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Clinical Trials/NCT04580004
NCT04580004TerminatedNot Applicable

The Optimization of Medications in Chronic Heart Failure Using a Website

University of Michigan1 site in 1 country3 target enrollmentStarted: September 24, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
1
Primary Endpoint
The change in medications will be measured by the Evidence Based Medicine Percent Score (EBMPS).

Study Overview

Brief Summary

Heart failure (HF) is the most common hospital discharge diagnosis among older adults in the United States. Strikingly, 2 in 5 patients are readmitted within 1-year following their first HF admission. This results in significant potentially avoidable costs to our already strained healthcare system since hospitalizations result in 70% of yearly HF management costs. One of the most common causes of readmission is lack of medication optimization. This study will determine the effectiveness of a medication optimization website.

Detailed Description

In a prospective design, 100 patients will be randomized to the intervention or usual care in a 1:1 fashion. Patients randomized to the intervention will receive an evidence-based medication recommendation intervention. Outcome measures will be collected at baseline and at 2 weeks post-intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •left ventricular ejection fraction (LVEF) </= 40%

Exclusion Criteria

  • •pregnancy
  • •active cancer with a life expectancy less than 12 months
  • •chronic inotropic therapy

Arms & Interventions

Medication Optimization Group

Experimental

Patients randomized to the medication optimization group will receive an evidence-based medication recommendation intervention.

Intervention: Med Optimization Arm (Other)

Control Group

No Intervention

Patients in the control group will receive the same intervention, delayed 2 weeks after the intervention group. During those initial 2 weeks they will act as a control.

Outcomes

Primary Outcomes

The change in medications will be measured by the Evidence Based Medicine Percent Score (EBMPS).

Time Frame: Change over 2 weeks

The Evidence Based Medicine Percent Score (EBMPS) is calculated by the medications and doses the patient is taking (in points) divided by the total eligible medications based on the evidence (in points).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Dorsch

Assistant Professor of Clinical Pharmacy

University of Michigan

Study Sites (1)

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