A Comparison of the Effectiveness of Telepsychiatry With a Randomized Waitlist Control Utilizing Patient Reported Outcome Measures (PROMs)
Phase: NA
Conditions: PROMs, Waitlist, Telemedicine, Mental Health Disorder, Psychiatric or Mood Diseases or Conditions
Sponsor: Carilion Clinic

Carilion IRB Application (Version 1.8)
1.0
General Information
*Please enter the full title of your study::
A Comparison of the Effectiveness of Telepsychiatry with a Randomized Waitlist Control 
Utilizing Patient Reported Outcome Measures (PROMs)
 
 
*Please enter an abbreviated study title or key words you would like to use to reference the study: 
Telepsychiatry, PROMs, Waitlist
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add departments
2.1 Add the departments of all Key Study Personnel that will be involved with the design, conduct, or reporting on this project:
Is 
Primary? Department Name
CC - Department of Psychiatry and Behavioral Medicine
CC - External- Virginia Tech Blacksburg
CC - HEALTH ANALYTICS RESEARCH
 
3.0
Assign key study personnel(KSP) access to the study  
3.1 
 Please add a Principal Investigator for the study: 
*
Name
Role
Training Record
O'brien, Virginia, MD
Principal Investigator
 View Training Record
3.2 
 
Please add the Research Staff, if applicable:
A) Additional Investigators 
Name
Role
Training Record
Kablinger, Anita
Sub-Investigator
 View Training Record
Mcnamara, Robert
Sub-Investigator
 View Training Record
Sharp, Hunter
Sub-Investigator
 View Training Record
Tenzer, Martha
Sub-Investigator
 View Training Record
B) Research Support Staff 
G

Name
Role
Training Record
Phenes, Ashlie, Master of Science
Other
 View Training Record
3.3 
Please add a Study Contact:
*
Name
Role
Training Record
Kablinger, Anita
Study Contact
 View Training Record
O'brien, Virginia, MD
Study Contact
 View Training Record
The Study Contact(s) will receive all important system notifications along with the Principal Investigator. (e.g. The 
project contact(s) are typically either the Study Coordinator or the Principal Investigator themselves). 
4.0  
Key Study Personnel (KSP) Info
4.1  Provide the following information below for each Carilion Clinic research team member: You will be asked to provide information about 
members of the research team that are outside Carilion at a later time.
Click "add another entry" to respond to this item.
 
*CITI Training in Human Subjects Research Biomedical Researchers and GCP (for FDA-
regulated and NIH-funded) will be verified for each team member before the 
application will be reviewed by the IRB. Detailed instructions for Carilion's CITI 
training requirements can be found at  https://www.carilionclinic.org/irb/education
.  Please ask all team members to ensure their Carilion email address is added to their 
CITI account profile so that their CITI training is pulled into this system. This feed 
occurs on a nightly basis.
       Entry 1       
Research team member 
name:
Kablinger, Anita
Degree:
MD
Status:
Physician
If other, specify:
Email address:
askablinger@carilionclinic.org
Phone number:
540-981-8582
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects

Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
       Entry 2       
Research team member 
name:
O'brien, Virginia, MD
Degree:
MD
Status:
Physician
If other, specify:
Email address:
vcobrien@carilionclinic.org
Phone number:
540-529-9063
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):

       Entry 3       
Research team member 
name:
Mcnamara, Robert
Degree:
PhD
Status:
Carilion Staff/Employee
If other, specify:
Email address:
rmcnamara@carilionclinic.org
Phone number:
540-512-1304
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
       Entry 4       
Research team member 
name:
Sharp, Hunter
Degree:
MS
Status:
Carilion Staff/Employee
If other, specify:
Email address:
hdsharp@carilionclinic.org
Phone number:

540-510-4632
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
       Entry 5       
Research team member 
name:
Tenzer, Martha
Degree:
BS
Status:
Carilion Staff/Employee
If other, specify:
Email address:
mmtenzer@carilionclinic.org
Phone number:
540-224-5192
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent

Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
       Entry 6       
Research team member 
name:
Phenes, Ashlie, Master of Science
Degree:
MS
Status:
Carilion Staff/Employee
If other, specify:
Email address:
arphenes@carilionclinic.org
Phone number:
540-981-8025
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):

5.0  
Application Type
5.1  Select the application type:
Human Subject Research Study 
Determination of Human Subjects Research (including QA/QI Determination) 
Establishing a prospective Data or Specimens Research Repository 
Humanitarian Use Device (non-research use) 
Expanded Access or Compassionate Use 
Single Patient Emergency Use 
Preparatory to Research Application 
IRB Grant Review ONLY for preliminary approval if required by funder 
Requesting Carilion Clinic RELY on another IRB of Record (WIRB, CIRB, VT, UVA, Advarra 
etc.) 
Conversion of a paper application due for Continuing Review or Annual Check-In 
Please ensure the PI has completed and submitted the R&D Application Department 
Level Review Form (eCRAF), and that the PI's Department Chair or signatory has 
signed off on the R&D Department Level Review eCRAF Form BEFORE you proceed any 
further with this IRB application. Please read the below bullet points carefully and 
acknowledge your understanding.
The R&D Application Department Level Review eCRAF Form must be submitted 
by the PI and signed off by Department Chair or signatory through RedCap
 BEFORE you may proceed with this IRB application.
The R&D Application Department Level Review eCRAF Form serves a major 
function for section and department level review and may result in this study 
not being permitted due to resources, scientific validity, or other reasons.  
You 
 submit a copy of the signed R&D Application Department Level Review 
must
eCRAF Form with this IRB application in the supplemental document section.
Failure to complete the steps in the above order will result in a significant delay 
in the IRB's review of this study. 
Acknowledged 
6.0  
Funding Information and Outside Services
6.1  Select the applicable funding source(s).
None (no money, equipment, supplies, and/or services will be provided by external source)
No monetary funding BUT equipment, supplies, and/or services will be provided
Federal Government
Foundation or Non-profit
Industry/Commercial Sponsor
State or Local Government
Investigator or Departmental/Unit Funds
Carilion RAP Grant
Other
Select all the Federal funding sources that apply:
National Institutes of Health (NIH)
National Science Foundation (NSF)
Department of Agriculture
Department of Commerce
Department of Defense

Department of Education
Department of Energy
Department of Energy, Office of Science, STTR
Department of Energy, Office of Science, SBIR
Department of Health and Human Services
Department of the Interior
Department of Justice
Department of Transportation
Environmental Protection Agency
National Institutes of Standards and Technology
U.S. Air Force Office of Scientific Research (AFOSR)
U.S. Army Research Office
U.S. Navy Office of Naval Research
Other
Please provide more detailed information about the funder, as applicable, including funder name or 
department (including name of NIH institute, center, or offices, name of NSF directorate, 
etc.).
iTHRIV award
Award / Contract Status:
awarded
Grant Title, if applicable:
A Comparison of the Effectiveness of Telepsychiatry with a Randomized Waitlist Control Utilizing 
Patient Reported Outcome Measures (PROMs)
6.2  Select services from all areas 
 of the Research Team members’ affiliations that are necessary to conduct the work.
outside
Research and Development (R&D) will contact you to arrange a Feasibility Meeting based on your responses 
below.  This will ensure roles, responsibilities, and costs associated with this project are understood by all 
parties. Final sign-off from leadership in the additional service areas, as well as contracts, may be required.
Animals
Basic Science Laboratory Services
Center for Simulation, Research & Patient Safety (CSRPS)
Department of Medicine
Department of Pediatrics
Department of Psychiatry
Department of Surgery
Emergency Department
Hazardous Materials
Health Analytics Research Team (HART), including Epic Data Extraction, Statistics Services, 
Carilion RedCap, Epic Research Access
Human Resources
Jefferson College
Nuclear Medicine
Nursing
Pathology
Pharmacy
Physical Therapy
Radiology
Recombinant DNA/RNA
Respiratory
Solstas Lab
Technology Services Group (TSG)

Other
None
Please specify:
VT Psychology
6.3  You have selected that HART services are needed for this research.  Specify the resources needed.
Epic Data Extract
Statistics Support (biostatisticians)
Carilion REDCap (Data management)
Epic Research Access for Chart Review
TriNetX Identifiable Patient List/Data Set
SPARC Carilion Secure Research Environment
Note: If you have not yet discussed this project with the HART team, please contact 
them at HART@carilionclinic.org before proceeding any further with this application. 
This will ensure that your request for this project is feasible.
7.0  
Regulatory Compliance
7.1  How many studies is the PI currently responsible for?
2
7.2  Does the PI have protected or dedicated time available to conduct this research?
 Yes  
 No
7.3  Has any member of the research team ever received a FDA 483, “Warning Letter”, Notice of Disqualification, or other 
warning or disciplinary action from an agency or licensing authority?
  Yes  
  No
7.4  Has this study been disapproved or terminated by another IRB?
  Yes  
  No
8.0  
Conflict of Interest
8.1  A Conflict of Interest, per the Carilion Clinic Organizational Policy, is a situation in which an Investigator’s and/or their Family 
Member’s financial, professional, or other personal consideration may directly or indirectly affect, or reasonably appear to affect, the 
Investigator’s professional judgement in performing their Institutional Responsibilities. A Conflict of Interest may be actual, apparent, 
or potential. Any research team member listed on the IRB application is considered to be an Investigator. It is the Principal Investigator’
s responsibility to query all Carilion research team members on this study to ensure they have honestly completed their Annual COI 
Disclosure and that it is current. The Principal Investigator should be notified by the study team member if the study team member has 
disclosed any related interests. Carilion Clinic’s Conflicts of Interest in Research Policy can be found here.
 
If this study has any external funding or support, have all Carilion research team 
members filed an Annual COI Disclosure through Carilion Clinic’s Office of 
Organizational Integrity and Compliance via the COI-Smart online disclosure system? 
Yes 
No 
N/A - this study does not have any external funding or support 

Do any Carilion research team members or their family members have a 
Conflict of Interest or related outside interest with the sponsor/funding 
agency of this study?
  Yes  
  No
It is the Principal Investigator and conflicted employee's responsibilities to ensure the 
conflict or any changes that result in a potential conflict are disclosed to the Office of 
Integrity and Compliance who will refer it to the Carilion Clinic's Research Conflict of 
Interest Commitee for appropriate management when necessary. Disclosure and 
management must occur before the conflicted employee is permitted to engage in any 
research activities. Any employee who violates the Conflict of Interest policy is subject 
to disciplinary actions, up to and including termination.
 
