Engaging Patients With Mental Disorders From the ED in Outpatient Care: A Comparative Effectiveness Workforce Study of Peer Specialist vs. Professional Care Managers
Phase: NA
Conditions: Mental Disorder
Sponsor: Emory University

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 1 
 
February 11, 2020 
 
 
 
PROTOCOL TITLE:  Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
(EPIC) 
 
 
 
Trial Registration: 
ClinicalTrials.gov ID: NCT02989805 
 
 
 
 
PRINCIPAL INVESTIGATOR: 
Benjamin Druss, MD, MPH 
Professor and Rosalynn Carter Chair in Mental Health 
Rollins School of Public Health 
404-712-9602 (office phone) 
bdruss@emory.edu 
 
 
 
VERSION: 
August 27, 2019, Updated February 11, 2020 
 
 
 
 
 
FUNDING SOURCE: Patient-Centered Outcomes Research Institute (PCORI) IHS-1510-32431 
 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 2 
 
February 11, 2020 
 
Table of Contents 
 
1.0 
Study Summary .................................................................................................................... 3 
2.0 
Objectives............................................................................................................................. 4 
3.0 
Background .......................................................................................................................... 4 
4.0 
Study Intervention / Design ................................................................................................. 5 
5.0 
Intervention Procedures Involved ....................................................................................... 6 
6.0 
Study Timelines .................................................................................................................... 7 
7.0 
Subject Population ............................................................................................................... 7 
8.0 
Number of Participants ........................................................................................................ 7 
9.0 
Recruitment Methods .......................................................................................................... 8 
10.0 Consent Process ................................................................................................................... 8 
11.0 Withdrawal of Participants .................................................................................................. 9 
12.0 Risks to Participants ............................................................................................................. 9 
13.0 Potential Benefits to Participants ........................................................................................ 9 
14.0 Qualitative Interviews .......................................................................................................... 9 
15.0 Data Sources ...................................................................................................................... 10 
16.0 Outcomes and Data Analysis ............................................................................................. 11 
17.0 Data Safety Monitoring ...................................................................................................... 12 
18.0 Provisions to Protect Privacy and Confidentiality ............................................................. 12 
19.0 Advisory Board ................................................................................................................... 12 
20.0 Dissemination .................................................................................................................... 13 
21.0 References ......................................................................................................................... 14 
22.0 Appendix A ......................................................................................................................... 16 
23.0 Appendix B ......................................................................................................................... 17 
24.0 Appendix C ......................................................................................................................... 18 
 
 
 
 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
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February 11, 2020 
 
 
1.0 
Study Summary 
 
Study Title 
Engaging Patients with Mental Disorders from the ED 
in Outpatient CARE: A Comparative Effectiveness 
Workforce Study of Peer Specialists vs. Professional 
Care Managers (EPIC) 
 
Study Design 
Multi-site randomized trial study design across 9 
Emergency Departments (EDs) in South Carolina with 
telepsychiatry programs and 8 matched community 
mental health centers (CMHC); each CMHC site had 
one professional care manager and one peer cares 
specialist manager to deliver Coordination, Access, 
Referral and Evaluation (CARE) intervention. 
 
Primary Objective 
Use quantitative data from the study sample to assess 
factors, including assignment to a peer versus 
professional, predicting patient engagement after a 
mental health emergency visit.  
 
Secondary Objective(s) 
Use qualitative interviews with patients and providers 
to understand stakeholder perspectives on patient 
engagement after a mental health emergency visit. 
 
Research 
Intervention(s)/Interactions 
The Coordination, Access, Referral and Evaluation 
(CARE) intervention is a manualized care management 
program to improve follow up and treatment 
engagement for patients after admission to 
psychiatric emergency rooms. CARE will be delivered 
by a Peer Specialist or Professional Care Manager.  
 
Study Population 
Patients admitted to Emergency Department for a 
primary diagnosis of a mental disorder.  
 
Sample Size 
290 
 
Study Duration for 
Individual Participants 
12 months 
Study Specific 
Abbreviations/ Definitions  
N/A 
Funding Source  
Patient-Centered Outcomes Research Institute 
(PCORI) IHS-1510-32431   
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
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February 11, 2020 
 
