A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments (VIBRANT)
Phase: NA
Conditions: Depression, Anxiety, Substance Use Disorders
Sponsor: Wake Forest University Health Sciences

 
 
 
 
 
TITLE: A VIRTUAL NAVIGATION INTERVENTION TO REDUCE 
BEHAVIORAL HEALTH ADMISSIONS FROM RURAL EMERGENCY 
DEPARTMENTS (VIBRANT) 
NCT Number: NA 
Document Date: 08-27-2019 

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Protocol #: 13952 
 
TITLE: A VIRTUAL NAVIGATION INTERVENTION TO REDUCE BEHAVIORAL HEALTH 
ADMISSIONS FROM RURAL EMERGENCY DEPARTMENTS (VIBRANT) 
 
Coordinating Site: 
Carolinas Medical Center 
1000 Blythe Boulevard 
Charlotte, NC 28203 
 
Principal Investigator: 
Wayne Sparks, MD 
1000 Blythe Boulevard 
Charlotte, NC 28203 
Phone: (704) 355-5375 
Email: Wayne.Sparks@AtriumHealth.org 
 
Co-Principal Investigator: 
Jason Roberge, PhD, MPH 
1540 Garden Terrace, Suite 410 
Charlotte, NC  28203 
Phone: (704) 355-0268 
Email: Jason.Roberge@AtriumHealth.org 
  
 
______________________________________________________________________________ 
The study will be conducted in compliance with the protocol, ICH-GCP and any applicable 
regulatory requirements. 
Confidential 
The information provided in this document is strictly confidential and is intended solely for the 
guidance of the clinical investigation.  Reproduction or disclosure of this document - whether in 
part or in full - to parties not associated with the clinical investigation, or its use for any other 
purpose, without the prior written consent of the Sponsor-Investigator is not permitted. 
Throughout this document, symbols indicating proprietary names (, TM) are not displayed.  
Hence, the appearance of product names without these symbols does not imply that these names 
are not protected. 
 
 
 

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PROTOCOL SUMMARY 
Study Title 
A Virtual Navigation Intervention to Reduce Behavioral Health Admissions from 
Rural Emergency Departments (VIBRANT) 
Study Design 
A randomized trial evaluating a quality improvement initiative 
Study 
Objectives 
 
Primary objective: 
• 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 objectives:   
• Compare demographics and Charlson comorbidity score between the two 
arms of the study 
 
• Compare the patient-centric 45-day utilization rate after the ED visit (ED, 
IP, OBS, encounter) between the 2 arms of the study 
 
• Compare the frequency of patients with an encounter with a self-harm 
diagnosis within 45 days of the ED visit between the 2 arms of the study 
 
• 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 
 
Reporting for the Duke Foundation: 
• Count/frequency of patients in the intervention and usual care arms 
presenting to an ED that have a telepsychiatric consult during the 
intervention 
 
• Count/frequency of patients with an admission after telepsychiatric consult 
in the intervention arm 
 
• Count/frequency of patients active in the BH-VPN 
 
• Count/frequency of patients active in the BH-VPN program that had an 
encounter with a self-harm code within 45 days of their ED visit 
 
• Count/frequency of patients active in the BH-VPN program that have an 
acute care visit (ED, IP, OBS) within 45 days of their ED visit 
 
• Count/frequency of patients active in the BH-VPN program that return to 
an Atrium Health emergency department with a telepsychiatric consult 
within 45 days of their ED visit 
 
• Count/frequency of patients active in the BH-VPN program that improve 
their PHQ-9 score, among patients with an initial score >10 

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• Count/frequency of active in the BH-VPN program that report suicide 
ideation on their initial PHQ-9 (Q2>0), that no longer report suicide 
ideation on their last PHQ-9 (Q2=0) 
 
• Count/frequency of patients active in the BH-VPN program with 
successful case closure (complete the program or have a successful referral 
in care) 
 
Inclusion/ 
Exclusion 
Criteria 
Inclusion: 
• 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 encounter 
Exclusion: 
• No exclusions 
Study 
Procedures 
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 who 
complete a telepsychiatric consult in the ED can be enrolled to either the control or 
intervention arm based on a randomization scheme that randomly allocates days 
that navigators are available. Psychiatrists are reminded through daily 
communication as to whether the BH-VPN program is available and the ED 
locations. 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. Each patient will receive the following core 
components:  
1. Introduction to the patient follow-up process prior to discharge  
2. Follow-up evaluation within 72 hours by phone and weekly contact  
3. Confirm that an in-person follow-up visit with an appropriate provider or 
clinician is scheduled. Where applicable, confirm in-network follow-up 
appointments are completed. 
4. Ongoing assessment: substance use disorder, medication barriers, and 
appointment barriers  
5. Assist with community resources, crisis planning, and supportive listening  
6. Placement into an appropriate case management program, if needed. 
 
On days where the navigator is available, all patients who meet eligibility criteria 
will be considered exposed to the intervention; whereas, on days the navigator is 
not available all patients will be considered exposed to usual care. 
 

