Teledermatology Mobile Apps: Implementation and Impact on Veterans' Access to Dermatology
Conditions: Introduction of Teledermatology Mobile Apps
Sponsor: VA Office of Research and Development

Study Application (Version 1.14)
1.0
General Information
*Enter the full title of your study:
Teledermatology mobile apps: Implementation and impact on Veterans' access to dermatology
*Enter the study number or study alias
Telederm Mobile Apps
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.
2.0
Add Department(s)
2.1 List the departments associated with this study. The Principal Investigator's department 
should be Primary.:
Primary 
Dept?
Department Name
UCSF - 
 - M_Dermatology
131020
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
Oh, Dennis H
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
3.2 If applicable, please select the Research Staff personnel:
A) Additional Investigators
B) Research Support Staff
Lachica, Olevie T 
Research Assistant
Peracca, Sara 
Study Coordinator
N
10/12/2021
NCT03241589

3.3 *Please add a Study Contact:
Oh, Dennis H 
Peracca, Sara 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
3.5 If applicable, please select the Designated Department Approval(s):
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
Initial Screening Questions 
Updated January 2019 - Revised Common Rule (January 2018) Compliant - v92
4.1  *
:
PROJECT SUMMARY  (REQUIRED) Give a brief overview of this project (250 words or less). Tell us
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH
Abstract, paste it here (Click on the orange question mark to the right for more detailed instructions):
VA’s Office of Connected Care has developed two mobile apps for teledermatology – VA Telederm and My 
Telederm.  The proposed research will test the hypothesis that successful implementation of each app 
enhances access of Veterans to dermatologic care. Each mobile app will be rolled out in a stepped wedge 
cluster randomized trial design to sites most likely to benefit.  Outcomes  will be compared for sites that 
have received an app to those that have not yet received it.  
 
Aim 1 (not the focus of this IRB 
 will test the hypothesis by measuring access to skin care as well as total instances of 
application)
care.  The data resides in VA's Corporate Data Warehouse, and will be obtained by VA's Center for Access 
Policy, Evaluation and Research under its own IRB application, and shared with the PI and other 
investigators.  
will examine factors that affect 
Aim 2 (which is the focus of this IRB application) 
successful implementation and impact of each app. Investigators at San Francisco, Providence, and 
Durham VA Medical Centers will conduct formative evaluations at 3 pilot sites for each app to 
determine characteristics that correlate with implementation of the apps. In addition, using nationally and 
remotely available enterprise-wide data, we will measure implementation and adoption of apps at all 
participating sites. At the end of the study, the research will have documented mobile teledermatology’s 
effectiveness in enhancing access to dermatology, and enhance understanding of the factors leading to 
successful mobile telehealth implementation.
4.2  
 
*
:
HUD DEVICE (REQUIRED) 
 
Does this application involve a Humanitarian Use Device (HUD):
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  *
: 
TYPE OF RESEARCH (REQUIRED) 
(
Select the option that best fits your project Click the orange
question mark to the right for definitions and guidance):
Biomedical research (including medical records review, biospecimen collection and/or use, other 
healthcare or health outcomes related activities, research database, biospecimen bank, or recruitment 
registry) 

Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is mainly social
/behavioral but also involves specimen collection or blood draws to look at biological measures) 
4.4  *
 
SUBJECT CONTACT: (REQUIRED) Does this study involve 
 contact or interactions with
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  * RISK LEVEL: (REQUIRED) What is your estimation of the risk level, including all screening
:
procedures and study activities
Minimal risk 
Greater than minimal risk 
4.6  * REVIEW LEVEL: (REQUIRED) Requested review level (Click on the orange question mark to the
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 
4.7  
 
* EXPEDITED REVIEW CATEGORIES: (REQUIRED) If you think this study qualifies for expedited
 
 
review, select the regulatory categories that the research falls under: (check all that apply)
Category 1: A very limited number of studies of approved drugs and devices
Category 2: Blood sampling
Category 3: Noninvasive specimen collection (e.g. buccal swabs, urine, hair and nail clippings, etc.)
Category 4: Noninvasive clinical procedures (e.g. physical sensors such as pulse oximeters, MRI, EKG, 
EEG, ultrasound, moderate exercise testing, etc.)
Category 5: Research involving materials (data, documents, records, or specimens) that were 
previously collected for either nonresearch or research purposes
Category 6: Use of recordings (voice, video, digital or image)
Category 7: Low risk behavioral research or research employing survey, interview, oral history, focus 
group, program evaluation, human factors evaluation, or quality assurance methodologies
4.9  
 