 
2.0 
Objectives 
The study will examine predictors, including peer versus professional care manager assignment, 
of treatment engagement after discharge from a mental health emergency visit. The project 
period will be structured around two aims, one quantitative and one qualitative. Each aim will 
seek to further the understanding of the patient, provider, and system-level barriers to, and 
facilitators of, treatment engagement after emergency department (ED) discharge. We will 
include randomization to peer versus professional care manager as one of the independent 
variables of interest.    
2.1 Aim 1: Use quantitative data from the study sample, including assignment 
to a peer versus professional care manager, to assess factors predicting 
patient engagement after a mental health emergency visit.   
2.2 Aim 2: Use qualitative interviews with patients and providers to understand 
stakeholder perspectives on patient engagement after a mental health 
emergency visit.  
3.0 
Background 
3.1 Emergency departments (EDs)serve a critical role as a safety net for the 
uninsured and medically disenfranchised.The growth of population-based 
models of care under the Affordable Care Act are providing an impetus to 
reduce uncesssary ED use and improve engagement with outpatient 
care.1,2 Patients with mental disorders are among the highest users of 
emergency department services,3-10  with visits characterized by long 
lengths of stay, high intensity, and elevated rates of discharge to hospital 
settings.11  After discharge, fewer than half of these patients successfully 
transition to outpatient care, with high rates of readmission.12,13 Programs 
that allow patients with mental disorders to successfully transition to 
outpatient care hold the potential not only to improve quality and 
outcomes of care for  mental disorders, but to free capacity within 
Emergency Departments to provide care for other urgent needs.14 
3.2 Despite the potential of care management programs to address transitions 
of care in people with mental illness, it has been difficult to disseminate 
these models more broadly.15 One reason for this challenge in 
dissemination has been a shortage of mental health professionals who can 
fill these roles. There are acute shortages of mental health nurses, 
particularly in community-based, public sector settings.16  These problems 
are likely to worsen in coming years as the mental health nursing workforce 
ages.16  Similar shortages are seen for mental health social workers.17 There 
is now an opportunity to improve care and fill these gaps with a new group 
of mental health providers, certified peer specialists -- persons with a 
history of mental illness offering services to other individuals with mental 
disorders.18 Beginning in the 1990s, certified peer specialists began to be 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
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February 11, 2020 
 
employed in providing peer support in community mental health settings.19 
Certified peer specialists help other patients improve outcomes by 
modeling successful behaviors and coping strategies, and by guiding them 
to more effectively utilize community resources.  Nationwide, there are 
more than 10,000 peer support specialists,20 and 32 State Medicaid 
programs recognize and reimburse mental health services delivered by 
certified peer specialists, helping ensure the financial sustainability of 
programs using these providers.21   
3.3 The existing literature indicates: 1. The potential effectiveness of care 
management delivered by mental health professionals in improving 
treatment engagement and reducing inpatient readmissions; and 2. The 
fact that certified peer specialists appear to be able to deliver an array of 
mental health services of similar or better quality as mental health 
professionals.  However, there have been no studies comparing certified 
peer specialists to professionals in interventions to increase treatment 
engagement and reduce readmissions.  This study will be the first to 
examine the potential benefits and tradeoffs between these two groups of 
providers.  
3.4 The study results will provide insights on the comparative effectiveness of 
professional and peer care managers in improving linkage to and 
engagement with outpatient care, as well as the potential mechanisms by 
which engagement occurs. The results will help patients to address the 
question “What are the best ways for me to engage with my mental health 
care?” It will help Emergency Room Providers to address the question 
“How can I most effectively reduce the likelihood of my patients being 
readmitted?”  For Community Mental Health providers, it can help address 
the question “How can I help my patients to more effectively engage with 
care in our facilities?”  And for policymakers, “How can we improve 
transitions of care between Emergency Departments and inpatient 
services?”  “How can certified peer specialists be used most effectively in 
the evolving mental health workforce?” 
4.0 
Study Intervention / Design  
4.1 The study used a multi-site randomized trial study design across 9 
Emergency Departments in South Carolina with telepsychiatry programs 
and 8 matched community mental health centers (CMHC); each CHMC site 
had one professional care manager and one peer specialist care manager 
to deliver the intervention.   
4.2 The Coordination, Access, Referral and Evaluation (CARE) intervention is a 
manualized care management program designed to improve follow up and 
treatment engagement for patients after admission to psychiatric 
emergency rooms.  It is built on the PCARE intervention, which was 
designed to improve treatment engagement and treatment outcomes for 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 6 
 
February 11, 2020 
 
patients in outpatient mental health settings.22,23  The primary 
enhancement to the PCARE intervention used to develop the CARE 
intervention was to add an initial treatment linkage call during the 
Emergency Department stay.  Professional and peer care managers 
delivered the same intervention.  
4.3 Care Managers: Licensed nurses/social workers/counselors or certified 
peer specialists working at the 8 state-funded CMHCs served as care 
managers. For each emergency department, one professional and one peer 
care manager was identified at the associated CMHC and dedicated to the 
project.  
 Training for the professional and peer care managers was 
identical; however, separate sessions were held to prevent 
contamination. The training program included a description of the 
overall study design and modules for each of the key domains 
covered in the intervention. Care managers received the CARE 
training manual and demonstrated adherence and competency 
through role-play scenarios.  
 Separate quarterly supervision calls were held with peer and 
professional care managers to reinforce key elements of the 
intervention.  
5.0 
Intervention Procedures Involved 
5.1 Treatment Linkage:  After a “warm handoff” from the research interviewer 
who screened the participant into the study, the care manager connected 
with the participant for the Treatment Linkage Call. During the call, the care 
manager began to establish rapport and collected contact information 
including telephone and address. The care manager also ascertained the 
reason for the ED visit and set an initial appointment with the care 
manager at the CMHC nearest the ED within two weeks.  
5.2 Initial Visit: The purpose of the initial visit at the CMHC was to take a 
history of the participant and began the process of identifying and 
addressing barriers to engagement in care. The care manager then 
reviewed the roles of the participant and care manager, emphasizing the 
importance of the collaborative relationship between them. The care 
manager and participant jointly examined the reasons for the ED visit, 
identified attitudinal and logistical barriers to care, and set goals to address 
those barriers.  
5.3 Follow up visits: After the initial visit, the care manager and patient met in-
person monthly, with telephone calls in between. The goal of these 
meetings was to monitor patients’ engagement in care and continue to 
help address attitudinal and logistical barriers to care and discuss progress 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 7 
 
February 11, 2020 
 
on goals. This pattern of visits and calls continued for the first 6 months of 
treatment with less frequent visits or calls from months 7 to 12.  
6.0 
Study Timelines 
6.1 Project Duration: October 2016 – March 2020 
6.2 Enrollment period: April 2017 – May 2019 
6.3 Individual subject’s participation: 12 months 
 
Participant enrolled in project and randomized to peer or professional 
case manager prior to ED discharge.  
 
