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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04148521
• Collaborator: The Duke Endowment (Other)
• Enrollment: 1,089
• Locations: 9
• Arms: 2
• Actual Duration (Months): 27.6
• Patients Per Site: 121
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Anxiety; Substance Use Disorders	Behavioral: Behavioral Health - Virtual Patient Navigation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1089 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments (VIBRANT)
• Actual Study Start Date: Oct 14, 2019
• Actual Primary Completion Date: Oct 31, 2021
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

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.	Behavioral: Behavioral Health - Virtual Patient Navigation; 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.

Outcome Measures

Primary Outcome Measures

1. Assessing Hospital Admissions [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

Secondary Outcome Measures

1. 45-day Post Discharge Utilization Rate [45 days]

   Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study

2. 45-day Post Discharge Utilization Rate With a Self-harm Diagnosis [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

3. 45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atrium Health - Stanly	Albemarle	North Carolina	United States	28001
2	Atrium Health - Kings Mountain	Kings Mountain	North Carolina	United States	28086
3	Scotland Memorial Hospital	Laurinburg	North Carolina	United States	28352
4	Atrium Health - Lincoln	Lincolnton	North Carolina	United States	28092
5	Carolinas HealthCare System - Blue Ridge - Morganton	Morganton	North Carolina	United States	28655
6	Atrium Health - Cleveland	Shelby	North Carolina	United States	28150
7	Carolinas HealthCare System - Valdese	Valdese	North Carolina	United States	28690
8	Atrium Health - Anson	Wadesboro	North Carolina	United States	28170
9	Columbus Regional Hospital	Whiteville	North Carolina	United States	28472

Sponsors and Collaborators

• Wake Forest University Health Sciences
• The Duke Endowment

Investigators

• Principal Investigator: Jason Roberge, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 27, 2019

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT04148521
• Other Study ID Numbers: 13952
• First Posted: Nov 1, 2019
• Last Update Posted: Jun 28, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies; Substance-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Behavioral Health - Virtual Patient Navigation	Usual Care Behavioral Health
Arm/Group 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. Behavioral Health - Virtual Patient Navigation: 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.	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.
Period Title: Overall Study
STARTED	534	555
COMPLETED	534	555
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Behavioral Health - Virtual Patient Navigation	Usual Care Behavioral Health	Total
Arm/Group 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. Behavioral Health - Virtual Patient Navigation: 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.	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.	Total of all reporting groups
Overall Participants	534	555	1089
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.1 (16.0)	41.6 (15.9)	41.4 (16.0)
Sex: Female, Male (Count of Participants)
Female	222 41.6%	248 44.7%	470 43.2%
Male	312 58.4%	307 55.3%	619 56.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	91 17%	92 16.6%	183 16.8%
White	420 78.7%	437 78.7%	857 78.7%
More than one race	16 3%	18 3.2%	34 3.1%
Unknown or Not Reported	7 1.3%	8 1.4%	15 1.4%
Region of Enrollment (Count of Participants)
United States	534 100%	555 100%	1089 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Health - Virtual Patient Navigation	Usual Care Behavioral Health
Arm/Group 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. Behavioral Health - Virtual Patient Navigation: 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.	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.
Measure Participants	534	555
Count of Participants [Participants]	332 62.2%	326 58.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Health - Virtual Patient Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.27
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Health - Virtual Patient Navigation	Usual Care Behavioral Health
Arm/Group 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. Behavioral Health - Virtual Patient Navigation: 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.	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.
Measure Participants	534	555
Number [participants]	88 16.5%	89 16%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Health - Virtual Patient Navigation, Usual Care Behavioral Health
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Health - Virtual Patient Navigation	Usual Care Behavioral Health
Arm/Group 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. Behavioral Health - Virtual Patient Navigation: 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.	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.
Measure Participants	534	555
Count of Participants [Participants]	47 8.8%	35 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Health - Virtual Patient Navigation, Usual Care Behavioral Health
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.43
	Confidence Interval	(2-Sided) 95%; 0.91 to 2.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Health - Virtual Patient Navigation	Usual Care Behavioral Health
Arm/Group 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. Behavioral Health - Virtual Patient Navigation: 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.	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.
Measure Participants	534	555
Count of Participants [Participants]	40 7.5%	36 6.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Health - Virtual Patient Navigation, Usual Care Behavioral Health
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	15 months
Arm/Group Title	Behavioral Health - Virtual Patient Navigation		Usual Care Behavioral Health
Arm/Group 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. Behavioral Health - Virtual Patient Navigation: 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.		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.
All Cause Mortality
	Behavioral Health - Virtual Patient Navigation		Usual Care Behavioral Health
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/534 (0%)		0/555 (0%)
Serious Adverse Events
	Behavioral Health - Virtual Patient Navigation		Usual Care Behavioral Health
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/534 (0%)		0/555 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral Health - Virtual Patient Navigation		Usual Care Behavioral Health
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/534 (0%)		0/555 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.