Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure，Congestive

Intervention / Treatment
-----------------
* Diagnostic Test: Sano Patient Medication Profile


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart failure care with Sano test<br>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<br>* 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<br>|
| No Intervention: Heart failure care as-usual<br>Scheduled outpatient care for patients at high risk of admission for heart failure, care as-usual (i.e. without the Sano Patient Medication Profile). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adherence to prescribed cardiology medications | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital admissions per patient within 90 days of enrollment in intervention vs. control group |  | 90 days | 
| Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 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 | 90 days | 
| Drug Related Problem identification and resolution | 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. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication therapy management, clinical decision support, drug levels in blood, therapeutic drug monitoring, medication adherence