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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05406193
Other study ID # MM14
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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