Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver
Recruiting · NCT07435662 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age ≥ 18 years
- Diagnosis of HFrEF (EF ≤ 40%)
- Receiving care within DHHA system
Exclusion criteria
- Estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73 m² or receiving dialysis.
- Cirrhosis
- Inability to consent
- Non-English or non-Spanish speaking
Where it is running
1 location listed across 1 US state.
- Denver Health and Hospital Authority - Denver, Colorado, United States