Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial
Phase: NA
Conditions: Pregnancy Related
Sponsor: Virginia Commonwealth University

STUDY TITLE: Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research 
– A Feasibility Randomized Controlled Trial  
 
VCU INVESTIGATOR: Caitlin E. Martin, M.D., MPH, Assistant Professor 
 
HM20023314/NCT05214118 
 
Approved date: 12/21/21 
 

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HM20023314
View: SF - Study Identification
Date: Monday, June 2, 2025 3:51:17 PM
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Study Identification
1. * Select the Principal Investigator:
Caitlin Martin
2. * Study Title:
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility
Randomized Controlled Trial
3. * Is this a student or trainee project in which activities will be carried out by that individual
under your supervision (for example, dissertation or degree-required projects):
  Yes
No
4. * Please select the primary department or center that this study is being conducted under:
Institute for Drug and Alcohol Studies
5. Select the VCU IRB numbers assigned to studies that are:
      1. Associated with this study
      2. Research registries this study will utilize
      3. Previously submitted versions of this study (closed, withdrawn, auto-withdrawn studies)
ID
Title
PI
HM20022131 Project BETTER: Bringing Education Through Technology, Empathic listening, and
Research - Pre-Testing Phase
Caitlin
Martin
6. Select all individuals who are permitted to edit the IRB protocol and should be copied on
communications (study staff will be entered later).  These individuals will be referred to as
protocol editors:
Last Name
First Name
E-Mail
Phone
Mobile
Martin
Caitlin
cemartin@vcu.edu
8046287023
 
Parlier
Anna
parlierab@vcu.edu
 
 
Thumma
Lillia
thummadl@vcu.edu
8048281193
 
7. * Select one of the following that applies to the project (selection will branch to new pages):
Note: VCU IRB offers guidance for many types of studies, including secondary data analysis
studies, internet research, registries, EFIC, HUD, and Emergency Use protocols.
See https://research.vcu.edu/human_research/guidance.htm 
Research Project or Clinical Investigation [*most exempt, expedited, and full board research studies]
Exception from Informed Consent (EFIC) for Planned Emergency Research
Humanitarian Use of Device for Treatment or Diagnosis
Humanitarian Use of Device for Clinical Investigation
Emergency Use of Investigational Drug, Biologic or Device

Treatment Use (Expanded Access to Investigational Product for Treatment Use)
Center or Institute Administrative Grant Review
Request for Not Human Subject Research Determination (i.e. request a letter confirming that IRB review is not
required)

HM20023314
View: SF2 - Federal Regulations
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Federal Regulations
1. * Is this a FDA regulated study?
FDA regulated research includes all clinical investigations involving a test article and a human
subject(s) that has been submitted for approval to the FDA or may be submitted in the future. 
Check Yes if
•    the study involves an IND/IDE, abbreviated IDE, IND/IDE exemption, HUD, expanded access,
or is otherwise subject to 21 CFR 56, 
•    the study involves a test article being administered or dispensed to subjects NOT according
to a clinicians’ medical judgment but rather, per the study protocol, OR
•    the study does not involve a test article but intends to provide safety or efficacy data to the
FDA.
 
  Yes
No
2. * Is this study supported by the Department of Defense (DoD):
  Yes
No
3. * Check if any of the following funding sources apply to this research (including Direct and/or
Indirect funding):

Department of Education

Department of Justice

Environmental Protection Agency

None of the above

HM20023314
View: SF2 - IRB Panel Setup
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
IRB Panel Setup
1. * To which IRB is this study being submitted for review?
VCU IRB
WCG IRB
NCI Central IRB
Advarra IRB
Other IRB
2. * Is this study transitioning to review by another IRB?
Yes - transitioning from VCU IRB to an external IRB (WCG, CIRB, Other)
Yes - transitioning from an external IRB (WCG, CIRB, Other) to VCU IRB
No or not applicable

HM20023314
View: SF2 - Review Setup
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Review Setup
1. * Select which study type best describes the majority of the study. Your response will help
determine which IRB panel should review this.
Bio-Medical Research
Social/Behavioral/Education (SBE) Research
2. * Which option(s) best describe the way(s) this study’s procedures will be conducted? (Select
all that apply.) This information may be used by the IRB in triaging studies during an
emergency.

In-person interactions / interventions with participants

Remote interactions / interventions with participants

Secondary data/specimen analyses with or without contact with study participants
3. * Would it be possible to convert in-person activities in your study to remote if there is an
approved contingency protocol? 
Yes, could convert to remote activities
 
4. * Does this study involve greater than minimal risk:
  Yes No
5. * Review type requested: (subject to IRB approval):
Full Board
Expedited
Exempt
 
6. * Is this study initiated by a VCU investigator or a sponsor:
VCU Investigator initiated
Sponsor or industry initiated
 
 
The IRB has determined that the selected types of anticipated individual and social benefit apply to this study
 
The below information is read-only to investigators, and the categories are set by the IRB
during review. All categories will appear blank until the IRB has made a determination. If a
category is not checked, it does not apply to this study. This information may be used by the
IRB in triaging studies during an emergency situation.
Scientific benefit
 
  
 
The following information applies to studies being reviewed by the VCU IRB.

The IRB has determined that the selected Exempt and/or Expedited categories apply to this study.
The below information is read-only to investigators, and the categories are set by the IRB during review. All
categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study or the study is being reviewed by an external IRB.
7. For Exempt Studies under the  Pre-2018 Common Rule:
There are no items to display
8. For Exempt Studies under the 2018 Common Rule:
Category
2(iii)
Research that only includes interactions involving educational tests, survey or interview procedures, or
observation of public behavior when Identifiable information is recorded by the investigator, and the IRB
conducted a limited IRB review
Category
3(i)(C)
Research involving benign behavioral interventions when the information obtained is recorded by the
investigator in an identifiable manner, and the IRB conducted a limited IRB review
Category
4(iii)
Secondary research for which consent is not required when the research involves only collection and
analysis of identifiable health information when the research use is regulated by HIPAA
  

HM20023314
View: SF2 - Initial Setup Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Initial Setup Complete
Protocol Progress:
w INITIAL SETUP
e BACKGROUND, RATIONALE & GOALS
f RESEARCH PLAN
g CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
 
Click Continue below to go to the next section
  

HM20023314
View: SF2 - Background, Rationale and Goals
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Background, Rationale and Goals
1. * Describe the study's background and what is currently known from the scientific literature,
including citations, or upload a citation list in document upload.  Use lay language whenever
possible.
Overdose has become a leading cause of pregnancy-associated deaths, with most occurring during the postpartum
period [1]. Providers and health systems across the country, including VCU, are responding to this crisis by integrating
women9s health and addiction medicine practices for opioid use disorder (OUD) treatment [2]. Evidence-based OUD
treatment includes medication for OUD (MOUD). A known effect of prenatal MOUD use is neonatal opioid withdrawal
syndrome (NOWS). Medically, we have witnessed advancements in NOWS and OUD treatments that lead to better
outcomes for women and their families [2]. However, we continue to see rising opioid related deaths and rapid
decreases in OUD treatment continuation rates as women progress farther from delivery [3]. This disconnect between
science and reality highlights the urgent need for improvements in the quality and effectiveness of the care this high-
risk population receives during pregnancy and postpartum.
During the transition from pregnancy to postpartum, women with OUD and in treatment for OUD face a host of
stressors including those common to the 8Fourth Trimester9 (period after delivery) [4] and often a child welfare
(ChildProtective Services) in addition to caring for a NOWS infant [5]. Despite provider counseling and traditional
prenatal preparation for families affected by OUD, women after delivery commonly report feeling overwhelmed and
frustrated by NOWS management, child welfare interactions, and the postpartum transition [3,5]. This interplay
between stressors may be driving the high vulnerability women with OUD face after delivery manifesting in opioid
overdose, now rated a leading cause of death through 12 months postpartum [1].
Current standard prenatal educational approaches for families in OUD treatment are insufficient, likely due to a lack of
tools tailored to patient needs that are also easy to use in clinical settings. Providing better prenatal education and
support for this vulnerable population is a high priority. Use of technology can supplement standard care and extend
the reach of prenatal educational interventions. It is important that any patient educational intervention for this unique
population be both feasible to implement in a clinical setting and acceptable to pregnant people in treatment for OUD.
Our research team designed a technology-based intervention using a process of iterative modification grounded in
formative data. First, interviews assessing patient (n=12) and provider (n=9) preferences identified three topic areas: 1)
recovery-oriented strategies for the postpartum transition, 2) guidance around caring for an infant with withdrawal
symptoms, and 3) preparation for child welfare interactions. Then novel modules matching these areas were drafted
and reviewed in successive rounds by an expert panel of patients, multidisciplinary providers, and technology-based
intervention researchers. After iterative revisions, modules were programmed into the web-based, easily accessible
platform (CIAS 3.0). Additionally, our team used a similar process to develop a brochure covering the same topics as
the technology-based intervention. Preliminary evaluation data indicate the intervention is highly acceptable to patients
and feasible to complete in a clinical setting and remotely. Therefore, the next phase is to scale up to an RCT to assess
the acceptability and feasibility of the novel technology-based intervention compared to the brochure. 
References.
1. Smid, M.C., et al., Pregnancy-Associated Death in Utah: Contribution of Drug-Induced Deaths. Obstet
Gynecol,2019. 133(6): p. 1131-1140.
2. Wakeman, S.E. and M.L. Barnett, Primary Care and the Opioid-Overdose Crisis - Buprenorphine Myths
andRealities. N Engl J Med, 2018. 379(1): p. 1-4.
3. Wilder, C., D. Lewis, and T. Winhusen, Medication assisted treatment discontinuation in pregnant and
postpartumwomen with opioid use disorder. Drug Alcohol Depend, 2015. 149: p. 225-31.
4. Tully, K.P., A.M. Stuebe, and S.B. Verbiest, The fourth trimester: a critical transition period with unmet maternalhealth
needs. Am J Obstet Gynecol, 2017. 217(1): p. 37-41.
5. Nielsen, T., et al., Maternal and infant characteristics associated with maternal opioid overdose in the year
followingdelivery. Addiction, 2019.
2. * Describe the study hypothesis and/or research questions.  Use lay language whenever
possible.
1. How feasible and acceptable is the technology-based intervention with content on NOWS, child welfare interactions,
and the postpartum transition compared to a brochure for pregnant patients receiving MOUD?
We hypothesize that integration of the technology based intervention into a busy prenatal clinic will be as feasible as
the brochure and more acceptable to patients.
2. How effective is the intervention for improving exploratory outcomes (i.e., mental health, recovery, functioning, and
quality of life)?
3. * Describe the study's specific aims or goals.  Use lay language whenever possible.
The primary objectives of this RCT are to assess the feasibility and acceptability of the technology-based educational
intervention with content on NOWS, child welfare interactions, and the postpartum transition compared to a brochure
for pregnant patients receiving MOUD.

Additional exploratory objectives are to evaluate intervention effectiveness on improving outcomes (i.e., mental health,
recovery, functioning, and quality of life).
4. * Describe the scientific benefit or importance of the knowledge to be gained:
Integrated treatment programs for pregnant and parenting women with OUD, like ours at VCU, need better educational
tools specific to the postpartum transition. The proposed study will provide critical feasibility and acceptability data to
improve the novel patient education materials and inform future studies evaluating clinically applicable patient centered
interventions focused on the mother-infant dyad affected by OUD. Ultimately, implementation of clinically applicable
patient-centered interventions focused on the mother-infant dyad could have broad positive impacts on the long-term
health of families in the opioid crisis.
5. * Describe any potential for direct benefits to participants in this study:
Participants may gain additional knowledge to help them prepare for the pregnancy to postpartum transition and take
care of their recovery.
6. * Describe any potential for direct social impact in this study . For example, any engagement
with specific communities to respond to community-identified needs, or ways the study will
strengthen the well-being of the specific communities if applicable:
At the conclusion of this study, we will make this program free and available to patients and providers.
7. Upload a supporting citation list if applicable:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER
Consent
Form
Community-
based
recruitment
Community-based recruitment Project
BETTER Consent Form_clean IRB
10.25.pdf
0.05
11/7/2022
10:47 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Community-
based Study
Interest Form
StudyInterest_ProjectBETTERCom.pdf 0.01
10/31/2022
4:01 PM
Anna Parlier Recruitment/Advertising
Yes
View SOP
HM20023314 Project BETTER RCT
SOP 10.31.22.docx
0.05
10/31/2022
3:59 PM
Anna Parlier Research Protocol
Yes
View Project
BETTER
Community-
based
recruitment
email
template
Project BETTER Community
Recruitment Study Notification Email
Template.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
script
Project BETTER Community Remote
Recruitment Scripts.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
flyer
Project BETTER Community-based
Flyer.docx
0.01
10/12/2022
5:00 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER RA
Forms 3
Delivery
Questions
Project BETTER Study Visit 3 Delivery
Questions.docx
0.01
10/5/2022
2:33 PM
Anna Parlier Research Measure
Yes
View Eligibility
Form
Revised 7.18.22 Project BETTER
Eligibility Form.docx
0.02
7/18/2022
5:45 PM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View In-person
Recruitment
Script
Revised 7.18.22 Project BETTER In
Person Recruitment Scripts.docx
0.04
7/18/2022
5:44 PM
Anna Parlier Recruitment/Advertising
Yes
View Remote
Recruitment
Script
Revised 7.18.22 Project BETTER
Remote Recruitment Scripts.docx
0.02
7/18/2022
5:43 PM
Anna Parlier Recruitment/Advertising
Yes
View Recruitment
Flyer
Revised Project BETTER Flyer
7.18.22.docx
0.02
7/18/2022
5:41 PM
Anna Parlier Recruitment/Advertising
Yes
View Consent
form
Project BETTER Consent
Form_revised 12.15.21.pdf
0.07
12/21/2021
10:35 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Informatics
consult
BETTER_Informatics_Email.pdf
0.01
12/3/2021
9:57 AM
Jessica
Lantz
Other
Not
Applicable
View PROC
APPROVAL
BETTER_PROC_Approval.pdf
0.01
11/17/2021
1:27 PM
Caitlin
Martin
Ancillary Committee
Approval
Not
Applicable
View Study
Notification
Email
Template
Project BETTER Study Notification
Email Template.docx
0.01
11/17/2021
9:27 AM
Anna Parlier Recruitment/Advertising
Yes
View Project
Better
Module
Transcript
Project BETTER Peedy
Transcript.docx
0.01
11/17/2021
9:24 AM
Anna Parlier Research Measure
Yes
View Project
BETTER
Module
Video Links
Project BETTER Video Links.docx
0.01
11/15/2021
12:02 PM
Anna Parlier Other
Yes
View Project
BETTER
Brochure
Webpage
Project BETTER Webpage.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Project
BETTER
Overview
Project BETTER Technology-based
Program Overview.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Technology-
based
modules
Project BETTER Technology-based
module links.docx
0.01
10/11/2021
7:42 PM
Anna Parlier Other
Yes
View Brochure
Project BETTER Brochure.pdf
0.01
10/11/2021
7:41 PM
Anna Parlier Research Measure
Yes
View Demographic
questions
Project BETTER Demographic
Questions .docx
0.01
10/11/2021
7:41 PM
Anna Parlier Recruitment/Advertising
Yes
View RA forms 3
Project BETTER Study Visit 3 RA
Form.docx
0.01
10/11/2021
7:40 PM
Anna Parlier Research Measure
Yes
View RA forms 2
Project BETTER Study Visit 2 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View RA forms 1
Project BETTER Study Visit 1 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 2
Project BETTER Follow-up Survey
2.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 1
Project BETTER Follow-up Survey
1.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Pre-survey
Project BETTER Pre-Survey.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
Project BETTER Study Visit 3 Chart
Abstraction Form.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
form 3
View Chart
abstraction
form 2
Project BETTER Study Visit 2 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 1
Project BETTER Study Visit 1 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Scheduling
and
Reminder
Scripts
Project BETTER Follow Up Scheduling
and Reminders Scripts.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Follow up
visit scripts
Project BETTER Follow-up Visits
Script.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Martin CV
CEM_CV_08.15.21_BT.pdf
0.01
10/10/2021
9:23 PM
Caitlin
Martin
CV/Biosketch
Yes
View Parlier CV
Parlier CV .pdf
0.01
10/10/2021
5:44 PM
Anna Parlier CV/Biosketch
Not
Applicable
 

