A New Care Model for Patients With Complicated Multimorbidity

Multimorbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406193
• Other study ID #: MM14
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Slagelse Hospital
• Contact: Anne Frølich, Professor
• Phone: +45 27121622
• Email: anfro[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multimorbidity

Intervention

Other:
• Patient-centred complex intervention in complicated multimorbidity (CIM2)
CIM2 is the second version of the Patient-centred complex intervention in complicated multimorbidity

Locations

Country	Name	City	State
Denmark	Lægerne Kanaltorvet	Albertslund
Denmark	Thorkil Christensen	Albertslund
Denmark	Brøndbyøster Torv	Brøndby
Denmark	Lægerne i Brohuset	Ishøj
Denmark	Lægecenter Korsør	Korsør
Denmark	Læge Depenau vej-Hansen	Slagelse
Denmark	Læge Jørgen Larsen	Slagelse
Denmark	Læge Lene Stiggaard	Slagelse
Denmark	Lægerne Reventlow, Wolfhagen og Bendtsen	Slagelse
Denmark	Lægerne ved Lystskoven	Slagelse
Denmark	Lægerne Vallensbæk Nord	Vallensbæk

Sponsors (2)

Lead Sponsor	Collaborator
Slagelse Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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