40 Participants NeededMy employer runs this trial

Pharmacy Follow-Up for Heart Failure

RC
Overseen ByRyan C Martin, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Denver Health and Hospital Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with heart failure and reduced ejection fraction (EF ≤ 40%) who get care at Denver Health. People can't join if they have severe liver disease, kidney failure needing dialysis, trouble giving consent, or don't speak English or Spanish.

Inclusion Criteria

Receiving care within DHHA system
I am 18 years old or older.
I have heart failure with an ejection fraction of 40% or less.

Exclusion Criteria

I have been diagnosed with cirrhosis.
I am unable to give my own consent for medical decisions.
I do not speak English or Spanish.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pharmacist-directed medication adjustment visits with patient education materials or standard of care

3 months
Regular visits for medication adjustment and education

Follow-up

Participants are monitored for changes in Kansas City Medication Optimization (KCMO) scores

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares regular care to extra pharmacy visits where pharmacists help adjust heart failure medications and provide education. Patients are randomly assigned to either group to see which approach better improves medication use.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention armExperimental Treatment1 Intervention
Group II: Standard of Care ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Denver Health and Hospital Authority

Lead Sponsor

Trials
106
Recruited
403,000+

Colorado Clinical & Translational Sciences Institute

Collaborator

Trials
21
Recruited
1,400+