 
9.0  
Collaboration
9.1  Is this research project a collaboration between Carilion Clinic and another institution (including, but not limited 
to Fralin Biomedical Research Institute at VTC, VTCSOM, VT, UVA)?
 Yes  
 No
9.2  Please provide the name(s) of the collaborating institution(s) and the name(s) and contact information of the lead PI(s) at that 
institution.
Lee Cooper, Ph.D., (Co-PI)
Clinical Associate Professor, Department of Psychology
Director, Psychological Services Center
Virginia Tech
ldcooper@vt.edu
9.3  Is Carilion acting as one site of a multicenter study?
 Yes  
 No
9.4  Will the multicenter protocol be followed as written or are there components or aspects of the research that this site will not 
participate in or that will be modified?
(E.x:, local site will not recruit into one of the cohorts or into a sub-study; the age range will be narrowed, a 
specific procedure or test isn’t available locally so another will be performed, etc.)
The protocol will be followed as written. 
The protocol will be modified locally. 
9.5  Is Carilion acting as the coordinating center for the multi-center study?
 Yes  
 No
9.7  Are any members of the research team listed on 
 IRB application under the jurisdiction of another institution's IRB?
this
 Yes  
 No
Please state specifically which external personnel are under the jurisdiction of another IRB, their role on 
this research study and the type of interaction they will have with the subjects, the name of the 
institution's IRB(s), and an explanation as to why they are listed on this IRB application.

Lee Cooper, Ph.D., (Co-PI)
Clinical Associate Professor, Department of Psychology
Director, Psychological Services Center
Virginia Tech
ldcooper@vt.edu
research design, data analysis (de-identified), scholarly products
Alyssa Gatto, M.S.
Graduate Student, Clinical Science
Department of Psychology
Brown University
alyssa_gatto@brown.edu
research design, data analysis (de-identified), scholarly products
Hayoung Ko, M. A.
Graduate Student, Clinical Science
Department of Psychology
Virginia Tech
Hayoungk@vt.edu
research design, data management, data analysis (de-identified), scholarly products
Sydney Jones B.S.
Graduate Student, Clinical Science
Department of Psychology
Virginia Tech
sydneybj@vt.edu
research design, data management, data analysis (de-identified), scholarly products
9.8  Are you requesting that Carilion Clinic serve as the IRB of record for the other participating institutions or organizations?
For more information on IRB reliance requests, please visit the Carilion Clinic IRB website or contact the 
IRB Office.
 Yes  
 No
List all the team members on the study at the collaborating site(s) and describe 
their role in the research, including if they will have access to identifiable data. 
Please also ensure all external team members have met the training 
requirements for their home institution. Failure to do so will delay the 
execution of the IRB Reliance.
Lee Cooper, Ph.D., (Co-PI)
Clinical Associate Professor, Department of Psychology
Director, Psychological Services Center
Virginia Tech
ldcooper@vt.edu
research design, data analysis (de-identified), scholarly products
Alyssa Gatto, M.S.
Graduate Student, Clinical Science
Department of Psychology
Brown University
alyssa_gatto@brown.edu
research design, data analysis (de-identified), scholarly products
Hayoung Ko, M. A.
Graduate Student, Clinical Science
Department of Psychology
Virginia Tech
Hayoungk@vt.edu
research design, data management, data analysis (de-identified), scholarly products
Sydney Jones B.S.
Graduate Student, Clinical Science
Department of Psychology
Virginia Tech
sydneybj@vt.edu

research design, data management, data analysis (de-identified), scholarly products
9.9  If this study has any external funding or support, do the external collaborators’ institutions possess a PHS-Compliant FCOI 
policy?
Yes
No
N/A - study does not have external funding or support
9.11  Describe any plans for initial and ongoing training of the other sites on important aspects of the protocol.
We meet weekly to review study progress, data acquisition and trends with focus on maintaining 
protocol procedures without deviation
9.12  Describe the plan to manage communication of information at the other sites that is relevant to the conduct of the research 
and the protection of human subjects, such as reporting of unexpected problems, protocol modifications, and interim results 
for all sites to the Carilion Clinic IRB.
For FDA-regulated clinical trials, the plan must include the plan for reporting serious adverse events or 
serious adverse device effects, significant new risk information, and any other reports mandated by 
regulation or policy.
We meet weekly to review study progress, data acquisition and trends with focus on maintaining 
protocol procedures without deviation
The PI or other Carilion IRB-approved team member will report any unexpected problems, 
protocol modifications and interim results to the Carilion Clinic IRB
9.13  Describe the Carilion Clinic investigator's plan for oversight of research activities at other sites including verification of 
Institutional approvals, data safety monitoring, and ensuring data quality and integrity.
For FDA-regulated clinical trials, the plan must include the use of trained and qualified monitors to oversee 
the progress of the research.
The study team meets weekly to ensure approvals, monitoring and data quality and integrity are 
maintained
9.14  Will identifiable data or specimens be transferred, transmitted, or shared outside of Carilion?
For example, transfer of data or specimens from Carilion Clinic to an external collaborator (including VT, 
VTCRI, UVA, etc.).
  Yes  
  No
9.15  Provide information about the types of specimens and/or data, including specific datapoints, that will be shared 
and the methods of storage of the data at the collaborating site.  Include a description of the process for 
shipping the specimens and/or transmitting the data to the collaborator, including the method of encryption if 
sharing data electronically.
Data collection will be entered into REDCap by Ashlie Phenes (Psychiatry Intake Coordinator) and 
reviewed by the PI or sub-investigator. Hayoung Ko, a VT Psychology graduate student, will be 
the data manager for the project. Thus, we request that she have access to REDCap data, without 
PHI access.
Data in REDCap that would be visible to Hayoung Ko at VT would be:
subject number
randomized group (no intervention or minimal intervention)
date of assessment by Ms. Phenes will be put as day 1 NOT a specific date of appointment
PHQ-9, GAD-7, BASE-6, USAUDIT, DAST-10 scores

Covid Event Checklist (positively checked answers with respect to COVID infection, prevention, 
negative mental health effects of Covid, SDOH and resiliency factors) - there are no dates or 
identifying information in this checklist, simply the check-marked items themselves
Adult Behavioral Health Screen (ABHS) (marked as completed or not)
The VT collaborator would not have access to any of the 18 HIPAA identifiers.
Data from REDCap will be exported to SPARC by HART and de-identified to allow other non-
Carilion study members (LD, HK, AG and SJ) to analyze data that is de-identified.
10.0  
Human Subjects Research Description
10.1  In the opinion of the Principal Investigator, does this research impart minimal risk or greater than minimal risk to 
subjects? 
As defined by regulation, minimal risk means that the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily 
life or during the performance of routine physical or psychological examinations or tests.  Please note that 
the IRB makes the final determination of risk level and may ask you to change this based on their decision.
 
If this is a Conversion of a Paper Application, select the risk level that has been determined already by the 
IRB  at most recent review per the most recent approval letter (expedited review = minimal risk, full board 
review = greater than minimal risk).
Minimal Risk 
Greater than minimal 
10.3  Select ALL the types of research activities that will be involved in your human subject research subject, or select None.
Drugs, biologics or other FDA-regulated products (other than devices)
Medical devices
Review of data/records (i.e. prospective clinical data collection from medical records, 
reviewing previously collected data)
Biospecimen collection (i.e. blood, tissue, urine, saliva)
Analysis of existing specimens from patients and/or bank or repository
Human genetic analysis or Recombinant DNA, or Gene Therapy
Invasive medical procedures (i.e. lumbar puncture, biopsy, endoscopy, surgery, etc.)
Non-invasive medical procedures routinely employed in medical practice (i.e., physical 
measurements, EKG, EEG, moderate exercise, etc.)
Imaging (i.e., x-ray, CT, DEXA, MRI, ultrasound, etc.), Use of Therapeutic or Diagnostic 
Radiation, Radioactive Drugs
Task-based activities or games, or Psychometric Testing
Surveys, questionnaires, focus groups, or interviews
Examination of educational practices, instructional techniques, curricula or classroom 
management
Observations of public behavior
Interventions or procedures involving deception
Use of Internet
Audio or Video recording
International Research
NONE OF THE ABOVE
10.4  Briefly describe the proposed research in language that can be understood by a non-scientist.
This description should summarize the objectives of the research and the procedures to be used, with an 
emphasis on what will happen to the subjects. If this is an application for the establishment of a research 
repository, summarize the objectives of the repository and how data/specimens will be used in the future. 