Treatment Linkage: Within 72 hours of enrollment, the care manager 
made initial contact with participant to establish rapport, obtain 
contact information, ascertain the reason for ED visit, and set initial 
appointment with care manager at nearest CMHC within two weeks.  
 
Initial Visit: Within 30 days of enrollment, the care manager and 
participant met at the CMHC to take a history of the participant and 
began the process of identifying and addressing barriers to 
engagement in care. The care manager then reviewed the roles of the 
participant and care manager, emphasizing the importance of the 
collaborative relationship between them.  
 
Follow up visits: After the initial visit, the care manager and patient 
met in-person monthly, with telephone calls in between. The goal of 
these meetings was to monitor patients’ engagement in care and 
continue to help address attitudinal and logistical barriers to care.  
7.0 
Subject Population 
7.1 Inclusion Criteria:  Broad inclusion criteria were chosen to maximize 
generalizability of study findings. Inclusion criterion included: 1. Being 18 
years of age or older; and 2. Admission to the ED for a primary diagnosis of 
a mental disorder (ICD-9 Codes 290.xx-302.xx, 306.xx-311.xx); 3. Plan for 
discharge to participating CMHC; and 4. Lives within the CMHC catchment 
area.  
7.2 Exclusion Criteria:  Exclusion criteria comprised of cognitive impairment 
based on a score of > 3 on a 6-item, validated screener developed for 
clinical research24 (which could impede capacity to provide informed 
consent as well as effective participation in the intervention), not able to 
speak English, and being admitted to the hospital from the ED. 
8.0 
Number of Participants 
8.1 Target Sample Size: 290 participants  
8.2 Actual Enrollment: 326 participants (see Appendix A for Consort Diagram) 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 8 
 
February 11, 2020 
 
9.0 
Recruitment Methods 
9.1 Study Setting: Nine Emergency Departments in South Carolina and 8 
associated community mental health center (CMHC) study sites (see 
Appendix B for Recruitment Flow Diagram).   
 Springs Memorial Hospital ED and Catawba CMHC in Lancaster, SC 
 Spartanburg Regional Hospital ED and Spartanburg CMHC in 
Spartanburg, SC 
 Palmetto Health Tuomey ED and Santee-Wateree CMHC in 
Sumter, SC 
 Conway Hospital ED and Waccamaw-Conway CMHC in Conway, 
SC 
 Carolinas Hospital ED and Pee-Dee Florence CMHC in Florence, SC 
 Laurens County Memorial Hospital ED and Beckman-Laurens 
CMHC in Laurens, SC 
 McLeod Regional Hospital ED and Pee-Dee Florence CMHC in 
Florences, SC 
 McLeod Medical Center and Tri-County CMHC in Dillon, SC 
 Palmetto Health Richland Hospital ED and Columbia area CMHC in 
Columbia, SC 
9.2 Identification and Recruitment: Emergency room telepsychiatrists, Mental 
Health Liaisons, nurses, and other key ED staff referred patients admitted 
for a primary diagnosis of a mental disorder for assessment of potential 
inclusion in the study.  A trained research interviewer assessed participants 
for potential study eligibility, either in person, telephone or via the site’s 
high speed telepsychiatry video connection.  
9.3 Screening by research staff involved assessment of all inclusion and 
exclusion criteria.  
 Document date of birth to ensure that patients are 18 years of age or older 
 Confirm the primary diagnosis of a mental illness with the person who 
identified the patient (nurse, liaison, staff, or telepsychiatrist) 
 Confirm that the patient lives within the CMHC’s catchment area 
 Determine that the patient speaks fluent English 
 Confirm that the patient will be discharged for care at the participating 
CMHC 
10.0 Consent Process 
10.1 Only trained members of the project participated in the informed consent 
dialogue and/or signing of the informed consent document.   
10.2 Trained members of the project assessed for cognitive impairment during 
the consent process using a 6-item, validated screener and an Informed 
Consent Quiz (see Appendix C for Informed Consent document and 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
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February 11, 2020 
 
