NCT03804606

Risk and Benefit Informed MTM Pharmacist Intervention in Heart Failure

Terminated NA Last updated 28 March 2025

What this trial tests

NA trial testing Referral to MTM Pharmacist in Heart Failure in 100 participants. Terminated before completion.

Timeline

28 February 2019

Primary endpoint
1 September 2023

1 September 2023

Quick facts

Lead sponsor	Geisinger Clinic
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	100
Start date	28 February 2019
Primary completion	1 September 2023
Estimated completion	1 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Referral to MTM Pharmacist

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Geisinger Clinic

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Out-of-hospital care of complex diseases, such as heart failure, is transitioning from an individual patient-doctor relationship to population health management strategies. As an example, at our institution, medication therapy management (MTM) pharmacists are being deployed to patients with heart failure with the intent of improving patient outcomes (through proper medication management and adherence) while reducing cost (e.g., keeping these patients out of the hospital). The success of such strategies will be dependent on the ability to effectively direct scarce resources to deliver appropriate/needed care to patients. In this prospective, pragmatic randomized and matched controlled study, the investigators hypothesize that the combination of accurate, data-driven benefit models and MTM pharmacist intervention in patients with heart failure will result in reduced 1-year mortality and hospital admissions. Using our extensive historical electronic health record data, the investigators have developed a machine learning model that, for individual patients with heart failure, predicts risk and benefit (that is, reduction in risk) associated with closing specific "care gaps". These care gaps represent standard evidence-based treatments that may be missing for an individual patient, such as beta blockers or flu shots. The investigators will use this model to define three cohorts to be studied: 1) a high risk/high benefit group to be referred for MTM pharmacist intervention, 2) a high risk/high benefit group to continue with existing standard of care (not necessarily involving MTM pharmacy), and 3) a high risk/low benefit group to be referred for MTM pharmacist intervention. Comparison of groups 1 and 2 (for which assignment is randomized) will evaluate the effectiveness of the MTM pharmacy intervention, while comparison of groups 1 and 3 will evaluate the accuracy of the benefit model prediction and importance of appropriate patient selection for treatment. The primary study outcomes will be mortality and number of hospital admissions during 1-year follow-up following study enrollment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.