The utilization of patient reported outcome measures (PROMs) during in-person care 
allows for on-going assessment of the severity of mental illness and patient outcomes 
across treatment (Lewis, et al., 2019; Douglas, et al., 2020). Additionally, it provides 
immediate feedback on the patient’s psychiatric status to both the patient and 
practitioner (Lambert, et al., 2018). Carilion Clinic - Psychiatry & Behavioral Medicine (CC-
P&BM) ambulatory clinic implemented PROMs prior to the start of the COVID-19 
pandemic and continues to utilize them as part of patient care. All new patients are asked 
to complete an initial PROM bundle of assessments twenty-four hours before their initial 
appointment, including the Brief Adjustment Scale (BASE-6), Patient Health 
Questionnaire (PHQ-9), Generalized Anxiety Disorder survey (GAD-7), US Alcohol Use 
Disorder Identification Test (USAUDIT), and Drug Assessment Screening Test (DAST-10). 
Automatic monthly reminders to complete the BASE-6, PHQ-9 and GAD-7 continue after 
the first visit with the clinician. 
The COVID-19 pandemic necessitated a rapid transition nationally from in-person to 
telemedicine (Augusterfer, Mollica, & Lavelle, 2018; Torous & Wykes, 2020; Kalin, et al., 
2020), a change that occurred in our clinic as well. Over the last 2 years, research 
members of Carilion Clinic Psychiatry and Virginia Tech Psychology departments have 
been actively using PROM data to assess psychiatric health outcomes before and after the 
outbreak of COVID-19 in the United States. Initial results indicate that patients who 
received care via telemedicine not only did not experience worsening symptoms, but 
.  How
showed improvements in depression, anxiety and psychological functioning
ever, without a control group of untreated patients to compare, the impact of 
telemedicine plus PROMs remains unclear. A wait-list control group design would allow us 
to compare patients receiving telemedicine and repeated completion of PROMs (current 
practice) to patients referred to psychiatry, but not receiving telemedicine treatment or 
completing PROMs during the same time period. We propose randomizing wait-list 
individuals to one of two groups to assess the influence of time alone awaiting initial 
psychiatric clinician assessment (no intervention) versus minimal intervention using 
repeated PROMs and microlearning patient education videos while awaiting initial 
psychiatric clinician assessment. This kind of design allows assessment for the influence 
of time and the type of health service contact that replicates the basics of measurement-
based psychiatric services (measurement of symptomology and well-being), but with 
none of the benefits of psychiatric supports, interventions, and techniques. 
10.5  Provide background information about the research question(s.)  Explain why the research is needed and include the 
relevance of this research to the contribution of this field of study.
Please include the current state of knowledge about your project topic by summarizing 
and synthesizing the available research (including published data) to provide 
justification for the study. Include a reference list of literature cited to support the 
protocol statement, either in your response below or as a supplemental document as 
part of the application packet.
Patient-reported outcome measures are a component of Measurement-Based Care (MBC) 
that involves collaboration between patient and clinician using structured evaluations of 
patient symptoms to inform behavioral health treatment and clinical decisions (Lewis, et 
al., 2019). In clinical settings, MBC has been found to improve outcomes and decrease 
dropout (Lambert, et al., 2018). Since patient-reported outcome measures can be 
performed by patients or clinicians, in session or out of session, and in-person or via 
telemedicine, their application is particularly pertinent during or after a crisis 
(Augusterfer, Mollica, & Lavelle, 2018). The COVID-19 pandemic abruptly accelerated the 
transition to telehealth for many and necessitated alterations to traditional therapeutic 
means (Torous & Wykes, 2020; Kalin, et al., 2020). PROMs are a tool that can improve 
the telehealth experience by strengthening patient-clinician relationships strained by the 
use of telemedicine, and allows for tracking of patient symptoms, which can be discussed 
and intervened upon in session (Douglas, et al., 2020). 
Over the last 2 years, research members of Carilion Clinic Psychiatry and Virginia Tech 
Psychology departments have been actively using PROM data to assess psychiatric health 
outcomes 
 in the United States (IRB approved 
before and after the outbreak of COVID-19
protocol 20-905). Initial results indicate that patients who received care via 
telepsychiatry not only did not experience worsening symptoms, but showed 

.  However, 
improvements in depression, anxiety and psychological functioning
without a control group of untreated patients to compare, the impact of telemedicine plus 
PROMs remains unclear. A wait-list control group design would allow us to compare 
patients receiving telemedicine and repeated completion of PROMs (current practice) to 
patients referred to psychiatry, but not receiving telemedicine treatment or completing 
PROMs during the same time period. We propose randomizing wait-list individuals to one 
 
of two groups to assess the influence of time alone awaiting initial psychiatric clinician 
assessment (no intervention) versus minimal intervention using repeated PROMs and 
reviewing microlearning patient education videos while awaiting initial psychiatric clinician 
assessment. This kind of design allows assessment for the influence of time and the type 
of health service contact that replicates the basics of measurement-based psychiatric 
services (measurement of symptomology and well-being), but with none of the benefits 
of psychiatric supports, interventions, and techniques. 
As of July 2021, 
 are engaged in Owl Insights, an 
32 Carilion psychiatric clinicians
MBC vendor. Approximately 
 
500 unique individuals complete monthly PROMs
through this system as part of routine clinical care. Our research group recently 
conducted analyses of nearly 900 ambulatory adult psychiatric patients in ambulatory 
psychiatry at Carilion Clinic (CC&PBM) engaging in PROMs via telepsychiatry and in-
person modalities. PROM results of a patient cohort in clinical care prior to the onset of 
COVID-19 (November 2019) through March 2021 demonstrated that depression, anxiety 
and psychological functioning did not decline as hypothesized but statistically improved 
(Kablinger, et al., 2021). Data also show that the engagement rates range from 33 to 
, and completion rates were significantly 
74% depending on demographic factors
different for diagnostic group and payor status of the patient (Kablinger, et. al, 2021). 
The standard goal for MBC utilization is 80%, while the department goal is to have 
 
all
patients participate in PROM completion. Our research group has also completed focus 
groups of psychiatric clinicians and staff with regards to Owl Insights and PROMs within 
the past year, identifying barriers and facilitators to its use and plan training 
implementation for improved adherence and satisfaction (summary of focus group data 
and training outline- included in grant application, IRB approved protocol 20-1065). Since 
March 2020, CC-P&BM has been engaging with patients via telephone and several 
telehealth platforms. Currently, ambulatory psychiatry uses AmWell, a telehealth 
platform that provides secure telemedicine visits between clinician and patient. The 
department has documented between 2100-2300 adult telemedicine sessions 
 between June 2020 and June 
 and 
monthly
200-700 in-person visits per month
2021.  
CC-P&BM currently has a wait-list of over 300 adults referred for mental health 
evaluation and treatment. Access to psychiatric clinicians remains insufficient despite 
increasing numbers of providers in our clinic and the mental health needs associated with 
the pandemic are rising. As a result, a clinical intake coordinator (Licensed Professional 
Counselor) began in the CC-P&BM ambulatory clinic September 2021. This coordinator 
will individually contact people on the wait-list for psychiatric care by phone as part of 
routine care, beginning with the referrals most remote in time. The coordinator will 
complete an intake assessment for each wait-list individual who wants a psychiatric 
referral. Prior to the initial intake assessment by the intake coordinator, wait-list 
individuals will receive a bundle of PROMs automatically (through Owl Insights) to 
complete. These measures include the PHQ-9, GAD-7, BASE-6, DAST-10, USAUDIT, 
Covid Event Checklist and the Adult Behavioral Health Screen (ABHS), all of which are 
currently used in routine ambulatory care. The intake coordinator will complete the intake 
assessment, noting the completion, and scores of, the PROMs. Scores of the PHQ-9, GAD-
7 and BASE-6 will be utilized to triage the most severe referrals and move them up for a 
sooner appointment (the triage system of scores and Nurse-Practitioner vs Medical 
Doctor screening questions are attached to this application). Any concern about patient 
safety is also addressed immediately during this intake and is also noted in the materials 
attached to this application. Up to this point, all intake coordinator/referral 
interaction are part of routine care.  
If eligible and capable of consent based on intake coordinator clinical judgement, 
individuals will then be randomized to participate to the no intervention group 
(completion of screening PROMs only during the intake coordinator assessment) or the 
minimal intervention group (intake coordinator assessment, including PROM screening 
and then prospective monthly PROM completion in addition to assigned microlearning 

patient education videos). We will analyze changes in PROM scores for individuals 
engaged in both wait-list groups and compare results to their PROM scores at the initial 
provider telemedicine visit and over time (6 months post first provider assessment). 
Consent may be in-person with hard copy consent forms and signatures or through e-
Consent either in-person using ipads or remotely using REDCap.
10.6  State the research hypothesis or the question that the research will answer.
List the research objectives and expected outcomes. A primary outcome or objective must be identified. After 
the statement of the primary objective, secondary objectives may be listed. Objectives should be simple and 
specific.
Aim 1 will use PROMs to assess the symptomology and well-being of adult 
individuals on a wait-list group referred to CC-P&BM clinic from their initial 
referral to their initial psychiatric session. 
In particular, we propose randomizing wait-list individuals to one of two groups 
to assess the influence of time alone awaiting initial psychiatric clinician 
assessment (no intervention) versus minimal intervention using prospective 
monthly repeated PROMs and viewing microlearning patient education videos 
while awaiting initial psychiatric clinician assessment. 
 will use PROMs to determine whether there is a difference in clinical 
Aim 2
symptomology and well-being for patients during telemedicine treatment with 
their practitioner compared to wait-list individuals.
10.7  State how qualitative and/or quantitative data will be analyzed in order to answer the research questions.
Include an analysis from a statistician (or someone familiar with statistical methods) that either indicates the 
power calculation for the sample size necessary to meet the primary study outcome or objective OR a 
statement from the statistician indicating reasons why a power calculation is waived or not necessary for this 
study.  Also include the statistical test(s) that will be used to analyze your primary study objective (t-test, chi-
square, etc.).  Secondary outcomes may be listed as descriptive.  
 
If this is a proof of concept or feasibility study that includes limited efficacy testing, please provide a 
description on how your design will determine if an intervention should be recommended for broader 
efficacy testing.  If a study is meant to be solely descriptive, then the primary outcome or objective must be 
limited in scope.  As such, the study results apply only to the sample being studied, and conclusions cannot be 
drawn about the larger population. 
section helps the IRB confirm the data being collected are relevant to 
This is required for ALL studies, as this 
the study aims and planned analysis. 
The primary outcome of interest is the change in total PROM score for each assessment 
required of patients enrolled in the study. Initial PROM scores will be acquired and 
assessed after referral into the CC-P&BM program. The potential to receive few records 
per patient is believed to be relatively high; therefore, the final PROMs completed for 
each assessment will be used to determine the change in total score. This change will be 
compared between patients receiving telemedicine and those of the control (wait-list) 
groups. A two-sample t-test or non-parametric equivalent of the mean change in total 
PROM will be performed to determine if the change is significantly different among 
treatment types. An alpha of 0.05 will be used to assess statistical significance. 
Univariate and multivariate analyses may occur to measure numeric variables by 
measures of central tendency and variation and categorical variables by frequencies and 
percentages. Trends of PROM scores will be evaluated between treatment types by the 
time in program.
10.8  Statistical Review
Name of statistician or person 
who prepared the statistical 
plan:
Department/Institution:
Date statistical review was 
conducted:

Hunter Sharp MS
HART
8.28.21
*Note: The statistician or individual that prepared the statistical plan must also be included on the study 
team if they meet the definition of key research personnel (ex: significantly involved in the study design, 
conduct, or reporting of the research).
If a statistical review has not been submitted, explain why:
NA
10.9  Do you want to view the minimal risk exempt categories to determine if your research may qualify for exemption before 
completing the full application?  Please note that determination of exemptions must be made by the IRB.
Your research may be Exempt from future IRB oversight if it only involves retrospective review of data 
(including Limited Data Sets), non-sensitive interviews or surveys, or falls into other minimal risk categories. 
If the research is determined to be exempt by the IRB, you will not be required to complete a full IRB 
application. If you complete the Exempt application and the IRB determines your research is not exempt, you 
will be required to complete the full IRB application. 
  Yes  
  No
11.0  
Subject Population
11.1  Please select the population(s) being 
 in this research study. (select all that apply)
targeted, or likely to be included
Medical Chart Review of patients only (no in-person contact)
Normal Adults/Healthy Volunteers
In-Patient Population
Out-Patient Population
Patients in emergency situations
Terminally ill patients
Employees/Staff
Students
Children/Minors (anyone younger than 18 years of age in the state of Virginia. For research 
conducted outside of the state of Virginia, age of majority is dependent on state/local law)
Prisoners
Pregnant Women
Fetuses
Neonates of uncertain viability and/or nonviable neonates
Adults with Impaired Decision-Making Capacity
Persons with Limited-English proficiency (LEP) or Non-English Speakers
Individuals of Childbearing Potential
11.2  Please indicate the total number of subjects anticipated to be enrolled at this site/by this investigator.
For the purposes of the IRB, a subject is enrolled once they have provided consent to participate, or for 
studies approved with a waiver of consent, once data has been collected on the subject.
200
11.3  If the research involves multiple subject groups or cohorts at this site, provide the anticipated number of subjects in each of 
group or cohort (e.g., control/experimental, adults/children, etc.).
wait-list (no intervention)- 100

wait-list (minimal intervention) - 100
11.4  Provide the age range for the proposed subject population (e.g., 0-5 years old):
18-99
11.5  Specify the inclusion criteria for each of the subject groups to be included in the research.
If there are multiple different groups being recruited with different eligibility criteria, 
instead add an Eligibility Criteria checklist for each group as a supplemental document 
after you complete this application. Please make note of this in the Inclusion Criteria 
below.
Order 
Number
Criteria
1 
Although there are two wait-list conditions (no intervention vs minimal 
intervention), all potential subjects must be 18 years old or above and provide 
consent for randomization. Potential subjects must have the ability to complete 
PROMs either by cell phone or through email.
 