HM20023314
View: SF2 - Study Population
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Study Population
1. * Provide the maximum number of individuals that
  1. May participate in any study interaction or intervention (Including screening, consenting,
and study activities)
      AND/OR
  2. You obtain any data/specimens about (regardless of identifiability) 
 at VCU and at other sites under the VCU IRB's oversight. See the help text for additional
guidance.
70 
2. If this is a multi-Center Project, what is the maximum anticipated number of subjects across all
sites?
N/A
3. * Provide justification for the sample size by explaining how you arrived at the expected number
of participants and why this number is adequate for answering the research questions:
Target sample size: N=30 (15 per study condition)
As this is a pilot feasibility trial, 30 study participants is the recommended sample size (Browne, 1995).
Browne R.H. (1995) On the use of a pilot sample for sample size determination. Statistics in Medicine 14, 1933–1940.
Based on our prior experience, we anticipate about 20% of eligible participants we approach will not be interested in
the study, which will be about 10.
Additionally, we will abstract information from the medical record on the birth hospitalization for participants' infants,
which includes an additional 30.
This makes a total of 70 as above.
4. * List the study inclusion criteria:
1) Female
2) g18 years of age
3) Meet criteria for Opioid Use Disorder
4) Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)
5) Pregnant (<34 weeks EGA)
6) Engaged in treatment at OB MOTIVATE for f10 weeks during the current pregnancy OR engaged in community-
based OUD treatment for f10 weeks during the current pregnancy
5. * List the study exclusion criteria:
1) Considering/planning adoption
2) Present with a serious cognitive/psychiatric impairment
3) Existing language barriers making true informed consent impossible
6. Justify the inclusion and exclusion criteria if you are either targeting, or excluding, a particular
segment of the population / community. Provide a description of the
group/organization/community and provide a rationale.
Pregnant people in treatment for OUD will be selected because the patient education intervention targets this specific
population. We want to make sure the program is feasible and acceptable to this unique population.
  

HM20023314
View: SF2 - Background, Rationale & Goals Section Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Background, Rationale & Goals Section Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
f RESEARCH PLAN
g CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
 
Click Continue below to go to the next section

HM20023314
View: SF2 - Study Procedures
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Study Procedures
 
1. * Describe the study hypothesis and/or research questions.  Use lay language whenever
possible.
1. How feasible and acceptable is the technology-based intervention with content on NOWS, child welfare interactions,
and the postpartum transition compared to a brochure for pregnant patients receiving MOUD?
We hypothesize that integration of the technology based intervention into a busy prenatal clinic will be as feasible as
the brochure and more acceptable to patients.
2. How effective is the intervention for improving exploratory outcomes (i.e., mental health, recovery, functioning, and
quality of life)?
2. * Describe the study's specific aims or goals.  Use lay language whenever possible.
The primary objectives of this RCT are to assess the feasibility and acceptability of the technology-based educational
intervention with content on NOWS, child welfare interactions, and the postpartum transition compared to a brochure
for pregnant patients receiving MOUD.
Additional exploratory objectives are to evaluate intervention effectiveness on improving outcomes (i.e., mental health,
recovery, functioning, and quality of life).
3. * Choose all types of recruitment materials that may be used and upload them below:

E-mail invitations

Phone Solicitation scripts (i.e. cold calls or random-digit-dialing)

Flyers, Mailed Letters or Newspaper/TV/Radio Ads

TelegRAM announcements

Website text

Study-specific web sites (provide the design and text)

Social Media

EPIC MyChart Patient Portal research study descriptions

Psychology Research Participant Pool (SONA) study descriptions

Scripts for announcements made to groups

Other recruitment document

No recruitment materials
4. * If Other was selected above, describe the recruitment document that will be used:
In person recruitment script
5. * Describe the study procedures/methods for identifying and recruiting participants. Address all
of the following three aspects of recruitment in your response. 
1. Identification of potentially eligible participants or secondary data/specimens of interest.
     - What database(s) will be queried to identify secondary data/specimens
     - How VCU Informatics or VCU IRDS will be used for cohort identification (when applicable, see help text)
    - How potential participants' contact information will be obtained
2. Recruitment procedures to invite participation in the study (when applicable):
     - How each of the written or verbal recruitment materials and reminders (selected above) will be used
     - Who will contact, approach, or respond to potential participants
     - Locations where recruitment procedures will take place
     - The timing and frequency of recruitment attempts
3. Eligibility screening prior to consent and how those activities will be carried out (when
applicable)

See the help text for additional guidance.
1. We will recruit pregnant women in treatment with the VCU OB MOTIVATE program. The OB MOTIVATE program
sees pregnant, postpartum, and parenting women for substance use disorder treatment no matter if they plan to or
delivered at VCU with no time limitation for treatment continuation, making our program a growing referral provider for
surrounding OBGYN and behavioral health practices. OB MOTIVATE currently sees approximately 70 pregnant and
postpartum/parenting women for at least one outpatient encounter each month between our two VCU locations
(Nelson/AOP Women9s Health and MOTIVATE Addiction Medicine clinics). The OB MOTIVATE at Nelson/AOP clinic
schedule and the medical record will be accessed by the research assistant to assess potential eligibility (18 or older,
pregnant, <34 weeks gestation, receiving MOUD, engaged in treatment at OB MOTIVATE for f10 weeks during the
current pregnancy) in order to identify which potential participants to approach about the study.
**We will also passively recruit participants from community-based sites including local addiction treatment centers and
OB/GYN clinics. Recruitment flyers will be posted at sites with a QR code. Individuals who are interested in participant
can use the QR code to provide contact information. The RA will contact potential participants to assess study eligibility
(18 or older, pregnant, <34 weeks gestation, receiving MOUD, engaged in OUD treatment for f10 weeks during the
current pregnancy).
2. Recruitment and enrollment will occur by phone or in-person during OB MOTIVATE clinics, located at Nelson/AOP
clinic (Thursday/Fridays) or MOTIVATE (Tuesday & Wednesday afternoons) based on potential COVID restrictions and
participant preference using the appropriate IRB-approved scripts. The IRB-approved study flyer will be provided to
potential participants during clinic visits. The IRB-approved recruitment scripts will be used by the research assistant to
assess potential participant interest in study participation and confirm eligibility. Additionally, the IRB-approved study
flyer will be used as a visual aid during the in-person recruitment conversation. In-person and phone recruitment will be
conducted by a research assistant (not a healthcare provider) who is a member of the research team. The research
assistant is embedded in the clinic and has access to patients during clinic hours; the RA will approach eligible
participants in private exam rooms while they are waiting to see their provider or by phone before/after a virtual
appointment with their provider. If the research staff is unable to get in touch with the potential participant with
communication linked to an in-person or virtual visit, then eligible participants will be sent a study notification email that
includes information about the study with a note that the research staff will follow-up with a phone call within one week
to assess their interest in participating. This email will also provide an option to opt-out of further contact. Eligible and
interested subjects will undergo the informed consent process and complete the baseline assessment (Study visit 1).
Subjects who are eligible and decline participation will be asked to answer 5 demographic questions by self-
administration of the 5 questions.
If participants are unable to complete the any part of the study in person at the clinic OR they prefer to complete the
study visits remotely, they will have the option to complete study visits by a confidential link to a unique redcap survey
that will be emailed or texted to them at their preferred email or phone number (which will be confirmed with them
before emailing the link) from the research assistant who will also call the patient over the phone for some questions.
No recruitment or consent procedures will be done by the PI who is clinical director of the OB MOTIVATE program.
**The IRB-approved study flyer will be posted in community-based addiction treatment and OB/GYN clinics. The study
research assistant will contact potential participants who provide contact information within one week of providing
information. The IRB-approved remote recruitment scripts will be used by the research assistant to assess potential
participant interest in study participation and confirm eligibility. Phone recruitment will be conducted by a research
assistant who is a member of the research team. If the research staff is unable to get in touch with the potential
participant by phone, then eligible potential participants will be sent a study notification email that includes information
about the study with a note that the research staff will follow-up with a phone call within one week to assess their
interest in participating. This email will also provide an option to opt-out of further contact. Eligible and interested
subjects will undergo the informed consent process and complete the baseline assessment (Study visit 1). Subjects
who are eligible and decline participation will be asked to answer 5 demographic questions by self-administration of the
5 questions.
3. Potential participants will be called and/or emailed by the research assistant (up to 4 times over 10 weeks) or
approached in the clinic when they arrive for a scheduled clinic appointments while waiting to see their provider in the
private exam rooms. If the potential participant does not answer the phone, the research assistant will leave a generic
voicemail without any identifying information (i.e., "This is (RA name) calling from VCU health about potential
participation in a research study. If you are interested in learning more, please return the call to XXX-XXX-XXXX").
When the RA talks to the potential participants, they will confirm their eligibility for the study verbally using the eligibility
form (see uploaded recruitment scripts).
**Potential participants who use the recruitment flyer QR code to provide contact information will be called and/or
emailed by the research assistant (up to 4 times over 10 weeks). If the potential participant does not answer the phone,
the research assistant will leave a generic voicemail without any identifying information (i.e., "This is (RA name) calling
from VCU health about potential participation in a research study. If you are interested in learning more, please return
the call to XXX-XXX-XXXX"). When the RA talks to the potential participants, they will confirm their eligibility for the
study verbally using the eligibility form (see uploaded recruitment scripts).
6. * Does this study have a separate protocol document (i.e. a multisite or sponsor's protocol) that
contains a detailed description of the study's methodology?
  Yes
No

7. * Upload the separate protocol document, and in the response below, provide all of the
following information:
1. Identify which specific sections of the protocol describe the study design and procedures.
2. A statement explaining the study design
3. A lay language overview of all research activities/procedures 
4. For multisite studies, a description of whether there are any local changes to the protocol's procedures, and
if so, what those changes are (i.e. different, omitted, or additional procedures)
5. Any necessary clarifications of the protocol’s content (i.e. what local standard of care or routine practice is)
1. Entire Standard Operating Procedures (SOP) document
2. Pilot feasibility randomized controlled trial comparing technology-based modules (intervention) to a brochure
(control)
3. Following consent, participants will complete the first study visit, a baseline assessment (electronic survey & brief RA
questions). Then participants will be randomized (1:1) to either the technology-based modules (intervention) group or
the brochure (control) group. Randomization and intervention introduction can be completed at the same time of the
other first study visit procedures (ie, pre-survey) or as a supplemental unpaid visit based on participant preference (ie,
if the participant wants to complete the pre-survey remotely and the intervention introduction in person). Participants
will be provided access via email/text to the modules or the electronic brochure (based on randomization) for three
weeks. Following the 3-week study intervention period, participants will complete two follow-up study visits (electronic
survey & brief RA questions): 1) during pregnancy within two weeks of intervention timeframe (Study visit 2) and 2)
within 4-8 weeks postpartum (Study visit 3). Enrolled, randomized participants not completing Study visit 2 within 5
weeks of study condition introduction, but wishing to do so, will be reviewed by the PI on a case-by-case basis for the
opportunity of continued study participation. Specifically, if the participant is no longer pregnant, study continuation will
not be allowed; if still pregnant, the PI will consider the option of study continuation (e.g., completion of follow-up visit
1) for the participant. For each study visit, we will also obtain health information (as per secondary data page and
uploaded document) via the health record after participants have agreed to the HIPAA authorization in the consent
form. Participants will be compensated $20 per study visit (up to $60 total).
Module condition: Participants in the module condition will have access to the 3 modules in the technology-based
intervention covering content on the pregnancy to postpartum transition, NOWS, and child welfare interactions
(approximately 25-minutes each). Modules can be reviewed in the OB MOTIVATE clinic using research tablets or they
can be reviewed remotely on a personal device in any order the participant chooses. Modules deliver information via
the Computerized Intervention Authoring System, Version 3 (CIAS 3.0) using professionally produced videos and an
interactive avatar using behavioral techniques, such as psychoeducation and aspects of motivational interviewing.
Participants in the technology-based modules intervention condition will access the modules through a link
emailed/texted to them by the study RA. They will enter their Study ID into the modules. No personal identifying
information will be collected or stored in CIAS 3.0 modules. All participants in this condition will be oriented to the
intervention with the RA via the program introduction (5 minutes).
CIAS 3.0 is an authoring tool that allows creation or editing of electronic screening and intervention packages without
the need of a programmer. Interventions built using CIAS feature a synthetic text to speech engine that reads all
questions and speaks aloud to the participant (usually via headphones); synchronous interactivity, natural language
reflections, branching logic, a clean user interface, and the ability to easily incorporate specific images, graphs, figures,
text, or videos. CIAS applications are HIPAA compliant with encryption of all data in transit and at rest, and are hosted
on a HIPAA-compliant cloud server. CIAS 3.0 is cross-platform compatible, meaning that it deploys readily on any
device including those running the Android or Apple mobile operating systems. CIAS 3.0 was developed by
researchers at Michigan State University under an award from NIH (1U24EB028990). Therefore, the Michigan State
University logo appears as part of the CIAS program. However, no information from our modules are shared with
Michigan State; they are solely providing the online platform for our intervention. The VCU logo will appear on the final
version of the technology based modules for the current study. Module links are provided for the current study (see
attachment).
Brochure condition: Provision of written materials to patients is often a component of standard care. Therefore,
participants in the brochure condition will be provided a paper copy and/or provided an electronic pdf of the study
brochure via email/text (in order to facilitate ease of participation for those who prefer remote study completion)
covering content on the pregnancy to postpartum transition, NOWS, and child welfare interactions. There is a QR code
within the brochure that leads to a website with additional information on the three educational topic areas. The
brochure is uploaded in the documents.
4. N/A
5. N/A
8. * The IRB only reviews research activities, so indicate for each of the study activities described
in the question above or in the protocol which activities are:
  - Being performed exclusively for research purposes (i.e. they would not otherwise be done apart from this
study) VERSUS.
  - Alterations of routine activities/procedures (e.g. the study is altering the timing, frequency, method,
location, amount, etc.) VERSUS.
  - Being done for other purposes and whose data/results will be used secondarily in the study (e.g. standard
medical or psychological tests, routine education practices, quality improvement initiatives, etc.).
    See the help text for additional guidance

