NCT02858674

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
958

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

August 3, 2016

Last Update Submit

November 7, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    90 Days

  • 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)

    90 Days

Study Arms (2)

Active Alerting Mechanism

EXPERIMENTAL

Traditional Pop Up Alert used in Epic

Other: Pop Up Interruption Alert

Passive Alerting Mechanism

ACTIVE COMPARATOR

Noninterruptive alert that sits in the checklist

Other: Side Bar Non Interruptive Provider Checklist

Interventions

Traditional Pop Up Alert used in Epic

Active Alerting Mechanism

Noninterruptive alert that sits in the checklist

Passive Alerting Mechanism

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Saul Blecker, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 8, 2016

Study Start

April 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations