Denver Health and Hospital Authority
Denver, Colorado, 80220, United States
Location status: Recruiting
Location contact
Ryan C Martin, MD, MPH
CONTACT
Ryan C Martin, MD, MPH
CONTACT
Ryan C Martin, MD, MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07435662
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Denver, Colorado, 80220, United States
Location status: Recruiting
Ryan C Martin, MD, MPH
CONTACT
Ryan C Martin, MD, MPH
CONTACT
Ryan C Martin, MD, MPH
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: This will be assessed at each visit up to 3 months after enrollment.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Denver Health and Hospital Authority
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07081711
Aortic Diseases, Arrhythmias, Cardiac
Cleveland, Ohio, United States
View Trial DetailsNCT07592494
Cardiac Resynchronization Therapy Devices, Cardiovascular Diseases
Çorum, Turkey (Türkiye)
View Trial DetailsNCT07574593
Cardiovascular Diseases, Heart Diseases
Chula Vista, California, United States
View Trial DetailsNCT07278583
Cardiovascular Diseases, Heart Diseases
Clermont-Ferrand, France
View Trial Details