2 
New adult ambulatory psychiatry patients seen in the psychiatry clinic between 
11.1.21 and 4.5.22 assessed by the intake coordinator Ms. Ashlie Phenes.
 
11.6  Specify the exclusion criteria for each of the subject groups to be included in the research.
If there are multiple different groups being recruited with different eligibility criteria, 
instead add an Eligibility Criteria checklist for each group as a supplemental document 
after you complete this application. Please make note of this in the Exclusion Criteria 
below.
Order 
Number
Criteria
1 
Patients who do not (or are unable to) provide consent for participation or do not 
have the ability to complete PROMs or watch microlearning videos remotely.
 
2 
Intellectual disability or non-verbal
 
3 
Patients with neurocognitive disorders who do not have the capacity to undergo 
informed consent and participate in the study
 
11.7  
(such as a family member or colleague of the 
Is information being obtained about individuals other than the “target subjects” 
subject), making the other individuals “secondary subjects”?
  Yes  
  No
12.0  
Pregnant Individuals, Individuals of Childbearing Potential, Breastfeeding Infants, Fetuses, or 
Neonates
12.2  Are there any additional risks to pregnant individuals by participating in this study?
If your research involves fetuses or neonates, please contact the 
IRB prior to submission.
  Yes  
  No

12.3  Are there any additional risks to individuals of childbearing potential, individuals who become pregnant, breastfeeding 
infant, or fetus or neonate by participating in this study?
  Yes  
  No
13.0  
Informed Consent for Adult Subjects
13.1  How do you plan to obtain consent from ADULT subjects or their Legally Authorized Representative?
Check all that apply:
Written consent document with signature (ie: obtaining signature from subject or Legally 
Authorized Representative)
Waiver of written documentation of consent (ie: consent will be obtained through verbal 
confirmation from the subject or Legally Authorized Representative rather than through a 
signed document)
Waiver of informed consent for minimal risk research (ie: typically appropriate only when the 
study does not involve any interaction or intervention with subjects)
Waiver or alteration of the elements of informed consent (ie: research involving deception)
Waiver of the informed consent document and process for PLANNED EMERGENCY RESEARCH. 
Contact the IRB before submission.
No adults are being enrolled; this study is only enrolling children. (You will answer questions 
about the assent and parental permission process later.)
You must attach all consent forms, consent scripts, and information sheets in the Initial Submission Packet.
13.2  Is it expected that surrogate consent will need to be obtained from Legally Authorized Representatives (LARs) for some or 
all adult subjects?
  Yes  
  No
13.3  If the research includes more than one subject group or you have selected multiple responses above due to the inclusion of 
multiple subject groups, please specify the requested consent method for each group, or state N/A.
The requested data from normal standard of care PROM completions (11.1.21-4.5.22) does not 
include consent as it is part of our clinical care with all ambulatory patients.
The signed informed consent was obtained for all participants in the study from 4.6.22 to present 
today.
13.4  How will written consent be documented?
Click the Help bubble to the right for more information about requirements for 
eConsent before selecting this option.
Traditional signed written consent form on paper document
eConsent: signed via an REDCap or other electronic or web-based form
Short Form Method (for non-English speaking subjects only)
Other
13.5  Describe the 
 of obtaining consent and 
 the process, including the following:
process
documenting
Circumstances under which consent will be obtained, including how the potential participant will first be 
approached;

Where the consent process will take place  (ex: in person in a private clinic room, over the phone, through WebEx, 
etc.);
When the consent process will take place and how long participants will be given to decide;
If eConsent is being utilized, describe how you will first contact the potential participants and provide the consent 
form to them to review;
Steps that will be taken to ensure voluntary participant and to minimize the possibility of coercion or undue 
influence;
Any cultural considerations (ex: tribal or group permission requirements, age of majority, technological 
implications, etc.);
If any participants do not speak English, whether a translator with witness will be used, whether translated materials will be 
used, whether the consent process changes based on the language;
If multiple participant groups or consent procedures are to be included, these need to be clearly delineated;
how participants will be provided with a copy of their signed consent;
Describe the method you will use to document the consent 
 
PROCESS within each participants' research record
/medical record (state which). This should include a process note or checklist that will document all the components 
listed above, the start and end time of the discussion, and is 
 to the signed and dated consent form (if 
in addition
applicable).
For example, describe it consent will take place in the research office, in a private conference room, in the 
doctor’s office, in a group setting, over the phone, etc.
The psychiatry intake coordinator contacts patients referred to the CC-P&BM ambulatory clinic 
over the phone, starting with the most remote referral.
Confirmation of patient identity using two identifiers will occur and the coordinator will ensure the 
patient has privacy to discuss referral, complete intake information, including PROM scores and 
then offer study participation. Emphasis is placed on psychiatric care which will occur even if the 
patient does not want to participate in the study and that there is no negative consequences if 
they do not want to participate. This assessment is preferred to occur by video (Amwell) and 
utilize remote e-consent procedures.
Alternatively, patients may be seen in the ambulatory psychiatry clinic in a private office with the 
coordinator or other IRB-approved team members while maintaining all COVID-19 precautions to 
discuss study participation and complete hard-copy or e-consent processes. The participant will 
also be required to answer multiple choice questions to demonstrate their 
understanding of the study before they sign the document. 
Guidelines for the intake coordinator assessment, including introduction and discussion of the 
wait-list study are attached to this application (Triage Program Working Details 10.22.21).
 The consent document will be created using a REDCap-based electronic consent form. 
Econsent:
The IRB-approved consent form will be developed in REDCap, a secure, web-based, HIPAA- 
compliant, data collection platform with a user management system allowing project owners to 
grant and control varying levels of access to data collection instruments and data (e.g. read only, 
de-identified-only data views) for other users. 
The IRB approved research team member (intake coordinator, LPC) will reach out to the 
participant to schedule time to talk over the phone or through Amwell. The study team will 
request verbal permission to send the eConsent via email or text so that the participant will be 
able to review before the call. The email/text will not include PHI. The investigator will first state: 
“Carilion Clinic cannot control the security of email or text messages once we send 
them, therefore we need your permission to text or email you the link to the e-Consent 
form for the study we discussed. Please be aware that while the email title will not 
include your disease status or symptoms, the body of the email will contain the link to 
the study. Someone else accessing your email/text messages could click on the link 
and read the consent, and therefore learn about your disease status or symptoms, 
which you may consider to be of a private or sensitive nature. Do you still wish to 
receive the link to the e-Consent via email/text?”  
The permission to send the consent form via text or email will be documented in the individual’s 
research record.
Once the investigator is on the phone or Amwell call with the potential participant, the 
investigator will ask the individual to verify their identity by using a combination of questions, 
including name, date of birth, and their specialist provider name. A passcode will be created from 
the first 3 letters of the subject’s last name and their provider’s last name. The link to the 
eConsent form will sent to the participant and will be accessed on the potential subject’s personal 

electronic devices (e.g., computers, portable tablets, smart telephones). The investigator will 
enter the passcode in REDCap and the potential participant will enter the passcode in order to 
access the consent. The investigator and potential participant will discuss the study and review 
the consent form page by page. If there is another study team member available, or the 
participant has a family member nearby, they will be asked to observe as a witness. The 
investigator will encourage the participants to follow along in the document and ask questions. 
The investigator will give the potential participant as much time as they would like either on the 
phone or after the call before the signing the consent. The participant will be told they can call the 
investigator with any follow-up questions. The investigator will document on the form by signing 
their name that they reviewed the consent with the participant and will document the date of this 
discussion. 
The participant will also be required to answer multiple choice questions to 
demonstrate their understanding of the study before they sign the document.  The 
questions will include: 1. Please describe the purpose of the study. 2. Please describe your 
responsibilities in the study 3. Please describe what you should do if you think you are injured by 
your participation in the study 4. Please describe what you should do if you wish to stop being in 
the study.  The questions must be answered correctly before the participant may proceed to the 
next page. The investigator will ensure the code is accurate when reviewing the participant’s 
signature. When the individual is ready to provide consent, they will type their name and then 
sign their name using their finger or stylus and will also be required to type the date of signature. 
They will be asked to provide their passcode number. They will then be asked how they would like 
to receive a copy of their signed consent. Once the consent form is signed and submitted, 
subjects will be able to receive a print-out of the paper copy, download a pdf, and/or receive an 
email with a PDF attachment of the signed consent form.  If the participant selected that they 
wish to receive an email copy of the signed consent, they should be presented with the following 
statement and confirm by providing their email address that they wish to receive via email.
“Carilion Clinic cannot control the security of email messages once we send them, 
therefore we need your permission to email you the copy of your signed consent. 
Please be aware that while the email title will not include your [disease status], the 
attachment to the email will contain the study consent you have signed. Someone else 
accessing your email messages could click on the attachment and read the consent, and 
therefore learn about your disease status or symptoms, which you may consider to be 
of a private or sensitive nature. By providing your email address, you are authorizing 
Carilion Clinic to email you a copy of your signed form.
The process of obtaining consent will be documented within a process note by the person 
obtaining consent in the research record. This process note will include statements about:
the process of verifying the individual’s identity over the phone and then with the 
eConsent signature;
the method that was used to discuss the study with the potential subject (discussion 
happened over the phone, Amwell, etc.);
the questions that the potential subject asked;
whether a witness was required and present, and who the witness is;
the time the potential subject was given to make their decision;
how long the conversation lasted;
how the participant received a copy of their signed document.
We are now requesting access to the baseline retrospective data that exists prior to the study. No 
recruitment or consenting were completed during this SOC.
13.6  How will you ensure that subjects or LARs have sufficient opportunity to consider whether or not to participate?
Check all that apply:
Subjects will be provided the consent form to take home for consideration prior to signing.
Subjects will be allowed a waiting period to consider their decision.
Other
Please specify waiting period:
48 hours-one week
13.7  How will the subjects’ or LARs understanding of the consent information presented be assessed? 