Informed Consent Quiz). Participants who scored <3 on the cognitive 
screener or did not score 100% on the Informed Consent Quiz were not 
eligible to participate in the project. Inability to complete either of these 
measures could impede capacity to provide informed consent as well as 
effectively participate in the intervention.  
10.3 The procedures of the study and the informed consent document were 
thoroughly reviewed with the participant in both verbal and written form 
by a trained study staff member. Only those participants demonstrating 
adequate comprehension were consented and enrolled in the project.  
 Informed consent was obtained in a private room in the ED or in 
the telepsychiatry room over HIPAA compliant video 
conferencing. In the latter case, oral consent was obtained via 
telepsychiatry and ED administrative staff obtained a signed 
documentation of consent.  
11.0 Withdrawal of Participants 
11.1 Participants were able to choose to withdraw from the project at any time.  
11.2 Participants who chose to withdraw from the project were no longer 
contacted by the study team or interventionist for project-related 
activities. Participants had the opportunity to designate preference for 
continued data collection in the event of withdrawal during the consent 
process.   
12.0 Risks to Participants 
12.1 Participants may experience discomfort in answering questions from the 
study team or interventionist.  
12.2 Participants may experience inconvenience when traveling to/from 
scheduled project visits. 
13.0 Potential Benefits to Participants 
13.1 Participants may not benefit personally from the project.  
13.2 Taking part in the project may help to improve participant’s mental health 
care.  
14.0 Qualitative Interviews 
14.1 In-depth interviews were conducted over the telephone with 30 patients 
and 15 care managers to examine the main factors influencing patients’ 
transitions of and engagement in care.     
14.2 Patients were invited to participate in the qualitative interviews after they 
had been in the study for at least 6 months. Additionally, all active care 
managers were invited to take part in an interview. 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
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February 11, 2020 
 
14.3 Patients provided informed consent either verbally after the researcher 
read the consent form to them (a paper copy was provided for their 
records by mail) or by signing and returning a consent form by mail. Care 
managers were emailed a consent form, which they signed and returned 
through secure email or fax.  
14.4 The study team developed two semi-structured interview guides—one for 
patients and one for care managers. The patient interview guides included 
questions on their reasons for going to the ED, connection to and 
attendance at the CMHC, barriers and facilitators to attending their 
appointments, and interactions with mental health providers. The care 
manager interview guide included questions on their assessment of their 
patients’ barriers and facilitators to transitioning from the ED and 
engagement in care at the CMHC, as well as questions on interactions with 
patients. 
14.5 Interviews were conducted by phone. All qualitative interviews were 
digitally recorded, de-identified and assigned a unique identifier, 
transcribed verbatim, and reviewed for accuracy. 
15.0 Data Sources 
15.1 South Carolina’s Integrated Data Warehouse: The South Carolina Revenue 
and Fiscal Affairs Office (RFA) has developed over a period of many years a 
comprehensive health and human services data. The RFA data warehouse 
pulls client-specific data from an array of health and human services 
facilities, agencies and organizations and makes possible the integration of 
data from disparate sources at the client level by means of an internally 
assigned unique tracking number. State legislation requiring reporting of 
both private sector and public sector client-level data ensures that the data 
are comprehensive and complete. The current data warehouse includes 
information from private sector systems (e.g., hospitals, surgery centers, 
home health), state agency systems (e.g., Medicaid, mental health, 
substance abuse, criminal justice), and not-for-profit systems (e.g., free 
clinics, community health centers).  For this study, data were de-identified 
by use of an encrypted tracking number and were stored on a secure 
Microsoft SQL Server. All data storage and access procedures are HIPAA 
compliant. The study team has a long history of collaboration with the 
South Carolina’s RFA in prior projects, with high data quality and 
completeness of study data.  
15.2 The Area Health Resource File was used to identify county-level community 
predictors of treatment engagement.  
 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
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16.0 Outcomes and Data Analysis  
16.1 Aim 1 Analytic Strategy: First, bivariate models were created to examine 
differences between each of the patient, provider, and system-level factors 
and each of the dependent variables.  Next, linear regression models were 
used to examine the association between factors within each of these 
levels to each of the study outcomes. Finally, hierarchical linear models 
examined the association between each of the independent and 
dependent variables simultaneously including all of the patient, provider, 
and system-level predictors.  
16.2 Service Use Outcomes:   
 At least one outpatient visit for a mental health problem in the 30 
days after ED discharge.  
 Proportion of scheduled outpatient visits attended in the 6 
months after ED discharge.  
 Emergency Department re-admissions in the 6 months after ED 
discharge.  
 All-cause inpatient admissions in the 6 months after ED discharge.  
16.3 Effect Size Estimates for 30-day Follow up After ED Discharge:  
 
Size 
Type of Model 
Effect Size for 30-day 
follow up after discharge 
detected with 80% 
power and p<0.05 
290 
 
Bivariate 
 
16% 
 
Multivariate 
17.5% 
16.4 Aim 2 Analytic Strategy: Transcripts were uploaded into the qualitative 
software package MaxQDA for data management and analysis. The study 
team developed an initial codebook using topics from the interview guides 
and categories of barriers to care from the literature.25 After the study 
team jointly coded a group of transcripts by hand to align application of 
codes, all transcripts were coded by two members of the study team. The 
lead qualitative researcher reviewed all coding to ensure reliability and 
updates were made when necessary. Qualitative data were analyzed using 
thematic analysis, with a focus on comparing themes across the patient 
and care manager groups.26 We examined patients’ experiences with 
transitions of care from the ED to outpatient treatment and providers’ 
experiences of supporting care transitions and engagement. We identified 
main themes related to the barriers and facilitators to patients accessing 
and engaging in outpatient mental health treatment at the patient, 
provider, and healthcare systems level.  