Participants will complete the three study visits and review the modules or brochure entirely for research purposes.
Their medical care will proceed in same manner regardless study participation and study group condition.
9. If applicable, describe alternatives (research or non-research) that are available to potential
participants if they choose not to participate in this study:
N/A
10. Upload any supporting tables or documents (e.g. protocol documents, figures/tables, data
collection forms, study communications/reminders):
Upload ALL instruments/guides that will be used or that participants will experience (i.e. see,
hear, complete), including measures, scripts/questions to guide interviews, surveys,
questionnaires, observational guides, etc,:
Upload ALL recruitment and screening materials, including such as ads, flyers, telephone or in-
person scripts, letters, email invitations, TelegRAM announcements, and postcard reminders,
screening scripts, screening forms, and screening measures:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER
Consent
Form
Community-
based
recruitment
Community-based recruitment Project
BETTER Consent Form_clean IRB
10.25.pdf
0.05
11/7/2022
10:47 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Community-
based Study
Interest Form
StudyInterest_ProjectBETTERCom.pdf 0.01
10/31/2022
4:01 PM
Anna Parlier Recruitment/Advertising
Yes
View SOP
HM20023314 Project BETTER RCT
SOP 10.31.22.docx
0.05
10/31/2022
3:59 PM
Anna Parlier Research Protocol
Yes
View Project
BETTER
Community-
based
recruitment
email
template
Project BETTER Community
Recruitment Study Notification Email
Template.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
script
Project BETTER Community Remote
Recruitment Scripts.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
flyer
Project BETTER Community-based
Flyer.docx
0.01
10/12/2022
5:00 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER RA
Forms 3
Delivery
Questions
Project BETTER Study Visit 3 Delivery
Questions.docx
0.01
10/5/2022
2:33 PM
Anna Parlier Research Measure
Yes
View Eligibility
Form
Revised 7.18.22 Project BETTER
Eligibility Form.docx
0.02
7/18/2022
5:45 PM
Anna Parlier Research Measure
Yes
View In-person
Recruitment
Script
Revised 7.18.22 Project BETTER In
Person Recruitment Scripts.docx
0.04
7/18/2022
5:44 PM
Anna Parlier Recruitment/Advertising
Yes
View Remote
Recruitment
Script
Revised 7.18.22 Project BETTER
Remote Recruitment Scripts.docx
0.02
7/18/2022
5:43 PM
Anna Parlier Recruitment/Advertising
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Recruitment
Flyer
Revised Project BETTER Flyer
7.18.22.docx
0.02
7/18/2022
5:41 PM
Anna Parlier Recruitment/Advertising
Yes
View Consent
form
Project BETTER Consent
Form_revised 12.15.21.pdf
0.07
12/21/2021
10:35 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Informatics
consult
BETTER_Informatics_Email.pdf
0.01
12/3/2021
9:57 AM
Jessica
Lantz
Other
Not
Applicable
View PROC
APPROVAL
BETTER_PROC_Approval.pdf
0.01
11/17/2021
1:27 PM
Caitlin
Martin
Ancillary Committee
Approval
Not
Applicable
View Study
Notification
Email
Template
Project BETTER Study Notification
Email Template.docx
0.01
11/17/2021
9:27 AM
Anna Parlier Recruitment/Advertising
Yes
View Project
Better
Module
Transcript
Project BETTER Peedy
Transcript.docx
0.01
11/17/2021
9:24 AM
Anna Parlier Research Measure
Yes
View Project
BETTER
Module
Video Links
Project BETTER Video Links.docx
0.01
11/15/2021
12:02 PM
Anna Parlier Other
Yes
View Project
BETTER
Brochure
Webpage
Project BETTER Webpage.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Project
BETTER
Overview
Project BETTER Technology-based
Program Overview.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Technology-
based
modules
Project BETTER Technology-based
module links.docx
0.01
10/11/2021
7:42 PM
Anna Parlier Other
Yes
View Brochure
Project BETTER Brochure.pdf
0.01
10/11/2021
7:41 PM
Anna Parlier Research Measure
Yes
View Demographic
questions
Project BETTER Demographic
Questions .docx
0.01
10/11/2021
7:41 PM
Anna Parlier Recruitment/Advertising
Yes
View RA forms 3
Project BETTER Study Visit 3 RA
Form.docx
0.01
10/11/2021
7:40 PM
Anna Parlier Research Measure
Yes
View RA forms 2
Project BETTER Study Visit 2 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View RA forms 1
Project BETTER Study Visit 1 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 2
Project BETTER Follow-up Survey
2.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 1
Project BETTER Follow-up Survey
1.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Pre-survey
Project BETTER Pre-Survey.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 3
Project BETTER Study Visit 3 Chart
Abstraction Form.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 2
Project BETTER Study Visit 2 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
Project BETTER Study Visit 1 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
form 1
View Scheduling
and
Reminder
Scripts
Project BETTER Follow Up Scheduling
and Reminders Scripts.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Follow up
visit scripts
Project BETTER Follow-up Visits
Script.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Martin CV
CEM_CV_08.15.21_BT.pdf
0.01
10/10/2021
9:23 PM
Caitlin
Martin
CV/Biosketch
Yes
View Parlier CV
Parlier CV .pdf
0.01
10/10/2021
5:44 PM
Anna Parlier CV/Biosketch
Not
Applicable

HM20023314
View: SF2 - Project Details
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Project Details
An intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
An interaction includes communication or interpersonal contact between investigator and subject. It may include in-person,
online, written, or verbal communications.
Secondary information/biospecimens are information or biospecimens that have been or will be collected for some other
<primary= or <initial= activity and that will be used secondarily in the research study.
 
1. * Select all of the following types of interventions that apply to this study (selections will
branch):

Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations

Deception (misleading participants through false or incomplete information)

Drug(s) / Biologics / Supplement(s) / Other Compounds (investigational products or products whose
administration is dictated by the study protocol and not per the physician's clinical judgment)

IV contrast administration for research-related imaging (will branch to the Drugs page)

Placebos

Safety and/or effectiveness evaluation of Bio-Medical Device(s), including in-vitro diagnostic devices/assays,
mobile medical apps, software functions, and HUDs used in clinical investigations

Washout Periods

Expanded Access – Treatment Use of an Investigational Product

Medical or Surgical Procedures (eg: physical exam, clinical procedures, scans, etc)

Specimen/biological sample collection

None of the Above
2. * Select all of the following types of interactions and methods of data collection that apply to
this study (selections will branch):

Surveys / Questionnaires /Written responses to questions (including data entry)

Active Internet data collection (i.e. using the internet to collect data, including online surveys, data
collection via Zoom, apps, etc.)

Passive Internet data collection (i.e. passively observing online behavior, bots)

Interviews / Focus Groups / Verbal responses to questions

Audio / Video recording or photographing participants

Observations

Educational Settings/Assessments/Procedures

None of the Above
3. * Select all types of secondary information and/or specimens that apply to this study (selections
will branch):
See the help text for definitions.

Individually Identifiable Health Information (PHI)

Secondary data/specimens NOT from a research registry or repository

Information/specimens from a research registry or repository (Usage Protocol)

Information/specimens originally collected for a previous research study

Publicly available information/specimens


Government-generated or collected information that was or will be obtained for nonresearch activities [only
applicable to research conducted by or on behalf of a Federal department or agency]

No secondary data/specimens will be used
 

HM20023314
View: SF2 - Behavioral Intervention/Task Details
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Behavioral Intervention/Task Details
This page asks for details about the social/behavioral intervention, task, or environmental manipulation in the research.
 
Interventions include both physical procedures by which information is gathered and manipulations of the subject or the
subject's environment that are performed for research purposes. This might include activities such as playing computer
games, performing a task, thought/cognition activities, environmental manipulations, and educational activities.
If the study only involves surveys, interviews, or secondary data collection, go back to the Project Details page and uncheck
<Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations= in Question 1.
1. * Describe the duration of the social/behavioral intervention, task, or
environmental manipulation:
Module condition: Participants in the module condition will have access to the 3 modules in the technology-based
intervention covering content on the pregnancy to postpartum transition, NOWS, and child welfare interactions
(approximately 25-minutes each). Modules can be reviewed in the OB MOTIVATE clinic using research tablets or they
can be reviewed remotely on a personal device in any order the participant chooses. Modules deliver information via
the Computerized Intervention Authoring System, Version 3 (CIAS 3.0) using professionally produced videos and an
interactive avatar using behavioral techniques, such as psychoeducation and aspects of motivational interviewing.
Participants in the technology-based modules intervention condition will access the modules for 3 weeks through a link
via email/text. Participants will enter their Study ID into the modules. No personal identifying information will be
collected or housed in CIAS 3.0 modules. All participants in this condition will be oriented to the intervention with the
RA via the program introduction (5 minutes).
Brochure condition: Provision of written materials to patients is often a component of standard care. Therefore,
participants in the brochure condition will be provided a paper copy and/or provided an electronic pdf of the study
brochure via email/text (in order to facilitate ease of participation for those who prefer remote study completion)
covering content on the pregnancy to postpartum transition, NOWS, and child welfare interactions. There is a QR code
within the brochure that leads to a website with additional information on the three educational topic areas. The
participants will have 3 weeks to review the brochure content (including the additional educational content through the
QR code). Review of all brochure information will take approximately 25-45 minutes.
2. * Describe any potential harms or discomforts that participants could experience during the
intervention activity:
Few risks are expected by taking part in this study. There is the possibility that participants may experience some
fatigue and/or discomfort when reviewing the content in the brochure or modules. The content in the brochure and
modules is a review of information covered in standard medical treatment for this population. Participants will be
informed of their right to refuse or stop study participation at any time, and their right to refuse to answer any questions
that make them uncomfortable. The following message will also be provided in each of the modules and on the
brochure, "If you have concerns or are experiencing a negative reaction to any of the content, please contact the
research assistant at 804-229-1261."
Participants may be disappointed if they are not assigned to their preferred group or are not able to access the
technology-based modules throughout the study. Following the conclusion of the study, research team plans to make
the technology-based modules accessible to clinicians and patients.
3. * Will the intervention activity be physically invasive or painful?
  Yes
No
4. * Describe the impact the intervention activity will have on participants, including the nature
and duration of any impact(s):
The brochure content will take approximately 25-45 minutes to review. The three modules each take approximately 25
minutes to review. Review of content based on study condition will take some sustained attention that will end after the
content has been reviewed.
5. * In the investigator's opinion, is there any reason to think that the participants will find the
intervention activity offensive or embarrassing? Explain why or why not.
No, the content in the brochure and modules is a review of information covered in standard medical treatment for this
patient population. As part of standard prenatal care for people with opioid use disorder, medical providers review
information about the pregnancy to postpartum transition, neonatal opioid withdrawal syndrome, and interactions with
child welfare. The modules and brochure provide the same information using a different medium. Additionally, the
brochure and modules were designed using a process of iterative modification grounded in formative data from both

patients and providers. Preliminary evaluation data indicate the modules and brochure are highly acceptable to
patients and feasible to complete in a clinical setting and remotely. Based on our preliminary evaluation, no patients
have found the modules or brochure to be offensive or embarrassing. In fact, some patients noted they are more
comfortable receiving the information using the modules and brochure rather than being told directly from their medical
provider.

HM20023314
View: SF2 - Active Internet Data Collection
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Active Internet Data Collection
1. * Describe the platform/technology chosen for collecting the data and transmitting data
securely over the internet. If proposing a non-VCU approved platform, give the rationale for
selecting the technology instead of a VCU-approved platform.
RedCap, a VCU approved platform, will be used to store/collect all study visit data (surveys, RA questions, chart
abstraction).
The Computerized Intervention Authoring System, Version 3 (CIAS 3.0) is an authoring tool that allows creation or
editing of electronic screening and intervention packages without the need of a programmer. Interventions built using
CIAS feature a synthetic text to speech engine that reads all questions and speaks aloud to the participant;
synchronous interactivity, natural language reflections, branching logic, a clean user interface, and the ability to easily
incorporate specific images, graphs, figures, text, or videos. CIAS applications are HIPAA compliant with encryption of
all data in transit and at rest, and are hosted on a HIPAA-compliant cloud server. CIAS 3.0 is cross-platform
compatible, meaning that it deploys readily on any device including those running the Android or Apple mobile
operating systems. CIAS versions 1.0 and 2.0 have been used with thousands of participants, and consistently
received extremely high satisfaction ratings (e.g., Naar-King et al., 2013; Ondersma et al., 2005, 2007, 2012), including
with high risk and low SES samples.
For the current study, no identifiable data will be collected using the CIAS 3.0 software. Unique hyperlinks to the CIAS
3.0 modules, associated with participant study ID's, will be provided via email/text by the study RA.
2. * Describe how data will be linked or unlinked to identifiers including email addresses, names,
and/or IP address.
A Study ID will be assigned to each participant upon study enrollment. All study visit data (survey, RA questions, chart
abstraction) will be stored in RedCap and will only be labelled with participant9s Study ID already associated with the
study. The key linking the participant information and Study ID will be kept in a separate secure VCU RedCap
database.
The participants will enter their Study ID into the CIAS platform when they complete the modules. Participants will not
enter any identifying information into the modules.
A unique VCU email address used by the research team only will be used to send emails with the links for the RedCap
surveys, modules, and the brochure.
3. * How will you protect your data collection from fraudulent responses:
Survey questionnaire links will not be publicly available. Each participant will be sent a RedCap link unique to their
study ID to complete study questionnaires. Additionally, the RA will remind the participant that they can skip or not
answer any questions that they would prefer not to answer and that they can end the survey at any time.
During brief RA-led questions, the RA will build rapport with participant to reduce stigma and encourage honest
responses. Additionally, the RA will remind the participant that they can skip or not answer any questions that they
would prefer not to answer and they can end the interview at any time.
Data checks for all data collection will be conducted regularly. Identified data irregularities will be discussed
immediately with the PI and handled on a case by case basis.
In the CIAS intervention, attention check questions are included in each module.
4. * Is there an alternative method for completion of the data collection other than the internet?
  Yes
No
5. * Describe how individuals will be able to skip or not answer particular questions.  If any
questions are mandatory, provide justification.
Participants will be able to skip or not answer particular questions if they choose by selecting "prefer not to answer."
6. If not including children, describe any procedures used to verify that research participants are
adults.
All potential participants will be screened for eligibility (at least 18 years of age) by the research assistant (RA) using
the OB MOTIVATE schedule and medical record. For potential participants that are not OB MOTIVATE patients, the RA
will screen for eligibility when individuals are contacted. All eligibility criteria will be confirmed by the RA with the
potential participant prior to study enrollment.

