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Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

P

Precera Bioscience

Status

Withdrawn

Conditions

Heart Failure,Congestive

Treatments

Diagnostic Test: Sano Patient Medication Profile

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03519477
SAN_UPMC_CV_001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Heart failure care with Sano test
Experimental group
Description:
Scheduled outpatient care for patients at high risk of admission for heart failure, supplemented with the Sano Patient Medication Profile
Treatment:
Diagnostic Test: Sano Patient Medication Profile
Heart failure care as-usual
No Intervention group
Description:
Scheduled outpatient care for patients at high risk of admission for heart failure, care as-usual (i.e. without the Sano Patient Medication Profile).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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