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
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February 11, 2020 
 
17.0 Data Safety Monitoring 
17.1 A three-member Data Safety Monitoring Board was assembled bi-annually 
to review study recruitment and potential adverse events.  
17.2 Semi-annual reports detailing information about the project description, 
baseline demographic characteristics, and retention and disposition of 
study participants were presented to the DSMB and IRB for review. 
18.0 Provisions to Protect Privacy and Confidentiality  
18.1 All study data was entered at time of screening and enrollment in a Redcap 
study database. Redcap is a secure, HIPAA compliant, web-based server, 
can only be accessed by authorized project personnel, and encrypted at 
rest by a product called GAZZANG. 
18.2 Access to and location of Personally Identifiable Information was granted 
to authorized users on the principle of least privilege.  
18.3 Unique identifiers were generated for all study participants; these were the 
only identifiers used in files for data entry and analysis. Identifying 
information such as name, address, telephone number was stored in 
password-protected computer files or locked file cabinets.  
18.4 The South Carolina Revenue and Fiscal Affairs Office (RFA) provided a 
dataset for all service use claims for the participant via secure, encrypted 
file transfer protocol (FTP). The data was stored on a password-protected, 
HIPAA-compliant server at Emory University.  
18.5 Participant interactions with project staff, including screening and 
enrollment procedures, and with interventionists, including calls and visits, 
were held in a private, closed door office, away from clinical care areas.  
18.6 Participants were informed that the agreement to participate in the project 
does not obligate participants to accept any particular treatment and that 
participants were free to refuse to answer questions and/or withdraw from 
any part of the project.  
19.0 Advisory Board  
19.1 The Advisory Board oversaw key study decisions and was involved in the 
planning for program sustainability and dissemination of results.  
19.2 The board included five members from consumer organizations, provider 
groups, and healthcare systems management.  
19.3 The Advisory Board convened for annual conference calls to review 
materials and make decisions regarding study procedures, implementation, 
and results. 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
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20.0 Dissemination  
20.1 The final analytic data file was de-identified using the “Safe Harbor” 
method outlined by the U.S. Department of Health and Human Services in 
order to meet standard §164.514(a) to make the data HIPAA compliant 
(https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-
identification/index.html). Specifically, any identifiers of the individual, 
relative, employers, or household members of the individual were 
removed. A full list of the 18 identifiers to be removed under the “Safe 
Harbor” method can be found at the above link. This HIPAA compliant data 
file is fully analyzable and will be made available upon request. All analytic 
code used in the final report will be provided upon request along with 
codebooks to accompany the de-identified analytic data file. 
20.2 The research team will provide results to the Advisory Board to assist in 
dissemination efforts to their member organizations.  
 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
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21.0 References 
 