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Statistical 
Analysis 
Analyses will include all patients identified as having completed telepsychiatric 
consult and meeting the inclusion criteria. Baseline comparisons of the 
intervention and usual care groups will be made using univariate analyses. The 
primary outcome, hospital admission, and secondary outcomes will be compared 
between the two groups of patients using generalized linear mixed-effects model 
with a logit link function. Results will be presented with odds ratios and 95% 
confidence intervals. 

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LIST OF ABBREVIATIONS 
 
BH-VPN 
Behavioral Health - Virtual Patient Navigation 
CORE 
Center for Outcomes Research and Evaluation 
C-SSRS 
Columbia – Suicide Severity Rating Scale 
DHHS 
Department of Health and Human Services 
EHR 
Electronic Health Record 
ED 
Emergency Department 
EDW 
Enterprise Data Warehouse 
FY 
Fiscal Year 
NC 
North Carolina 
OCTR 
Office of Clinical and Translational Research 
PHI 
Private Health Information 
SOP 
Standard Operating Procedures 
 
 

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TABLE OF CONTENTS 
1.1. 
Hypothesis ....................................................................................................................................8 
1.2. 
Primary Objective .......................................................................................................................8 
1.3. 
Secondary Objectives..................................................................................................................8 
1.4. 
Reporting for the Duke Foundation ..........................................................................................8 
2. BACKGROUND .....................................................................................................................................9 
3. RATIONALE ........................................................................................................................................10 
4. SUBJECT AND SITE SELECTION ..................................................................................................10 
4.1. 
Accrual .......................................................................................................................................10 
4.2. 
Eligibility Criteria .....................................................................................................................11 
4.2.1. 
Inclusion Criteria ....................................................................................................................11 
4.2.2. 
Exclusion Criteria ...................................................................................................................11 
4.3. 
Evaluable Population ................................................................................................................11 
5. OVERALL DESIGN ............................................................................................................................11 
5.1. 
Outcome Variables....................................................................................................................11 
5.1.1. 
Primary Outcome Variable .....................................................................................................11 
5.1.2. 
Rates and Variable Descriptions ............................................................................................11 
5.1.3. 
Reporting for the Duke Foundation ........................................................................................12 
5.2. 
Randomization and Allocation ...............................................................................................12 
5.3. 
Behavioral Health Virtual Patient Navigation (BH-VPN) Program ......................................13 
5.4. 
Follow-up ...............................................................................................................................14 
5.5. 
Patient Graduation from the BH-VPN Program ...................................................................14 
5.6. 
Continuation of the Intervention .............................................................................................14 
6. DATA COLLECTION AND REPORTING ......................................................................................14 
6.1. 
Sample size analysis and statistical analysis ..........................................................................15 
6.2. 
Statistical analysis ..................................................................................................................15 
6.3. 
Data Collection Dates ...............................................................................................................16 
7. INTERVENTION PLAN .....................................................................................................................16 
7.1. 
Navigator Assessments .............................................................................................................16 
7.2. 
Follow-up Assessments .............................................................................................................16 
8. STUDY GOVERNANCE .....................................................................................................................17 
8.1. 
Protocol and Pathway Training ...............................................................................................17 

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9. SAFETY RISKS AND REPORTING .................................................................................................17 
9.1. 
Data Quality Assurance ............................................................................................................18 
9.2. 
Data Monitoring by the Sponsor .............................................................................................18 
10. RESEARCH COMPLETION .............................................................................................................18 
11. ETHICAL AND LEGAL ISSUES .......................................................................................................19 
11.1. Ethical and Legal Conduct of the Study .................................................................................19 
11.2. Confidentiality ...........................................................................................................................19 
11.3. Disclosure of Data .....................................................................................................................19 
12. RETENTION OF RECORDS .............................................................................................................20 
13. PUBLICATION POLICY ....................................................................................................................20 
REFERENCES ............................................................................................................................................21 
APPENDICES .............................................................................................................................................22 
APPENDIX 1: Patient Navigation .......................................................................................................22 
APPENDIX 2: Suicide Ideation steps .................................................................................................23 

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OBJECTIVES  
1.1. Hypothesis 
 
Index admission rates will be lower among patients who complete a tele-psych consult at an ED on 
days where the Behavioral Health - Virtual Patient Navigation (BH-VPN) program is available 
compared to patients who complete a tele-psych consult at an ED on days where the BH-VPN program 
is not available. 
1.2. Primary Objective 
 
Compare the effectiveness of having the VBHI program available compared to usual care, on 
modifying the admission rate from the ED. 
1.3. Secondary Objectives 
 
The secondary objectives are to compare the behavioral health – virtual patient navigation team’s effect 
on additional patient outcomes 
 
I. 
Compare the patient-centric 45-day utilization rate after the ED visit (ED, IP, OBS, encounter)  
II. 
Compare the frequency of patients with an encounter with a self-harm diagnosis within 45 days 
of the ED visit  
III. 
Compare the frequency of patients who return to the ED and have a telepsychiatric consult 
within 45 days of their initial ED visit 
 
