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Health Information Technology in Heart Failure Care

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pop Up Interruption Alert
Side Bar Non Interruptive Provider Checklist
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients hospitalized 2 years prior and 18 months after the time of implementation of the Computerized clinical decision support systems (CDSS) in the (Electronic Health Record (EHR).

Exclusion Criteria:

  • Patients on the obstetrical service, who died during hospitalization, or on hospice care.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active Alerting Mechanism

Passive Alerting Mechanism

Arm Description

Traditional Pop Up Alert used in Epic

Noninterruptive alert that sits in the checklist

Outcomes

Primary Outcome Measures

Percent of Patients with a Secondary Diagnoses of Heart Failure
These patients will also have had of left ventricular function (LV) Assessment either prior to or during the hospitalization or planned for post discharge
Percentage of patients with a secondary diagnosis of heart failure and LV systolic dysfunction who have been prescribed an Angiotensin-converting enzyme (ACE) inhibitor or Angiotensin II receptor blockers (ARB)

Secondary Outcome Measures

Full Information

First Posted
August 3, 2016
Last Updated
November 7, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02858674
Brief Title
Health Information Technology in Heart Failure Care
Official Title
Health Information Technology in Heart Failure Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this proposal is to develop, implement, and test the effectiveness of a computerized clinical decision support system for hospitalized patients with heart failure. Aim 1: Develop an electronic health record (EHR) based search method that uses both structured data and natural language processing of unstructured text to identify hospitalized patients with heart failure while they are still in the hospital. Aim 2: Develop and test the usability of an electronic health record (EHR) based clinical decision support system (CDSS) to support delivery of evidence-based care to hospitalized heart failure patients using human computer interaction methods. Aim 3: Assess the effect of an electronic health record (EHR) based clinical decision support system (CDSS) on processes of care for heart failure patients who are hospitalized for other causes. As part of the evaluation, we will test two implementation strategies, one of which will introduce the CDSS as an interruptive alert to providers, the second of which will introduce the CDSS as part of a provider checklist that exists on the side of the screen for each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
958 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Alerting Mechanism
Arm Type
Experimental
Arm Description
Traditional Pop Up Alert used in Epic
Arm Title
Passive Alerting Mechanism
Arm Type
Active Comparator
Arm Description
Noninterruptive alert that sits in the checklist
Intervention Type
Other
Intervention Name(s)
Pop Up Interruption Alert
Intervention Description
Traditional Pop Up Alert used in Epic
Intervention Type
Other
Intervention Name(s)
Side Bar Non Interruptive Provider Checklist
Intervention Description
Noninterruptive alert that sits in the checklist
Primary Outcome Measure Information:
Title
Percent of Patients with a Secondary Diagnoses of Heart Failure
Description
These patients will also have had of left ventricular function (LV) Assessment either prior to or during the hospitalization or planned for post discharge
Time Frame
90 Days
Title
Percentage of patients with a secondary diagnosis of heart failure and LV systolic dysfunction who have been prescribed an Angiotensin-converting enzyme (ACE) inhibitor or Angiotensin II receptor blockers (ARB)
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients hospitalized 2 years prior and 18 months after the time of implementation of the Computerized clinical decision support systems (CDSS) in the (Electronic Health Record (EHR). Exclusion Criteria: Patients on the obstetrical service, who died during hospitalization, or on hospice care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saul Blecker, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31525580
Citation
Blecker S, Austrian JS, Horwitz LI, Kuperman G, Shelley D, Ferrauiola M, Katz SD. Interrupting providers with clinical decision support to improve care for heart failure. Int J Med Inform. 2019 Nov;131:103956. doi: 10.1016/j.ijmedinf.2019.103956. Epub 2019 Sep 4.
Results Reference
derived

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Health Information Technology in Heart Failure Care

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