- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07714239
Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure (PATRIOT-HF)
Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure (PATRIOT-HF) (QUE 25-018)
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
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Paul L Hess, MD MS
- 전화번호: (720) 857-6889
- 이메일: paul.hess@va.gov
연구 연락처 백업
- 이름: Lexus L Ujano-De Motta, BS
- 전화번호: (808) 990-3993
- 이메일: lexus.ujano-demotta@va.gov
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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연락하다:
- Paul L Hess, MD MS
- 전화번호: 720-857-6889
- 이메일: paul.hess@va.gov
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수석 연구원:
- Paul L Hess, MD MS
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
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
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 |
|---|---|
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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.
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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:
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
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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.
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From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
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A composite GDMT metric assessing the breadth and completeness of guideline-recommended heart failure pharmacotherapy.
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From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)
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All-cause mortality
기간: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
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Death from any cause, ascertained from the VA Death Ascertainment File.
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30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
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Heart Failure Readmission
기간: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
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A claim for inpatient admission with any HF diagnosis on the claim, ascertained from the VA Corporate Data Warehouse and Consolidated Data Set.
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30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
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Medication-related adverse outcomes - acute kidney injury
기간: 90 days after hospital discharge or Veteran eligibility identification
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Acute kidney injury identified by creatinine levels and ICD diagnostic codes in the VA Corporate Data Warehouse.
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90 days after hospital discharge or Veteran eligibility identification
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Medication-related adverse outcomes - bradycardia
기간: 90 after hospital discharge or Veteran eligibility identification
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Bradycardia identified by vital sign readings and ICD diagnostic codes in the VA Corporate Data Warehouse.
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90 after hospital discharge or Veteran eligibility identification
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Medication-related adverse outcomes - hyperkalemia
기간: 90 days after hospital discharge or Veteran eligibility identification
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Hyperkalemia identified by potassium laboratory values and ICD diagnostic codes in the VA Corporate Data Warehouse.
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90 days after hospital discharge or Veteran eligibility identification
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공동 작업자 및 조사자
수사관
- 수석 연구원: Paul L Hess, MD MS, Rocky Mountain Regional VA Medical Center, Aurora, CO
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
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?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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