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Effects of a Multidisciplinary Integrated Care Model on Care Outcomes in Patients With Heart Failure With Preserved Ejection Fraction (MICM-HFpEF)

30. august 2026 oppdatert av: Chimei Medical Center

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Kai-Ning Chung, RN, MSN
  • Telefonnummer: 57121 +886-6-+886-6-2812811
  • E-post: 9608L7@chimei.org.tw

Studiesteder

  • Taiwan
    • Yongkang Dist
      • Tainan, Yongkang Dist, Taiwan, 71004
        • Chi Mei Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kai-Ning Chung, RN, MSN

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Multidisciplinary Integrated Care Model (MICM)
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.
Annen: 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.
Annen: Usual Care
Standard, non-integrated cardiology care as routinely provided prior to implementation of the multidisciplinary integrated care model.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of Hospital Stay
Tidsramme: 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.
From hospital admission to discharge, up to 30 days
30-Day Hospital Readmission Rate
Tidsramme: 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.
30 days post-discharge
90-Day Hospital Readmission Rate
Tidsramme: 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.
90 days post-discharge

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Quality of Life as Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Tidsramme: 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.
Baseline and 3 months post-intervention
Change in Self-Care Ability as Measured by the Self-Care of Heart Failure Index v8.0 (SCHFI v8.0)
Tidsramme: 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.
Baseline and 3 months post-intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chimei Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

9. august 2026

Først innsendt som oppfylte QC-kriteriene

30. august 2026

Først lagt ut (Faktiske)

1. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CMMC11506-020

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared, as this study involves data collected under local institutional review board approval, and the study protocol does not include provisions for external data sharing due to patient privacy and confidentiality considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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