 

HM20023314
View: SF2 - Secondary Data/Specimen Details
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Secondary Data/Specimen Details
1. * Describe the source(s) and nature of the information/specimens being obtained. This response
should:
  a. Identify where the data/specimens will come from (e.g., another researcher's registry,
pathology lab, commercial source, medical records, etc.); and
  b. List what types of specimens will be obtained (when applicable); and/or
  c. List all data elements that will be obtained (when applicable). A data collection form or
other documentation may be uploaded and referenced here.
OB MOTIVATE patients:
a. Data will be abstracted from the participants medical record for each study visit.
b. No specimens will be obtained
c. See chart abstraction forms (attached) for information to be abstracted from the medical record at each study visit.
**Community-based addiction treatment:
No secondary data will be obtained. All data will be self-reported by the participant via survey and interview questions. 
2. * Describe whether any agreement exists between you and data/specimen provider that states
you will never have access to the ability to identify the participants (i.e. access to identifiers or
the code key) and that you will not attempt to re-identify individuals.
Each participant9s StudyID will be linked to their medical record number to allow other study visit data to be linked to
the protocoled medical record abstraction. This information will be kept in a separate key file within the secure RedCap
database. The key linking the Study ID to the participant medical record ID will be destroyed upon completion of the
study.
3. * When the information/specimens were originally collected, did individuals provide consent for
secondary research use of their data/specimens (i.e. consent to another research study or to a
research registry)?
  Yes
No
 

HM20023314
View: SF2 - Costs to Participants
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Costs to Participants
1. * Select all categories of costs that participants or their insurance companies will be
responsible for:

Participants will have no costs associated with this study

Study related procedures that would be done under standard of care

Study related procedures not associated with standard of care

Administration of drugs / devices

Study drugs or devices

Other
 

HM20023314
View: SF2 - Compensation
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Compensation
It is recommended that investigators consult with VCU Procurement Services before proposing a compensation plan
(monetary or non-monetary) to the IRB to ensure the plan will comply with VCU policies. Refer to WPP XVII-2 for the IRB9s
guidelines about compensating research participants.
1. * Describe any compensation that will be provided including:
   1. total monetary amount
   2. type (e.g., gift card, research pre-paid card, cash, check, merchandise, drawing, extra class
credit)
   3. how it will be disbursed
   4. how you arrived at this amount
   5. What identifiers and tax forms will be required for compensation purposes (i.e. W-9 form,
SSN, V#, addresses, etc.)
Participants will receive $20 for each of the three study visits. Total possible compensation is $60.
All participants will be offered the option to receive a mailed check or cash following the completion of a study visit OR
the option to delay individual visit payments in order to receive a subsequent cumulative payment mailed check or cash
after completion of multiple completed study visits.
2. If compensation will be pro-rated, explain the payment schedule.
N/A
  

HM20023314
View: SF2 - Contingency Plan
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Contingency Plan
This page will be used by the IRB in the event that an institution-wide emergency situation arises that requires
contingency plans. 
A contingency plan describes the alternative procedures that a study would want to use in case of an emergency that
prevented normal study activities from occurring. It is a form of adaptive protocol. It enables the VCU IRB to quickly
approve alternative study activities along with criteria for when those activities would or would not be put into effect.
For example, in 2020, some studies had a COVID-19 Contingency Protocol approved that described alternative
remote procedures that they would switch to whenever the University restricted in-person research activities.
In all studies, investigators are strongly encouraged to plan prospectively and build flexibilities into their regular
protocols (regardless of whether an emergency situation exists) as well as think about what they would do in an
emergency situation. For example, windows for timed study visits, ranges instead of exact values, flexibilities in
inclusion criteria, etc. Flexibility and adaptations that are built into the protocol will reduce the number of changes
that have to be submitted to the IRB and should reduce the number of incidents of deviations and noncompliance by
investigators.
Further instructions and smartform questions on this page will be released from the IRB in the event of such an
institution-wide emergency situation.
 
  

HM20023314
View: SF2 - Research Plan Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Research Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
g CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section
 

HM20023314
View: SF2 - Exempt Information Sheet Upload
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Exempt Information Sheet Upload
While informed consent consistent with federal regulations is not required for exempt studies, VCU strongly
advocates, and may require, that participants be provided with an information sheet. Information sheets provide
some of the information usually included in a consent document.
At a minimum, the information sheet should indicate in language understandable to the potential participant:
       1. the activity involves research
       2. brief description of what participants will be asked to do
       3. the activity is voluntary
       4. how the participants may ask questions
Participants should be able to retain a copy of the information sheet, so if provided as a cover sheet to a survey, the
ability to print or tear off would be helpful.
A template Exempt Information Sheet can be found at https://research.vcu.edu/forms/ under IRB Forms.
1. Upload information sheets if applicable:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER
Consent
Form
Community-
based
recruitment
Community-based recruitment Project
BETTER Consent Form_clean IRB
10.25.pdf
0.05
11/7/2022
10:47 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Community-
based Study
Interest Form
StudyInterest_ProjectBETTERCom.pdf 0.01
10/31/2022
4:01 PM
Anna Parlier Recruitment/Advertising
Yes
View SOP
HM20023314 Project BETTER RCT
SOP 10.31.22.docx
0.05
10/31/2022
3:59 PM
Anna Parlier Research Protocol
Yes
View Project
BETTER
Community-
based
recruitment
email
template
Project BETTER Community
Recruitment Study Notification Email
Template.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
script
Project BETTER Community Remote
Recruitment Scripts.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
flyer
Project BETTER Community-based
Flyer.docx
0.01
10/12/2022
5:00 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER RA
Forms 3
Delivery
Questions
Project BETTER Study Visit 3 Delivery
Questions.docx
0.01
10/5/2022
2:33 PM
Anna Parlier Research Measure
Yes
View Eligibility
Form
Revised 7.18.22 Project BETTER
Eligibility Form.docx
0.02
7/18/2022
5:45 PM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View In-person
Recruitment
Script
Revised 7.18.22 Project BETTER In
Person Recruitment Scripts.docx
0.04
7/18/2022
5:44 PM
Anna Parlier Recruitment/Advertising
Yes
View Remote
Recruitment
Script
Revised 7.18.22 Project BETTER
Remote Recruitment Scripts.docx
0.02
7/18/2022
5:43 PM
Anna Parlier Recruitment/Advertising
Yes
View Recruitment
Flyer
Revised Project BETTER Flyer
7.18.22.docx
0.02
7/18/2022
5:41 PM
Anna Parlier Recruitment/Advertising
Yes
View Consent
form
Project BETTER Consent
Form_revised 12.15.21.pdf
0.07
12/21/2021
10:35 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Informatics
consult
BETTER_Informatics_Email.pdf
0.01
12/3/2021
9:57 AM
Jessica
Lantz
Other
Not
Applicable
View PROC
APPROVAL
BETTER_PROC_Approval.pdf
0.01
11/17/2021
1:27 PM
Caitlin
Martin
Ancillary Committee
Approval
Not
Applicable
View Study
Notification
Email
Template
Project BETTER Study Notification
Email Template.docx
0.01
11/17/2021
9:27 AM
Anna Parlier Recruitment/Advertising
Yes
View Project
Better
Module
Transcript
Project BETTER Peedy
Transcript.docx
0.01
11/17/2021
9:24 AM
Anna Parlier Research Measure
Yes
View Project
BETTER
Module
Video Links
Project BETTER Video Links.docx
0.01
11/15/2021
12:02 PM
Anna Parlier Other
Yes
View Project
BETTER
Brochure
Webpage
Project BETTER Webpage.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Project
BETTER
Overview
Project BETTER Technology-based
Program Overview.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Technology-
based
modules
Project BETTER Technology-based
module links.docx
0.01
10/11/2021
7:42 PM
Anna Parlier Other
Yes
View Brochure
Project BETTER Brochure.pdf
0.01
10/11/2021
7:41 PM
Anna Parlier Research Measure
Yes
View Demographic
questions
Project BETTER Demographic
Questions .docx
0.01
10/11/2021
7:41 PM
Anna Parlier Recruitment/Advertising
Yes
View RA forms 3
Project BETTER Study Visit 3 RA
Form.docx
0.01
10/11/2021
7:40 PM
Anna Parlier Research Measure
Yes
View RA forms 2
Project BETTER Study Visit 2 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View RA forms 1
Project BETTER Study Visit 1 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 2
Project BETTER Follow-up Survey
2.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 1
Project BETTER Follow-up Survey
1.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Pre-survey
Project BETTER Pre-Survey.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
Project BETTER Study Visit 3 Chart
Abstraction Form.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
form 3
View Chart
abstraction
form 2
Project BETTER Study Visit 2 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 1
Project BETTER Study Visit 1 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Scheduling
and
Reminder
Scripts
Project BETTER Follow Up Scheduling
and Reminders Scripts.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Follow up
visit scripts
Project BETTER Follow-up Visits
Script.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Martin CV
CEM_CV_08.15.21_BT.pdf
0.01
10/10/2021
9:23 PM
Caitlin
Martin
CV/Biosketch
Yes
View Parlier CV
Parlier CV .pdf
0.01
10/10/2021
5:44 PM
Anna Parlier CV/Biosketch
Not
Applicable
 

HM20023314
View: SF2 - Consent Plan Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Consent Plan Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
 
Click Continue below to go to the next section
  

HM20023314
View: SF2 - Privacy
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Privacy
Privacy refers to an individual’s right to control how others view, record, or obtain information about them. When
privacy is violated it can involve such things as
Being asked personal questions in a public setting;
Being publicly identified as having a particular characteristic or diagnosis;
Being seen entering a place that might be stigmatizing;
Being photographed, videotaped or observed without consent;
Disclosure of personal information to unauthorized people
Privacy is not the same as confidentiality because privacy protections apply to people, and confidentiality
protections apply to data. Confidentiality protections should be described on the Data Confidentiality page of this
form, not here.
Instructions for this page:
Select all the applicable ways that the research team will protect participants' privacy throughout the course of the
study. The options listed include some of the most common best practices. Not all will be applicable to every study. 
**The IRB will expect studies to operationalize all selected checkboxes into the conduct of the research.
To elaborate on any response, also click the <Other Protections= checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections when conducting one-on-one in-person interventions or interactions (for groups
see Q2 below):

Conducting study activities in locations that maximize privacy (limited people around, closing doors,
drawing drapes around beds, monitoring voice volume, etc.)

Verifying identity before discussing personal information.

Asking the participant if they are comfortable answering questions in that location

Asking the participant if they are comfortable with having other people present (if any)

Moving away from other people when conducting activities in public spaces or offering a private space

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing) if
uncomfortable verbally responding

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Other protections not listed in this question – describe below

N/A – study has no in-person interventions or interactions with participants
 
2. * Protections when conducting group interventions or interactions:

Conducting study activities in locations that maximize privacy (limited people passing by, closing doors,
monitoring voice volume, etc.)

Moving to a more private area to answer questions or to discuss concerns

Discussing privacy with the participants and the importance of not talking outside the group about what other
people say during the group session

Allowing participants to use a pseudonym or limiting use of individuals9 names during the group activity

Asking everyone in a public group setting (e.g. classrooms, workshops) to turn something in (blank or filled) so
participants do not have to self-identify when turning in materials

Collecting paper forms in a closed box or envelope rather than passing to others or leaving in an open area

Limiting participant identifiers that would be visible on paper documents (i.e. using study IDs instead of direct
identifiers)

Allowing people to distance themselves from other participants during group activities


Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing instead of
speaking)

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Ensuring non-participating individuals are not captured on recordings or in photos

Other protections not listed in this question – describe below

N/A – study has no group interventions or interactions
 
3. * Protections when conducting remote interventions or interactions (e.g. phone, text, email,
video-conference, tele-health, online, etc.):

Conducting study activities in locations where study staff can maximize their own privacy (limited
people around, closing doors, monitoring voice volume, etc.)

Leaving/sending generic messages that avoid using study and participant identifiers, such as names,
study titles, clinics, study topics, etc.

Obtaining permission prior to sending text messages

Advising the participant to move to a location where they are comfortable answering questions and will
not be overheard - incorporate this instruction into your study materials

Advising online participants to complete the activity at a time and location where they will be
comfortable answering questions - incorporate this instruction into your study materials

Ensuring non-participating individuals are not captured on recordings or in photos

Offering other options of ways to complete the activity (i.e. online, paper, phone) if more privacy is
desired

Offering a way to save and return later to the online activity if privacy is compromised

Other protections not listed in this question – describe below

N/A – study has no remote interventions or interactions with participants
 
4. * Protections when mailing study materials to/from participants:

Obtaining permission to mail study materials

Confirming/verifying the accuracy of addresses before mailing items

Ensuring the participant is able to personally receive mailed materials and has a way to protect their
own privacy if they do not want others to know they are receiving research communications (i.e.
notifying participants of when to expect it)

Using return address labels and document headers that avoid study identifiers, such as study names,
clinics, study topics, etc.

Avoiding or limiting use of participant identifiers and health information on mailed documents (i.e. using
study IDs instead of direct identifiers)

Providing a return mailing address label or pre-addressed envelope to ensure returned items are sent to the
correct address

Communicating receipt of mail from participants and/or asking them to notify you when they mail it to ensure
study documents are not lost in transfer

Offering other options of ways to complete the activity (i.e. by phone or online) if desired

Other protections not listed in this question – describe below

N/A – not mailing any materials to/from participants
 
5. * Protections when analyzing or disseminating study data *Applicable to all studies*:

Working only in locations where the study team can ensure privacy (not working in close proximity to
non-study personnel, closing doors, closing/putting away documents/files before leaving, etc.)

Securing physical materials only in locations that ensure privacy (access limited to authorized study
personnel)

Only sharing data/specimens in accordance with the Sharing Plan outlined in this smartform

Obtaining explicit parental permission before disseminating or sharing recordings or photos of children

Blurring/redacting/hiding faces and other identifiable features/marks (tattoos, scars, birthmarks, distinctive voice,
etc.) in recordings or photos prior to disseminating or sharing

Only publishing or presenting aggregate results or findings (i.e. no individual-level information)


Taking additional steps to protect participant identities when publishing or presenting individual-level information,
quotations, results, images – describe below

Other protections not listed in this question – describe below
 
6. Describe any other way(s) that the research team will protect participants' privacy. See the
help text for additional guidance.
N/A
 

HM20023314
View: SF2 - Data Confidentiality and Storage
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Data Confidentiality and Storage
Confidentiality refers to the way private, identifiable information about a participant or defined community is
maintained and shared. It describes how the study’s research materials (data, specimens, records, etc.) are protected
from unauthorized access.
Instructions for this page:
Select all the ways that the research team will keep the study materials and data confidential throughout the course
of the study. Not all will be applicable to every study. 
To elaborate on any response, also click the <Other Protections= checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections for paper research materials:

Maintaining control of paper documents at all times, including when at an off-campus location

Limiting or avoiding use of participant identifiers on paper documents (i.e. using study IDs instead of
direct identifiers)

Storing paper documents in a secure location accessible only to authorized study personnel

Promptly transcribing, scanning, or abstracting data from paper into electronic platforms with
destruction of the paper copy

Proper destruction of paper records (and obtaining prior permission when required) in accordance with
VCU Records Management policies

Other protection not listed in this question – describe below

N/A – no paper research materials
2. * Protections for research specimens:

Maintaining control of specimens at all times, including when at an off-campus location

Storing specimens in a secure location accessible only to authorized study personnel

Labeling specimens with subject ID or other coded information instead of direct identifiers

Final destruction of specimens will be in accordance with VCU policies and specimen containers will be devoid
of any identifiable information

Other protection not listed in this question – describe below

N/A – no research specimens
3. * Protections for electronic files/data - See https://ts.vcu.edu/about-us/information-security/data-
management-system/

*Required for all studies* Use VCU-approved methods of data storage, transmission, and transfer (see
https://dms.vcu.edu)

Remotely accessing VCU network storage to store data when at off-campus locations

Ensuring unauthorized individuals who might share a device do not have access to study materials (e.g.
individual logins, separate accounts)

Using VCU-approved data collection tools and apps (e.g. REDCap) and storing exported analysis files in
VCU-approved storage locations (see https://dms.vcu.edu)

When using non-VCU-approved electronic data collection tools, storage locations, data transfer
platforms, and mobile apps (e.g. Dropbox, Box, Survey Monkey, Fitbits, novel apps, multi-site data
collection platforms):
• consulting with VCU Information Security on proper data management (see
https://ts.vcu.edu/askit/essential-computing/information-security/);
• advising participants about the terms of use and privacy policies of those sites/apps;
• limiting or avoiding use of identifiers; and
• removing data promptly from the external location after transferring it to a VCU storage location

De-identifying the research data by replacing subjects’ names with assigned subject IDs

Storing the study’s linkage key in a password-protected and VCU-approved storage location (see
https://dms.vcu.edu)

When analyzing particularly sensitive information, using computers that are unconnected from the internet.


