • appropriate medicine
  • comorbidity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Clinic for multimorbidity

    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

  • OtherClinic for Multimorbidity

    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.

05

What researchers measure

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.

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

06

Study locations

1 site
  • Clinic for Multimorbidity, Medical Diagnostic Centre, Central Denmark Region, Denmark
    Silkeborg, 8600, Denmark
    • Cathrine Bell, ph.d · Contact · catbel@rm.dk · +4578417884
    • Marlene L Krogh, MD · Contact
07

References and documents

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06735339
Lead sponsor
Central Jutland Regional Hospital
Responsible party
Sponsor
First posted
Dec 16, 2024
Start date
Jan 5, 2025 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 16, 2024

Study contacts

Cathrine Bell, PhD., cand.scient.san
Contact
catbel@rm.dk
004578417884
Charlotte W Appel, PhD, cand.scient.san
Contact
charlotte.appel@midt.rm.dk
004578417821

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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