Effects of a Multidisciplinary Integrated Care Model on Care Outcomes in Patients With Heart Failure With Preserved Ejection Fraction (MICM-HFpEF)
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
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kai-Ning Chung, RN, MSN
- 전화번호: 57121 +886-6-+886-6-2812811
- 이메일: 9608L7@chimei.org.tw
연구 장소
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Yongkang Dist
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Tainan, Yongkang Dist, 대만, 71004
- Chi Mei Medical Center
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연락하다:
- Kai-Ning Chung, RN, MSN
- 전화번호: 57121 +886-6-2812811
- 이메일: 9608L7@chimei.org.tw
-
수석 연구원:
- Kai-Ning Chung, RN, MSN
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: MICM Intervention Group
Participants prospectively enrolled and managed under the Multidisciplinary Integrated Care Model (MICM), receiving coordinated care from cardiologists, case managers, pharmacists, dietitians, and rehabilitation specialists, in addition to standard cardiology follow-up.
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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.
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다른: Historical Control Group
A retrospective cohort of patients with heart failure with preserved ejection fraction who received usual, non-integrated cardiology care prior to implementation of the multidisciplinary integrated care model.
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Standard, non-integrated cardiology care as routinely provided prior to implementation of the multidisciplinary integrated care model.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Length of Hospital Stay
기간: From hospital admission to discharge, up to 30 days
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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.
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From hospital admission to discharge, up to 30 days
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30-Day Hospital Readmission Rate
기간: 30 days post-discharge
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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.
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30 days post-discharge
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90-Day Hospital Readmission Rate
기간: 90 days post-discharge
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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.
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90 days post-discharge
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Quality of Life as Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
기간: Baseline and 3 months post-intervention
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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.
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Baseline and 3 months post-intervention
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Change in Self-Care Ability as Measured by the Self-Care of Heart Failure Index v8.0 (SCHFI v8.0)
기간: Baseline and 3 months post-intervention
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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.
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Baseline and 3 months post-intervention
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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