NCT03519477

Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Precera Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Heart Failure，Congestive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-01-21
• Completion: 2019-01-21
• First posted: 2018-05-09
• Last updated: 2019-01-25

Locations

1 site across 1 country: United States