NCT03519477

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
Last Updated

January 25, 2019

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

April 26, 2018

Last Update Submit

January 23, 2019

Conditions

Heart Failure，Congestive

Keywords

clinical decision supportdrug levels in bloodtherapeutic drug monitoringmedication adherencemedication therapy management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    90 days

  • Drug Related Problem identification and resolution

    30 days

Study Arms (2)

Heart failure care with Sano test

EXPERIMENTAL

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

Heart failure care as-usual

NO INTERVENTION

Scheduled outpatient care for patients at high risk of admission for heart failure, care as-usual (i.e. without the Sano Patient Medication Profile).

Interventions

Sano Patient Medication ProfileDIAGNOSTIC_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 with Sano test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • 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.

    PMID: 20013875BACKGROUND

  • 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.

    PMID: 28461599BACKGROUND

MeSH Terms

Conditions

Heart FailureMedication Adherence

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 9, 2018

Study Start

September 1, 2018

Primary Completion

January 21, 2019

Study Completion

January 21, 2019

Last Updated

January 25, 2019

Record last verified: 2018-08

Locations

US(1)