Effects of a Multidisciplinary Integrated Care Model on Care Outcomes in Patients With Heart Failure With Preserved Ejection Fraction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChimei Medical Center

About this trial

Heart failure with preserved ejection fraction (HFpEF) accounts for approximately half of all heart failure cases and is associated with frequent hospitalizations, poor quality of life, and limited effective treatment options. Fragmented, single-discipline care often fails to address the multiple comorbidities and self-management needs of this population.

This study evaluates a Multidisciplinary Integrated Care Model (MICM) for patients with HFpEF, delivered by a coordinated team including cardiologists, case managers, pharmacists, dietitians, and rehabilitation specialists. The intervention group will receive structured team-based care, including regular follow-up, medication optimization, dietary and lifestyle counseling, and exercise guidance, in addition to standard cardiology care.

Using a prospective quasi-experimental design with a historical control group, this study compares clinical and patient-reported outcomes between patients receiving the multidisciplinary integrated care model and a historical cohort receiving usual care. The primary aim is to determine whether this integrated care approach improves outcomes such as heart failure-related hospitalization, functional status, and quality of life in patients with HFpEF.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Hospitalized with a physician diagnosis of heart failure with preserved ejection fraction (HFpEF)

Left ventricular ejection fraction (LVEF) ≥50% on echocardiography performed during the index hospitalization

New York Heart Association (NYHA) functional class III to IV

Disqualifiers

Patients who elected hospice or palliative care as part of an advance care plan during the index hospitalization

Severe cognitive impairment without a family member or caregiver available to assist with the digital platform

Anticipated inability to complete post-discharge follow-up or lack of regular follow-up at the study institution's outpatient clinic

Length of index hospital stay less than 24 hours

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary Integrated Care Model (MICM)

    Other intervention

    A structured, team-based care program integrating cardiology management, case management, pharmacist-led medication review, nutritional counseling, and exercise guidance, delivered to patients with heart failure with preserved ejection fraction.

  • Usual Care

    Other intervention

    Standard, non-integrated cardiology care as routinely provided prior to implementation of the multidisciplinary integrated care model.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MICM Intervention GroupExperimental treatment 1 intervention
Group B: Historical Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Length of Hospital Stay

Mean length of hospital stay, measured in days from hospital admission to discharge, among patients with heart failure with preserved ejection fraction (HFpEF), compared between the multidisciplinary integrated care intervention group and the historical usual care control group.

Time frame
From hospital admission to discharge, up to 30 days
2

30-Day Hospital Readmission Rate

Proportion of participants readmitted to the hospital for any cause within 30 days of discharge, compared between the multidisciplinary integrated care intervention group and the historical usual care control group.

Time frame
30 days post-discharge
3

90-Day Hospital Readmission Rate

Proportion of participants readmitted to the hospital for any cause within 90 days of discharge, compared between the multidisciplinary integrated care intervention group and the historical usual care control group.

Time frame
90 days post-discharge

Secondary outcomes

1

Change in Quality of Life as Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Change in quality of life among patients with HFpEF following the multidisciplinary integrated care intervention, assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The total score ranges from 0 to 105, with lower scores indicating better health-related quality of life and higher scores indicating worse health-related quality of life.

Time frame
Baseline and 3 months post-intervention
2

Change in Self-Care Ability as Measured by the Self-Care of Heart Failure Index v8.0 (SCHFI v8.0)

Change in self-care ability among patients with HFpEF following the multidisciplinary integrated care intervention, assessed using the Self-Care of Heart Failure Index version 8.0 (SCHFI v8.0), which includes three scales: self-care maintenance, symptom perception, and self-care management. Each scale is standardized to a score ranging from 0 to 100, with higher scores indicating better self-care ability.

Time frame
Baseline and 3 months post-intervention

Other outcomes

Sponsors and contacts

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