The Optimization of Medications in Chronic Heart Failure Using a Website
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Med Optimization Arm
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- left ventricular ejection fraction (LVEF) </= 40%
Exclusion Criteria:
- pregnancy
- active cancer with a life expectancy less than 12 months
- hospice
- chronic inotropic therapy
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Medication Optimization Group
Control Group
Arm Description
Patients randomized to the medication optimization group will receive an evidence-based medication recommendation 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 Outcome Measures
The change in medications will be measured by the Evidence Based Medicine Percent Score (EBMPS).
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 Outcome Measures
Full Information
NCT ID
NCT04580004
First Posted
October 1, 2020
Last Updated
January 24, 2022
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04580004
Brief Title
The Optimization of Medications in Chronic Heart Failure Using a Website
Official Title
The Optimization of Medications in Chronic Heart Failure Using a Website
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of personnel to run the study.
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medication Optimization Group
Arm Type
Experimental
Arm Description
Patients randomized to the medication optimization group will receive an evidence-based medication recommendation intervention.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Med Optimization Arm
Intervention Description
An evidence-based medication recommendation website that is provided to the patients.
Primary Outcome Measure Information:
Title
The change in medications will be measured by the Evidence Based Medicine Percent Score (EBMPS).
Description
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).
Time Frame
Change over 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
left ventricular ejection fraction (LVEF) </= 40%
Exclusion Criteria:
pregnancy
active cancer with a life expectancy less than 12 months
hospice
chronic inotropic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Dorsch, PharmD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Optimization of Medications in Chronic Heart Failure Using a Website
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