1.4. Reporting for the Duke Foundation 
• Count/frequency of patients presenting to an ED that have a telepsychiatric consult during the 
intervention 
• Count/frequency of patients with an admission after telepsychiatric consult in the intervention 
arm 
• Count/frequency of patients enrolled in the BH-VPN program  
• Count/frequency of patients enrolled in the BH-VPN program that had an encounter with a self-
harm code within 45 days of their ED visit 
• Count/frequency of patients enrolled in the BH-VPN program that have an acute care visit (ED, 
IP, OBS) within 45 days of their ED visit 
• Count/frequency of patients enrolled in the BH-VPN program that return to an Atrium Health 
emergency department with a telepsychiatric consult within 45 days of their ED visit  
• Count/frequency of patients enrolled in the BH-VPN program that improve their PHQ-9 score, 
among patients with an initial score >10  
• Count/frequency of patients enrolled in the BH-VPN program that report suicide ideation on 
their initial PHQ-9 (Q2>0), that no longer report suicide ideation on their last PHQ-9 (Q2=0) 

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• Count/frequency of patients enrolled in the BH-VPN program with successful case closure 
(complete the 45-day follow-up period or have a successful referral in care)  
 
2. BACKGROUND 
The primary arena for emergency psychiatric care is in emergency departments (ED), largely because of 
the impact of deinstitutionalization and other social forces on the mentally ill community.1,2 Lack of 
community-based care for mental illness has contributed to increasing inpatient behavioral health 
admissions and long stays in the emergency department.3 The high volume of psychiatric patients seen and 
waiting in hospital EDs may prevent other medical patients from obtaining timely care.4 The average delay 
for admission to a NC state hospital for psychiatric care in 2012 was 3 days and rose to 3.5 days in 2013.5 
Other contributors to the problem of patients with psychiatric conditions crowding EDs include 
diminishing access to mental health care in the community, shrinking mental health resources, and 
increasing fragmentation of resources.6  
 
Mental health care in rural regions is a national priority.7 In 2016, 18.7% of residents of rural counties have 
some diagnosed form of mental illness. In addition, 3.9%, or approximately 1.3 million residents of rural 
counties experienced serious thoughts of suicide.8 The Tennessee Hospital Authority estimates a cost of 
$9,472 for an inpatient admission with a behavioral health diagnosis.9 EDs servicing rural areas often do 
not have the staff to support patients presenting with a behavioral health crisis. In North Carolina, 70 of its 
100 counties have no child and adolescent psychiatrists, 28 have no practicing psychiatrists and 18 counties 
have only one psychiatrist.10  
 
Visits to EDs for behavioral health crises are common; in North Carolina, a person in behavioral health 
crisis presents to an ED every 2.5 minutes.11 Due to the lack of coordinated resources and high recidivism, 
many patients are admitted to a psychiatric facility perhaps unnecessarily, rather than receiving the care 
coordination that could prevent as admission.6 Virtual care offers an efficient means for patient evaluation, 
treatment recommendations, and follow-up care due to the remoteness of rural EDs and lower volume of 
patients needing services. Integrating patient navigation into emergency mental health care delivery may 
address many of the barriers to patient success post-discharge. Patient navigation has a growing evidence 
base for improving patient outcomes.12 The use of virtual care has been shown to improve access and 
engagement of patients with their care teams. Post-discharge follow-up has also been shown to effectively 
reduce suicide attempts, with one study that evaluated periodic phone check-in after ED discharge showing 
a 30% reduction in suicide attempts.13  
 
The proposed study builds upon evidence of virtual patient navigation effectiveness among prior research. 
The novelty of this study is in its design, as prior studies have used cohort designs for causal inference to 
inform care delivery for patients with mental illness. This randomized trial will provide greater precision 
and rurality to assess evidence of whether the addition of virtual patient navigation to telepsychiatric 
consults decreases initial hospitalization, readmissions, and repeated use of the ED among patients 
presenting to rural EDs with a behavioral health crisis. 
 

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3. RATIONALE 
To enhance the care of patients with a telepsychiatric consult, Atrium Health has designed a Behavioral 
Health Virtual Patient Navigation (BH-VPN) program. Navigators will monitor patients and assist with 
navigation through a weekly phone call after their index ED encounter for up to 45 days post ED discharge. 
The BH-VPN aims to improve patient outcomes through standardized approaches that leverage analytics 
and technology, while bridging care coordination. When a patient presents to a participating Atrium Health 
ED, those with a telepsychiatric consult completed on a randomized intervention day, during the hours of 
operation, are provided the option of participating in the BH-VPN program. A patient can choose not to 
receive care by a navigator post discharge. 
 
The BH-VPN program includes the following key components: introduction to the patient follow-up 
process prior to ED discharge, follow-up evaluation within 72 hours by phone and weekly contact, 
confirmation that a follow-up visit is scheduled, where applicable confirm in-network follow-up 
appointments are completed with an Atrium Health provider, and placement into an appropriate case 
management program, if needed. There may be cases where patients are eligible to enroll in full case 
management programs based on their insurance and other criteria. For example, if a patient has Medicaid 
through Cardinal Innovations, a managed care organization providing local behavioral health care, and 
meets specific criteria, would no longer require navigation services. A patient’s contact with the BH-VPN 
program ends after 45 days following ED discharge, or if there is a failure to contact, becomes enrolled 
with a case-management program, declines services, or the patient dies. For those patients enrolled in a 
case management program, then navigator will ensure the patient is in contact with case management 
program staff before ending contact with the patient. 
 
