A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments (VIBRANT)

March 17, 2023 updated by: Wake Forest University Health Sciences

A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments (VIBRANT)

This research project is a pragmatic, randomized evaluation of a quality improvement initiative which seeks to evaluate the effects of standardizing the use of a BH-VPN program among patients with a telepsychiatric consult. The outcomes evaluation of this intervention has been designed to integrate with routine care and minimize frontline staff burden by deploying an evaluation in a real-world setting.

Study Overview

Detailed Description

Hospital admissions are common amongst those with mental illness. Significant morbidity exists for patients who are being admitted to a psychiatric hospital from the Emergency Department (ED).Additionally, commitment to a hospital setting may have adverse effects on patients psychologically, degrade relationships with therapists, and disrupt continuity of care. ED providers often decide to admit to a psychiatric hospital because of limited availability of behavioral health resources. To better enhance transitions of care for those with mental illness, Atrium Health has designed a behavioral health virtual patient navigation (BH-VPN)program that helps coordinate services and follow-up care, while facilitating the safe discharge of patients. Patients presenting to an ED that have a tele psychiatric consult who are recommended for discharge are eligible for services. The Behavioral health Service line is expanding the program to additional rural emergency departments. Using an outcomes evaluation, the investigators will inform Atrium Health on the effect of the BH-VPN program to reduce hospital admissions among patients with a tele psychiatric consult in the ED. The proposed hypothesis is that by having the BH-VPN program available in an ED, more patients will be discharged from the ED than admitted.

Study Type

Interventional

Enrollment (Actual)

1089

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Albemarle, North Carolina, United States, 28001
        • Atrium Health - Stanly
      • Kings Mountain, North Carolina, United States, 28086
        • Atrium Health - Kings Mountain
      • Laurinburg, North Carolina, United States, 28352
        • Scotland Memorial Hospital
      • Lincolnton, North Carolina, United States, 28092
        • Atrium Health - Lincoln
      • Morganton, North Carolina, United States, 28655
        • Carolinas HealthCare System - Blue Ridge - Morganton
      • Shelby, North Carolina, United States, 28150
        • Atrium Health - Cleveland
      • Valdese, North Carolina, United States, 28690
        • Carolinas HealthCare System - Valdese
      • Wadesboro, North Carolina, United States, 28170
        • Atrium Health - Anson
      • Whiteville, North Carolina, United States, 28472
        • Columbus Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Eligible patients must meet each of the following criteria:

  • Present to an ED at participating sites
  • Complete a telepsychiatric consult as captured in the electronic medical record
  • Complete a telepsychiatric consult during the navigator's hours of operation
  • ≥ 18 years of age at time of ED admission

Exclusion Criteria:• Patients currently enrolled in the BH-VPN program upon their index ED encounter

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Health - Virtual Patient Navigation
All patients who meet eligibility criteria at sites where the virtual patient navigation behavioral health program is offered will be considered exposed to the intervention.
Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention.
No Intervention: Usual care Behavioral Health
All patients who meet eligibility criteria at sites where the virtual patient navigator behavioral health program is not offered will be considered exposed to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing Hospital Admissions
Time Frame: Up to 2 weeks from initial ED admission
Compare the effectiveness of having the Behavioral Health - Virtual Patient Navigation (BH-VPN) program available compared to usual care, on admission rates among patients in the ED with a telepsychiatric consult
Up to 2 weeks from initial ED admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
45-day Post Discharge Utilization Rate
Time Frame: 45 days
Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study
45 days
45-day Post Discharge Utilization Rate With a Self-harm Diagnosis
Time Frame: 45 days
Compare the frequency of patients with any encounter with a self-harm diagnosis within 45 days of the ED visit between the 2 arms of the study
45 days
45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis
Time Frame: 45 days
Compare the frequency of patients who return to the ED and have a telepsychiatric consult within 45 days of their initial ED visit between the 2 arms of the study
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00081746
  • 13952 (Other Identifier: Atrium Health)
  • Pro00038573 (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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