Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

January 23, 2019 updated by: Precera Bioscience, Inc.

A Pilot Prospective, Randomized Controlled Trial Assessing the Impact of Clinical Decision Support Using Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

The purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Congestive heart failure has an exceptionally high rate of hospital admission and is responsible for more re-admissions (23.5% at 30 days) in the United States than the 2nd and 3rd leading causes combined. Inadequate medication reconciliation both on admission and discharge from the hospital is a significant cause of medical error. In one study of cardiovascular patients, 44% believed they were taking a medication they were not, and 96% were unable to recall at least one medication they were taking. In the same study patients omitted on average 6.8 medications from their medication list. Medication optimization through improved adherence and reconciled medical records has been postulated to significantly improve admission and 30-day hospital readmission rates.

Sano has developed a blood-based comprehensive medication monitoring tool that identifies and quantitates 235 prescription drugs and drug metabolites. It does not detect illicit drugs. This tool, which produces an output report designated the 'Patient Medication Profile', is designed to be used with clinical decision support to improve medication adherence, reduce medication errors, and optimize medication therapy. For heart failure patients, the investigators hypothesize that deploying the Patient Medication Profile with clinical decision support at key points of treatment intervention will A) improve medication adherence, B) identify and reconcile significant discrepancies in the medication list, C) result in reduced hospital admissions, and D) result in better overall patient outcomes. These outcome expectations are relative to usual care for heart failure patients.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have a regularly scheduled visit to a University of Pittsburgh Medical Center (UPMC) cardiology clinic in Oakland
  • Patients must have Heart Failure with Reduced Ejection Fraction (≤40%)
  • Patients have admitted to UPMC hospital facility between one and five times in past 12 months
  • Patients must be able to provide informed consent for present study
  • Patient age > 18 years

Exclusion Criteria:

  • Enrolled in Hospice
  • Patient on home inotrope (Dobutamine or milrinone)
  • World Health Organization (WHO) Group 1 or Group 5 pulmonary hypertension
  • Patient with current ventricular assist device (VAD)
  • Not able to communicate in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart failure care with Sano test
Scheduled outpatient care for patients at high risk of admission for heart failure, supplemented with the Sano Patient Medication Profile
Diagnostic test: Sano Patient Medication Profile
The Sano Patient Medication Profile (PMP) is a graphical report comparing prescribed medications to liquid (chromatography/tandem mass-spectrometry) LC/MS/MS-detected drugs from patient blood samples
No Intervention: Heart failure care as-usual
Scheduled outpatient care for patients at high risk of admission for heart failure, care as-usual (i.e. without the Sano Patient Medication Profile).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in adherence to prescribed cardiology medications
Time Frame: 30 days
For each patient, the proportion of prescribed medications that are detected using the baseline and final PMP will be calculated; change in adherence will be defined as proportion using final PMP, minus proportion using baseline PMP. Compare adherence difference in intervention vs. control groups.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hospital admissions per patient within 90 days of enrollment in intervention vs. control group
Time Frame: 90 days
90 days
Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 90 days
Time Frame: 90 days
Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 90 days. This endpoint will use baseline adherence and the Patient Medication Profile will not have been discussed with the care team in the intervention group, therefore both intervention and control groups will be pooled
90 days
Drug Related Problem identification and resolution
Time Frame: 30 days
Documented drug related problems identified by medication reconciliation will be compared between the intervention and control groups. The number of changes in medications to resolve drug related problems, such as medication additions, terminations, dosage or frequency changes will be compared between the intervention and control groups.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precera Bioscience, Inc.

Collaborators

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Actual)

January 21, 2019

Study Completion (Actual)

January 21, 2019

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAN_UPMC_CV_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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