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.   
 
4. SUBJECT AND SITE SELECTION 
4.1. Accrual 
 
As part of current care, patients are identified by a provider in the ED as needing psychiatric evaluation, 
and a referral is made to the telepsychiatric provider for a virtual consult. Patients are eligible to be 
included in analysis for the project if they meet the inclusion criteria and the telepsychiatric 
consultation occurs during potential BH-VPN program hours. We will accrue patient data for 
evaluation during a period starting in October 2019. Based on prior data, we estimate about 1,100 
patients will complete a telepsychiatric consult in a 14-month period. Patients will not be accrued on 
days/times when the navigators would be not available (e.g. holidays). 
 

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Once a patient is in the intervention arm, the patient remains in the intervention arm until 45 days, or if 
there is a failure to contact (4 phone calls in 12 days), if the patient becomes enrolled with a case 
management program, declines services, or if the patient dies. 
 
4.2. Eligibility Criteria 
4.2.1. 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 (Monday-Friday 
7AM to 11PM and Saturday 7AM to 7PM) 
• ≥ 18 years of age at time of ED admission 
4.2.2. Exclusion Criteria 
• Patients currently enrolled in the BH-VPN program upon their index ED encounter 
 
4.3. Evaluable Population 
Patients included in the evaluable population for this project, will contribute data to the final outcomes 
assessment. All patients who meet the inclusion criteria will be assessed for the primary outcome 
(intent to treat). Patients will have one of the following ED discharge dispositions: (admission to the 
hospital for medical reasons, admission to a behavioral health facility by voluntary or involuntary 
commitment, discharge from the ED, or death). A patient will contribute to the analysis once, using 
their initial enrollment to either arm of the study. 
5. OVERALL DESIGN 
5.1. Outcome Variables 
5.1.1. Primary Outcome Variable 
The primary outcome variable is ED to hospital admission. This is a patient that presents to an Atrium 
Health ED and then is admitted for any reason. A patient’s disposition is tracked in the electronic 
medical record. The disposition is simply indicated as admitted or not admitted.  
 
5.1.2. Rates and Variable Descriptions 
a. Demographic characteristics (age, race, gender) 
b. Charlson comorbidity index score 

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c. Patient-centric defined 45-day utilization rate. This is a utilization rate among patients with an 
ED, inpatient, or observation encounter to any Atrium Health facility (<= 45 days after the ED 
admit date) 
d. Frequency of self-harm diagnoses within 45 days of the index ED encounter at any Atrium 
Health location facility (<= 45 days after the ED admit date) 
e. Frequency of patients who return to the ED and have a telepsychiatric consult (<= 45 days after 
the ED admit date) 
5.1.3. Reporting for the Duke Foundation 
• Count/frequency of patients presenting to an ED that have a telepsychiatric consult during the 
intervention 
• Count/frequency of patients with an admission after telepsychiatric consult in the intervention arm 
• Count/frequency of patients enrolled in the BH-VPN program 
• Count/frequency of patients enrolled in the BH-VPN program that have an encounter with a self-harm 
code within 45 days of their ED visit 
• Count/frequency of patients enrolled in the BH-VPN program that have an acute care visit (ED, IP, 
OBS) within 45 days of their ED visit 
• Count/frequency of patients enrolled in the BH-VPN program that return to an Atrium Health 
emergency department with a telepsychiatric consult within 45 days of their ED visit 
 
PHQ-9 are taken about every 2 weeks during a patient’s enrollment. The post PHQ-9 score will be the score 
closest to the 45-day follow-up period.  
• Count/frequency of patients enrolled in the BH-VPN program that improve their PHQ-9 score, among 
patients with an initial score >10 
• Count/frequency of patients enrolled in the BH-VPN program that report suicide ideation on their initial 
PHQ-9 (Q9>0), that no longer report suicide ideation on their last PHQ-9 (Q9=0)  
• Count/frequency of patients enrolled in the BH-VPN program with successful case closure (complete 
the 45-day follow-up period or have a successful referral in care)  
 
5.2. Randomization and Allocation  
Randomization will be based on days the navigators are available to treat patients who’ve completed 
their telepsychiatric consult. Patients may be in the ED for multiple days. Their enrollment status 
depends on the day and time of their initial telepsychiatric consultation. Navigation will only be 
available for those patients whose consult occurs during intervention day/times. As part of the research 
design and rollout of this project, randomization will occur at the day level with the days being 
identified as intervention or usual care days for the duration of the study. Patients will accrue in both 
arms of the study during the navigators’ days and hours of operation. Patients will not be accrued on 
days where the navigators are not potentially available such as weekends, nights, and holidays. 

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Block randomization will be used to assign days the intervention is offered. In each 7-day period 
(Monday through Saturday) there will be three days the program is offered and three days where the 
program is not offered. The program is not available to patients in the ED on Sundays. The hours of 
availability are 7AM to 11PM Monday through Friday and 7AM to 7PM on Saturdays. 
 