1.  
Hernandez-Boussard T, Burns CS, Wang NE, Baker LC, Goldstein BA. The Affordable Care 
Act reduces emergency department use by young adults: evidence from three States. Health Aff 
(Millwood). 2014;33(9):1648-54. PMCID: 4453768.  
2. 
McClelland M, Asplin B, Epstein SK, Kocher KE, Pilgrim R, Pines J, Rabin EJ, Rathlev NK. 
The Affordable Care Act and emergency care. Am J Public Health. 2014;104(10):e8-10. 
3. 
Knowlton A, Weir BW, Hughes BS, Southerland RJ, Schultz CW, Sarpatwari R, Wissow L, 
Links J, Fields J, McWilliams J, Gaasch W. Patient demographic and health factors associated 
with frequent use of emergency medical services in a midsized city. Academic emergency 
medicine: official journal of the Society for Academic Emergency Medicine. 2013;20(11):1101-
11. PMCID: 4063348.  
4. 
Doran KM, Raven MC, Rosenheck RA. What drives frequent emergency department use 
in an integrated health system? National data from the Veterans Health Administration. Ann 
Emerg Med. 2013;62(2):151-9. 
5. 
Clark RE, Samnaliev M, McGovern MP. Treatment for co-occurring mental and 
substance use disorders in five state Medicaid programs. Psychiatr Serv. 2007;58(7):942-8. 
6. 
Hampton LM, Daubresse M, Chang HY, Alexander GC, Budnitz DS. Emergency 
department visits by adults for psychiatric medication adverse events. JAMA Psychiatry. 
2014;71(9):1006-14. 
7. 
Harman JS, Scholle SH, Edlund MJ. Emergency department visits for depression in the 
United States. Psychiatr Serv. 2004;55(8):937-9. 
8. 
Albert M, McCaig LF. Emergency Department Visits Related to Schizophrenia Among 
Adults Aged 18-64: United States, 2009-2011. NCHS Data Brief. 2015(215):1-8. 
9. 
Olfson M, Marcus SC, Bridge JA. Emergency department recognition of mental disorders 
and short-term outcome of deliberate self-harm. Am J Psychiatry. 2013;170(12):1442-50. 
10. 
Ting SA, Sullivan AF, Boudreaux ED, Miller I, Camargo CA, Jr. Trends in US emergency 
department visits for attempted suicide and self-inflicted injury, 1993-2008. Gen Hosp 
Psychiatry. 2012;34(5):557-65. PMCID: 3428496. 
11. 
Case SD, Case BG, Olfson M, Linakis JG, Laska EM. Length of Stay of Pediatric Mental 
Health Emergency Department Visits in the United States. J Am Acad Child Adolesc Psychiatry. 
2011;50(11):1110-9. 
12. 
Boudreaux ED, Niro K, Sullivan A, Rosenbaum CD, Allen M, Camargo CA, Jr. Current 
practices for mental health follow-up after psychiatric emergency department/psychiatric 
emergency service visits: a national survey of academic emergency departments. Gen Hosp 
Psychiatry. 2011;33(6):631-3. 
13. 
Boudreaux JG, Crapanzano KA, Jones GN, Jeider TA, Dodge VH, Hebert MJ, Kasofsky JM. 
Using Mental Health Outreach Teams in the Emergency Department to Improve Engagement in 
Treatment. Community Ment Health J. 2016;52(8):1009-1014. 
14. 
Currier GW. Impact of the Patient Protection and Affordable Care Act on Emergency 
Psychiatry. J Nerv Ment Dis. 2015;203(12):901-5. 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
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15. 
Gaynes BN, Brown C, Lux LJ, Ashok M, Coker-Schwimmer E, Hoffman V, Sheitman B, 
Viswanathan M. Management Strategies To Reduce Psychiatric Readmissions. Rockville 
(MD)2015. 
16. 
Hanrahan NP. Analysis of the psychiatric-mental health nurse workforce in the United 
States. Journal of psychosocial nursing and mental health services. 2009;47(5):34-42. 
17. 
Lin V, Lin J, Zhang X. US Social Worker Workforce Report Card: Forecasting Nationwide 
Shortages." Soc Work. 2016;swv047:7-15. 
18. 
Davidson L, Chinman M, Sells D, Rowe M. Peer support among adults with serious 
mental illness: a report from the field. Schizophr Bull. 2006;32(3):443-50. PMCID: 2632237. 
19. 
Sterling E, Von Esenwein SA, Tucker S, Fricks L, Druss BG. Integrating wellness, recovery 
and self-management for mental health consumers. Journal of Community Mental Health. 
2010;46(2):130-8. 
20. 
Goldstrom ID, Campbell J, Rogers JA, Lambert DB, Blacklow B, Henderson MJ, 
Manderscheid RW. National estimates for mental health mutual support groups, self-help 
organizations, and consumer-operated services. Adm Policy Ment Health. 2006;33(1):92-103. 
21. 
Trusts PC. 'Peers' Seen Easing Mental Health Worker Shortage 2013 September 11, 
2013.  
22. 
Sirey JA, Bruce ML, Alexopoulos GS, Perlick DA, Raue P, Friedman SJ, Meyers BS. 
Perceived stigma as a predictor of treatment discontinuation in young and older outpatients 
with depression. Am J Psychiatry. 2001;158(3):479-81. 
23. 
Henderson C, Noblett J, Parke H, Clement S, Caffrey A, et al. Mental health related 
stigma in health care and mental health care settings. Lancet Psychiatry. 2014;1(6):467-482.  
24.  
Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify 
cognitive impairment among potential subjects for clinical research. Med Care. 2002;40(9):771-
781. 
25.  
Mojtabai R, Olfson M, Sampson NA, Jin R, Druss B, Wang PS, Kessler RC.  (2011). Barriers 
to mental health treatment: results from the National Comorbidity Survey Replication. 
Psychological Medicine. 2011; 41(8):1751–61. 
26.  
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in 
Psychology. 2006;3(2):77-101.  
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 16 
 
February 11, 2020 
 
22.0 Appendix A 
Consort Diagram 
 
EPIC CONSORT Flow Diagram (12/31/2019) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Excluded from EPIC 
304 
REASONS FOR EXCLUSIONS 
Does Not Speak English 
6 
No Plans to follow up with CMHC 
100 
No Capacity to Consent 
19 
CMHC non-EPIC site 
40 
Already enrolled in EPIC 
19 
Outside EPIC catchment 
13 
No Diagnosis of Mental Illness 
8 
Referred after business hours 
7 
Later admitted  
2 
No way to follow-up 
Refused/Declined 
25 
65 
Identified for EPIC (n=630) 
Allocation 
Enrollment 
Randomized (n=326) 
Randomized to peer (n=166) 
 
Randomized to professional (n=160) 
 
Analysis 
Analyzed as professional (n=154) 
Excluded due to invalid consent (n=6) 
 
30-day Outpatient Data Available: 154/154 (100%)   
 
6-month Admin Data Available: 131/154 (85%) 
Analyzed as peer (n=162) 
Excluded due to invalid consent (n=4) 
 
30-day Outpatient Data Available: 162/162 (100%) 
 
6-month Admin Data Available: 134/162 (83%)  

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A Comparative Effectiveness Workforce 
Study of Peer Specialists vs. Professional Care Managers 
Page | 17 
 
February 11, 2020 
 
23.0 Appendix B 
Recruitment Flow 
 
 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 18 
 
February 11, 2020 
 
24.0 Appendix C 
 
Informed Consent Document with Quiz 
 
Name of participant: ________________________________________ Age: ___________ 
 
Title: Engaging Patients in Care (EPIC) 
 
Introduction 
You are being asked to take part in a study of a new care navigation program. This opportunity 
is offered to people who talked to a psychiatrist by video phone call in the Emergency Room, 
and who were asked to make an appointment at the Community Mental Health Center. This 
form will tell you everything you need to think about before you decide to take part. 
Participation is entirely your choice. If you decide to participate, you can change your mind 
later on and stop participating. Joining or not joining the study will not have any effect on your 
treatment. Before making your decision, carefully read this form, or have it read to you. Ask 
questions about anything that is not clear. You will be given a copy of this form.   
 
