Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hemodynamic instability
Receiving comfort care measures alone or enrolled in hospice
Trial design
Design model
Sequential
Treatments tested in this trial
Pharmacist/Cardiologist Virtual Team Digital Consultation
BehavioralA 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.
Treatment groups
585 Participants
are divided into 2 treatment groupsGroup A: Pharmacist/Cardiologist Virtual Team (Intervention)Experimental treatment 1 intervention
Group B: Usual Care (Control Period)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score
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.
Time frame
From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)Secondary outcomes
1
Change in NIH Heart Failure Collaboratory Score
A composite GDMT metric assessing the breadth and completeness of guideline-recommended heart failure pharmacotherapy.
Time frame
From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)2
All-cause mortality
Death from any cause, ascertained from the VA Death Ascertainment File.
Time frame
30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)3
Heart Failure Readmission
A claim for inpatient admission with any HF diagnosis on the claim, ascertained from the VA Corporate Data Warehouse and Consolidated Data Set.
Time frame
30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)4
Medication-related adverse outcomes - acute kidney injury
Acute kidney injury identified by creatinine levels and ICD diagnostic codes in the VA Corporate Data Warehouse.
Time frame
90 days after hospital discharge or Veteran eligibility identificationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: