Heart Failure, Medication Optimization
Conditions
Keywords
heart failure, limited access to care
Brief summary
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
OTHERPharmacy 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.
Sponsors
Denver Health and Hospital Authority
Colorado Clinical & Translational Sciences Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of visits with initiation or intensification of heart failure medications | This will be assessed at each visit up to 3 months after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kansas City Medical Optimization (KCMO) score from baseline. | Calculated at enrollment and at 3 months. | 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. |
Countries
United States
Contacts
CONTACTRyan C Martin, MD, MPH
Outcome results
None listed