Proper destruction of electronic records (and obtaining prior permission when required) in accordance
with VCU Records Management policies

Other protection not listed in this question – describe below
4. * Protections for computers and research devices/apps that are provided to participants for use
in the study and taken out of the lab (i.e., giving participants a phone or iPad to take home,
wearable trackers, apps, etc.):

Transferring data promptly from the device/app given to the participant to a VCU storage location

Setting strong passwords on computers and research devices (when applicable) that leave VCU with
participants

Device/app set up by VCU Information Security

When providing devices or mobile apps to children, informing parents about the settings and how to manage
them (if applicable), internet access, and any other installed apps on the device

Other protection not listed in this question – describe the device/app and protection below

N/A – no computers or devices/apps being provided for participant use outside the lab
5. * Protections for email/online communications

Only using VCU/VCU Health email addresses for study-related communications

Only using VCU/VCU Health–approved methods of teleconferencing or video conferencing (e.g. Zoom)
(for studies involving HIPAA, contact VCU or VCU Health Information Security [as appropriate] about
HIPAA-compliant systems)

Other protection not listed in this question – describe below

N/A – no email/online communications
6. Specify any other places where this study’s paper and electronic research data and/or physical
specimens will be stored and any other ways they will be secured from improper use and
disclosure. 
See the help text for additional guidance.
N/A
7. * If research data/specimens will be sent/released to person(s) or group(s) outside of the VCU
study team or the PI’s department for the conduct of this protocol (not for future sharing),
1) identify the data/specimen recipient(s) along with their VCU department or other institutional
or organizational affiliation(s).
2) give a description of what identifiers and/or codes will accompany the data/specimens.
If data/specimens are not being sent/released outside of the VCU study team or the PI’s
department, state that:
There are no plans to release patient level data/identifiers to anyone outside of VCU. If this changes, we will revise the
submission accordingly, prior to any release of information
8. * Select all identifiers that will be collected at any time as part of this study (including for
recruitment, data gathering, data analysis, etc.), even if the data will eventually be anonymized:

Names

Geographic Locators Below State Level

Social Security Numbers

Dates (year alone is not an identifier)

Ages over 89 (age under 89 is not an identifier)

Phone Numbers

Facsimile Numbers

E-mail Addresses

Medical Record Numbers

Device Identifiers

Biometric Identifiers

Web URLs


IP Addresses

Account Numbers

Health Plan Numbers

Full Face Photos or Comparable Images

License/Certification Numbers

Vehicle ID Numbers

Other Unique Identifier

No Identifiers

Employee V#
9.   * If the study will code (i.e. de-identify) the research data by replacing subjects’ names and/or
other identifiers with assigned subject IDs, explain the following aspects of the coding process:
- The process for how subject IDs will be generated/assigned (e.g. random, sequential)
- Whether there will be a key that links the subject ID with direct identifiers. If there will be no
linkage key, state that.
If a key will be created, describe
- The place where the key will be stored
- The role(s) of all individuals who will have access to the key
- When the key will be destroyed
See the help text for guidance.  
A study ID will be assigned in sequential order for all study participants and will not be related to participant
information. A key with the participant identifier (e.g., MRN) linked to study ID numbers will be kept in a document
within RedCap separate from the research data and consent forms. Only key study personnel involved in study
procedures will have access to the key. Patient identifying information will be kept (linked to study ID numbers) to
facilitate contact for follow up study visits within the study. The key will be destroyed when the study is complete and
the study manuscripts are published.

HM20023314
View: SF2 - Data Retention
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Data Retention
1. * Select all of the ways that individually identifiable information obtained during pre-screening
and/or screening will be handled for individuals who DO NOT qualify for the study:

N/A - study does not require screening procedures

Immediately destroy the information and identifiers (no data collected)

Immediately destroy the identifiers connected with the data (anonymization)

Store until the end of study & then destroy

Use as "screening failure" data by members of the study team

Provide to others outside of the research team (with the participant's permission)

Request permission from participant to maintain and use the identifiable information

Other
2. * Will participants be able to withdraw their data (paper, electronic, or specimens) from the
study (e.g. ask that it be destroyed or returned) if they no longer wish to participate? (FDA-
regulated studies should select No – see help text)
  Yes
No
3. * If Yes , describe the process (oral, written, email, letter, etc.) that participants should use to
request withdrawal of their data/specimens. Identify if there is a timepoint when withdrawal
will no longer be an option and/or if the amount of data that can be withdrawn is reduced at
different points in the study.
Participants will be given contact information (phone number) for study personnel with their copy of the consent form
and be informed to contact the study team if they would like their data withdrawn. Data used in published findings
cannot be withdrawn.
4. * What will happen to the research materials (e.g. data, specimens, documents, etc.) when the
research has been completed?
Stored indefinitely with identifiers removed
Stored indefinitely with identifiers attached
Destroyed at the end of study once the minimum time required for data retention has been met per VCU
Data Retention Policy and/or sponsor retention requirements
Destroyed when notified by sponsor but not less than the minimum time required for data retention per VCU
Data Retention Policy
Other
 

HM20023314
View: SF2 - Sharing Plan
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Sharing Plan
This page addresses times when investigators may be required to share information about participants or may desire
to share their research information/specimens with the aim of advancing science. This page creates a plan for when
and how information/specimens could be shared.
Try to anticipate all reasonably foreseeable sharing so that the consent document can also reflect that information.
However, it is acceptable to amend this page later and explain either how re-consent of previously and currently
enrolled participants will occur or why re-consent should not be required.
The IRB reviews this page against the consent document (if one exists) to demonstrate the ethical principle of
Respect for Persons by confirming that plans for sharing do not go against what participants would understand
about the use of their data/specimens.
The IRB also ensures there are adequate protections for the privacy of participants and the confidentiality of
participants' data/specimens when data is shared with others.
 
1. * Is it likely investigators could discover information about child/elder abuse or neglect that
would require mandatory reporting by the investigators or staff?
The Code of Virginia requires that most medical personnel and all employees of institutions of higher
education report suspected child/elder abuse or neglect.
  Yes
No
2. *  Is it likely investigators could discover a previously unknown reportable disease or condition
that would require mandatory reporting by the investigators or staff (i.e., HIV , coronavirus,
hepatitis, etc.)?
  Yes No
3. * Will the sponsor or investigator obtain a Certificate of Confidentiality for this study?
Certificates of Confidentiality  (CoC) are issued by the National Institutes of Health (NIH), the FDA and CDC to
protect identifiable research information from forced disclosure. All human subject research studies
regardless of funding can qualify to receive a CoC. A CoC is automatically issued for research that was
ongoing on December 13, 2016. or initiated after that date. For more information, see
https://humansubjects.nih.gov/coc/
Yes – Plan to submit request for CoC and will amend study/ICF once status of request is known
No – Will not obtain CoC for this study
Yes – CoC has been obtained or issued automatically
Yes – CoC request is pending
4. * Select the way(s) that information or biospecimens (including DNA) may be used by the VCU PI
or VCU study team for other future research projects (i.e. analyses beyond/apart from the aims
of this study)?
See help text for definitions.

Will use directly identifiable information or specimens.
(8Directly identifiable9 means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research is treated as a
registry by the VCU IRB. The IRB must approve the new research use in an amendment to this study or as part
of a new study before the project is initiated. VCU IRB studies will be asked more questions about this on a later
page)


Will use de-identified or indirectly identifiable information or specimens.
(8De-identified9 means that a linkage/key code exists that links identifiers to data/specimens. When the
researcher holds both the data and the key, the VCU IRB considers the subjects to be readily identifiable.
Maintaining identifiable data for future research uses is treated by the IRB as a registry. The IRB must approve
the new research use in an amendment to this study or as part of a new study before the project is initiated.
VCU IRB studies will be asked more questions about this on a later page)

Will use anonymized information or specimens.
(8Anonymized9 means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified, i.e. no direct or indirect identifiers or identifiable combinations of variables. The VCU
IRB considers uses of anonymized data/specimens to not be human subject research.)

Will use aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects.)

Will contribute to an existing registry or repository
(VCU IRB studies will be asked more questions about this on a later page.)

Will not use information/specimens for purposes beyond this study.

Not sure and will submit an amendment when known

Other use(s) of individual-level information in a way not listed above
5. * Select the way(s) the VCU PI/study team may share information or biospecimens (including
DNA) with other researchers who are not on this study team (i.e. for analyses beyond/apart
from the aims of this study). 
See help text for definitions.

Will share directly identifiable information or specimens with other researchers.
(8Directly identifiable9 means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research uses is treated
by the VCU IRB as a registry. The data recipient9s use of identifiable data would require them to obtain IRB
review. VCU IRB studies will be asked more questions about this on a later page.)

Will share de-identified or indirectly identifiable information or specimens with other researchers.
(8De-identified9 means that a linkage/key code exists that links identifiers to data/specimens. The VCU
researcher maintains the key but does not share it with any other researchers. The recipient9s use of de-
identified data/specimens may not be human subject research if there is documentation that the key will never
be shared with the recipient, but they should check with their own IRB about review requirements. VCU IRB
studies will be asked more questions about this on a later page.)

Will share anonymized information or specimens with other researchers.
(8Anonymized9 means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified (i.e. no direct or indirect identifiers or identifiable combinations of variables). The
VCU IRB considers uses of anonymized data/specimens by other researchers to not be human subject
research, but the recipient should check with their own IRB about review requirements.)

Will only share aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects. The data recipient should check with their own IRB about review requirements.)


Will contribute to an existing registry or repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will submit data to an NIH genomic data repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will not share information/specimens with other researchers.

Not sure and will submit an amendment when known

Other sharing of individual-level information with other researchers
6. * Since you responded in a question above that you may use or share anonymous, individual
level data, indicate why the proposed use or sharing of anonymous data/specimens is not
inconsistent with what participants would have reasonably understood from the consent
document about the uses of their information. (Select all that apply.)

The consent form states that after identifiers are removed, information or specimens could be used for future
research studies without additional informed consent from the subject (this is a new element of consent included
in consent templates as of May 2018)

The consent form or exempt information sheet is silent about whether/how information or specimens
could be used for future research studies.

The information or specimens were/will be obtained under a waiver of informed consent, waiver of HIPAA
authorization, or an exempt study that did not use an information sheet.

Other reason why anonymous use/sharing is not inconsistent with the consent document
7. * The Principal Investigator certifies that prior to releasing an anonymized dataset or
anonymized specimens the following conditions will all be met:
 - all 18 HIPAA identifiers (including all dates) will be removed;
  - all indirectly identifiable data elements (unusual, rare, uncommon data) will be removed, grouped,
suppressed, or otherwise transformed to no longer be readily identifiable;
  - a different subject ID will be assigned than the one used for the main study and a linkage key will not be
kept; and
  - the PI will review the dataset/specimens to confirm that the remaining information could not be used alone
or in combination with any other information to re-identify the participants represented in the data.
See help text for more information.
Yes
No
8. * The Principal Investigator certifies that after the study has been closed with the VCU IRB, the
following conditions will be met whenever individual level research information and/or
specimens are used or shared:
  - The identities of participants who are represented in the dataset/specimens will not be readily ascertainable
or otherwise re-identifiable by the recipient;
  - If a linkage/code key is created, it will be maintained at VCU and not shared with the recipient under any
circumstances;
  - The PI will have no knowledge that the remaining information could be used alone or in combination with
any other information to identify the individuals represented in the data; and
  - The PI agrees to abide by this sharing plan even after the study has been closed with the VCU IRB.
Yes
No
N/A - No sharing will occur
 

HM20023314
View: SF2 - Pertinent Results and Incidental Findings
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Pertinent Results and Incidental Findings
1. * Is it likely investigators could discover a participant's previously unknown condition (e.g.
pregnancy, disease, suicidal thoughts, wrong paternity, genetic results, or other findings that
may be of importance to health or well-being) or if a participant is engaging in illegal or
reportable activities:
  Yes
No
2. * Describe what possible pertinent results or incidental findings stemming from research-only
procedures may be discovered.
The RA-led questions at each study visit ask about substance use which may include use of illicit
substances.
3. * Explain what actions or procedures research personnel should take to inform the PI of such a
discovery :
No additional actions will be taken if participants do disclose substance use.
4. * Will findings be disclosed to participants and/or any other person/group outside of the study
team?
  Yes
No
5. If pertinent and/or incidental findings will not be disclosed, explain why not:
Because the research is centered around women in recovery from substance use disorder and being conducted in
clinics where these women are receiving care for their substance use disorder, there is not a necessity to take any
action if participants do disclose substance use.
 

HM20023314
View: SF2 - Risk Benefit Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Risk Benefit Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section
 

HM20023314
View: SF2 - Populations with Special Considerations
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Populations with Special Considerations
1. * Check all participant groups that will be either
  a) Specifically included in this study or
  b) Discernable in the research data/specimens.
  (Selections will branch)

Children

Emancipated minors

Wards of the State

Pregnant women or fetuses

Neonates or Post-delivery Materials

Prisoners

Decisionally Impaired Adults

VCU / VCUHS students or trainees

VCU / VCU Health System employees

Individuals with limited English proficiency

Active military personnel

Student populations in K-12 educational settings or other learning environments

Members of a federally recognized American Indian and Alaska Native tribe

None of the Above
 
2. * Check all of the following categories that apply to this research:

45 CFR 46.204
Research involving pregnant women or fetuses.

45 CFR
46.205(a) and
(b)
Research involving neonates of uncertain viability.

45 CFR
46.205(a) and
(c)
Research involving nonviable neonates

45 CFR
46.205(d)
Research involving viable neonates.

45 CFR 46.206
Research involving, after delivery, the placenta, the dead fetus, or fetal material.

45 CFR 46.207
Research not otherwise approvable which presents an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or
neonates.
          
          

HM20023314
View: SF2 - Children
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Children
1. * Check all that apply to the study:

45 CFR
46.404
Research involving no greater than minimal risk to children, with adequate provisions for
soliciting the assent of the children and permission of their parents or guardians, as set forth
in Sec. 46.408

45 CFR
46.405
Research involving greater than minimal risk but presenting the prospect of direct benefit to individual
participants

45 CFR
46.406
Research involving greater than minimal risk and no prospect of direct benefit to individual
participants, but likely to yield generalizable knowledge about the participant9s disorder or condition

45 CFR
46.407
Research not otherwise approvable which presents an opportunity to understand, prevent or alleviate
a serious problem affecting the health or welfare of children. (Research in this category must be
reviewed and approved by the Secretary of the Department of Health & Human Services)
2. If multiple categories are selected above, explain which study groups are covered by each
selected category (e.g. treatment vs. control groups):
N/A
3. * Describe how you plan to obtain permission of parents or legal guardians. If you have
indicated this study will fall into categories 406 or 407, please describe here how you will
obtain permission from both parents.
Pregnant females will be consented and enrolled in this study. For OB MOTIVATE patients, consent will include chart
abstraction of information about their babies after birth
4. * Describe how children will be assented to participate in the study (i.e. what will the study
team do during the assent process to ensure the child understands what the research involves).
We will not be including children, just abstracting data about newborn health right after birth for OB MOTIVATE
patients.
  

HM20023314
View: SF2 - Pregnant Women or Fetuses
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Pregnant Women or Fetuses
1. * When scientifically appropriate, briefly describe any preclinical studies (including studies on
pregnant animals) and clinical studies (including studies on nonpregnant women) that have
provided data for assessing potential risks to pregnant women and fetuses [45 CFR 46.204(a)].
N/A
2. * Select the condition that is applicable to this study [45 CFR 46.204(b)]:
The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit
for the woman or the fetus.
If there is no prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the
research is the development of important biomedical knowledge which cannot be obtained by any other
means.
3. * Provide protocol-specific information to support the selected condition above [45 CFR
46.204(b)].
Surveys and interviews are widely utilized in day-to-day life, in clinical settings, etc. Additionally, because participants
are in substance use disorder treatment, the information provided in the study condition materials is already being
provided as part of standard medical care.
4. * Describe how the risk is the least possible for achieving the objectives of the research [45
CFR 46.204(c)].
Participants will be informed of their right to refuse or stop study participation at any time, and their right to refuse to
answer any questions that make them uncomfortable. All participant data will be kept confidential. Participants will be
able to complete the study in person at their clinic visit or virtually to reduce time burden.
5. * Describe how consent will be obtained from the pregnant woman if the research may:
_directly benefit the pregnant woman,
_directly benefit the pregnant woman and the fetus, or
_offer no benefit for the woman nor the fetus (when risk to the fetus is not greater than
minimal) and the purpose of the research is the development of important biomedical
knowledge that cannot be obtained by any other means [45 CFR 46.204(d)].
Consent will be obtained from the mother only, as the study is no greater than minimal risk and offers no prospect of
benefit for the woman nor the fetus.
 