5.3. Behavioral Health Virtual Patient Navigation (BH-VPN) Program 
The BH-VPN outlines the flow of patients from initial contact to their follow-up calls (see Appendix 1). 
In the existing ED workflow, 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 who complete a 
telepsychiatric consult in the ED can be enrolled to either the control or intervention arm based on a 
randomization scheme that randomly allocates days that navigators are available. Psychiatrists are 
reminded through daily communication as to whether the BH-VPN program is available and the ED 
locations. The psychiatrist will make a recommendation to admit or discharge the patient. The ED 
physician will make the final decision on whether to admit or discharge the patient from the ED. 
Patients that have a discharge recommendation on days the program is available, will be offered the 
BH-VPN program. Enrolled patients are followed for up to 45 days.  
 
If a discharge recommendation is made, a patient will be approached again by the navigator virtually 
for enrollment into the BH-VPN program. The patient has the option not to be followed by the 
navigator. Before discharge, the navigator will complete an initial virtual behavioral health assessment. 
The initial health assessment contains information such as preferred communication method, primary 
care provider, psychiatry provider, PHQ-9 screening, collateral resources, recent ED and hospital 
utilization, substance use disorder, medication barriers, appointment barriers, community resources, and 
crisis planning. 
 
The follow-up assessments, which will occur during navigation phone calls at least weekly, may 
include information such as a suicide ideation safety screening, an appointment reminder, appointment 
barrier evaluations, medication obtainment follow-up, substance use disorder follow-up, PHQ-9 
screening, supportive listening, psychoeducation, community resource follow-up, and additional crisis 
planning. Phone calls are weekly as standard care but may be more often depending on the individual 
needs of the patient. Appointments are dependent on a patient’s specific needs and may be with a 
therapist or psychiatrist as well as other providers in the community such as primary care or referral to 
a community provider. 
 
The Columbia-Suicide Severity Rating Scale (C-SSRS) helps identify whether someone is at risk for 
suicide, and the severity and immediacy of the risk. It also identifies level of support the person needs. 
The screening tool is administered during each phone contact to measure suicide ideation. If a patient is 
deemed actively suicidal, then the navigator will recommend transfer to mobile crisis, call 911 for a 
well-check, or call 911 to send the patient to the ED as per current standard of care.  

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5.4. Follow-up 
Patients being treated in the BH-VPN program will receive a follow-up phone call within 24 to 72 
hours from discharge, and then weekly for up to 45 days. A follow-up assessment is completed upon 
each phone call. 
 
5.5. Patient Graduation from the BH-VPN Program 
For the intervention arm, successful completion is defined as 
• Enrolled for 45 days post ED admit date 
• Enrolled in another Care Management program 
For the intervention arm, failure to complete is defined as 
 
• Unable to connect: 4 calls attempted over 12 days 
• Death  
• Declined services initially or after enrollment 
5.6. Continuation of the Intervention 
Participating ED sites may continue utilizing the BH-VPN program after the study period has ended. 
 
6. DATA COLLECTION AND REPORTING 
Patient demographics, comorbid conditions, and utilization will be obtained from the electronic medical 
record and billing systems. Data from the initial assessment and follow-up contacts will be stored in 
HealtheCare, a care management platform in Cerner. Data will be retrieved by an application specialist on 
the research team. Data may be retrieved retrospective to a patient’s completion of the intervention or usual 
care arm of the study.  
 
A bi-monthly report will be produced for the intervention arm. The report will be by ED site and overall. 
• Count of patients meeting the inclusion criteria 
• Count of patients with a HealtheCare account 
• Count of patients enrolled in the BH-VPN program 
• Patient list with their enrollment status in HealtheCare 
 
A monthly report will be produced for the intervention arm. The report will be by ED site and overall. 
Report to be generated following the end of the previous month. 
• Count of patients meeting the inclusion criteria 
• Count of patients with a HealtheCare account 
• Count of patients enrolled in the BH-VPN program 

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• Patient list with their enrollment status in HealtheCare 
 
An Annual report will be prepared for the Duke Foundation measures. 
 
6.1. Sample size analysis and statistical analysis 
Given the preliminary data from our previous study, we will power the proposed study to detect at least 
an 8% absolute difference between hospital admission in the VIBRANT intervention and usual care 
groups. The usual care group is assumed to have a 60% inpatient admission rate based on prior data. 
There is 85% power to detect this reduction with a total sample size of 1,030 (α=0.05) using a Chi-
square test for independence. To account for the possible correlation among patients seen in the ED on 
the same day, we inflated the sample size by 10% assuming the average number of patients per ED per 
day is 2 with a 0.1 intra-class correlation coefficient (design effect = 1 + (2-1)*ICC).14 Thus, the target 
sample size is n=1,133. The power was calculated using PASS 15 Power Analysis and Sample Size 
Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. 
6.2. Statistical analysis 
Prior to analysis, descriptive statistics will be calculated to screen all variables for accuracy and to 
examine distributions.   
 
All analyses will follow the intention-to-treat (“ITT”) principle, such that patients will be analyzed 
based on their assignment to the BH-VPN program or usual care. Balance in baseline characteristics 
between the groups will be assessed using Student’s t-test for normally distributed data, the Wilcoxon 
rank sum test for ordinal data or interval data that are not normally distributed, and the chi-square test 
for categorical data. Normality will be assessed using the Shapiro Wilk test and Q-Q plots. 
 