* DATA/SPECIMEN ANALYSIS ONLY: (REQUIRED) Does this study 
 involve records review and
ONLY
/or biospecimen analysis (do not check 'Yes' if this is a registry, research or recruitment database, or
biospecimen repository):
  Yes   
  No
4.10  
 
* CLINICAL TRIAL: (REQUIRED)
Is this a clinical trial:
According to The World Health Organization (WHO) and the International 
Committee of Medical Journal Editors (ICMJE) a clinical trial is:
Any research study that prospectively assigns human participants or groups 
of humans to one or more health-related interventions to evaluate the effects 
on health outcomes.

ICMJE requires 
 of a clinical trial in a public database (such as 
registration
ClinicalTrials.gov) prior to enrollment, for eventual publication of results in 
member biomedical journals.
Public Law 110-85 requires that all investigators who perform an 
Guidance: 
 must ensure that the trial is registered on a government 
applicable clinical trial
 
.
web site called ClinicalTrials.gov
The FDA requires registration for 'applicable clinical trials,' defined as 
follows:
For any trials of drugs and biologics: controlled clinical investigations, other 
than Phase 1 investigations, of a product subject to FDA regulation.
For trials of biomedical devices: controlled trials with health outcomes of 
devices subject to FDA regulation, other than small feasibility studies, and 
pediatric post-market surveillance.
 
 
For additional information on the ClinicalTrials.gov registration process at UCSF 
 
and the definition of a clinical trial for purposes of registration, visit the
ClinicalTrials.gov section of the UCSF Clinical Research Resource HUB.
 Yes   
 No
 - 'NCT' number for this trial:
Clinical Trial Registration
SDR 16-192
4.11  *
: 
CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s):
Phase 0
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
Phase 4
Not Applicable
4.12  
: 
* INVESTIGATOR-INITIATED (REQUIRED) Is this an investigator-initiated study:
 Yes   
 No
 of the 
 to 
The UCSF IRB recommends use
Virtual Regulatory Binder
manage your study.
4.13  *
 
CANCER: (REQUIRED) Does this study involve cancer (e.g., the study involves patients with cancer
or at risk for cancer, including behavioral research, epidemiological research, public policy research,
specimen analysis, and chart reviews):
  Yes   
  No
4.14  *
 
RADIATION EXPOSURE: (REQUIRED) Does your protocol involve any radiation exposure to patients
/subjects 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-
EITHER
standard care OR 
research

guided biopsy, radiation therapy, or nuclear medicine including PET, MUGA or bone scans):
  Yes   
  No
4.15  SCIENTIFIC REVIEW: If this study has undergone scientific or scholarly review, please indicate 
which entity performed the review (check all that apply):
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final IRB approval 
for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Departmental scientific review
Other:
* Specify Other: (REQUIRED)
VA Health Services Research scientific review panel on 3/8/17. Impact Score = 173
4.16  
 
* STEM CELLS: (REQUIRED) 
 
Does this study involve human stem cells (including iPS cells and adult 
stem cells), gametes or embryos:
No 
Yes, and requires IRB and GESCR review 
Yes, and requires GESCR review, but NOT IRB review 
4.17  
 
*
 
FINANCIAL INTERESTS: (REQUIRED) Do you or any other responsible personnel (or the spouse,
 
 
registered domestic partner and/or dependent children thereof) have financial interests related to 
 
this study:
  Yes   
  No
5.0
Funding
5.1  
 
* FEDERAL FUNDING: (REQUIRED) Is this study currently supported in whole or in part by Federal
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
 Yes   
 No
5.2  *
Is this project linked in any way to the Department of Defense (DoD):
DoD INVOLVEMENT: 
(REQUIRED)
  Yes   
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:
External Sponsors:
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution
Contract 
Type:
UCSF RAS 
"P 
number" 
or 
eProposal 
number 
UCSF RAS 
System 
Award 
Number 
("A" + 6 
digits) 

