A New Care Model for Patients With Complicated Multimorbidity

A New Care Model for Patients With Complicated Multimorbidity A Cluster-randomised Pilot Study in General Practice, Municipalities, and Hospitals

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.

Study Overview

• Status: Recruiting
• Conditions: Multimorbidity
• Intervention / Treatment: Other: Patient-centred complex intervention in complicated multimorbidity (CIM2)

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Frølich, Professor; Phone Number: +45 27121622; Email: anfro@sund.ku.dk
• Study Contact Backup: Name: Sanne L Lundstrøm, Senior Researcher; Phone Number: 51171721; Email: sanlu@regionsjaelland.dk

Study Locations

• Denmark
  • Albertslund, Denmark, 2620
    • Active, not recruiting
    • Lægerne Kanaltorvet
  • Albertslund, Denmark, 2620
    • Active, not recruiting
    • Thorkil Christensen
  • Brøndby, Denmark, 2605
    • Active, not recruiting
    • Brøndbyøster Torv
  • Ishøj, Denmark, 2635
    • Active, not recruiting
    • Lægerne i Brohuset
  • Korsør, Denmark, 4220
    • Active, not recruiting
    • Lægecenter Korsør
  • Slagelse, Denmark, 4200
    • Active, not recruiting
    • Læge Depenau vej-Hansen
  • Slagelse, Denmark, 4200
    • Withdrawn
    • Læge Jørgen Larsen
  • Slagelse, Denmark, 4200
    • Recruiting
    • Læge Lene Stiggaard
    • Contact: Lene Stiggaard, GP
  • Slagelse, Denmark, 4200
    • Recruiting
    • Lægerne Reventlow, Wolfhagen og Bendtsen
    • Contact: Johan Reventlow, GP
  • Slagelse, Denmark, 4200
    • Active, not recruiting
    • Lægerne ved Lystskoven
  • Vallensbæk, Denmark, 2625
    • Active, not recruiting
    • Lægerne Vallensbæk Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Patient-centred complex intervention in complicated multimorbidity (CIM2); CIM2 is the second version of the Patient-centred complex intervention in complicated multimorbidity
No Intervention: Usual care; Patients with a general practitioner allocated to the control group will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 6 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 6-month follow-up
Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 6 months	The EQ-5D-5L assess the patients' health-related quality of life. It contains two main elements: a descriptive profile comprising five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-5D visual analogue scale (EQ VAS). Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The EQ-VAS range from 0 (the worst imaginable health state) at the bottom to 100 (the best imaginable health state) on the top for respondents to rate their overall health.	From baseline to 6-month follow-up
Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 12 months	The EQ-5D-5L assess the patients' health-related quality of life. It contains two main elements: a descriptive profile comprising five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-5D visual analogue scale (EQ VAS). Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The EQ-VAS range from 0 (the worst imaginable health state) at the bottom to 100 (the best imaginable health state) on the top for respondents to rate their overall health.	From baseline to 12-month follow-up
Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 6 months	The Multimorbidity Treatment Burden Questionnaire (MTBQ) is a 10-item questionnaire designed to measure treatment burden (the effort of looking after one's health) in patients with multimorbidity in primary care. Each question is scored as follows: zero (not difficult/ does not apply), one (a little difficult), two (quite difficult), three (very difficult), four (extremely difficult). To calculate a global score, each participant's average score is calculated from the questions answered and multiplied by 25 to give a score from 0-100. Higher MTBQ score indicate higher treatment burden.	From baseline to 6-month follow-up
Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 12 months	The Multimorbidity Treatment Burden Questionnaire (MTBQ) is a 10-item questionnaire designed to measure treatment burden (the effort of looking after one's health) in patients with multimorbidity in primary care. Each question is scored as follows: zero (not difficult/ does not apply), one (a little difficult), two (quite difficult), three (very difficult), four (extremely difficult). To calculate a global score, each participant's average score is calculated from the questions answered and multiplied by 25 to give a score from 0-100. Higher MTBQ score indicate higher treatment burden.	From baseline to 12-month follow-up

Collaborators and Investigators

• Sponsor: Slagelse Hospital
• Collaborators: University of Copenhagen
• Investigators: Study Chair: Anne Frølich, Professor, Innovation and Research Centre for Multimorbidity, Slagelse hospital, Region Zealand

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Integrated care; General practice; Multimorbidity
• Other Study ID Numbers: MM14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No