Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

NCT ID: NCT03519477

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2019-01-21

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Sano Patient Medication Profile

Intervention Type: DIAGNOSTIC_TEST

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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Precera Bioscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Cumbler E, Wald H, Kutner J. Lack of patient knowledge regarding hospital medications. J Hosp Med. 2010 Feb;5(2):83-6. doi: 10.1002/jhm.566.

Reference Type: BACKGROUND

PMID: 20013875 (View on PubMed)

Gupta P, Patel P, Strauch B, Lai FY, Akbarov A, Maresova V, White CMJ, Petrak O, Gulsin GS, Patel V, Rosa J, Cole R, Zelinka T, Holaj R, Kinnell A, Smith PR, Thompson JR, Squire I, Widimsky J Jr, Samani NJ, Williams B, Tomaszewski M. Risk Factors for Nonadherence to Antihypertensive Treatment. Hypertension. 2017 Jun;69(6):1113-1120. doi: 10.1161/HYPERTENSIONAHA.116.08729. Epub 2017 May 1.

Reference Type: BACKGROUND

PMID: 28461599 (View on PubMed)

Other Identifiers

SAN_UPMC_CV_001

Identifier Type: -

Identifier Source: org_study_id