The primary outcome, hospital admission (yes/no), is a binary dependent variable and will be compared 
between the BH-VPN and usual care groups using a generalized linear mixed-effects model with a logit 
link function. To adjust for correlation among patients seen on the same day and in the same ED, the 
model will include a random effect term for day nested within ED. The primary predictor in the model 
is an indicator for assignment to the BH-VPN program versus usual care. Additional baseline covariates 
will be included in the model if they are either strongly correlated with the dependent variable or show 
baseline imbalance between the two groups. 
 
A similar approach will be used for the secondary outcomes to assess the patient-centric 45-day 
utilization rate, encounters with a self-harm diagnosis rate, and ED readmission rate. The models 
assessing these measures will be generalized linear mixed-effects models with a logit link, where 
utilization, diagnosis, or readmission, (yes/no) is the binary dependent variable. Independent variables 
in the models will be as described above for the primary analysis. 
 
In addition, per-protocol analyses of the primary and secondary outcomes will be performed to evaluate 
the effect of BH-VPN program participation, in contrast to the ITT analysis evaluating the effectiveness 
of randomization to the program. The per-protocol analyses will include only subjects who received 
and adhered to the treatment (BH-VPN program or usual care).  

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Other binary outcome variables (e.g., frequency of patients active in the BH-VPN program) will be 
analyzed using descriptive statistics, unadjusted odds ratios, and 95% confidence intervals. 
 
All tests will be two sided and the data will be analyzed using SAS Enterprise Guide 7.1 (SAS Institute 
Inc., Cary, NC, USA).   
 
 
 
 
6.3. Data Collection Dates 
The implementation of the BH-VPN will begin in October 2019 among patients with a completed 
telepsychiatric consult. 
 
7. INTERVENTION PLAN 
7.1. Navigator Assessments 
The initial assessment within 72 hours will capture the following components: 
• Communication method 
• PHQ-9 
• Insurance 
• Primary care provider 
• Outpatient Psychiatry provider 
• Collateral resource 
• Recent visit summary 
• Substance abuse 
• Medication barriers 
• Appointment Barriers 
• Transportation needs 
• Access to medications 
• Community Resources 
• Columbia-Suicide Rating Scale to assess for suicide ideation 
7.2. Follow-up Assessments 
The weekly follow-up contact assessments may be comprised of the following components: 
• Columbia-Suicide Rating Scale to assess for suicide ideation 
• PHQ-9 
• Appointment reminder\follow-up 
• Medication access barriers 
• Substance use disorder follow-up 
• Supportive listening 

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• Psychoeducation 
• Utilization of community resources 
• Crisis planning and adherence to the plan by the patient 
8. STUDY GOVERNANCE 
This randomized trial will be conducted at Atrium Health. It will be run jointly by the Center for Outcomes 
Research and Evaluation (CORE) and the Behavioral Health Service Line. Wayne Sparks, MD, (Psychiatry) 
will serve as the clinical principal investigator with oversight from the Executive Committee (EC). Jason 
Roberge, PhD, MPH will serve as co-principal investigator on behalf of CORE. The EC will consist of 
leaders across the System involved in the trial, quality improvement, and implementation (Table 1). The EC 
will provide trial oversight and direction. The EC will support dissemination of project findings and next 
steps. The EC will receive progress reports from the team. When appropriate, ad hoc committee meetings 
will be scheduled to discuss pressing concerns. 
 
Table 1. Executive Committee 
James Rachal 
Atrium Health Executive Leadership – Psychiatry 
Wayne Sparks 
Atrium Health Executive Leadership – Psychiatry 
Martha Whitecotton 
Atrium Health Executive Leadership – Behavioral Health 
Sue Deluca 
Atrium Health Executive Leadership – Behavioral Health 
Michael Gibbs 
Atrium Health Executive Leadership – Emergency Medicine 
Andrew McWilliams 
Atrium Health Executive Leadership – CORE Medical Director 
 
8.1. Protocol and Pathway Training 
Background, protocol and process steps will be presented to psychiatrists and nurse practitioners who will 
be providing virtual psychiatric consultations. The role of virtual patient navigator and randomization 
scheme will be presented so expectations are clear that this is not available every day/time or weekends. 
This will be presented at the Department of Psychiatry meeting, which includes Emergency and 
Telepsychiatry Departments. Attendees may also include providers, who at some point may see patients 
who have been through this pathway but will not be directly involved in providing evaluations. Education 
will be provided to the emergency department staff involved in this project, so that they are aware of the 
process and the role of the virtual patient navigator. 
9. SAFETY RISKS AND REPORTING 
The data collection and intervention for this project presents no more than minimal risk to patients. The 
implementation of the BH-VPN program and its components complement ongoing patient care through 
virtual patient navigation within Atrium Health. The BH-VPN program is currently offered at 10 urban 
EDs within Atrium Health. This study is evaluating the BH-VPN program among additional rural EDs that 
will offer the program to their patients. The addition of an evaluation design that aligns with existing 
patient care where there are limited resources thus confers minimal additional risk to patients. 

