- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04148521
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
Status
Completed
Conditions
Intervention / Treatment
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
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Albemarle, North Carolina, United States, 28001
- Atrium Health - Stanly
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Kings Mountain, North Carolina, United States, 28086
- Atrium Health - Kings Mountain
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Laurinburg, North Carolina, United States, 28352
- Scotland Memorial Hospital
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Lincolnton, North Carolina, United States, 28092
- Atrium Health - Lincoln
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Morganton, North Carolina, United States, 28655
- Carolinas HealthCare System - Blue Ridge - Morganton
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Shelby, North Carolina, United States, 28150
- Atrium Health - Cleveland
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Valdese, North Carolina, United States, 28690
- Carolinas HealthCare System - Valdese
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Wadesboro, North Carolina, United States, 28170
- Atrium Health - Anson
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Whiteville, North Carolina, United States, 28472
- Columbus Regional Hospital
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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
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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.
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|
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.
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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
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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
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Up to 2 weeks from initial ED admission
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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
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45 days
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45-day Post Discharge Utilization Rate With a Self-harm Diagnosis
Time Frame: 45 days
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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
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45 days
|
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45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis
Time Frame: 45 days
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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
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45 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Additional Relevant MeSH Terms
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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