6. If the research may directly benefit the fetus only, describe how the consent of the pregnant woman and the
father will be obtained. [45 CFR 46.204(e)]\
Note: The father's consent is not required if he is unable to consent because he is unavailable, incompetent,
temporarily incapacitated, or the pregnancy resulted from rape or incest.
N/A
7. * Describe how each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the fetus or neonate [45 CFR 46.204(f)].
it is anticipated that the research will have no impact on the fetus or neonate. 
8. For children who are pregnant, describe how you will obtain assent from the child and
permission from the parent(s) of the pregnant child [45 CFR 46.204(g)].
No one under 18 years of age will be enrolled in the study. 
9. * Will inducements, monetary or otherwise, be offered to terminate a pregnancy [45 CFR
46.204(h)]?
  Yes
No
 
10. * Will individuals engaged in the research have any part in any decisions as to the timing,
method, or procedures used to terminate a pregnancy [45 CFR 46.204(i)]?

  Yes
No
 
11. * Will individuals engaged in the research have any part in determining the viability of a neonate
[45 CFR 46.204(j)]?
  Yes
No
 
 

HM20023314
View: SF2 - Populations with Special Considerations Section Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Populations with Special Considerations Section Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
| POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
 
Click Continue below to go to the next section

HM20023314
View: SF2 - Study Funding
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Study Funding
1. * Have you applied for funding:
  Yes
No
2. Is this study already funded:
  Yes
No
3. * Select all funding sources for this study (pending or awarded):

Industry

Direct Federal

Indirect Federal

State/Local Government

Non-Profit - Sponsored Project

Non-Profit - Gift

Internal Grant

Investigator/Departmental Funds

None

Other
4. * In addition to providing funding support, what is the funding source’s role in this study? Select
all that apply:

Solely providing funding support

Providing resources (e.g. study drug, device)

Providing guidance to the researcher but does NOT make decisions about study design

Study design/Creation of the study protocol

Collaborator in the research (helps design and/or conduct the study) [list the funder as a site on the Types of
Sites page]

Data or sample analysis regardless of identifiability
5. Select all related funding proposals and contracts that have been submitted through the
Division of Sponsored Programs (DSP):
RAMS-SPOT ID# (FP/PT/PD#)
Direct Sponsor
PI Title
Status
Start
End
There are no items to display
 

HM20023314
View: SF2 - Types of Sites
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Types of Sites
VCU Site Information
1. * Select all VCU sites that will be utilized in this study:

Children's Hospital of Richmond at VCU

Clinical Research Services Unit (CRSU)

Massey Cancer Center

VCU Health Community Memorial Hospital

VCU Health Tappahannock Hospital

VCU Medical Center

Other VCU Health Location

VCU Monroe Park Campus

VCU Qatar

Other VCU Site
 
Non-VCU Site Information 
Non-VCU sites should be selected whenever any of the following situations apply:
   a) Non-VCU sites that will be collaborating  on a VCU-led study (i.e. involved in conducting the research,
including being involved in the study interpretation or analysis of data and/or authorship of presentations or
manuscripts related to the research.)  
   b) Non-VCU sites that will be deferring to the VCU IRB for IRB review
   c) Non-VCU sites where VCU investigators will be overseeing study interventions or interactions
   d) Non-VCU sites/locations where VCU investigators will conduct study activities
2. * Select any of the following non-VCU sites utilized in this study:

McGuire VAMC

Foreign Sites

Other Non-VCU Sites

No Non-VCU Sites
3. * Is this a multi-center study being led by VCU?
  Yes No
4. For Non-VCU Sites: For each site or institution listed as "Site Engaged -- Requests to Rely on
VCU IRB Review," upload:
- Completed Local Context Form for Relying on VCU's IRB
- Site specific informed consent form(s)  and HIPAA authorization(s), if applicable
For Foreign Sites: For each Cultural Consultant upload a CV/Biosketch that includes a clear
description of cultural expertise:

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER
Consent
Form
Community-
based
recruitment
Community-based recruitment Project
BETTER Consent Form_clean IRB
10.25.pdf
0.05
11/7/2022
10:47 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Community-
based Study
Interest Form
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10/31/2022
4:01 PM
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HM20023314 Project BETTER RCT
SOP 10.31.22.docx
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Anna Parlier Research Protocol
Yes
View Project
BETTER
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based
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email
template
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Template.docx
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BETTER
Community-
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Project BETTER Community Remote
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Yes
View Project
BETTER
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flyer
Project BETTER Community-based
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Anna Parlier Recruitment/Advertising
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View Project
BETTER RA
Forms 3
Delivery
Questions
Project BETTER Study Visit 3 Delivery
Questions.docx
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2:33 PM
Anna Parlier Research Measure
Yes
View Eligibility
Form
Revised 7.18.22 Project BETTER
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0.02
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Anna Parlier Research Measure
Yes
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Script
Revised 7.18.22 Project BETTER In
Person Recruitment Scripts.docx
0.04
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Anna Parlier Recruitment/Advertising
Yes
View Remote
Recruitment
Script
Revised 7.18.22 Project BETTER
Remote Recruitment Scripts.docx
0.02
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Yes
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Flyer
Revised Project BETTER Flyer
7.18.22.docx
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Yes
View Consent
form
Project BETTER Consent
Form_revised 12.15.21.pdf
0.07
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10:35 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Informatics
consult
BETTER_Informatics_Email.pdf
0.01
12/3/2021
9:57 AM
Jessica
Lantz
Other
Not
Applicable
View PROC
APPROVAL
BETTER_PROC_Approval.pdf
0.01
11/17/2021
1:27 PM
Caitlin
Martin
Ancillary Committee
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Not
Applicable
View Study
Notification
Email
Template
Project BETTER Study Notification
Email Template.docx
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Yes
View Project
Better
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Transcript.docx
0.01
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Yes

 
Document
Name
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VersionDate
Modified
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By
Type
Approved
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Transcript
View Project
BETTER
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Video Links
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Yes
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BETTER
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Webpage
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Yes
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10/11/2021
7:41 PM
Anna Parlier Recruitment/Advertising
Yes
View RA forms 3
Project BETTER Study Visit 3 RA
Form.docx
0.01
10/11/2021
7:40 PM
Anna Parlier Research Measure
Yes
View RA forms 2
Project BETTER Study Visit 2 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View RA forms 1
Project BETTER Study Visit 1 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 2
Project BETTER Follow-up Survey
2.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 1
Project BETTER Follow-up Survey
1.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Pre-survey
Project BETTER Pre-Survey.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 3
Project BETTER Study Visit 3 Chart
Abstraction Form.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 2
Project BETTER Study Visit 2 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 1
Project BETTER Study Visit 1 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Scheduling
and
Reminder
Scripts
Project BETTER Follow Up Scheduling
and Reminders Scripts.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Follow up
visit scripts
Project BETTER Follow-up Visits
Script.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Martin CV
CEM_CV_08.15.21_BT.pdf
0.01
10/10/2021
9:23 PM
Caitlin
Martin
CV/Biosketch
Yes
View Parlier CV
Parlier CV .pdf
0.01
10/10/2021
5:44 PM
Anna Parlier CV/Biosketch
Not
Applicable

HM20023314
View: SF2 - Personnel
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Personnel
1. * List all VCU/VCUHS personnel who are key study personnel.
Key personnel are defined as including:
     - Conflict of interest investigators, including
     - the PI
     - the Lead Student/Trainee Investigator,
     - medically/Psychologically responsible investigator(s)
     - FDA Form 1572 investigators, and
     - Other personnel whose roles are essential to the conduct of the research.
Note: Individuals who are not key personnel are not required to be listed here, but PIs still bear the
responsibility to document the delegation of responsibilities in the study records.
PIs may elect to use the Study Roster activity button in RAMS-IRB (available after approval) as an alternative
way to document study staff involvement and delegation of responsibilities. Personnel changes made to the
non-key personnel listed in the separate Study Roster activity do not require an amendment.
 
Name Roles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
View Caitlin
Martin
Principal Investigator
 
Data Analysis
Project
Coordination
Participant
Identification
Study Design
 
Experience -
Research
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
View Anna
Parlier
Research Coordinator
 
Data Analysis
Project
Coordination
Participant
Consent
Data Management
Data Collection -
Clinical
Participant
Identification
Data Entry
Study Design
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
Student
 
no
View Andrea-
Kayle
Andaya
Research Assistant
 
Participant
Consent
Data Collection -
Clinical
Participant
Identification
 
Experience -
Research
Education
and/or
Professional
Preparation
 
no

 
Name Roles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
Data Entry
Participant
Recruitment
Data Collection -
Interviews/Surveys
View Sarah
Martin
Trainee/Student(working
on project)
 
Participant
Consent
Data Collection -
Clinical
Participant
Identification
Data Entry
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Clinical
Education
and/or
Professional
Preparation
Student
 
no
View Michelle
Eglovitch
Trainee/Student(working
on project)
 
Data Analysis
Participant
Consent
Data Management
Data Collection -
Clinical
Participant
Identification
Data Entry
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Education
and/or
Professional
Preparation
Student
 
no
View Dace
Svikis
Pickens
Co/Sub-Investigator
 
Study Design
 
Experience -
Research
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
2. Identify all independent investigators and key personnel at non-VCU sites who will be engaged
in this study AND who DO NOT have IRB approval for this study from their own institution.
 NameRoles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
There are no items to display
3. If independent investigators or community engaged investigators are listed above,describe the human subjects
training these individuals will complete and the process that will be used to ensure that all
persons assisting with the research are adequately informed about the protocol and their
research related duties and functions: 
4. * Upload a CV or Biosketch for the PI, Medically/Psychologically Responsible Investigators and
the lead Student/Trainee Investigators. Do not upload CVs or Biosketches for other individuals.

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER
Consent
Form
Community-
based
recruitment
Community-based recruitment Project
BETTER Consent Form_clean IRB
10.25.pdf
0.05
11/7/2022
10:47 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Community-
based Study
Interest Form
StudyInterest_ProjectBETTERCom.pdf 0.01
10/31/2022
4:01 PM
Anna Parlier Recruitment/Advertising
Yes
View SOP
HM20023314 Project BETTER RCT
SOP 10.31.22.docx
0.05
10/31/2022
3:59 PM
Anna Parlier Research Protocol
Yes
View Project
BETTER
Community-
based
recruitment
email
template
Project BETTER Community
Recruitment Study Notification Email
Template.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
script
Project BETTER Community Remote
Recruitment Scripts.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
flyer
Project BETTER Community-based
Flyer.docx
0.01
10/12/2022
5:00 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER RA
Forms 3
Delivery
Questions
Project BETTER Study Visit 3 Delivery
Questions.docx
0.01
10/5/2022
2:33 PM
Anna Parlier Research Measure
Yes
View Eligibility
Form
Revised 7.18.22 Project BETTER
Eligibility Form.docx
0.02
7/18/2022
5:45 PM
Anna Parlier Research Measure
Yes
View In-person
Recruitment
Script
Revised 7.18.22 Project BETTER In
Person Recruitment Scripts.docx
0.04
7/18/2022
5:44 PM
Anna Parlier Recruitment/Advertising
Yes
View Remote
Recruitment
Script
Revised 7.18.22 Project BETTER
Remote Recruitment Scripts.docx
0.02
7/18/2022
5:43 PM
Anna Parlier Recruitment/Advertising
Yes
View Recruitment
Flyer
Revised Project BETTER Flyer
7.18.22.docx
0.02
7/18/2022
5:41 PM
Anna Parlier Recruitment/Advertising
Yes
View Consent
form
Project BETTER Consent
Form_revised 12.15.21.pdf
0.07
12/21/2021
10:35 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Informatics
consult
BETTER_Informatics_Email.pdf
0.01
12/3/2021
9:57 AM
Jessica
Lantz
Other
Not
Applicable
View PROC
APPROVAL
BETTER_PROC_Approval.pdf
0.01
11/17/2021
1:27 PM
Caitlin
Martin
Ancillary Committee
Approval
Not
Applicable
View Study
Notification
Email
Template
Project BETTER Study Notification
Email Template.docx
0.01
11/17/2021
9:27 AM
Anna Parlier Recruitment/Advertising
Yes
View Project
Better
Project BETTER Peedy
Transcript.docx
0.01
11/17/2021
9:24 AM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
Module
Transcript
View Project
BETTER
Module
Video Links
Project BETTER Video Links.docx
0.01
11/15/2021
12:02 PM
Anna Parlier Other
Yes
View Project
BETTER
Brochure
Webpage
Project BETTER Webpage.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Project
BETTER
Overview
Project BETTER Technology-based
Program Overview.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Technology-
based
modules
Project BETTER Technology-based
module links.docx
0.01
10/11/2021
7:42 PM
Anna Parlier Other
Yes
View Brochure
Project BETTER Brochure.pdf
0.01
10/11/2021
7:41 PM
Anna Parlier Research Measure
Yes
View Demographic
questions
Project BETTER Demographic
Questions .docx
0.01
10/11/2021
7:41 PM
Anna Parlier Recruitment/Advertising
Yes
View RA forms 3
Project BETTER Study Visit 3 RA
Form.docx
0.01
10/11/2021
7:40 PM
Anna Parlier Research Measure
Yes
View RA forms 2
Project BETTER Study Visit 2 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View RA forms 1
Project BETTER Study Visit 1 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 2
Project BETTER Follow-up Survey
2.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 1
Project BETTER Follow-up Survey
1.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Pre-survey
Project BETTER Pre-Survey.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 3
Project BETTER Study Visit 3 Chart
Abstraction Form.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 2
Project BETTER Study Visit 2 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 1
Project BETTER Study Visit 1 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Scheduling
and
Reminder
Scripts
Project BETTER Follow Up Scheduling
and Reminders Scripts.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Follow up
visit scripts
Project BETTER Follow-up Visits
Script.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Martin CV
CEM_CV_08.15.21_BT.pdf
0.01
10/10/2021
9:23 PM
Caitlin
Martin
CV/Biosketch
Yes
View Parlier CV
Parlier CV .pdf
0.01
10/10/2021
5:44 PM
Anna Parlier CV/Biosketch
Not
Applicable
 

HM20023314
View: SF2 - Conflict of Interest
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Conflict of Interest
The PI should ask the questions on this page of all research personnel who are engaged in the research, including
subrecipient investigators and personnel. 
1. * To the best of your knowledge, do you (as PI) or any other engaged individual have a financial
interest related to this study?
Financial interest include utilizing your licensed intellectual property in the study; serving as a
paid consultant, or advisory board member, or officer/director with a related entity; and equity
or business ownership in a company that is related to this project
  Yes No
2. * To the best of your knowledge, do you (as PI) or any other engaged individual have a non-
financial interest related to this study?
Non-financial Interests could include such things as:
- utilizing your unlicensed intellectual property in the study,
- serving as an unpaid advisory board member or officer/director with a related entity, and
- equity or business ownership in a company that has yet to make a profit and is related to this
project
- conflict of time/effort,
- personal and professional relationships/affiliations,
- intellectual passions or personal beliefs
- other factors that could create bias in the study
  Yes No
3. Describe any institutional conflict of interest that you or any member of the research team are aware of that
pertains to this research:
 An institutional conflict of interest is a situation in which financial interests of the University or University
leadership may affect research activities at VCU.
N/A
 

