Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver

Conditions

• Heart Failure
• Medication Optimization

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pharmacy follow up — OTHER
  Patients in the intervention will have additional follow ups with pharmacy between heart failure provider visits. They will also receive specialized simple patient education re: heart failure meds.

Study Details

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.

Key Dates

Start date

Oct 1, 2025

Status verified

Dec 2025

Primary completion

May 1, 2026

Completion

Jul 1, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intervention arm
  Intervention arm will receive specialized education materials and dedicated pharmacy visits between provider visits.
• No Intervention: Standard of Care Arm
  Standard of care arm will see heart failure providers as usual

Primary Outcome Measure

Proportion of visits with initiation or intensification of heart failure medications [ Time Frame: This will be assessed at each visit up to 3 months after enrollment. ]

Central Contacts

• Ryan C Martin, MD, MPH
  303-602-3899
  [email protected]

Locations (1)

Find similar trials in Denver, CO

Related Studies

• Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
  Recruiting · Medtronic · Birmingham, Alabama
• The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
  Recruiting · Cardiac Dimensions, Inc. · Gilbert, Arizona
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Phoenix, Arizona
• Goals of Care Conversations Study
  Enrolling By Invitation · VA Office of Research and Development · Palo Alto, California