Recruiting

Pharmacist-Directed Care

Sponsor:

Denver Health and Hospital Authority

Code:

NCT07435662

Conditions

Heart Failure

Medication Optimization

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharmacy follow up

Study Details

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.

Conditions

Heart Failure

Medication Optimization

Study ID

NCT07435662

Start date

Oct 1, 2025

Status verified date

Dec, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention arm

Intervention arm will receive specialized education materials and dedicated pharmacy visits between provider visits.

no intervention: Standard of Care Arm

Standard of care arm will see heart failure providers as usual

Interventions

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 measure

  • 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. ]

Central Contacts and Locations

Central contacts

Locations

Denver Health and Hospital Authority

Recruiting

Denver, Colorado, United States, 80220

Contacts

Ryan C Martin, MD, MPH

303-602-3899ryan.martin@dhha.org

Ryan C Martin, MD, MPH

303-602-3899

Principal Investigator:

Ryan C Martin, MD, MPH

More Information

Sponsor

Denver Health and Hospital Authority

Last update posted

Aug 26, 2026

Last verified

Dec, 2025

Keywords

  • heart failure
  • limited access to care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Denver Health and Hospital Authority on 2026-08-26.