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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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 1, 2020
Last Updated
January 24, 2022
Sponsor
University of Michigan
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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

Learn more about this trial

The Optimization of Medications in Chronic Heart Failure Using a Website

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