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NCT Number: NCT07798856

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chi Mei Medical Center

Tainan, Yongkang Dist, 71004, Taiwan

Location contact

Kai-Ning Chung, RN, MSN

CONTACT

[email protected]

+886-6-2812811 ext. 57121

Kai-Ning Chung, RN, MSN

PRINCIPAL_INVESTIGATOR

About this study

Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous clinical syndrome characterized by signs and symptoms of heart failure with a left ventricular ejection fraction ≥50%. It disproportionately affects older adults and patients with multiple comorbidities, including hypertension, diabetes, obesity, and chronic kidney disease. Despite its high prevalence and disease burden, few pharmacologic therapies have demonstrated consistent benefit in this population, highlighting the importance of non-pharmacologic and system-level interventions.

This study investigates whether a Multidisciplinary Integrated Care Model (MICM) improves care outcomes for patients with HFpEF compared with historical usual care. The MICM intervention integrates the following components:

  • Cardiology-led clinical management with guideline-directed medical therapy optimization
  • Case management for care coordination, symptom monitoring, and care transitions
  • Pharmacist-led medication review and adherence support
  • Nutritional counseling tailored to heart failure and comorbidity management
  • Structured exercise and cardiac rehabilitation guidance
  • Patient and caregiver education on self-management and warning signs

Eligible participants are adults diagnosed with HFpEF (left ventricular ejection fraction ≥50%) who receive care at the study institution. The intervention cohort will be prospectively enrolled and followed under the MICM program, while the historical control cohort will consist of patients who received standard usual care prior to program implementation, matched on relevant baseline characteristics.

Outcomes of interest include heart failure-related hospitalization and emergency visits, all-cause mortality, functional capacity, NYHA functional class, and health-related quality of life. Data will be collected through structured clinical assessments and medical record review at baseline and at scheduled follow-up intervals.

Findings from this study are intended to generate evidence on the effectiveness of multidisciplinary, team-based care models in improving outcomes for patients with HFpEF, and to inform future integrated care program development in similar clinical settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Able to communicate in Mandarin or Taiwanese and understand the study intervention
  • For the prospective intervention group: willing to participate and provide written informed consent. For the historical control group: existing medical record data will be collected under a waiver of informed consent.

Exclusion criteria

  • 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

Treatment and study plan

Multidisciplinary Integrated Care Model (MICM)

Other

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

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

Primary outcomes

  1. Length of Hospital Stay

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

    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.

  2. 30-Day Hospital Readmission Rate

    Time frame: 30 days post-discharge

    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.

  3. 90-Day Hospital Readmission Rate

    Time frame: 90 days post-discharge

    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.

Secondary outcomes

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

    Time frame: Baseline and 3 months post-intervention

    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.

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

    Time frame: Baseline and 3 months post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai-Ning Chung, RN, MSN

CONTACT

[email protected]

+886-6-+886-6-2812811 ext. 57121

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Registry information

Official study title

A Prospective Quasi-Experimental Study With Historical Control to Evaluate the Effects of a Multidisciplinary Integrated Care Model on Care Outcomes in Patients With Heart Failure With Preserved Ejection Fraction

Acronym: MICM-HFpEF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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