HM20023314
View: SF2 - Other VCU Requirementsv2
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Other VCU Requirements
This page asks questions on behalf of other ancillary offices, committees and departments at VCU regarding
institutional requirements that could apply to this research. In some cases, these requirements could also
impact the consent process or other aspects of the IRB's review.
Based upon answers provided earlier in this form, certain ancillary sections below may not have questions
displayed if those requirements are not applicable to this study.
1. Cost Coverage Analysis
         Information on coverage analysis requirements and processes can be found through VCU’s Clinical
Research Compliance Program at https://research.vcu.edu/human-research/clinical-research/vcu-clinical-research-
coverage-analysis/ 
 
1. * VCU requires that all clinical research studies be evaluated to determine if a Coverage
Analysis is required. Has your study been evaluated by an institutionally designated
Coverage Analysis Specialist?
Yes
No
Not Applicable
 
2. ClinicalTrials.gov Program & OnCore
For guidance, see https://cctr.vcu.edu/support/consultation/clinical-trials-gov/ or email CCTRCTGOV@vcu.edu
1. * Is this a Clinical Trial?
  Yes No 
2. * ThePI acknowledges awareness of the following requirements for posting clinical trial
consent forms:
 
  - Each clinical trial under the 2018 Common Rule that is conducted or supported by a Federal
department or agency must post one IRB-approved consent form that was used to enroll subjects on a
publicly available Federal website [45 CFR 46.116(h)].
  - When engaged in multi-site research, the VCU PI is responsible for confirming with the lead site who
is responsible for posting the informed consent form.
  - When VCU is the lead site, the VCU PI is responsible for posting the informed consent form (unless
the federal department or agency will post it).
  Yes No 
3. Community Engagement
For more information, see https://community.vcu.edu/
1. * Is this a community engaged research study? (See help text for definitions)
  Yes
No
 
4. Family Educational Rights and Privacy Act (FERPA) Requirements
For guidance, see  https://rar.vcu.edu/records/family-educational-rights-and-privacy-act/
1. * Does this study involve obtaining information from VCU students' educational records
(see help text)?
  Yes
No

5. Research Data Privacy Requirements
Contact the VCU Research Data Privacy Office with questions: https://research.vcu.edu/integrity-and-
compliance/compliance/research-data-privacy/
1. * Does this study involve the VCU site (regardless of the IRB of record), or any sites under
the VCU IRB'’s oversight, obtaining data in, or from, a foreign country? 
  Yes No   
 
6. Information Security
For guidance, see https://ts.vcu.edu/askit/essential-computing/information-security/
1. * Using the VCU Data Classification Tool, please determine the appropriate data
classification category for the data that will be collected or used in this research.
Note: if the data falls into Category 1, a data security management plan is required by University
Information Security Office.
See help text for information on accessing the VCU Data Classification Tool, and for information on
creating a data security management plan at https://dms.vcu.edu.
Category 1: all data that require breach notifications in the event of improper release, including
personally identifiable information covered by HIPAA and Commonwealth of Virginia regulations.
Category 2: all proprietary data that if improperly released has the potential to cause harm to the
institution, its mission or its reputation that do not require breach notifications.
2. * I confirm use of the VCU Data Classification Tool at https://go.vcu.edu/dataclassification in
determining the data classification category selected in Question 1:
  Yes
No
3. * The PI is aware that if the study’s data is classified as Category 1, a Data Management
Plan must be submitted to and approved by VCU Information Security prior to IRB
approval. See https://ts.vcu.edu/askit/essential-computing/information-security/data-management-system/
  Yes No  
 
4. * I confirm that any use of external technology has been submitted to Information
Security in the study’s Data Management Plan. If this study uses any technology
platforms, apps, services, etc. that are maintained external to VCU or hosted by another
institution and are NOT currently listed in the DMS system as an approved service for the
storage, processing, or transmission of VCU data, I am required to have VCU Information
Security conduct a security review of that technology. I may contact infosec@vcu.edu
with questions.
I also confirm that if the study involves use of external technology and VCUHS HIPAA
data, I must also seek security review from the VCUHS Data Governance group (contact
Mary Harmon at mary.harmon@vcuhealth.org):
Yes
No
N/A - not using external technology
7. Massey Cancer Center Protocol Review and Monitoring Committee (PRMC)
For guidance, see https://www.masseycancercenter.org/research/~/link.aspx?
_id=ee49e95faa8b44d09b6e89d8e3b48b57&_z=z
1. * Does this study involve any of the following?
- Research involving patients with cancer, their families or their health care providers
- Research involving cancer screening, diagnosis or prevention
- Secondary data collected from cancer patients or their medical records
- Cancer-related surveys (e.g., attitudes about risk, prevention and treatment) of the

general population
  Yes
No
8. VCU ONETRAC Protocol Review Oversight Committees (PROCs) For guidance, see https://onetrac.vcu.edu/
1. * Does this study involve research with any of the following?
- VCU Health System patients
- VCU Health System facilities
- VCU Health System data   Yes
No
 
 If Yes, upload documentation of approval or review by the PROC or PRMC in this study’s topic area. If
you do not have PROC or PRMC approval, please visit onetrac.vcu.edu for additional information and
to submit your project for review.
 
9. VCU Health Department of Patient Centered Services
 
1. * Does your study involve a satisfaction survey  administered to VCUHS patients (*See
Help Text):
Yes
No
Not Applicable
10. VCU Faculty-Held IND or IDE
For guidance, see https://research.vcu.edu/human-research/regulatory-affairs/.
Questions related to if you need an IND or IDE for your study should be emailed to: indide@vcu.edu. Please submit a
copy of your FDA 
submission prior to submitting to the FDA to https://redcap.vcu.edu/surveys/?s=NR7K7LR4JW.
11. VCU Health System locations
1. * Will research activities occur in patient care areas of the VCU Health System (including
at CHoR, Community Memorial Hospital, Tappahannock Hospital, VCU Medical Center and
Massey Cancer Center)?
  Yes
No
2. * The PI has reviewed and agreed to comply with the  VCU Health System Research in
Patient Care Areas policy (https://research.vcu.edu/compliance_program/vcuhs_policies.htm):
  Yes
No
12. VCUHS Department of Pathology
Learn more about requesting and establishing an account with Pathology here:  See
https://pathology.vcu.edu/research-services/
1. * I have contacted VCUHS Department of Pathology to determine feasibility if my study
involves the following: 
- Storage of Microbiology isolates
- New instrumentation provided by clinical trial/study sponsor, or 
- Non-routine specimen processing (examples include but aren’t limited to the following:
addition of reagents to samples/aliquots, buffy coat processing, DNA sample processing)
Yes

No
N/A - my study does not involve any of the listed processes.
2. * If my study involves specimen retrieval from the Pathology laboratory, I have established
a process with Pathology to deidentify and retrieve specimens.
Yes
No
N/A - my study won't involve specimen retrieval from Pathology
 
 
13. VCU Institutional Biosafety Committee (IBC)
To contact the Biosafety Office see their website at:  https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/
1. * Does this project involve any of the following hazardous biological agents
(<biohazardous agents=) that have NOT been FDA approved? These may include, but are
not limited to, any of the following. If you are unsure, please contact the Biosafety Office:
       - Any functional recombinant viruses (especially viruses that may integrate into the
patients’ genome).
       - Expression or administration of biological toxins.
       - Live pathogenic or potentially pathogenic organisms of plants or animals (bacteria,
fungi, wild-type viruses, parasites, etc.), that are, or potentially may be, in experimental
products.
       - Introduction or expression of rDNA or synthetic nucleic acids
       - Use of a product (e.g., monoclonal antibodies, recombinant cytokines) produced
from virally infected mammalian cells.
       - Use of a product (purified growth factors, cytokines) produced from mammals or
their cells.
  Yes No
 
 
14. VCU Radiation Safety Committee (RSC)
To contact the Radiation Safety Section see their website at: https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/ 
1. * Does this study involve radiation exposure and/or scans involving radiation (e.g.: PET,
MRA, CT, DXA, nuclear medicine, etc.)?
  Yes
No
           
15. VCU Scientific Review Committee (SRC)
For guidance, see https://cctr.vcu.edu/support/consultation/scientific-review-committee/
1. * Has this human subjects protocol (not the grant application) already been reviewed by
the funder of a sponsored project (e.g. a federal, state or non-profit funding sponsor)?
  Yes
No
16. Upload any documents requested in the questions above:

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER
Consent
Form
Community-
based
recruitment
Community-based recruitment Project
BETTER Consent Form_clean IRB
10.25.pdf
0.05
11/7/2022
10:47 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Community-
based Study
Interest Form
StudyInterest_ProjectBETTERCom.pdf 0.01
10/31/2022
4:01 PM
Anna Parlier Recruitment/Advertising
Yes
View SOP
HM20023314 Project BETTER RCT
SOP 10.31.22.docx
0.05
10/31/2022
3:59 PM
Anna Parlier Research Protocol
Yes
View Project
BETTER
Community-
based
recruitment
email
template
Project BETTER Community
Recruitment Study Notification Email
Template.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
script
Project BETTER Community Remote
Recruitment Scripts.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
flyer
Project BETTER Community-based
Flyer.docx
0.01
10/12/2022
5:00 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER RA
Forms 3
Delivery
Questions
Project BETTER Study Visit 3 Delivery
Questions.docx
0.01
10/5/2022
2:33 PM
Anna Parlier Research Measure
Yes
View Eligibility
Form
Revised 7.18.22 Project BETTER
Eligibility Form.docx
0.02
7/18/2022
5:45 PM
Anna Parlier Research Measure
Yes
View In-person
Recruitment
Script
Revised 7.18.22 Project BETTER In
Person Recruitment Scripts.docx
0.04
7/18/2022
5:44 PM
Anna Parlier Recruitment/Advertising
Yes
View Remote
Recruitment
Script
Revised 7.18.22 Project BETTER
Remote Recruitment Scripts.docx
0.02
7/18/2022
5:43 PM
Anna Parlier Recruitment/Advertising
Yes
View Recruitment
Flyer
Revised Project BETTER Flyer
7.18.22.docx
0.02
7/18/2022
5:41 PM
Anna Parlier Recruitment/Advertising
Yes
View Consent
form
Project BETTER Consent
Form_revised 12.15.21.pdf
0.07
12/21/2021
10:35 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Informatics
consult
BETTER_Informatics_Email.pdf
0.01
12/3/2021
9:57 AM
Jessica
Lantz
Other
Not
Applicable
View PROC
APPROVAL
BETTER_PROC_Approval.pdf
0.01
11/17/2021
1:27 PM
Caitlin
Martin
Ancillary Committee
Approval
Not
Applicable
View Study
Notification
Email
Template
Project BETTER Study Notification
Email Template.docx
0.01
11/17/2021
9:27 AM
Anna Parlier Recruitment/Advertising
Yes
View Project
Better
Project BETTER Peedy
Transcript.docx
0.01
11/17/2021
9:24 AM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
Module
Transcript
View Project
BETTER
Module
Video Links
Project BETTER Video Links.docx
0.01
11/15/2021
12:02 PM
Anna Parlier Other
Yes
View Project
BETTER
Brochure
Webpage
Project BETTER Webpage.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Project
BETTER
Overview
Project BETTER Technology-based
Program Overview.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Technology-
based
modules
Project BETTER Technology-based
module links.docx
0.01
10/11/2021
7:42 PM
Anna Parlier Other
Yes
View Brochure
Project BETTER Brochure.pdf
0.01
10/11/2021
7:41 PM
Anna Parlier Research Measure
Yes
View Demographic
questions
Project BETTER Demographic
Questions .docx
0.01
10/11/2021
7:41 PM
Anna Parlier Recruitment/Advertising
Yes
View RA forms 3
Project BETTER Study Visit 3 RA
Form.docx
0.01
10/11/2021
7:40 PM
Anna Parlier Research Measure
Yes
View RA forms 2
Project BETTER Study Visit 2 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View RA forms 1
Project BETTER Study Visit 1 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 2
Project BETTER Follow-up Survey
2.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 1
Project BETTER Follow-up Survey
1.docx
0.01
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7:39 PM
Anna Parlier Research Measure
Yes
View Pre-survey
Project BETTER Pre-Survey.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 3
Project BETTER Study Visit 3 Chart
Abstraction Form.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 2
Project BETTER Study Visit 2 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 1
Project BETTER Study Visit 1 Chart
Abstraction Form.docx
0.01
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7:37 PM
Anna Parlier Research Measure
Yes
View Scheduling
and
Reminder
Scripts
Project BETTER Follow Up Scheduling
and Reminders Scripts.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Follow up
visit scripts
Project BETTER Follow-up Visits
Script.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Martin CV
CEM_CV_08.15.21_BT.pdf
0.01
10/10/2021
9:23 PM
Caitlin
Martin
CV/Biosketch
Yes
View Parlier CV
Parlier CV .pdf
0.01
10/10/2021
5:44 PM
Anna Parlier CV/Biosketch
Not
Applicable

HM20023314
View: SF2 - HIPAA
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
HIPAA
In order for VCUHS to meet HIPAA regulations regarding accounting of disclosures, data retention, and data destruction
requirements for PHI data obtained without patient authorization, members of the study team (including principal investigators)
are directed to consult with VCU Informatics to obtain any VCUHS data. This does not include obtaining data for which the
study team has patient authorization. [VCU Health System Authority and Affiliates Policy COMP-014] 
For data requests, including preparatory to research and research with decedents, submit a request for the desired PHI, or for
a consultation on alternate methods to obtain the data, at https://informatics.vcu.edu.
HIPAA Privacy Board Requirements
       For guidance, see https://www.vcuhealth.org/our-story/who-we-are/compliance-services/compliance-services
1. * Select the source of the Individually Identifiable Health Information. See help text for
definitions.

PHI associated with or derived from (i.e. obtained from or entered into) VCU Health medical records or
VCU Dental Care records

Research Health Information (RHI) created or received by a study and kept solely in study records (e.g.
self reported or the result of research tests and not entered into health records)

PHI associated with or derived from (i.e. obtained from or entered into) a non-VCU HIPAA covered entity9s health
records
2. * Summarize the types of health information that will be obtained or used in this research. Do
not describe only the identifiers that you will collect or use during the study.
For OB MOTIVATE patients: Medical record data will be abstracted for each participant including physician notes (e.g.,
substance use and treatment history) and test results (e.g., urine drug testing). All medical record chart abstraction
items are included in the attached chart abstraction forms. Each participant9s study ID will be linked with patient
identifiers in a key kept in a secure database to facilitate this data abstraction.
Phone numbers and email addresses will be used to contact participants to schedule and complete study visits.
Community-based addiction treatment: All health information will be self-reported by participants using surveys and
RA-led questions.
3. * Describe the source(s) of the protected health information (e.g. Informatics or which clinical
databases):
OB MOTIVATE patients: The source will be VCU Cerner/EPIC electronic medical record.
Community-based addiction treatment: Participant self report
4. * Does the PI certify that this study's access to and use of the protected health information is
limited to the minimum amount necessary to be able to effectively conduct the research?
  Yes No 
5. * Select all pathways this research will employ to use or access PHI  (selections will branch):

De-Identified Data (none of the 18 identifiers are recorded or associated with the research data)

Limited Data Set

Waiver of Authorization

Partial Waiver of Authorization (temporary waiver for recruitment purposes and/or waiver of some
elements of Authorization)

Signed Authorization Combined with Consent Form

Signed Authorization as Stand-Alone Form
 
 

HM20023314
View: SF2 - Partial Waiver of Authorization
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Partial Waiver of Authorization
1. * Select the purpose for requesting the partial waiver of authorization:

Identify possible participants to recruit for the study

Waive some elements of authorization (such as signature)
2. * If you selected "Waive some elements of authorization" above, list the elements you want to
waive (see the help text) and explain why:
Signatures are requesting to be waived to facilitate remote study procedures, such as consent, and to utilize IRB
approved REDCap e-consent procedures. A signature will be obtained from participants recruited and completing
research procedures in person.
3. * Explain how the partial waiver of authorization poses no greater than minimal risk to
participants' privacy:
(Alternative question phrasing: How do the risk(s) of this use of identifiable health information
compare to the risks to privacy a person might reasonably experience in normal everyday life?).
Regarding waiving the signature, participants are provided with all other elements of HIPAA authorization in their
informed consent process, and their PHI remains protected as described in the authorization, regardless of whether a
signature is obtained.
OB MOTIVATE patients: Regarding the partial waiver to review the clinic schedules and medical record for basic
eligibility criteria, in order to approach eligible participants in their private exam rooms (or over the phone in case of
virtual apts), this will pose no greater than minimal risk to participants' privacy - first the RA is part of the study team
and no information about the potential participant will be shared, second all patients coming to the OB MOTIVATE clinic
have a substance use disorder so the RA reviewing the schedule for potential participants would not reveal anything
new about their alcohol/drug use history given that is already the 'norm' at the OB MOTIVATE clinics.
4. * If you selected "Identify possible participants to recruit" above,  describe when will the 18
HIPAA identifiers be destroyed for those who do not eventually enroll in the study?

