Heart Failure,Congestive Clinical Trial
Official title:
A Pilot Prospective, Randomized Controlled Trial Assessing the Impact of Clinical Decision Support Using Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
Verified date | August 2018 |
Source | Precera Bioscience, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 21, 2019 |
Est. primary completion date | January 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Heart and Vascular Institute | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Precera Bioscience, Inc. | University of Pittsburgh |
United States,
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. — View Citation
Gupta P, Patel P, Štrauch B, Lai FY, Akbarov A, Marešová V, White CMJ, Petrák O, Gulsin GS, Patel V, Rosa J, Cole R, Zelinka T, Holaj R, Kinnell A, Smith PR, Thompson JR, Squire I, Widimský 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of hospital admissions per patient within 90 days of enrollment in intervention vs. control group | 90 days | ||
Secondary | 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 | |
Secondary | 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 |
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