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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
350
CIM2 is the second version of the Patient-centred complex intervention in complicated multimorbidity
Lægerne Kanaltorvet
Albertslund, Denmark
ACTIVE_NOT_RECRUITINGThorkil Christensen
Albertslund, Denmark
ACTIVE_NOT_RECRUITINGBrøndbyøster Torv
Brøndby, Denmark
ACTIVE_NOT_RECRUITINGLægerne i Brohuset
Ishøj, Denmark
ACTIVE_NOT_RECRUITINGLægecenter Korsør
Korsør, Denmark
ACTIVE_NOT_RECRUITINGLæge Depenau vej-Hansen
Slagelse, Denmark
ACTIVE_NOT_RECRUITINGLæge Jørgen Larsen
Slagelse, Denmark
WITHDRAWNLæge Lene Stiggaard
Slagelse, Denmark
RECRUITINGLægerne Reventlow, Wolfhagen og Bendtsen
Slagelse, Denmark
RECRUITINGLægerne ved Lystskoven
Slagelse, Denmark
ACTIVE_NOT_RECRUITING...and 1 more locations
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.
Time frame: From baseline to 12-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12-month follow-up
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