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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kai-Ning Chung, RN, MSN
- 電話番号：57121 +886-6-+886-6-2812811
- メール：9608L7@chimei.org.tw
研究場所
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Yongkang Dist
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Tainan、Yongkang Dist、台湾、71004
- Chi Mei Medical Center
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コンタクト：
- Kai-Ning Chung, RN, MSN
- 電話番号：57121 +886-6-2812811
- メール：9608L7@chimei.org.tw
-
主任研究者：
- Kai-Ning Chung, RN, MSN
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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|
他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of Hospital Stay
時間枠：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.
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From hospital admission to discharge, up to 30 days
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30-Day Hospital Readmission Rate
時間枠：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
時間枠：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.
|
90 days post-discharge
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Quality of Life as Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
時間枠：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.
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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)
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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