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The Optimization of Medications in Chronic Heart Failure Using a Website

Sponsor
University of Michigan (Other)
Overall Status
Terminated
CT.gov ID
NCT04580004
Collaborator
(none)
3
Enrollment
1
Location
2
Arms
4.5
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Med Optimization Arm
 N/A

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
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Optimization of Medications in Chronic Heart Failure Using a Website
Actual Study Start Date :
Sep 24, 2020
Actual Primary Completion Date :
Feb 8, 2021
Actual Study Completion Date :
Feb 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Medication Optimization Group

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

Other: Med Optimization Arm
An evidence-based medication recommendation website that is provided to the patients.
No Intervention: Control Group

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

  • hospice

  • chronic inotropic therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Michael P Dorsch, PharmD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Dorsch, Assistant Professor of Clinical Pharmacy, University of Michigan
ClinicalTrials.gov Identifier:
NCT04580004
Other Study ID Numbers:
  • HUM00158766
First Posted:
Oct 8, 2020
Last Update Posted:
Feb 8, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Feb 8, 2022