Check all that apply:
Subjects will be asked to “Teach-Back” the study to the researchers
Subjects will be asked open-ended questions about the research (purpose, procedures, risks, 
alternatives, voluntary nature)
A tool or post-consent assessment will be used
Other
Specify the "teach back" questions or open-ended questions that the subject will be asked to describe in their 
own words in order to assess their understanding.
Check for Understanding
1.I want to make sure that we have the same understanding about this research. Could you
 please tell me what this project is about in your own words?
 2.Would you please walk me through what will happen if you agree to be in this study?
Randomized (like a flip of a coin) to either complete psychiatric intake assessment with an intake 
coordinator, including completion of PROMs OR complete psychiatric intake assessment with an 
intake coordinator, including completion of PROMs initially and monthly until provider 
appointment, AND be encouraged to watch videos about symptoms the patient is experiencing to 
learn about emotional illness and treatment approaches
 3.What do you understand as the benefits and risks of this study, if you join?
Benefits: assessment of your symptoms to better pair you with a provider and assure timely 
provider assessment and treatment initiation; you may help determine ways to triage referrals to 
psychiatry that will be more helpful to patients in the future
Risks: Completing measures of your symptoms may make you feel poorer emotionally as you 
complete them but the intake coordinator will be available to answer any questions or concerns 
and ensure you get timely provider assessment and treatment initiation
 4.What will happen to you and your information if you decline to be a part of this study at any 
point?
 You may withdraw at any point and your information will be destroyed. Your care at Carilion will 
not be affected.
 5.Who will be able to see the information that you share with us?
 Research Study Team and Carilion Clinic Institutional Review Board (IRB)
 6.If you have any questions or concerns about the study, who will you contact?
 Dr. Anita Kablinger
Answers to these questions are required to ascertain understanding prior to signing consent 
document.
13.8  Utilizing 
 has additional requirements. Please describe the following:
eConsent
The method to verify the identity of the individual providing consent;
How participants will sign the eConsent (ex: type their name, use stylus or finger to sign);
If potential participants will sign the consent while having a virtual conversation or if they will have additional time 
to consider their participation;
If use of LAR is being requested, how you will ensure this individual is an appropropriate LAR per Virginia 
requirements and verify their identity.
Verifying identification through two identifiers (name, DOB, address, contact info) over the 
phone, on Amwell or in-person
Sign econsent by typing their name

Sign the consent after virtual or in-person consultation either at the end of the initial discussion 
or up to one week for consideration of study involvement
LAR or witness NA for this study
13.9  If the enrollment of subjects who cannot read the consent form, due to visual impairment, literacy, or other issues, is 
anticipated, how will consent be obtained and documented? 
Refer to 45 CFR 46.117(b)(2) or 21 CFR 50.27(b)(2) for information regarding when the use of a short form 
is appropriate. A witness to the consent process is needed.
N/A
Short form
Other mechanism
Consent form read to participant with witness present
13.10  How will you ensure research participants remain informed about the study and continue to agree to participate in the 
research study after their initial informed consent has been obtained?
N/A
14.0  
Request for Waiver, Alteration, or Waiver of Documentation of Consent for Adult Participants
14.1  Select the type of Waiver of Informed Consent or Alteration of Informed Consent being requested.
Full Waiver – Informed Consent will not be sought from any subjects or for any research 
activities 
Partial Waiver – Informed Consent will not be sought for some subjects (such as a historical 
cohort) or for some activities (such as for recruitment or screening) 
14.2  General (46.116(d))
In order to waive the requirement for informed consent, the research must not be FDA-regulated and ALL of the following 
criteria must be met. If the waiver is only for recruitment or screening, justify the criteria for the waiver usage you are 
requesting.
The research involves no more 
than minimal risk*.
 
*Minimal Risk means that the 
probability and magnitude of 
harm or discomfort anticipated 
in the research are not greater 
in and of themselves than those 
ordinarily encountered in daily 
life or during the performance 
of routine physical or 
psychological examinations or 
tests.
Please explain:
request is to access 
clinical data of patients 
seen in ambulatory 
psychiatry for baseline 
research purposes; 
confidentiality regulations 
will be maintained
The waiver or alteration will 
not adversely affect the rights 
and welfare of the subjects.
Please explain:
as above
The research could not 
practicably be carried out 
without the requested waiver. 
Please explain:

If the research involves using 
identifiable private information 
or identifiable biospecimens, 
the research could not 
practicably be carried out 
without using such information 
or biospecimens in an 
identifiable format.
as above - accounts for 
all ambulatory psychiatry 
patient data used for 
clinical purposes; # is 
impractical without waiver
Whenever appropriate, the 
subjects will be provided with 
additional pertinent 
information after participation.
Please explain:
post iTHRIV data results 
will be shared as part of 
the grant requirements
15.0  
 Privacy and Confidentiality
15.1  Does the research include interaction with or observation of subjects?
 Yes  
 No
15.3  Select the data points that will be reviewed, collected, recorded, or created for research purposes, including screening or 
recruitment.
Check all that apply:
name
all geographic subdivisions smaller than a State, including street address, city, county, 
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip 
code if, according to the current publicly available data from the Bureau of the Census:
an element of a date, except year, for dates related to an individual, including birth date, 
admission date, discharge date and date of death; and all ages over 89 and all elements of 
such ages may be aggregated into a category of age 90 or older
telephone numbers
fax numbers
electronic mail address
social security number
medical record number/ master patient index (MPI)
health plan beneficiary numbers
account numbers
hospital account receivable (HAR)/contact serial number (CSN)
certificate/license numbers
vehicle identifiers, including license plate number
device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
biometric identifiers, including finger and voice prints
full face photographic images and any comparable image
any other unique identifying number, characteristic, code
None of the above
15.4  Will any of the above data points be reviewed, collected, recorded, or created from the medical record (or other healthcare 
records)?
 Yes  
 No

Since you plan to access or use PHI from the Medical Record, you must contact the 
 at 
HART Team
Carilion Clinic immediately to ensure the data you will need is accessible and to discuss data management 
and storage.  Do not proceed with the submission of this application until you have done so.
15.5  Is the private information being requested the minimum necessary to meet the research goals?
 Yes  
 No
15.6  Under the 
, when accessing or using PHI, a HIPAA Authorization of the subject must be obtained, or the 
HIPAA Privacy Rule
IRB must grant a waiver.
Indicate which of the following apply (more than one may be selected):
The HIPAA Authorization is embedded in the research consent document.
A partial waiver of the requirement for HIPAA Authorization is requested (e.g., for screening 
or for some subjects, such as a retrospective cohort)
A full waiver of the requirement for HIPAA Authorization is requested
The HIPAA Authorization will be sought but one or more required elements will be eliminated 
or altered
The PHI accessed or used for this research is a Limited Data Set (LDS) and a Data Use 
Agreement (DUA) is or will be in place prior to accessing or obtaining the LDS.
HIPAA Authorization will be obtained as a separate document (only permitted if required by 
sponsor)
Other
15.7  Will educational records protected under the 
(FERPA) be accessed or used for the 
Family Educational Rights and Privacy Act 
research?
  Yes  
  No
15.8  Does the research involve the administration or use of surveys, interviews, or other evaluations or examinations protected 
under the 
(PPRA)?
Protection of Pupil Rights Amendment 
  Yes  
  No
15.9  Will the research records (other than the consent form) and/or specimens contain data that is identifiable, coded, or de-
identified?
Identifiable (includes direct identifiers or information such that subject identities could be 
ascertained)
Coded or linked (identifying information that would enable the investigator or collaborator to 
readily ascertain the identity of the individual to whom the private information or specimens 
pertain has been replaced with a number, letter, symbol, etc., and a key to decipher the code 
exists, enabling linkage of the identifying information to the private information or specimens)
De-identified or unlinked (specimens/data cannot be linked to specific individuals by anyone, 
including the Carilion investigator, either directly or indirectly through coding systems)
15.10  Where will research data be stored during the period the research is active? Describe the security controls in place, 
including physical safeguards for paper records and technical safeguards for electronic records 
Storage options other than those listed below are NOT currently permitted, including the use of Carilion 
provided or personal laptops, flash drives or other portable devices, non-Carilion cloud or other hosted 
environment. Any exceptions to the list above must be approved by the Carilion Privacy and Information 
Security Officer and documentation provided to the IRB.
 
 

Hardcopy data in a locked office in a locked cabinet
Electronic data on a password protected, secure drive on a Carilion server (contact 
mmtenzer@carilionclinic.org to set up a shared drive)
REDCap (contact mmtenzer@carilionclinic.org to discuss use of REDCap)
Sponsor’s electronic data capture system
SPARC Carilion Secure Research Environment (contact mmtenzer@carilionclinic.org to discuss)
15.11  Provide any additional information pertaining to the storage and management of the 
research data. 
Best research pratice is to have data management plan which will help you manage 
and protect your data, meet funder requirements, and help others use and protect 
your data, if shared. A well structured project can help protect the confidentiality of 
patient and participant data. Carefully planned data management also allows for a 
better use of your time and resources. For guidance on data management pratices, 
please review the 
 and upload your data management plan 
Harvard Catalyst document
into the Supplemental documents.
Intake coordinator will maintain a data collection sheet in a share drive for this purpose; all data 
and consents will be completed and stored in REDCap.
15.12  How long will research records, data, and specimens be retained following completion of the 
study?  Where will study records will be retained when the study has been closed (long-term 
storage)?
Describe when and how the identifiers, if applicable, will be destroyed. If specimens will be retained, describe 
where.  
Please note that any data involving PHI must be maintained for a minimum of 6 years, and data that does 
not contain PHI must be maintained for a minimum of 3 years. In many cases, identifiers will need to be 
retained after the research is completed (e.g., for publication or data verification purposes or because of 
contractual requirements or grant terms). 
Please click the Help bubble to the right for more information on minimum storage requirements.
Records will be retained for 6 years post study
REDCap study data will be destroyed as per guidelines
Data in secure share-drive will be destroyed as per guidelines
15.13  Describe the structure of the code (e.g., randomly generated number, sequential number plus initials, etc.) and indicate 
whether a linking file (key) will be created and, if so, how it will be protected.
sequential number plus EMPI - placed in REDCap build and on protected share drive
see data collection sheet attached to this application
15.15  Who will have access to identifiers?
Only IRB-approved Carilion team members 
15.16  How will access to the identifiers be protected?
Password protected for REDCap 
Secure access to share-drive for Carilion team members
15.17  Describe whether data will be aggregated/summarized in publications or presentation, or whether individual participant 
results will be published/presented.