Following Participant Contact

Upon Reaching Study Accrual Objectives

Other
 
5. * Other than the PI and research personnel identified in this research application, who else will
have access to the Protected Health Information?
None.
6. * Explain why the study cannot practicably be conducted without the partial waiver of
authorization:
(Alternative question phrasing: Why is this partial waiver necessary to make the study achievable or viable?)
Waiving the signature on the consent form is necessary to make the study practical and feasible for study participants
to complete all study procedures remotely. A signature will be obtained from participants recruited and completing
research procedures in person.
OB MOTIVATE patients: In order to approach potential participants while they are in a private area, in their exam
rooms while presenting for routine prenatal care or over the phone (eg, if the potential participant had a virtual apt with
their provider), the clinic schedule will need to be assessed so participants are not screened for eligibility in the public
waiting area space. Also, the study would not be achievable if the RA had to approach every patient presenting to the
OB MOTIVATE clinic, as that would take substantial time and effort; review of the clinic schedule and medical record
(solely for eligibility criteria) will allow the RA to only approach potentially eligible participants, making the study
feasible.
7. * In applying for a partial waiver of authorization, the PI agrees to the following:
A)  The identifiers used for this research study will not be used for any other purpose or
disclosed to any other person or entity (aside from members of the research team identified in
this application), except as required by law.

B)  If at any time I want to reuse this information for other purposes or disclose the information
to other individuals, I will seek approval from the IRB/Privacy Board.
C)  I will comply with VCU HIPAA policies and procedures and to the use and disclosure
restrictions described above. 
D)  I assume responsibility for all uses and disclosures of the PHI by members of my study
team.
  Yes
No
 

HM20023314
View: SF2 - Institutional Requirements Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Institutional Requirements Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
| POPULATIONS WITH SPECIAL CONSIDERATIONS
} INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
 
Click Continue below to go to the next section
  

HM20023314
View: SF2 - Documents
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Documents
1. Upload any documents that the VCU IRB will need to conduct a review of this submission:
A list of potential documents is given in the help text.
NOTE: The delete function should only be used if an incorrect document is uploaded or added to the system AND that
document has not been reviewed and approved by the IRB. Do NOT delete documents that the IRB previously
reviewed and approved.
Once you have uploaded a document to RAMS-IRB, any changes to that document (i.e. different
versions of the same document) should be added to the IRB submission by using the Update
button. To provide updated documents, follow these steps:
  - Click the Update button located to the left of the document to be updated.
  - In the Add Document window, click the Choose File or Browse button, select the file you are adding, and
click on the Open button.
  - Click OK to close the Add Document window, and the system will upload the revised document. RAMS-IRB
will automatically provide a version number for the document.
To access previous versions of a document in RAMS-IRB you must use the History link
associated with the document.
- Click the View or Update button located to the left of the document you wish to access.
- In the Add/View Document window, click the "History" hyperlink located to the right of the file name.
- A separate window will open that shows all versions of the document that have been added to RAMS-IRB.
Click on any file name to download and view the document.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER
Consent
Form
Community-
based
recruitment
Community-based recruitment Project
BETTER Consent Form_clean IRB
10.25.pdf
0.05
11/7/2022
10:47 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Community-
based Study
Interest Form
StudyInterest_ProjectBETTERCom.pdf 0.01
10/31/2022
4:01 PM
Anna Parlier Recruitment/Advertising
Yes
View SOP
HM20023314 Project BETTER RCT
SOP 10.31.22.docx
0.05
10/31/2022
3:59 PM
Anna Parlier Research Protocol
Yes
View Project
BETTER
Community-
based
recruitment
email
template
Project BETTER Community
Recruitment Study Notification Email
Template.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
script
Project BETTER Community Remote
Recruitment Scripts.docx
0.01
10/31/2022
3:58 PM
Anna Parlier Recruitment/Advertising
Yes
View Project
BETTER
Community-
based
recruitment
flyer
Project BETTER Community-based
Flyer.docx
0.01
10/12/2022
5:00 PM
Anna Parlier Recruitment/Advertising
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Project
BETTER RA
Forms 3
Delivery
Questions
Project BETTER Study Visit 3 Delivery
Questions.docx
0.01
10/5/2022
2:33 PM
Anna Parlier Research Measure
Yes
View Eligibility
Form
Revised 7.18.22 Project BETTER
Eligibility Form.docx
0.02
7/18/2022
5:45 PM
Anna Parlier Research Measure
Yes
View In-person
Recruitment
Script
Revised 7.18.22 Project BETTER In
Person Recruitment Scripts.docx
0.04
7/18/2022
5:44 PM
Anna Parlier Recruitment/Advertising
Yes
View Remote
Recruitment
Script
Revised 7.18.22 Project BETTER
Remote Recruitment Scripts.docx
0.02
7/18/2022
5:43 PM
Anna Parlier Recruitment/Advertising
Yes
View Recruitment
Flyer
Revised Project BETTER Flyer
7.18.22.docx
0.02
7/18/2022
5:41 PM
Anna Parlier Recruitment/Advertising
Yes
View Consent
form
Project BETTER Consent
Form_revised 12.15.21.pdf
0.07
12/21/2021
10:35 AM
Anna Parlier Consent/Assent/Information
Sheet
Yes
View Informatics
consult
BETTER_Informatics_Email.pdf
0.01
12/3/2021
9:57 AM
Jessica
Lantz
Other
Not
Applicable
View PROC
APPROVAL
BETTER_PROC_Approval.pdf
0.01
11/17/2021
1:27 PM
Caitlin
Martin
Ancillary Committee
Approval
Not
Applicable
View Study
Notification
Email
Template
Project BETTER Study Notification
Email Template.docx
0.01
11/17/2021
9:27 AM
Anna Parlier Recruitment/Advertising
Yes
View Project
Better
Module
Transcript
Project BETTER Peedy
Transcript.docx
0.01
11/17/2021
9:24 AM
Anna Parlier Research Measure
Yes
View Project
BETTER
Module
Video Links
Project BETTER Video Links.docx
0.01
11/15/2021
12:02 PM
Anna Parlier Other
Yes
View Project
BETTER
Brochure
Webpage
Project BETTER Webpage.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Project
BETTER
Overview
Project BETTER Technology-based
Program Overview.pdf
0.01
11/15/2021
12:01 PM
Anna Parlier Other
Yes
View Technology-
based
modules
Project BETTER Technology-based
module links.docx
0.01
10/11/2021
7:42 PM
Anna Parlier Other
Yes
View Brochure
Project BETTER Brochure.pdf
0.01
10/11/2021
7:41 PM
Anna Parlier Research Measure
Yes
View Demographic
questions
Project BETTER Demographic
Questions .docx
0.01
10/11/2021
7:41 PM
Anna Parlier Recruitment/Advertising
Yes
View RA forms 3
Project BETTER Study Visit 3 RA
Form.docx
0.01
10/11/2021
7:40 PM
Anna Parlier Research Measure
Yes
View RA forms 2
Project BETTER Study Visit 2 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View RA forms 1
Project BETTER Study Visit 1 RA
Form.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Follow up
survey 2
Project BETTER Follow-up Survey
2.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Follow up
survey 1
Project BETTER Follow-up Survey
1.docx
0.01
10/11/2021
7:39 PM
Anna Parlier Research Measure
Yes
View Pre-survey
Project BETTER Pre-Survey.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 3
Project BETTER Study Visit 3 Chart
Abstraction Form.docx
0.01
10/11/2021
7:38 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 2
Project BETTER Study Visit 2 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Chart
abstraction
form 1
Project BETTER Study Visit 1 Chart
Abstraction Form.docx
0.01
10/11/2021
7:37 PM
Anna Parlier Research Measure
Yes
View Scheduling
and
Reminder
Scripts
Project BETTER Follow Up Scheduling
and Reminders Scripts.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Follow up
visit scripts
Project BETTER Follow-up Visits
Script.docx
0.01
10/11/2021
7:36 PM
Anna Parlier Study
reminders/communications
Yes
View Martin CV
CEM_CV_08.15.21_BT.pdf
0.01
10/10/2021
9:23 PM
Caitlin
Martin
CV/Biosketch
Yes
View Parlier CV
Parlier CV .pdf
0.01
10/10/2021
5:44 PM
Anna Parlier CV/Biosketch
Not
Applicable

HM20023314
View: SF2 - Documents Complete
ID: HM20023314
HM20023314 - Caitlin Martin
Project BETTER: Bringing Education Through Technology, Empathic listening, and Research - A Feasibility Randomized Controlled Trial
  
Documents Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
| POPULATIONS WITH SPECIAL CONSIDERATIONS
} INSTITUTIONAL REQUIREMENTS
~ DOCUMENTS
End of Application
Click Continue below to exit and submit this project
  

HM20023314
View: Personnel
ID: HM20023314
  
Personnel
1. * Name:
Caitlin Martin
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Yes
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
 

HM20023314
View: Personnel
ID: HM20023314
  
Personnel
1. * Name:
Anna Parlier
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
 

HM20023314
View: Personnel
ID: HM20023314
  
Personnel
1. * Name:
Andrea-Kayle Andaya
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
 

HM20023314
View: Personnel
ID: HM20023314
  
Personnel
1. * Name:
Sarah Martin
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
 

HM20023314
View: Personnel
ID: HM20023314
  
Personnel
1. * Name:
Michelle Eglovitch
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
 

HM20023314
View: Personnel
ID: HM20023314
  
Personnel
1. * Name:
Dace Svikis Pickens
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

 

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER Consent Form Community-based recruitment
2. * Type:
Consent/Assent/Information Sheet
3. * File:

Community-based recruitment Project BETTER Consent Form_clean IRB 10.25.pdf(0.05)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Community-based Study Interest Form
2. * Type:
Recruitment/Advertising
3. * File:

StudyInterest_ProjectBETTERCom.pdf(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
SOP
2. * Type:
Research Protocol
3. * File:
HM20023314 Project BETTER RCT SOP 10.31.22.docx(0.05)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER Community-based recruitment email template
2. * Type:
Recruitment/Advertising
3. * File:
Project BETTER Community Recruitment Study Notification Email Template.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER Community-based recruitment script
2. * Type:
Recruitment/Advertising
3. * File:
Project BETTER Community Remote Recruitment Scripts.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER Community-based recruitment flyer
2. * Type:
Recruitment/Advertising
3. * File:
Project BETTER Community-based Flyer.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER RA Forms 3 Delivery Questions
2. * Type:
Research Measure
3. * File:
Project BETTER Study Visit 3 Delivery Questions.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Eligibility Form
2. * Type:
Research Measure
3. * File:
Revised 7.18.22 Project BETTER Eligibility Form.docx(0.02)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
In-person Recruitment Script
2. * Type:
Recruitment/Advertising
3. * File:
Revised 7.18.22 Project BETTER In Person Recruitment Scripts.docx(0.04)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Remote Recruitment Script
2. * Type:
Recruitment/Advertising
3. * File:
Revised 7.18.22 Project BETTER Remote Recruitment Scripts.docx(0.02)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Recruitment Flyer
2. * Type:
Recruitment/Advertising
3. * File:
Revised Project BETTER Flyer 7.18.22.docx(0.02)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Consent form
2. * Type:
Consent/Assent/Information Sheet
3. * File:

Project BETTER Consent Form_revised 12.15.21.pdf(0.07)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Informatics consult
2. * Type:
Other
3. * File:

BETTER_Informatics_Email.pdf(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
PROC APPROVAL
2. * Type:
Ancillary Committee Approval
3. * File:

BETTER_PROC_Approval.pdf(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Study Notification Email Template
2. * Type:
Recruitment/Advertising
3. * File:
Project BETTER Study Notification Email Template.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project Better Module Transcript
2. * Type:
Research Measure
3. * File:
Project BETTER Peedy Transcript.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER Module Video Links
2. * Type:
Other
3. * File:
Project BETTER Video Links.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER Brochure Webpage
2. * Type:
Other
3. * File:

Project BETTER Webpage.pdf(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Project BETTER Overview
2. * Type:
Other
3. * File:

Project BETTER Technology-based Program Overview.pdf(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Technology-based modules
2. * Type:
Other
3. * File:
Project BETTER Technology-based module links.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Brochure
2. * Type:
Research Measure
3. * File:

Project BETTER Brochure.pdf(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Demographic questions
2. * Type:
Recruitment/Advertising
3. * File:
Project BETTER Demographic Questions .docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
RA forms 3
2. * Type:
Research Measure
3. * File:
Project BETTER Study Visit 3 RA Form.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
RA forms 2
2. * Type:
Research Measure
3. * File:
Project BETTER Study Visit 2 RA Form.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
RA forms 1
2. * Type:
Research Measure
3. * File:
Project BETTER Study Visit 1 RA Form.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Follow up survey 2
2. * Type:
Research Measure
3. * File:
Project BETTER Follow-up Survey 2.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Follow up survey 1
2. * Type:
Research Measure
3. * File:
Project BETTER Follow-up Survey 1.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Pre-survey
2. * Type:
Research Measure
3. * File:
Project BETTER Pre-Survey.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Chart abstraction form 3
2. * Type:
Research Measure
3. * File:
Project BETTER Study Visit 3 Chart Abstraction Form.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Chart abstraction form 2
2. * Type:
Research Measure
3. * File:
Project BETTER Study Visit 2 Chart Abstraction Form.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Chart abstraction form 1
2. * Type:
Research Measure
3. * File:
Project BETTER Study Visit 1 Chart Abstraction Form.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Scheduling and Reminder Scripts
2. * Type:
Study reminders/communications
3. * File:
Project BETTER Follow Up Scheduling and Reminders Scripts.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Follow up visit scripts
2. * Type:
Study reminders/communications
3. * File:
Project BETTER Follow-up Visits Script.docx(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Martin CV
2. * Type:
CV/Biosketch
3. * File:

CEM_CV_08.15.21_BT.pdf(0.01)   
 

HM20023314
View: SF_IRB_Summary_Document
ID: HM20023314
Add Document
1. * Document Name:
Parlier CV
2. * Type:
CV/Biosketch
3. * File:

Parlier CV .pdf(0.01)