The Optimization of Medications in Chronic Heart Failure Using a Website

NCT04580004 | Terminated

• 1 other identifier: HUM00158766
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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).

  Change over 2 weeks

Study Arms (2)

Medication Optimization Group

EXPERIMENTAL

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

Other: Med Optimization Arm

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.

Interventions

Med Optimization Arm OTHER

An evidence-based medication recommendation website that is provided to the patients.

Medication Optimization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael P Dorsch, PharmD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pharmacy

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: September 24, 2020
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)