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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pharmacy follow up

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Standard of Care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Change in Kansas City Medical Optimization (KCMO) score from baseline.

KCMO is calculated by averaging the percent of target doses for each class of GDMT that is not contraindicated in the patient. The value is thus expressed as a percentage ranging from 0 to 100.

Time frame
Calculated at enrollment and at 3 months.

Other outcomes

Sponsors and contacts

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Denver Health and Hospital Authority

Lead sponsor

Colorado Clinical & Translational Sciences Institute

Collaborator