Primary -Percentage of time that the treating clinician agrees with the DE GDMT medication recommendations. For this endpoint, all patients will be considered regardless of enrollment time and will begin after RPM has been initiated. Key Secondary -The primary endpoint will be the difference between the control and the intervention arm in the percentage of patients on a beta blocker, ARNI, MRA, and SGLT2 inhibitor, at least 50% target dose at the end of each phase using the CHAMP Registry methodology. -Study coordinator will input the patient?s GDMT at the beginning of the study period and a statistician will calculate composite score based on the CHAMP registry methodology. At the outset of the study, the statistician will calculate the ratio of GDMT beta blocker, ACE/ARB/ARNI, MRA, and SLGT2i, at least 50% target dose divided by 4. At the end of 3 months, the statistician will calculate the ratio of GDMT beta blocker, ACE/ARB/ARNI, MRA, and SLGT2i, at least 50% target dose divided by the 4 GDMT medications that the patient was eligible to take. If patient refused initiation or uptitration of a beta blocker, ARNI/ACE/ARNI, MRA, or SLGT2i, then that class of medication will be deemed ineligible and not be included in the denominator. The patient could be eligible for 0, 1, 2, 3 or 4 medications at the end of the study period. For each patient, a relative change will be calculated from the end of three months compared to beginning of the study period. The relative change in the intervention and control arm will be compared for each patient and averaged across all patients in each arm of the study. Exploratory -Percentage of patients unable to fill recommended medication due to cost. -Percentage of patients with intolerance due to recommended medication. -Percentage of patients who refuse physician recommendation. -Difference between control and intervention arm in the ER visits, unscheduled clinic visits, and hospitalizations. -Difference between control and intervention arm in the number of safety endpoints.
What is the full name of this clinical trial?
A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients with Heart Failure and Reduced Ejection Fraction Using a Digital Therapeutics Platform
Antoine Hage, David Chang, Erika Jones, Raymond Zimmer, Suhail Dohad, Yaron Elad