Study Overview 
This study provides ‘care navigation’. Care navigation is a service that helps guide patients with 
their health care. If you decide to take part in this study, care navigation will be provided to you 
at the Community Mental Health Center, and will be in addition to your regular care and 
treatment. A care navigator can be a professional case manager, like a social worker, a nurse, or 
a psychologist. A care navigator can also be someone who is not a professional, called a “peer 
support specialist”. A peer support specialist is someone who has a mental health problem and 
has gotten treatment.  Peer support specialists have recovered from their mental illness and 
now help other patients to succeed with their care and recovery. In this study, we will compare 
patients who have a professional care navigator with patients who have a peer support 
specialist. Care Navigation will take place at the Community Mental Health Center that is 
closest to the Emergency Department you visited. We plan to have 1000 people take part in the 
study over the next 4 years.  
 
Study Procedures: What will happen if you agree to be part of this study? 
Screening: 
If you decide to take part you will sign this form giving your permission. We will ask you some 
questions to make sure the study is right for you. We will also ask for your contact information. 
Then you will be randomly assigned (like tossing a coin) to have care navigation with either a 
peer support specialist or with a professional case manager at the Community Mental Health 
Center. We will put you in touch with the care navigator by phone while you are still in the ER. 
After briefly introducing himself or herself, the care navigator will schedule an appointment to 
meet with you in person. This first meeting will take place at the Community Mental Health 
Center, on the day of your first appointment,  A few days before your first appointment, your 
care navigator will call or text you with an appointment reminder. 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 19 
 
February 11, 2020 
 
Clinic Visits:  
First visit : At the first visit to the clinic, your care navigator will talk with you for about 30 
minutes and ask you about your mental health history and your symptoms, the reasons for your 
recent emergency room visit, and any difficulties you have getting the care you need.  
 
Months 1-6: During the first 6 months, you will meet in person with your care navigator once a 
month. These monthly in-person meetings will take about 20 minutes each time. In between 
these monthly visits, your care navigator will speak with you by phone. These visits and phone 
calls are designed to help you participate in treatment, manage your mental health better, and 
overcome problems or issues that may affect attending your mental health appointments. You 
will be compensated for your effort with a $20 gift card for each of the 6 in-person visit.   
 
Months 7-12: During months 7-12 there are no planned, in-person meetings with your care 
navigator but he/she will call you monthly during months 7-12 to check on you.  
 
Study Interviews:  
There will be 3 study interviews. The first interview will be done by phone either a few days 
after you have left the Emergency Room, or by phone at your first visit to the Mental Health 
Clinic. The other two interviews will be done by phone with a study staff member from Emory 
University. These interviews will take about 30-45 minutes and you will be asked questions 
about your mental health care, your mental health medications, substance use history, and any 
problems you have with getting mental health care. You will be compensated for your time and 
effort with a $50 gift card for each interview you complete.   
 
Risks and Discomforts  
We do not think there are any significant risks or discomforts related to this study, but there 
may be possible risks that we don’t yet know about. Some participants could get tired during 
the interviews. If you get tired, you can take a break at any time. You do not have to answer 
questions you do not want to answer. There is a minor risk of a loss of confidentiality. All of the 
information that you give us is private and we will do everything we can to protect your 
information, in ways that we talk about later in this form.  
 
Benefits  
Taking part in this program may or may not benefit you personally, but we may learn new 
things that will help other patients in the future. Taking part in the program may help to 
improve your mental health care and could possibly reduce problems and issues that might 
prevent you from getting the care you need. The results of the study of the care navigation 
program will be used to decide whether this sort of program is helpful for patients. 
Costs 
There will be no additional costs for participating in the project. Your insurance will be billed for 
services you get at the mental health center. 
 
Compensation  
Interviews: You will get a $50 gift card for completing the 3 study interviews.  

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 20 
 
February 11, 2020 
 
Monthly in-person visits: For each in-person visit with your care navigator, you will get a $20 gift 
card to cover study-related expenses, like travel and phone minutes. You will only get a gift card 
for visits you have completed. You will get up to $270 if you complete all the study visits and all 
the research interviews.  
 
Alternatives 
At this time there is no alternative to the care navigation we will provide. However, you do not 
have to take part in this study to be treated at the mental health center or to get linked to a 
case manager to help you access the appropriate care you need.  
 
New Information 
You will be told about anything new that might change your decision to be in the study.   
 