Aggregated and summarized; no individual data will be presented or published
15.18  Will research records include information that subjects or others might consider to be sensitive in nature?
E.g.,communicable disease status, substance abuse, mental health information, illegal behaviors, etc.
 Yes  
 No
Explain what sensitive information is included, why it is needed, and any additional safeguards that will 
be taken to protect it:
Patient-rated outcome measurements focus on psychiatric symptoms, substance use:
PHQ-9
GAD-7
BASE-6
USAUDIT
DAST-10
Owl Insights is a cloud-based platform for measurement based care (MBC) that enables patients 
to complete scales remotely for use in clinical care on a routine basis, by setting up a secure login 
and password.
The intake coordinator will assess symptom severity and safety risk at each step (initial 
assessment by phone, Amwell video or in-person and monthly scale measurements if randomized 
to minimal intervention group). An alert is automatically sent to the clinical team if the patient 
answers PHQ-9 question 9 (suicidality) with anything other than zero (0). Procedures for handling 
a patient at risk is outlined in the Triage Program details attached to this application and is 
identical to any clinical intervention done currently.
15.19  Do you plan to obtain a 
 from NIH for this research or is one already in place (ex: for NIH-
Certificate of Confidentiality (CoC)
funded research) that covers this site and any recipient site or organization?
Per Section 2012 of the 
 as implemented in the 
21
 Century Cures Act
st
2017 NIH 
, all ongoing or new research funded by NIH as 
Certificates of Confidentiality Policy
of December 13, 2016 that is collecting or using identifiable, sensitive information is 
automatically issued a CoC. Please note that for research that is not NIH-funded, the IRB may require 
you to obtain a CoC if it deems the data to be sensitive.
 
 Yes  
 No
Please do not apply for the CoC until your study receives full IRB approval. Please reference the 
approval letter for instructions on completing this process. This should be done before enrolling 
subjects in the study.
16.0  
Request for Partial Waiver, Full Waiver, or Alteration of HIPAA Authorization
16.1  Describe how the use of PHI in this study poses no greater than minimal risk to participants’ privacy.
There is no recruitment for this data but currently exists in our OWL database.
PHI including name, EMPI # and DOB are part of the patient database in OWL - we request to 
download data from OWL between 11.1.21-4.5.22
16.2  Describe why the research could not practicably be carried out without the use of PHI.
This is retrospective data in our OWL database and does not involve recruitment.
16.3  Describe why the research could not be practicably carried out without the waiver or alteration.

The psychiatry ambulatory clinic sees approx 250-300 patients per week - the PROMs are 
completed as part of clinical care. This is retrospective data in our OWL database and does not 
involve recruitment.
16.4  Do you assure that any data identifying subjects used in this study will not be disclosed to anyone other than the research 
team, sponsor, and oversight groups?
 Yes  
 No
16.5  Do you assure that you will not reuse or disclose this data for any other research unless you first receive IRB approval?
 Yes  
 No
16.6  Describe how you will utilize PHI for purposes of recruitment and describe how the use of PHI in this study poses no greater 
than minimal risk to participants’ privacy.
There is no recruitment for this data but currently exists in our OWL database.
PHI including name, EMPI # and DOB are part of the patient database in OWL - we request to 
download data from OWL between 11.1.21-4.5.22
16.7  Describe why the research could not practicably be carried out without the use of PHI for recruitment.
This is retrospective data in our OWL database and does not involve recruitment.
16.8  Describe why the research could not be practicably carried out without the partial waiver for recruitment.
The psychiatry ambulatory clinic sees approx 250-300 patients per week - the PROMs are 
completed as part of clinical care. This is retrospective data in our OWL database and does not 
involve recruitment.
16.9  Do you assure that any data identifying subjects used in this study will not be disclosed to anyone other than the research 
team, sponsor, and oversight groups?
 Yes  
 No
16.10  Do you assure that you will not re use or disclose this data for any other research unless you receive IRB approval?
 Yes  
 No
17.0  
Research Settings/Performance Sites
17.1  Indicate the sites where research activities will occur, or from which subject data or specimens will be obtained, and a brief 
summary of the activities that will occur at each.
N/A (Select this option if this research is a Medical/Chart Review ONLY)
Site
Summary
CRMH
CRCH
CNRVMC

CFMH
JCHS
CRMH Rehab
Patients seen in, or 
referred to, ambulatory 
psychiatry clinic
Riverside
Crystal Spring Medical Office 
Building
Other Carilion Clinic 
Physician’s Office
Blue Ridge Cancer Care 
(BRCC) / US Oncology
Fralin Biomedical Research 
Institute at VTC
VT Blacksburg Campus
VT colleagues are 
involved in data 
management and 
analysis but no patients 
or patient care occurs at 
this location
Assisted Living Facility 
or Nursing home
Other Locations (specify):
18.0  
Applicable Regulations for ClinicalTrials.gov Registration
18.1  Is this study FDA-regulated?
  Yes  
  No
18.2  Is this research funded wholly or in part by NIH?
 Yes  
 No

18.3  Is this study a Clinical Trial, as defined by FDA or NIH, and therefore needing registration on ClinicalTrials.gov? Click the 
help button to the right to learn more about the definition of a clinical trial.
 Yes  
 No
18.5  Is the clinical trial already registered in ClinicalTrials.gov?
Not yet, but clinical trial will be registered prior to enrolling any subjects 
Yes 
No, this clinical trial will not be registered 
ClinicalTrials.gov #:
The following statement must be included verbatim in the consent form for  trials that are/will be 
Note: 
registered on ClinicalTrials.gov:
 
"A description of this clinical trial will be available on 
, as required by U.S. 
http://www.ClinicalTrials.gov
Law. This website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time."
 
18.6  Who is responsible for registering this trial in ClinicalTrials.gov and ensuring information is updated, as necessary? Please 
provide a name if the person is at Carilion or listed on the research team, or state the sponsor or lead site if the sponsor or 
lead site will register the trial.
 The responsible party for an applicable clinical trial (ACT) must register the trial and 
submit results information. The responsible party is defined as:
The sponsor of the clinical trial, as defined in 21 CFR 50.3; or
The principal investigator (PI) of such clinical trial if so designated by a sponsor, 
grantee, contractor, or awardee, so long as the PI is responsible for conducting the 
trial, has access to and control over the data from the clinical trial, has the right to 
publish the results of the trial, and has the ability to meet all of the requirements for 
the submission of clinical trial information
The responsible party for an ACT must submit the required clinical trial information no later 
 after enrollment of the 
 participant, but registration is highly recommended 
than 21 days
first
before enrollment begins due to some journal requirements.
Anita Kablinger MD, CPI
19.0  
Study Procedures
19.1  Provide a step-by-step description of the research procedures and/or and interactions with human subjects. 
Provide a study schedule and list all activities or procedures that will be performed and 
describe the frequency and duration of research procedures, diagnostic and research 
tests, questionnaires or surveys, specimen collection, and experiments, including 
screening, intervention, follow-up etc in step-by-step chronological order. State the 
length of time subjects will be in the study and the expected amount of time required for 
each study visit or activity.  Describe how, when and where research activities will be 
administered and analyzed.   If the research includes blinding, indicate 
whether researchers or subjects will be “unblinded” to study assignment and describe 
when and how this will be done.
See Triage Program Working Details attached to this application for detailed description. Each 
survey is also included as attachments to this application.

1.  
1.  
2.  
3.  
Steps include:
The study will be introduced after the patient has completed the intake. At the end of the intake
/assessment, the intake coordinator (team member) will describe the study to the potential 
participant and participant is able to confirm understanding about the study using the questions 
detailed in section 12.7. Consent is obtained either remotely or in-person, and a copy will be 
given to the patient in-person or emailed/mailed if remote. Introduction of the study will be, “We 
are researching if these measurements are helpful to people waiting for a psychiatric evaluation. 
Participation in the research is voluntary and you will be assigned randomly to either wait until 
your first appointment with your provider to complete these measurements again or complete 
these measurements every month until your first appointment with your provider.” (The three 
measures they complete each month are the PHQ-9 depression, GAD-7 anxiety, and BASE-6 daily 
functioning). “Participation in this study is not linked to your psychiatric care – that is, it won’t 
affect the wait-time to getting your initial appointment with your provider either way. Are you 
interested in participating in this study?”
If patient says yes, proceed to REDCap and complete consent process – you will need to 
set up a new participant record in RedCap and enter demographic information. 
Depending on which group the patient is assigned you will need to change the OWL 
Insights to not automatically send the inventories monthly if they are only in the 1x 
at onset group (no intervention). 
Randomly assign patient into group (REDCap will do this when you start a new patient 
record); inform patient of the group they have been randomly assigned into to provide 
further instructions. 
Provide all patients with CONNECT phone number at termination of the call.
Initial consenting process occurs after routine clinical psychiatry intake assessment by intake 
coordinator (if intake coordinator assesses that patient has capacity to pursue study discussion): 
30-45 min consent process through REDCap or hard copy in-person. REDCap will be utilized to 
perform randomization. There is no blinding due to the nature of the wait-list control groups; both 
patients and investigators will be aware of study group assignment.
No intervention group randomization: no additional time/study procedures occur after consent; SO
C monthly PROMs DO NOT begin until after initial psychiatric provider evaluation for 6 
additional months.
Minimal intervention randomization: each month PROMs including PHQ-9, GAD-7 and BASE-6 are 
sent automatically for subject to complete via email or cell phone before initial psychiatric 
provider appointment - takes approximately 15 minutes to complete; watching microlearning 
videos about illness/symptoms takes approximately 15-30 minutes to watch depending on # 
videos recommended. Current wait-time for patients to see MD provider is 3-4 months; therefore, 
subjects in the minimal intervention group will participate in the study for up to 6 months before 
beginning regular treatment with provider. 
PROM data from both groups will continue at initial psychiatric provider evaluation and monthly as 
is current clinical practice. Therefore, an additional 6 months of PROM data for each group will be 
followed to assess the research question of whether a no intervention or minimal intervention 
group may provide benefits to patients waiting to be seen and followed by psychiatric providers.
Total study participation time = 
 depending on length of wait time before first 
6-12 months
psychiatric provider appointment
You must attach surveys, instruments, interview questions, focus group questions, etc. in the Initial 
Submission Packet and label them clearly. 
19.2  Specify which procedures, tests, visits, etc. described above are part of 
 at Carilion Clinic and which 
usual standard of care
are being performed solely for research purposes. If procedures, tests, visits are routinely performed for clinical care, but 
are providing data for this research study, state this as well.
All surveys and microlearning education videos are part of routine clinical care in ambulatory 
psychiatry. The study focuses on how often the surveys are completed and how this may affect 
outcomes in ambulatory psychiatry visits and care.
Microlearning videos: Mytonomy
URL: https://carilionclinic.org\learn
Username: carilion@mytonomy.com

