Clinical trial NCT03519477: Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
Official title: A Pilot Prospective, Randomized Controlled Trial Assessing the Impact of Clinical Decision Support Using Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure，Congestive
Keywords: clinical decision support
drug levels in blood
therapeutic drug monitoring
medication adherence
medication therapy management
Lead sponsor: Precera Bioscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh
First posted: 2018-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in adherence to prescribed cardiology medications
timeFrame: 30 days
Secondary outcomes:
measure: Number of hospital admissions per patient within 90 days of enrollment in intervention vs. control group
timeFrame: 90 days
measure: Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 90 days
timeFrame: 90 days
measure: Drug Related Problem identification and resolution
timeFrame: 30 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Heart and Vascular Institute
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.