Confidentiality and Privacy  
Your privacy is important to us.  Health information that identifies you is called “protected 
health information” or “PHI.”  To protect your PHI, we will follow all federal and state privacy 
laws, including the Health Insurance Portability and Accountability Act (HIPAA).   
 
Emory University and the University of South Carolina (USC) will keep your participation and 
any records we create private as required by law. To protect your privacy you will be assigned a 
unique I.D. number that will be used in our records instead of your name. The only file linking 
your I.D. number to your name and address will be stored in a secure computer file on a secure 
network. Only study staff will have access to the secure computer file with your name and 
unique I.D. number. Study information will be collected and stored in a secure online research 
storage system, called RedCap on encrypted servers at Emory University. RedCap is a secure 
online system for collecting and storing information from research studies. RedCap is password-
protected and meets the highest levels of security. Only study staff that needs your information 
for study purposes will have access to RedCap. Any paper study information, other than this 
form and the contact sheet, will contain only your I.D. number and not your name. Paper study 
information will be transmitted using secure fax machines. All paper documents will be stored 
in locked file cabinets, in locked offices at the Community Mental Health Center, or at USC. No 
information that could identify you will be included in any publications that may come from the 
study results. Any private or identifying information will be destroyed at the earliest 
opportunity after the study is complete. 
 
Protected Health Information (PHI) That Will Be Used/Disclosed   
In this study, some of your personal information (name, social security number, date of birth, 
hospital number, etc.) will be used to help us get records that relate to your health and well-
being. These records may include information about you such as hospital and doctor visits, 
mental health services, drug and alcohol services or healthcare visits paid for by Medicaid or 
Medicare. Our use of this information will not affect your benefits in any way, and the study 
staff can’t use your information until you allow them. Taking part in the study means that you 
allow the researchers to use your information for the study. 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 21 
 
February 11, 2020 
 
People Who Will Use/Disclose Your PHI 
Your PHI may be used or shared with others outside Emory, USC and the South Carolina 
Department of Mental Health for reasons directly related to how we conduct the study. Once 
this information leaves our agencies, we cannot guarantee that it will be protected.  
 
Your PHI will be shared with the South Carolina Revenue and Fiscal Affairs Office (RFA) to obtain 
data for the study.  
 
Your PHI may be shared with the following groups to make sure the research is done correctly 
and safely: 
The study sponsor, PCORI (Patient Centered Outcomes Research Institute) 
Institutional Review Boards of Emory University, USC and the South Carolina Department of 
Mental Health  
Government agencies that regulate the research (e.g. the Office of Human Research Protection) 
 
Authorization to Use PHI Is Required to Participate 
By signing this form, you give us permission to use and share your PHI in the ways we discussed 
above. You do not have to sign this form.  If you choose not to sign this form you will not be 
able to participate in the study and will still receive usual care.  If you do decide to participate in 
the study and you do sign this form, your PHI will be used until this research study ends. 
 
If I Sign this Authorization, Can I Change My Mind?  
You can change your mind about participating in the study at any time. If you no longer want to 
be part of the study, we may still use information you have already provided, but we will not 
collect any new information about you. If you want to withdraw from the study, please contact 
Suzanne Hardeman, NP at 803-434-1100. 
 
Voluntary Participation and Withdrawal from the Study 
You have the right to leave the study at any time without any penalty. You may refuse to do any 
procedures you do not feel comfortable with or refuse to answer any questions that you do not 
want to answer.  
 
Who to call if you have questions 
If you have any questions about this study please contact Laura Reparaz, (803)-434-6089, or 
Anna Gordon, (803)-434-1100, during normal business hours.  
 
For questions or concerns about your mental health care, please call your Community Mental 
Health Center.  
 
If you have questions about the way the study is conducted, please contact Dr. Ligia Latiff-Bolet at 
the SC Department of Mental Health Institutional Review Board at (803)-898-8619.  
 
 
 

Protocol Title: Engaging Patients with Mental Disorders from the ED in Outpatient CARE: A 
Comparative Effectiveness Workforce Study of Peer Specialists vs. Professional Care Managers 
Page | 22 
 
February 11, 2020 
 
Consent Review Questions:  
 
The goal of this study is to see how well care navigation works to help 
people improve their mental health.  
True 
False 
Being a part of this project does not affect my care and I will still receive 
treatment at the mental health center.  
True 
False 
Study staff believes there are no significant risks to being in the study. 
True 
False 
Everyone in the study has care navigation from the same person.  
True 
False 
Over the study I will complete 3 interviews, one at the beginning, one at the 
end of 6 months and one at the end of 12 months.  
True 
False 
I will not receive any payment for participating in the program. 
True 
False 
I can change my mind about being in the study whenever I want.  
True 
False 
 
Consent & Authorization 
 
I have read this consent form (or had it read to me), and the research study has been explained 
to me. All of my questions have been answered, and I freely and voluntarily choose to take part 
in this study. 
 
____________________________________________ 
Printed name of Participant  
 
 
_____________________________________________ 
 
  
 
 
 
Signature of Participant  
 
 
 
 
 
Date              Time 
 
 
_____________________________________________ 
Printed name of Person Conducting Informed Consent Discussion   
 
___________________________________________________ 
 _______________________ 
Signature of Person Conducting Informed Consent Discussion           Date              Time