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Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

Sponsor
Precera Bioscience, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03519477
Collaborator
University of Pittsburgh (Other)
0
Enrollment
1
Location
2
Arms
4.7
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sano Patient Medication Profile
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
A Pilot Prospective, Randomized Controlled Trial Assessing the Impact of Clinical Decision Support Using Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
Anticipated Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Jan 21, 2019
Actual Study Completion Date :
Jan 21, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Change in adherence to prescribed cardiology medications [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.

Secondary Outcome Measures

  1. Number of hospital admissions per patient within 90 days of enrollment in intervention vs. control group [90 days]

  2. Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 90 days [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

  3. Drug Related Problem identification and resolution [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UPMC Heart and Vascular Institute Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • Precera Bioscience, Inc.
  • University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Precera Bioscience, Inc.
ClinicalTrials.gov Identifier:
NCT03519477
Other Study ID Numbers:
  • SAN_UPMC_CV_001
First Posted:
May 9, 2018
Last Update Posted:
Jan 25, 2019
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Precera Bioscience, Inc.
clinical decision support
drug levels in blood
therapeutic drug monitoring
medication adherence
medication therapy management
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jan 25, 2019