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Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure (PATRIOT-HF)

2026년 7월 15일 업데이트: VA Office of Research and Development

Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure (PATRIOT-HF) (QUE 25-018)

Many Veterans who are hospitalized with heart failure do not receive all the recommended heart medications at the right doses before they leave the hospital or in the weeks following discharge. This study tests whether a team of clinical pharmacists and cardiologists, working virtually, can improve heart failure medication prescribing for Veterans at VA medical centers. The pharmacist and cardiologist team reviews patient records and provides recommendations to the treating doctors and primary care providers caring for Veterans with heart failure. The goal is to increase use of guideline-recommended medications, which have been shown to improve survival, reduce hospitalizations, and improve quality of life.

연구 개요

상세 설명

Heart failure with reduced ejection fraction (HFrEF) affects a large proportion of Veterans and isa leading cause of hospitalization and death. Clinical guidelines recommend four classes of medications (commonly called "quadruple therapy") that improve survival and reduce hospitalizations, yet 42% of Veterans hospitalized with heart failure do not receive all recommended medications at discharge.

This study implements a virtual pharmacist and cardiologist team (hub) that provides digital consultation to hospitalists and primary care providers (spoke) at VA medical centers regarding use of guideline-directed medical therapy (GDMT) during hospitalization and the post-discharge period. The pharmacist/cardiologist team identifies eligible Veterans using a VA hospital-specific dashboard, reviews electronic health records, and places digital consultation notes with individualized medication recommendations, safety surveillance information, and out-of-pocket medication cost data.

The intervention also incorporates identification of Veterans hospitalized in VA-paid community care settings. Veterans hospitalized with heart failure in community hospitals within the preceding 3 months are identified via VA-paid community care claims data, and actionable recommendations are provided through the VA electronic health record or by facsimile to community providers.

Six VA medical centers served by Clinical Resource Hubs in VISNs 4, 16, 17, 19, and 23 are participating. Sites are randomized to one of three implementation waves in a cluster-randomized stepped-wedge design, with implementation occurring every 6 months at two sites per wave. This design allows estimation of intervention effects using both within- and between-site comparisons while controlling for secular trends. A difference-in-differences analytic approach with covariate-constrained randomization is used to estimate causal effects.

The primary effectiveness outcome is change in GDMT optimization score from admission to 14 days after discharge. Secondary effectiveness/safety outcomes include mortality, heart failure readmission, and medication-related adverse events at 90 days. Implementation outcomes are assessed using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and include fidelity to identification of at-risk Veterans, provision of recommendations,, outpatient follow-up rates, and barriers and facilitators to implementation Additional outcomes derived from the RE-AIM framework will also be captured.

연구 유형

중재적

등록 (추정된)

585

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Paul L Hess, MD MS
  • 전화번호: (720) 857-6889
  • 이메일: paul.hess@va.gov

연구 연락처 백업

연구 장소

    • Colorado
      • Aurora, Colorado, 미국, 80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • 연락하다:
        • 수석 연구원:
          • Paul L Hess, MD MS

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Admission to a VA medical center or VA-paid community hospital within the preceding 3 months with a primary diagnosis of heart failure

    • The primary study cohort will consist of those admitted to a VA medical center, while the secondary study cohort will consist of patients admitted to VA-paid community hospitals
  • Left ventricular ejection fraction ≤ 40%
  • Not on optimal guideline-directed heart failure medication classes or doses, as assessed in the electronic health record
  • Receiving care within one of the 6 participating VA medical centers

Exclusion Criteria:

  • Hemodynamic instability
  • Receiving comfort care measures alone or enrolled in hospice

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Pharmacist/Cardiologist Virtual Team (Intervention)
VA medical centers randomized to the active intervention period receive digital consultation from a centralized pharmacist and cardiologist virtual team regarding guideline-directed medical therapy for hospitalized Veterans with heart failure and during the post-discharge period. The intervention includes identification of eligible Veterans, placement of digital consultation notes in the EHR, facilitation of outpatient follow-up, and Veteran education.
A centralized pharmacist and cardiologist virtual team (hub) provides protocol-based digital consultation notes to inpatient and outpatient providers(spoke) regarding initiation and intensification of guideline-directed medical therapy (GDMT) for heart failure during hospitalization and the post-discharge transitional care period. Eligible Veterans are identified via VA dashboards and community care claims data. Recommendations cover quadruple therapy (beta blockers, ACEI/ARB/ARNI, MRA, SGLT2i) and are tailored to individual clinical presentations. The pharmacist arranges outpatient follow-up and delivers medication adherence education.
다른 이름들:
  • PATRIOT-HF intervention; pharmacist-assisted GDMT optimization
간섭 없음: Usual Care (Control Period)
VA medical centers during their pre-implementation (control) period provide usual care for Veterans hospitalized with heart failure without input from the pharmacist/cardiologist virtual team. In the stepped-wedge design, all sites eventually cross over to the intervention arm.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score
기간: From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)
The GDMT Optimization Score reflects the proportion of eligible guideline-recommended heart failure medications prescribed relative to the total for which the Veteran is eligible. Points are assigned as follows - Numerator: ACEI/ARB=1, ARNI=2, evidence-based beta blocker=2, MRA=2, SGLT2i=2, Vericiguat=1, Ivabradine=1, Hydralazine/Nitrates=1. Denominator reflects eligibility for each class. A higher score indicates greater concordance with guidelines.
From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in NIH Heart Failure Collaboratory Score
기간: From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)
A composite GDMT metric assessing the breadth and completeness of guideline-recommended heart failure pharmacotherapy.
From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)
All-cause mortality
기간: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
Death from any cause, ascertained from the VA Death Ascertainment File.
30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
Heart Failure Readmission
기간: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
A claim for inpatient admission with any HF diagnosis on the claim, ascertained from the VA Corporate Data Warehouse and Consolidated Data Set.
30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
Medication-related adverse outcomes - acute kidney injury
기간: 90 days after hospital discharge or Veteran eligibility identification
Acute kidney injury identified by creatinine levels and ICD diagnostic codes in the VA Corporate Data Warehouse.
90 days after hospital discharge or Veteran eligibility identification
Medication-related adverse outcomes - bradycardia
기간: 90 after hospital discharge or Veteran eligibility identification
Bradycardia identified by vital sign readings and ICD diagnostic codes in the VA Corporate Data Warehouse.
90 after hospital discharge or Veteran eligibility identification
Medication-related adverse outcomes - hyperkalemia
기간: 90 days after hospital discharge or Veteran eligibility identification
Hyperkalemia identified by potassium laboratory values and ICD diagnostic codes in the VA Corporate Data Warehouse.
90 days after hospital discharge or Veteran eligibility identification

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Paul L Hess, MD MS, Rocky Mountain Regional VA Medical Center, Aurora, CO

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 24일

기본 완료 (추정된)

2030년 9월 30일

연구 완료 (추정된)

2030년 9월 30일

연구 등록 날짜

최초 제출

2026년 7월 15일

QC 기준을 충족하는 최초 제출

2026년 7월 15일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 15일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))
  • QUE 25-018 (기타 보조금/기금 번호: VA Quality Enhancement Research Initiative (QUERI))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared publicly due to VA data governance and privacy requirements governing VA Corporate Data Warehouse data. Aggregate study results will be published in peer-reviewed journals.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심부전에 대한 임상 시험

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