US Dept of Veterans 
Affairs 
01 
SF VAMC 
Research 
Office 
Grant 
not 
applicable 
not 
applicable 
Sponsor Name:
US Dept of Veterans Affairs 
Sponsor Type:
01 
Sponsor Role:
Funding Data Coordination Monitoring
CFDA Number:
Grant/Contract Number:
SDR 16-192 
Awardee Institution:
SF VAMC Research Office 
Is Institution the Primary Grant 
Holder:
Yes 
Contract Type:
Grant 
UCSF RAS "P number" or 
eProposal number:
not applicable 
UCSF RAS System Award Number 
("A" + 6 digits):
not applicable 
Grant Number for Studies Not 
Funded thru UCSF:
Grant Title:
Teledermatology mobile apps: Implementation and impact on 
Veterans' access to dermatology 
PI Name:
(If PI is not the same as identified 
on the study.)
Significant Discrepancy:
Other Funding Sources and Unfunded Research - Gift, Program, 
Departmental or other Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
6.0
Sites, Programs, Resources, and External IRB Review
6.1  
 
 (check all that apply):
UCSF AND AFFILIATED SITES
UCSF Benioff Children's Hospital Oakland (BCHO)
UCSF China Basin clinics and facilities
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF Langley Porter Psychiatric Institute (LPPI)
UCSF Medical Center at Mission Bay (Benioff Children's Hospital, the Betty Irene Moore Women's 
Hospital, Bakar Cancer Hospital, or outpatient clinics)
UCSF Mount Zion
UCSF Parnassus (Moffitt-Long hospital, dental clinics or other outpatient clinics)
UCSF Other Sites (including Laurel Heights and all the other sites outside the main hospitals)
Zuckerberg San Francisco General (ZSFG)
SF VA Medical Center (SF VAMC)
Fresno - UCSF Fresno OR Community Medical Center (CMC)
Gladstone
Institute on Aging (IOA)

Jewish Home
SF Dept of Public Health (DPH)
Vitalant (formerly Blood Centers of the Pacific and Blood Systems Research Institute)
Research involving the SF VAMC: P
 
lease thoroughly review the Working 
webpage 
with the SF VAMC 
and/or consult the VA Research Office (
 or (415) 221-4810 x6425) 
 to submitting your 
V21SFCHRPP@va.gov
prior
application to the IRB and:
, identify who is serving 
If this study involves both UCSF and the VA
as the VA PI under 'Descriptions of Study Responsibilities' in the 
'Qualifications of Investigators' section at the end of this form
Include the additional required VA forms in the Study Documents 
section of the Initial Review Submission Packet form
6.2  
At what locations will study visits and activities occur:
LOCATIONS: 
San Francisco VA Health Care System
4150 Clement Street, San Francisco, CA  94121
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
  Yes   
  No
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research 
 units or utilize 
:
Services (CRS)
CRS services
  Yes   
  No
6.6  * MULTI-CENTER TRIAL: (REQUIRED) Is this a multi-center or multi-site research trial:
By 
' we mean a study where the protocol is developed by an 
'multi-center trial
lead investigator, an industry sponsor, consortium, a disease-group, etc.,and 
multiple sites across the nation or in different countries participate in the trial. The 
local sites do not have any control over the design of the protocol.
 Yes   
 No
6.7  * COORDINATION: (REQUIRED) Is UCSF the coordinating center:

  Yes   
  No
6.8  OTHER SITE TYPES: Check all the other types of sites not affiliated with UCSF with which you are 
cooperating or collaborating on this project:
Do NOT check any boxes below if this is a multi-center clinical trial, UCSF 
is just one of the sites, and neither UCSF nor one of its faculty-linked 
affiliates (SF VAMC, Gladstone, ZSFG) are the coordinating center.
Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.11  * OUTSIDE RELIANCES: (REQUIRED) Are any of the collaborating sites requesting to rely on UCSF's
IRB:
  Yes   
  No
6.12  *
 
NIH sIRB
 
APPLICABILITY: (REQUIRED) 
 