Password: Healthy2021
19.3  Describe the data collection methods and how data be compiled and collected for assessment. State 
whether the data/specimens to be utilized in the repository are already in existence (retrospective) or 
if the data will be generated in the future (prospective).
 is 
"Retrospective data"
data that is already in existence at the time of application receipt by the 
 Retrospective is in reference to the date the data was 
, 
IRB.
GENERATED not the date the data is 
If all data is retrospective, please provide the start date from which data will be 
COLLECTED. 
collected and the end date, and note that ALL data must be in existence at time of submission of 
this application.
Example: This IRB application is being submitted on 12/1/21 and is collecting data on a 
standard of care surgery and looking at patient outcomes. All surgeries for this 
retrospective studies will be completed between 11/31/2018 and 11/31/2021 (the day 
before the study is submitted to the IRB). This study will likely qualify for a waiver of 
consent.
 includes any data (including data from the medical record) that are 
"Prospective data"
not 
 
, even if the data is 
currently in existence at the time of receipt of the application by the IRB
being collected solely for Standard of Care. Prospective data collection typically requires 
 from the participant to be able to use their clinical data or specimens for 
informed consent
research purposes. If all data is prospective, please state date range from which data will be 
generated.
Example: This IRB application is being submitted on 12/1/21 and the study is collecting 
data on a standard of care surgery and looking at patient outcomes. All surgeries for this 
prospective studies will be completed between 1/1/2022 and 1/1/2025. This study will 
require informed consent UNLESS a waiver of consent is requested and justified.
Attach a copy of your data collection tool or spreadsheet listing exactly what data is to 
be gathered during this research study.
The intake assessments beginning 10/25/21 are Standard of Care (SOC). This data would not be 
included in this proposed study/consent because only NEW patients being referred/assessed by 
the intake coordinator are part of the study. If patients have already been assessed and are 
waiting for a provider appointment they are not part of any study. This data between 10/25/21 
and date of IRB approval for this study would be requested in an amendment should the 
investigators want to include this preliminary SOC data.
Data collection sheet source document attached to this application.
Psychiatry intake assessments began October 25, 2021.
This study, with randomization to wait-list control groups (no intervention vs minimal 
intervention), will begin once IRB approval and REDCap build has been completed - estimate by 
end of January 2022.
Retrospective data involving initial psychiatric intake and intake PROM completion scores 
beginning October 25, 2021 
 after approval of this 
may be requested as a future amendment
study.
19.4  Describe how long individual participants will be actively in the study. If there will be a period of time after the active 
component of the study where participants will still be in the study (ex: participants outcomes are being extracted from the 
medical record at 1 year, but the last research study visit was at 3 months), state this as well.
Participants will be active in the study for 6-12 months - monthly PROMs will be collected for 6 
months after initial psychiatric provider assessment in addition to wait-time prior to first 
appointment.
19.5  Describe how long the entire study is expected to last, including data analysis.
The entire study including data analysis will be two years (estimate 12.1.21-11.30.23 estimate 
based on date of IRB approval) - iTHRIV funding is approved for 2.1.22 to 1.31.23.
19.6  Describe the qualifications of study personnel conducting the research procedures. This could include medical training 
specific to conducting the interventional procedures in this research, phlebotomy training for those drawing blood, study 
protocol specific training to be provided by the sponsor, or any other training to demonstrate that the research personnel 

 
are appropriately quailified to conduct the study.  
Ashlie Phenes is an LPC with psychiatric care experience
Drs. O'Brien, Kablinger, McNamara are physicians in psychiatry with experience in psychiatric 
care and research using PROMs
Mattie Tenzer and Hunter Sharp are part of HART and have experience with study design and 
analysis of PROMS from Owl Insights
Lee Cooper, Alyssa Gatto, Sydney Jones and Hayoung Ko (external collaborators) are psychology 
providers and educators who, not only utilize PROMs in their own practice - though none of their 
patient population is included in this study - and have been part of our MBC research team for the 
past 2 years
19.7  Please describe appropriate alternatives to the study procedures or course of treatment.
(For example: not to participate, standard of care treatment, other research study, same treatment offered off 
study)
Alternatives are not to participate in the randomized study. PROMs, however, are utilized in 
routine patient care and would continue to be assigned to, and completed by, ambulatory patients 
in the psychiatric clinic.
20.0  
Research Review of Data/Records
20.1  What types of records will be reviewed for this research study?
Medical record/medical chart
Films/x-rays
Data in a database
Hospital administrative/billing records
Quality improvement records
Publically available database
Other
Provide a detailed description about your selection above, including if the records are already in existence 
at the time of this submission or if you will be accessing future records, and special permissions that may 
be needed to access the data/records:  
EMR review for initial psychiatric intake assessment (part of routine care) with PHI elements put 
into REDCap for research purposes. Owl Insights is a cloud-based system that provides PROMs 
and is a database of PROM measures for the past 2.5 years in our ambulatory clinic. Over 
100,000 individual PROMs have been completed to date by patients in ambulatory psychiatry.
20.2  What is the original purpose of the data being reviewed?
Clinical Care
Collected as part of routine business activities
Research Study
Collected under Repository Protocol
Other
20.3  If collected as part of a previous research study or repository protocol, enter the IRB number for the study.
20.4  Is the data identifiable private information or Protected Health Information (PHI)?
 Yes  
 No

21.0  
Incidental Findings
21.1  Does this study involve any imaging procedures (x-rays, CT, MRI, PET, ultrasound, etc.) specifically for research purposes?
  Yes  
  No
21.2  Does the research include any of the following?
Exams, blood tests, genetic tests or markers, or other tests or procedures that may generate 
incidental or secondary findings, including disease or conditions other than the one under 
study, or familial relationships including paternity and ancestry.
Testing for communicable diseases
None
22.0  
Identification/Recruitment of Subjects
22.1  How do you plan to identify potential subjects?
To “identify” a potential subject refers to procedures to determine which individuals may qualify to 
participate in the study in order to decide which individuals to contact about taking part.
 
Check all that apply:
Existing Record Review, 
including Medical Chart 
Review, Clinic Schedule 
Review, or QA-QI Database 
Review.
Select all that apply:
Patients’ records 
reviewed will be those 
from research team’s 
own patient population
Patients’ records will 
be those from other 
physicians or medical 
practices’ patient 
population
* You must request Waiver of 
Informed Consent and, if any 
HIPAA identifiers are 
collected, a Waiver of HIPAA 
Authorization for recruitment 
purposes.
Researchers who ARE NOT 
treating clinicians of potential 
subjects will ask treating 
clinicians for referrals of 
eligible patients interested in 
the study.
Select all that apply:
Treating clinicians will 
identify potentially 
eligible patients and 
obtain patient 
permission before 
providing researchers 
with patient contact 
information.
Treating clinician will 
provide 
documentation of 
patient permission in a 
email/letter to 
researcher, and 
researcher must 

document permission 
in research record.
*You must request a Waiver of 
Informed Consent/HIPAA 
Authorization for recruitment 
purposes.
Potential subjects will not be 
directly identified by the 
researchers from existing 
records.  The potential subject 
will obtain IRB-approved 
information about the study 
from an advertisement, flyer, 
brochure, website, grand 
rounds presentation, 
department meeting, etc.  In 
most cases, the potential 
subject will contact the 
researcher if interested.
Comments:
Review of Registry/Database 
in which individuals have 
previously signed a consent 
giving their permission to be 
contacted for future studies.
Comments:
Student Records
Comments:
Other
Please specify other:
22.2  Please describe the identification process.
List all information you plan to collect and record during the identification process PRIOR to contacting 
potential subjects. This includes the inclusion/exclusion criteria and demographics to determine if a person 
qualifies for a study before contacting that person to be a potential subject.
No information will be collected specifically for the study prior to contacting the person.
The psychiatry intake coordinator will call all people referred to adult ambulatory psychiatry and 
complete an intake assessment. Once the assessment is completed, patients will be asked if they 
would like to participate in the wait-list study and be randomized to either a no intervention group 
(no further interaction between intake and first clinician appointment) or to minimal intervention 
group (patients will receive monthly reminders to complete PHQ-9, GAD-7 and BASE-6 and be 
assigned micro-learning videos to view during the wait-time for their first clinician appointment).
A waiver of informed consent/HIPAA authorization is requested for recruitment purposes only.
22.3  Through what methods will potential subjects be contacted or recruited?
Check all that apply. To “recruit” a potential subject refers to the initial contact method you plan to use to 
convey information to a potential subject to determine if he or she would be interested in taking part in your 
study.
Direct in-person contact
Telephone call
Letter

