Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDenver Health and Hospital Authority

About this trial

Numerous pharmacotherapies have been proven to reduce mortality and hospitalization rates for heart failure with reduced ejection fraction (HFrEF) patients. However, these are underutilized clinically, preventing realization of proven benefits. Simplified patient education tools and multidisciplinary teams including pharmacists have been used to improve medication optimization but in predominantly private payer groups. This study will translate these evidence-based interventions to patients with limited access to care. In this randomized, prospective study, patients with HFrEF at a local hospital dedicated to care for participants with limited access will receive either pharmacist-directed medication adjustment visits with patient education materials or standard of care. This study will assess the hypothesis that the implementation of the intervention is feasible in this population, as demonstrated by the number of visits and proportion of visits with medication adjustments. Further, medication dosing in each arm will be evaluated via the Kansas City Medication Optimization (KCMO) score, which will average the percentage of maximal doses of appropriate HFrEF medication classes a patient is on. The change in KCMO scores over the course of the pilot in the two arms will then be compared to assess the hypothesis that the intervention will better increase patients' KCMO scores than the standard of care. The findings of this study will help address knowledge gaps in the care of patients not well represented previously in the literature. This proposal addresses the translational science roadblock of recruitment and engagement of participants with limited access to care.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Diagnosis of HFrEF (EF ≤ 40%)

Receiving care within DHHA system

Disqualifiers

Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73 m² or receiving dialysis.

Cirrhosis

Inability to consent

Non-English or non-Spanish speaking

Trial design

Treatments tested in this trial

  • Pharmacy follow up

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Denver Health and Hospital Authority

Lead sponsor

Colorado Clinical & Translational Sciences Institute

Collaborator