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Other potential risks of participation in this project include, the risk of health information disclosure. There 
is always the risk of disclosure of a patient’s private health information (PHI) or medical information. 
However, the processes identified in this protocol to enable the execution of this project, do not increase 
inherent risk of disclosure. Atrium Health utilizes several hard and soft safety controls in the protection of 
patient information and medical records. Security controls include, but are not limited to, multiple system 
firewalls, access restrictions to patient records and information, locked offices and buildings housing 
research and patient data, and multiple layers of username and password protected computer and system 
access. The project team will ensure that appropriate handling of patient PHI follows standard Atrium 
Health procedure. In the event of PHI disclosure, the appropriate internal departments will be informed and 
processed per legislation and privacy regulations. 
 
9.1. Data Quality Assurance 
This study will be organized, performed, and reported in compliance with the study protocol, standard 
operating procedures (SOPs) of CORE and Atrium Health, and other applicable regulations and 
guidelines (e.g. GCP). 
 
9.2. Data Monitoring by the Sponsor 
The conduct of this project will abide by standard operating procedures set forth by both Atrium 
Health and CORE. The Principal Investigators, statistician, and other team members will meet as 
needed to review enrollment and retention, study progress, and validity/integrity of the data. 
Documentation of these meetings will be kept with study records. 
 
10. RESEARCH COMPLETION 
The Principal Investigator has the right to close the project at any site any time. 
For any closure, the following applies: 
• Closures should occur only after consultation between involved parties. 
• In case of a partial study or site closure, patients still participating in the BH-VPN program, or those 
who are considered in follow-up, must be taken care of in an ethical manner. 
 
The study will be considered complete when one or more of the following conditions is met: 
• 
The enrollment period has ended, and the data collection period is complete. 
• 
All subjects have dropped out or discontinued from the study after the enrollment period is 
completed, but prior to data collection cutoff. 
• 
The IRB or Principal Investigator discontinues the study. 
• 
The Principal Investigator defines an administrative or clinical cut-off date. 

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Upon study completion, a final report will be presented to the Executive Committee and all key 
stakeholders. The final report will detail findings including primary, secondary and exploratory outcomes. 
The team will also prepare a manuscript for publication focused on outcomes and feasibility of 
implementation of the BH-VPN program.   
 
11. ETHICAL AND LEGAL ISSUES 
11.1. 
Ethical and Legal Conduct of the Study 
The procedures set out in this protocol, pertaining to the conduct, evaluation, and documentation of this 
study, are designed to ensure that the Investigators abide by Good Clinical Practice (GCP) guidelines 
and under the guiding principles detailed in the Declaration of Helsinki. The study will also be carried 
out in keeping with the applicable local laws and regulation(s). 
 
Documented approval from appropriate agencies (e.g. IRB) will be obtained before the start of the 
study, per GCP, local laws, regulations, and organizations.  
 
Strict adherence to all specifications laid down in this protocol is required for all aspects of study 
conduct. 
 
Modifications to the study protocol will not be implemented without consulting the Principal 
Investigator and IRB approval, as applicable. The Principal Investigator must assure that all study 
personnel, including co-investigators and other study staff members, adhere to the study protocol and 
all applicable regulations and guidelines regarding research both during and after study completion. 
 
The Principal Investigator will be responsible for assuring that required data will be collected and 
properly documented. 
11.2. 
Confidentiality 
All records identifying the subject will be kept confidential and, to the extent permitted by the 
applicable laws and/or regulations, will not be made publicly available. 
11.3. 
Disclosure of Data 
The Principal Investigator, his associates and co-workers, and the appropriate regulatory agencies may 
use the information and data included in this protocol as necessary for the conduct of the study.  
Information contained in this study, and data and results from the study are confidential and may not be 
disclosed without the written permission of the Principal Investigator.  
 
 

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12. RETENTION OF RECORDS 
Essential documentation will be retained for at least 2 years after the investigation is completed. 
Documentation will be readily available upon request. 
 
13. PUBLICATION POLICY 
The Principal Investigator or designee must send any draft manuscript, abstract, or conference presentation 
to members of the project Executive Committee for feedback and transparency, prior to submission of the 
final version. The Principal Investigator will be responsible for all relevant aspects regarding data reporting 
and publication.  
 
The Principal Investigator or designee will ensure that the information and results regarding the study will 
be made publicly available on the internet at www.clinicaltrials.gov. 
 