E-mail
Brochure
Radio/Television script
Newspaper Ad
Online advertisement (including Facebook, Twitter, Craigslist, other websites, etc.)
Flyer/Poster
Snowball sampling
Clinical trial website posting
Other
None (there will be no interaction or intervention with potential participants in this study)
22.4  Please provide any additional details about how potential subjects will initially be contacted, who will contact them, or how 
they will be introduced to the research.
If recruitment material is being mailed, emailed, or otherwise distributed, 
describe where/how the distribution list will be obtained.
If potential subjects will be recruited by telephone, describe how many times 
the research team will attempt to call / leave a voice message. 
When subjects respond to recruitment material, describe the information that 
will be provided to them about the study and the information that will be 
collected from subjects (e.g. name, telephone number, etc.). Describe also, how 
many times you will attempt to respond to call the subject back / leave a voice 
message.
Please see section 17.1 and the Triage Program Working Details 12.1.21 document attached to 
this application.
22.5  After potential subjects are identified, describe the pre-screening process that will take place prior to obtaining informed 
consent.
This could include asking questions to a potential subject to determine whether he or 
she meets eligibility criteria, for example: patients will answer questions about their 
medical history, be expected to come to the first screening visit after fasting, stop 
taking medications, change diet, etc.  To comply with HIPAA regulations, only the 
minimum necessary protected health information may be collected at this time. This 
means only questions relating to the inclusion and exclusion criteria may be asked.
No prescreening will take place
The psychiatric intake coordinator will call all adult psychiatry referrals to perform a psychiatric 
intake and triage prior to an initial psychiatric provider appointment. At the end of the intake, and 
in the clinical judgment of the intake coordinator, patients capable of consenting to this study will 
be offered participation and undergo an informed consent process either over the phone, through 
Amwell or in-person. Consenting may be completed via econsent or hard copy consent. Patients 
unable to complete PROMs via cell phone or email (or have no internet access) are not eligible to 
participate in the study.
22.6  Indicate whether pre-screening information will be retained on persons who do not ultimately participate in the study and 
what specific information, including identifiers, will be retained.
Pre-screening information will be kept to ascertain the percentage of people who are unable to 
participate due to lack of ability to complete PROMs or who do not have the capacity for informed 
consent.
Demographics of these individuals (including age, gender, reason for not participating) will be 
maintained to compare to the groups of individuals who do participate and assess differences.
Attach all recruitment materials, letters, phone scripts, flyers, etc. in the Supplemental 
Documents section after you complete the IRB application.

23.0  
Risks and Risk Minimization and Benefits
23.1  List the possible risks, discomforts, or harms to subjects associated with the research.
If the risks differ based on group assignment, describe for each group. Estimate the (1) probability of 
occurrence, (2) the seriousness, and (3) the duration of each risk. If this information is captured in the 
protocol or investigators brochure (IB) or other materials, indicate the document and page numbers where 
the information can be located.
Possible risks or discomforts to subjects include a minimal risk of security/data breach of mental 
health information and change in emotional symptoms and functioning from completing surveys 
or watching education videos.
Outside collaborator (Hayoung Ko from VT)  is requested to have REDCap access - to minimize 
risk of security breach, training in maintaining security measures will be implemented. As a 
psychology graduate student, Hayoung is aware of the importance of maintaining confidentiality 
for those with mental illness. However, to decrease the risk of breach, REDCap access for 
Hayoung will be to collected data that DOES NOT include PHI. 
The most severe risk of change in emotional symptoms is to have suicidal ideation. Alerts for any 
answer > 0 on question 9 of the PHQ-9 will be immediately emailed/texted to the intake 
coordinator or the primary provider (if the subject has begun treatment with the psychiatric 
provider). Crisis intervention for safety concerns is a part of the intake coordinator's training and 
specific step-by-step interventions are included in the Triage Program Working Details 12.1.21 
attached to this application.
23.2  Define adverse events (AEs), serious adverse events (SAEs), and unanticipated problems (UAPs) for the study. Describe the 
protocol-specific reporting procedures, including who will be responsible for each step (e.g., PI), timeframes for reporting, 
how reports will be distributed, and follow-up that will occur.
Ensure that the reporting procedures meet the reporting requirements of Carilion 
Clinic IRB, the FDA, NIH, OHRP, sponsor, study leadership and any other 
regulatory body that applies to the study, as applicable. Please note that all 
Carilion Privacy breaches must also be reported to the Privacy office by the 
PI.  Noncompliance must be reported to the IRB as well as Office of Integrity and 
Compliance.
Unanticipated problems are security/data breach of mental health information. Safeguards to 
access data will be put in place as above.
AEs include suicidal ideation - see previous section for how safety concerns are addressed by 
intake coordinator. All alerts will be assessed and handled by the intake coordinator and 
communicated with Drs. O'Brien or Kablinger. In addition, all contacted patients have the phone 
number for CONNECT to address urgent needs 24/7.
The study team will notify the IRB and Privacy Office of any breaches of confidentiality within 48 
hours of identification.
23.3  Describe the actions that will be taken to minimize the risks associated with participation in this research. 
If this research includes risks that might require immediate or prompt medical management, describe access 
to/availability of emergency medical equipment and trained personnel at each setting where procedures that 
impart physical/health risks will take place. If this information is available in the study protocol indicate the 
page numbers where the information can be located.
Please see section 20.1 and 20.2
23.4  For studies involving drugs, devices, biologics, or imaging, describe the type of pregnancy testing that will occur and how 
frequently it will be conducted on women of reproductive potential.
Include:

1.  
2.  
3.  
4.  
5.  
If pregnancy testing will not be conducted, provide the reason. 
State the types of  birth control methods women of reproductive potential will 
be instructed to use.
If women will not be instructed about acceptable methods of birth control, 
provide the reasoning. 
Describe the birth control methods men of reproductive potential will be 
instructed to use. If men will not be instructed about acceptable methods of 
birth control, provide the reasoning.
NA
23.5  Does the research include screening tools, questionnaires, or procedures that may indicate the presence of serious depression 
and/or suicidal ideation?
 Yes  
 No
Describe the criteria that will be used in the screening tools/questionnaires to determine if the participant 
is considered to be at risk. Describe or upload the plan to refer or intervene in the event that potential 
serious depression and/or suicidal ideation are identified.
Tiered Levels of Severity of PROMs: 
Tier 1: (severe) PHQ-9 = 21-27, or GAD-7 =17-21, or Suicidal Ideation (Q9 >0)
Tier 2: (moderate) PHQ-9 = 16-20, or GAD-7 = 11-15
Tier 3: (mild) PHQ-9 =11-15 or GAD-7 = 6-10
PHQ-9 <11, GAD < 6 (normal to minimally ill)
Tier 1 severe - patient will be put at the top of the referral list for sooner appointment time (if 
currently safe), otherwise crisis intervention occurs as below.
If patient answers “yes” to question 9 (ie >0) on the PHQ-9, or reports suicidal ideation, ask 
follow-up questions regarding this: provide number to CONNECT, offer number to the National 
Suicide Hotline, complete a wellness check if necessary. 
National Suicide Hotline: 1-800-273-8255
CONNECT: (540) 981-8181
Roanoke County Wellness Check: (540) 562-3265
Roanoke City Wellness Check: (540) 853-2212
Emergency/Actively Suicidal: 911 
23.6  Describe the Data Safety Monitoring Plan or Data Safety Monitoring Board, or indicate the page(s) of the protocol or name 
of the document where this information can be located.  While a robust Data Safety Monitoring Plan is REQUIRED for 
greater than minimal risk studies, a plan should also be in place for studies that are minimal risk.  Please click on the Help 
circle to the right for information on writing a DSM plan based in risk levels of the research.
Include:
The data that will be reviewed, including safety data, untoward events, and 
efficacy data;   
Who is responsible for reviewing the data;
How the safety information will be obtained and documented (e.g., case report 
forms, by telephone calls with participants, printouts of laboratory results, 
etc.);   
The frequency or periodicity of review of cumulative data;
The statistical tests for analyzing the safety data to determine whether harm is 
occurring;
Any conditions that trigger an immediate suspension of the research or other 
action for the research.
Patient data related to the wait-list and triage program (including study participants) -  the intake 
coordinator will review weekly with Dr. O'Brien as ambulatory psychiatry director.
A data safety monitoring plan includes assessment of PROM trends and any apparent safety
/efficacy concerns.  Drs. O'Brien and Kablinger will review accumulated data and communicate 
and address any untoward events.

23.7  Describe the plans and rationale for conducting an interim analysis.
  Yes  
  No
23.8  Have stopping rules been established for the study, including for reasons of futility?
  Yes  
  No
23.9  Are there defined criteria (ex: rates of adverse events) for when study interventions should be discontinued?
  Yes  
  No
23.10  Are there exams or procedures that the subject will be asked to have done or follow to safely withdraw from the study?
  Yes  
  No
23.11  Will subjects who withdraw from the interventional component of the study be asked for their permission to continue to 
gather information about them through follow up visits, phone calls, records review, or other methods?
Yes 
No 
N/A 
23.12  Describe the potential benefits to science and/or society expected from this research.
Evaluating PROMs in patients seen in a psychiatric outpatient clinic wait-list will provide important 
information about abilities to provide intervention while waiting for psychiatric provider 
appointments.
Results can inform wait-list groups for pending psychiatric care around the country in different 
systems.
23.13  Are individual subjects expected to directly benefit from participating in this research? 
Note: Compensation is not considered a benefit.
 Yes  
 No
Please explain:
Intake with a coordinator to triage appointment needs in conjunction with completion of PROMs 
may show direct benefit to subjects by ensuring timely evaluations and safety assessments with 
those referred and interested in psychiatric care.
24.0  
Costs and Compensation
24.1  Will the subject, or the subject’s insurance, be responsible for any medical costs incurred as a result of participation in the 
research? 
Take into account medical costs associated with study procedures, drugs, or devices.
  Yes  
  No
24.3  Will subjects be reimbursed for any expenses related to their research participation, including medical costs, travel, parking, 
or transportation?

  Yes  
  No
24.4  Will subjects receive any monetary compensation (cash, check, or giftcard) or non-monetary gifts, incentives, or tokens of 
appreciation for participating in this research? 
Note: Reimbursement for costs is not considered compensation.  Use of raffles or lotteries are discouraged at 
Carilion Clinic since the compensation is not being equitably dispersed to participants. Raffles and lotteries 
may be permitted on a case-by-case basis with appropriate justification.
  Yes  
  No
25.0  
Application Questions Complete
25.1  You have now completed the IRB Application. Please click Save & Continue to proceed to the Initial Submission Packet.
Date Completing Form:
03/16/2023
The Initial Submission Packet is a short form filled out after the IRB application has been completed and 
is where you will attach protocol-related documents, such as consent forms and recruitment materials. 
You will also be able to conduct a final review of the IRB application.
 
The PI will be required to sign off on the final Initial Submission Packet. The study may then proceed to 
the Department Signoff, if necessary based on the application type selected, and may require COI review 
before proceeding to the IRB.
 
You can view the Submission History of the study at any time to determine the status.