A New Care Model for Patients With Complicated Multimorbidity

NCT ID: NCT05406193

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-05-31

Brief Summary

Patients with complex multimorbidity experience a high treatment burden, fragmentation of care and poor clinical outcomes. General practice is the key organizational setting in terms of offering these patients integrated, longitudinal, and patient-centered care. Therefore, we propose a new general practice based model to improve overview, patient involvement and integration of care. The new care model consist of a teaching session on multimorbidity for the health care professionals, a prolonged overview consultation for patients with complex multimorbidity with the general practitioner, resulting in an individual care plan shared with the municipalities and secondary care, access to cross-sectoral video conferences with secondary care specialists and. Control practices provide health care as usual. We evaluate the care model in a cluster-randomized non-blinded, parallel-group trial in general practice. Fourteen general practices are allocated 1:1 to either intervention or control. We evaluate the effectiveness of the intervention with patient-reported questionnaire at baseline, 6-month follow-up, and 12-month follow-up. Primary outcome measure is the Patient Assessment of Chronic Illness Care (PACIC). Secondary outcome measure includes patient-reported quality of life and the treatment burden for the patients with multimorbidity. Furthermore, the project include a process evaluation of the complex intervention with the objective to assess how the intervention is delivered and to identify important facilitators and barriers for implementing the intervention. The new model is integrated into the existing health care system structures and has the potential for a sustainable improvement in care for patients with complex multimorbidity.

Conditions

Multimorbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention (CIM2)

An extended overview consultation, lasting 45 minutes, with the general practitioner, the patient (and maybe a relative), and the care coordinator. An individual care plan is developed, covering planned activities in the three sectors (general practice, municipality, and hospital) that will take place within the 12-month intervention period. General practice coordinates the planned patient care between general practice, the municipality, and the hospital, and follow-up on the execution of planned healthcare activities. The individual care plan is shared electronically with the healthcare center in the municipality and with the outpatient clinics using the standard IT-communication tool provided by MedCom and a routinely used national standard in general practice, hospitals, and municipalities.

Group Type: EXPERIMENTAL

Patient-centred complex intervention in complicated multimorbidity (CIM2)

Intervention Type: OTHER

CIM2 is the second version of the Patient-centred complex intervention in complicated multimorbidity

Usual care

Patients with a general practitioner allocated to the control group will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient-centred complex intervention in complicated multimorbidity (CIM2)

CIM2 is the second version of the Patient-centred complex intervention in complicated multimorbidity

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Has more than one of the 3 common chronic diseases (diabetes, chronic obstructive pulmonary, chronic heart conditions)

2. Has been hospitalised, or visited an outpatient clinic due to their chronic diseases during the previous year

3. Take at least five different prescription drugs assessed from the Shared Medicine Card recording in the general practice

4. The general practitioner or the nurse in the practice recognise the patient as a "demanding" patient with complicated multimorbidity that will benefit from an overview consultation.

Exclusion Criteria

• Patients who cannot speak Danish,
• Patients who cannot give informed consent,
• Patients who have a life expectancy of less than 12 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slagelse Hospital

OTHER

Sponsor Role: lead

University of Copenhagen

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Frølich, Professor

Role: STUDY_CHAIR

Innovation and Research Centre for Multimorbidity, Slagelse hospital, Region Zealand

Locations

Lægerne Kanaltorvet

Albertslund, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Thorkil Christensen

Albertslund, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Brøndbyøster Torv

Brøndby, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Lægerne i Brohuset

Ishøj, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Lægecenter Korsør

Korsør, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Læge Depenau vej-Hansen

Slagelse, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Læge Jørgen Larsen

Slagelse, , Denmark

Site Status: WITHDRAWN

Læge Lene Stiggaard

Slagelse, , Denmark

Site Status: RECRUITING

Lægerne Reventlow, Wolfhagen og Bendtsen

Slagelse, , Denmark

Site Status: RECRUITING

Lægerne ved Lystskoven

Slagelse, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Lægerne Vallensbæk Nord

Vallensbæk, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Countries

Denmark

Central Contacts

Anne Frølich, Professor

Role: CONTACT

anfro@sund.ku.dk

+45 27121622

Sanne L Lundstrøm, Senior Researcher

Role: CONTACT

sanlu@regionsjaelland.dk

51171721

Facility Contacts

Lene Stiggaard, GP

Role: primary

Johan Reventlow, GP

Role: primary

References

Lundstrom SL, Kamstrup-Larsen N, Barrett BA, Jorgensen LMB, Hansen SS, Andersen JS, Friderichsen B, Stockmarr A, Frolich A. A patient-centred care model for patients with complicated multimorbidity: Protocol for a pilot cluster randomised trial in general practice, municipalities, and hospitals. PLoS One. 2024 Dec 4;19(12):e0310697. doi: 10.1371/journal.pone.0310697. eCollection 2024.

Reference Type: DERIVED

PMID: 39630823 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

MM14

Identifier Type: -

Identifier Source: org_study_id