Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacy follow up.
- Who it may be relevant to
- Registry conditions: Heart Failure, Medication Optimization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Pharmacy follow up
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.
Primary outcome measures
- 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 outcome measures (1)
- Change in Kansas City Medical Optimization (KCMO) score from baseline. [Time frame: Calculated at enrollment and at 3 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Denver Health and Hospital Authority — Denver
Identifiers
NCT: NCT07435662 · 25-1425