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NCT03804606 · ClinicalTrials.gov registry record · NA
Risk and Benefit Informed MTM Pharmacist Intervention in Heart Failure
A NA study, sponsored by Geisinger Clinic.
- Terminated
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT03804606 is a NA study that was terminated before completion, run by Geisinger Clinic. The registered enrollment target is 100 participants.
The verdict
NCT03804606, a NA study, was terminated before completion, sponsored by Geisinger Clinic.
- TERMINATED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
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 st
Interventions
- OTHER Referral to MTM Pharmacist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-02-28 |
| Est. Completion | 2023-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03804606
The ClinicalTrials.gov registry entry for NCT03804606 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Geisinger Clinic, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Referral to MTM Pharmacist is the first listed.
NCT03804606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03804606 about?
NCT03804606 is a clinical study titled "Risk and Benefit Informed MTM Pharmacist Intervention in Heart Failure". 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 fa...
What is the current status of trial NCT03804606?
This trial is currently terminated. It is a NA study. The enrollment target is 100 participants. The study started on 2019-02-28. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT03804606?
The interventions under investigation include: Referral to MTM Pharmacist (OTHER).
Who is sponsoring clinical trial NCT03804606?
This trial is sponsored by Geisinger Clinic, which has 107 total clinical trials registered on ClinicalTrials.gov.
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