A New Care Model for Patients With Complicated Multimorbidity

NCT05406193 | Unknown DMC

• 1 other identifier: MM14
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 11

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

Keywords

General practice; Integrated care; Multimorbidity

Outcome Measures

Primary Outcomes (1)

• Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 12 months

  PACIC is a 20-item patient report instrument that assesses patient's receipt of clinical services and actions. Each item was scored on a 5-point scale ranging from 1 (no or never) to 5 (yes or always). Respondents rate how often they experienced the content described in each item. The scale range from 1-5 and is scored by averaging of items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. Higher scores indicate higher patient assessment delivery of high-quality care for patients with chronic diseases.

  From baseline to 12-month follow-up

Secondary Outcomes (5)

• Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 6 months

  From baseline to 6-month follow-up

• Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 6 months

  From baseline to 6-month follow-up

• Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 12 months

  From baseline to 12-month follow-up

• Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 6 months

  From baseline to 6-month follow-up

• Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 12 months

  From baseline to 12-month follow-up

Study Arms (2)

Intervention (CIM2)

EXPERIMENTAL

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.

Other: Patient-centred complex intervention in complicated multimorbidity (CIM2)

Usual care

NO INTERVENTION

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

Interventions

Patient-centred complex intervention in complicated multimorbidity (CIM2) OTHER

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

Intervention (CIM2)

Eligibility Criteria

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

You may qualify if:

• Has more than one of the 3 common chronic diseases (diabetes, chronic obstructive pulmonary, chronic heart conditions)
• Has been hospitalised, or visited an outpatient clinic due to their chronic diseases during the previous year
• Take at least five different prescription drugs assessed from the Shared Medicine Card recording in the general practice
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Slagelse Hospital: lead
• University of Copenhagen: collaborator

Study Sites (11)

Lægerne Kanaltorvet

Albertslund, 2620, Denmark

ACTIVE NOT RECRUITING

Thorkil Christensen

Albertslund, 2620, Denmark

ACTIVE NOT RECRUITING

Brøndbyøster Torv

Brøndby, 2605, Denmark

ACTIVE NOT RECRUITING

Lægerne i Brohuset

Ishøj, 2635, Denmark

ACTIVE NOT RECRUITING

Lægecenter Korsør

Korsør, 4220, Denmark

ACTIVE NOT RECRUITING

Læge Depenau vej-Hansen

Slagelse, 4200, Denmark

ACTIVE NOT RECRUITING

Læge Jørgen Larsen

Slagelse, 4200, Denmark

WITHDRAWN

Læge Lene Stiggaard

Slagelse, 4200, Denmark

RECRUITING

Lægerne Reventlow, Wolfhagen og Bendtsen

Slagelse, 4200, Denmark

RECRUITING

Lægerne ved Lystskoven

Slagelse, 4200, Denmark

ACTIVE NOT RECRUITING

Lægerne Vallensbæk Nord

Vallensbæk, 2625, Denmark

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 39630823 DERIVED

Study Officials

• Anne Frølich, Professor

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

  STUDY CHAIR

Central Study Contacts

Anne Frølich, Professor

CONTACT

+45 27121622; anfro@sund.ku.dk

Sanne L Lundstrøm, Senior Researcher

CONTACT

51171721; sanlu@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 6, 2022
• Study Start: November 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

DK (11)