 

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REFERENCES 
 
1. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood) 
2008;27:759-69. 
2. Wellin E, Slesinger DP, Hollister CD. Psychiatric emergency services: evolution, adaptation and 
proliferation. Soc Sci Med 1987;24:475-82. 
3. North Carolina’s Mental Health Crisis [Fact Sheet]. 2014. at http://crisissolutionsnc.org/wp-
content/uploads/2014/01/CSIfactsheet12-27-13.pdf.) 
4. Swartz MS. Emergency Department Boarding: Nowhere Else to Go. Psychiatr Serv 2016;67:1163. 
5. State Psychiatric Hospital Data Reports. (Accessed 7/11/18, at https://www.ncdhhs.gov/facility-data-
reports.) 
6. Pager LM IA. Emergency psychiatry. In: Massachusetts General Hospital comprehensive clinical 
psychiatry. 2nd ed2016. 
7. Rural Mental Health. (Accessed 7/12/18, at https://www.ruralhealthinfo.org/topics/mental-health.) 
8. RESULTS FROM THE 2016 NATIONAL SURVEY ON DRUG USE AND HEALTH: DETAILED 
TABLES. (Accessed 7/15/16, at https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-
2016/NSDUH-DetTabs-2016.pdf.) 
9. Reducing Behavioral Health Emergency Department Utilization and Readmissions. 2014. (Accessed 
7/15/18, at https://tha.com/wp-content/uploads/2015/12/Jeri-Davis-THA-PPT-2016.pdf.) 
10. NC Health Professions Data System: http://www.shepscenter.unc.edu/hp/index.html; 2017. 
11. Virtual Behavioral Health Services. (Accessed 7/13/18, at http://www.hpoe.org/resources/chair-files/3052.) 
12. Reuland DS, Brenner AT, Hoffman R, et al. Effect of Combined Patient Decision Aid and Patient 
Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A 
Randomized Clinical Trial. JAMA Intern Med 2017;177:967-74. 
13. Miller IW, Camargo CA, Jr, Arias SA, et al. Suicide prevention in an emergency department population: 
The ed-safe study. JAMA Psychiatry 2017. 
14. Sedgwick P. Cluster randomised controlled trials: sample size calculations. BMJ 2013. 
 
 
 

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APPENDICES 
APPENDIX 1: Patient Navigation 
 
This diagram shows the contact points among patients receiving care in the BH-VPN program. 
 
Patient is admitted to the ED 
and has a recommendation for a 
telepsychiatric consult by the 
medical physician
Usual care day
Intervention
• 
Virtual navigator reviews the patient 
chart
• 
Informs the psychiatrist of resources 
that can be provided if discharged 
from the ED
Telepsychiatric consult
Recommendation for 
Admission
Inpatient 
Admission
ED discharge
No further 
contact with 
patient
Approached for 
enrollment into the 
virtual navigation  
program
Primary outcome of the trial 
to assess the conversion rate 
is based at this step
Telepsychiatric 
consult
Randomized to 
intervention day
Yes
No
Yes
No
Recommendation for 
Admission
Inpatient 
Admission
ED discharge
Yes
No
Yes
Suicidal at ED 
admission
Call w/in 72hrs 
From D/C or per 
MD request
Call w/in 24hrs 
From D/C or per 
MD request
No
Yes
Enrolled and then 
discharged Call 
Back Protocol
At least weekly phone 
calls until graduation
Graduation
• 
45 days from ED discharge
• 
Enrolled with a case management program
Failed to Complete
• 
Unable to contact (4 calls in 12 days)
• 
Death
• 
Declined services initially or after enrollment
Not enrolled and 
discharged
No
 
 
 

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APPENDIX 2: Suicide Ideation steps 
 
This diagram shows the procedure if a patient is identified with suicidal ideation from the C-SSRS screening 
tool. This tool is administered during each phone contact. 
 
Does C-SSRS Reassess indicate 
suicide ideation?
Complete phone call as 
usual
No
Is pt actively suicidal 
with plan/means?
Create Safety Plan, give 
number for BH Call Center
No
 Talk to collateral 
-Ask if they think pt is at 
risk of harm
- Ask if pt has any 
previous self-harming/
suicide attempt behaviors
- Ask it pt has access to 
weapons/firearms?
- Ask if collateral can take 
patient to the nearest 
hospital and provide 
support
Does patient have 
collateral you can 
speak with where 
the pt is located?
Is Pt willing to go to 
nearest ED?
No
Call 911 for well 
check, request CIT 
officer
No
Give phone number & address 
to nearest CHS ED or call 911 to 
transport them.  Explain to pt if 
they do not present to ED 
within agreed upon timeframe, 
clinician will call back and will 
contact 911 for wellcheck if no 
answer; notify telepsych 
clinicians on duty; check chart 
to see if pt arrived
Can collateral take 
or accompany pt 
to the nearest 
hospital and 
provide support?
Yes
Does Pt consent to 
Mobile Crisis being 
dispatched?
No
Yes
Yes
Warm transfer to Mobile Crisis:  
Meck:  704-566-3410, 1
Union/Rowan/Stanly/Cabarrus 
866-275-9552
800-939-5911
Gaston/Lincoln
855-527-4747
888-235-4673
Anson:
866-508-9490
910-673-9111
Yes
Call 911 for 
transportation to ED
No
Did Pt arrive to ED 
within agreed upon 
timeframe?
Proceed per 
disposition
Yes
Attempt to 
contact pt and 
proceed 
accordingly
No
Does collateral 
believe the pt is in 
no danger of 
harming 
themselves?  Is 
collateral reliable 
and able to help 
form a safety plan?
No
Provide BH Call 
Center phone 
number and call 
patient within 24 
hours
Yes
Call back within 24 
hrs
Yes
Yes
Crisis Protocol if patient reports suicide ideation from phone contact