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

Primary Purpose

Depression, Anxiety, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Health - Virtual Patient Navigation
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

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

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

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Sites / Locations

  • Atrium Health - Stanly
  • Atrium Health - Kings Mountain
  • Scotland Memorial Hospital
  • Atrium Health - Lincoln
  • Carolinas HealthCare System - Blue Ridge - Morganton
  • Atrium Health - Cleveland
  • Carolinas HealthCare System - Valdese
  • Atrium Health - Anson
  • Columbus Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Health - Virtual Patient Navigation

Usual care Behavioral Health

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assessing Hospital Admissions
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

Secondary Outcome Measures

45-day Post Discharge Utilization Rate
Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study
45-day Post Discharge Utilization Rate With a Self-harm Diagnosis
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-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis
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

Full Information

First Posted
October 30, 2019
Last Updated
March 17, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
The Duke Endowment
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1. Study Identification

Unique Protocol Identification Number
NCT04148521
Brief Title
A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments
Acronym
VIBRANT
Official Title
A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments (VIBRANT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
The Duke Endowment

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Substance Use Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1089 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Health - Virtual Patient Navigation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care Behavioral Health
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Health - Virtual Patient Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing Hospital Admissions
Description
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
Time Frame
Up to 2 weeks from initial ED admission
Secondary Outcome Measure Information:
Title
45-day Post Discharge Utilization Rate
Description
Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study
Time Frame
45 days
Title
45-day Post Discharge Utilization Rate With a Self-harm Diagnosis
Description
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
Time Frame
45 days
Title
45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis
Description
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
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Roberge, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health - Stanly
City
Albemarle
State/Province
North Carolina
ZIP/Postal Code
28001
Country
United States
Facility Name
Atrium Health - Kings Mountain
City
Kings Mountain
State/Province
North Carolina
ZIP/Postal Code
28086
Country
United States
Facility Name
Scotland Memorial Hospital
City
Laurinburg
State/Province
North Carolina
ZIP/Postal Code
28352
Country
United States
Facility Name
Atrium Health - Lincoln
City
Lincolnton
State/Province
North Carolina
ZIP/Postal Code
28092
Country
United States
Facility Name
Carolinas HealthCare System - Blue Ridge - Morganton
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Atrium Health - Cleveland
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Carolinas HealthCare System - Valdese
City
Valdese
State/Province
North Carolina
ZIP/Postal Code
28690
Country
United States
Facility Name
Atrium Health - Anson
City
Wadesboro
State/Province
North Carolina
ZIP/Postal Code
28170
Country
United States
Facility Name
Columbus Regional Hospital
City
Whiteville
State/Province
North Carolina
ZIP/Postal Code
28472
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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