:
Is this research subject to the NIH’s sIRB Policy
  Yes   
  No
You indicated this study is a 'multi-site trial' and has federal funding. If 
this is a multi-center study with federal funding, domestic sites are most 
likely subject to the NIH sIRB review requirements. Talk to your RMS 
analyst about the terms of your grant if you are not sure.
6.14  * RELYING ON AN EXTERNAL IRB: (REQUIRED) Does this application include a request to rely on an
external IRB (a central IRB (other than the NCI CIRB) or an external IRB (other UC campus,
commercial, or institutional):
  Yes   
  No
7.0
Outside Site Information
7.1  Outside Site Information
If you have more than 10 sites to add, list the outside sites in the Outside 
Sites List document and upload it in the Other Study Documents section of 
the Initial Review Submission Packet form. Any sites requesting to rely on 
UCSF's IRB must be listed below. 
Click "Add a new row" to enter information for a site. Click it again to add a second site again to add a 
third site, a fourth site, etc.

Outside Site Information
Non-UCSF affiliated site information:
Site name:
Providence VA Medical Center
Contact name:
Martin Weinstock, MD, PhD
Email:
martin.weinstock@va.gov
Phone:
415-935-5362
For Federally-funded studies only, corresponding FWA#:
FWA00001273
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of record for this study 
The non-affiliated site is not engaged in the human subjects research and has 
provided a letter of support 
If the other site's IRB approval letter is available now, attach it to the 
application.  If the IRB approval letter is not yet available, submit it once you 
receive it. 
  Or, if the other site is 
 in human subjects research, attach the 
 
not engaged
letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Duram VA Health Care System
Contact name:
John D. Whited, MD, MHS
Email:
john.whited@va.gov
Phone:

919-286-0411
For Federally-funded studies only, corresponding FWA#:
FWA00001600
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of record for this study 
The non-affiliated site is not engaged in the human subjects research and has 
provided a letter of support 
If the other site's IRB approval letter is available now, attach it to the 
application.  If the IRB approval letter is not yet available, submit it once you 
receive it. 
  Or, if the other site is 
 in human subjects research, attach the 
 
not engaged
letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Ann Arbor VA Health Care System
Contact name:
Aliya HInes, MD PhD
Email:
Aliya.Hines@va.gov
Phone:
(443) 414-7148
For Federally-funded studies only, corresponding FWA#:
FWA00001681
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of record for this study 
The non-affiliated site is not engaged in the human subjects research and has 
provided a letter of support 
If the other site's IRB approval letter is available now, attach it to the 
application.  If the IRB approval letter is not yet available, submit it once you 
receive it. 

  Or, if the other site is 
 in human subjects research, attach the 
 
not engaged
letter of support to your application.
8.0
Research Plan and Procedures
8.1  
Describe the hypothesis or what the study hopes to prove:
HYPOTHESIS: 
Access to healthcare is currently a key priority for Department of Veterans Affairs (VA).  Store-and 
Forward (SFT) Teledermatology has emerged as an important strategy to enhance the access of 
patients to high quality skin care within VA.  The current practice of teledermatology in VA is 
effective but has not been uniformly implemented, and inefficiencies in the current workstation-
based process may discourage teledermatology adoption by primary care clinics.  VA Office of 
Connected Care’s (OCC’s) mobile app, 
, has been developed as a more facile and 
VA Telederm
efficient option that may enhance teledermatology adoption among providers.
Once patients establish care in a dermatology clinic, they often need follow-up visits to evaluate 
responses to treatment and to adjust management, neither of which necessarily requires a face-to-face 
visit.  To address these issues, OCC has additionally developed the 
 app to allow 
My Telederm
established dermatology clinic patients to follow-up remotely using their own mobile devices.  By 
reducing the need for some patients to follow-up in person, the app may improve clinic access to in-
person dermatology clinics.
The overall 
 of this proposal is that sites implementing VA’s teledermatology mobile apps 
hypothesis
will significantly augment the use of teledermatology and improve Veterans’ access to skin care 
relative to control sites.  Specifically, we hypothesize that 
 will facilitate the 
VA Telederm
implementation and adoption of teledermatology among primary care clinic staff, increasing use by 
existing programs and potentially expanding teledermatology to new sites while reducing patient 
travel to dermatology clinics.  Additionally, we hypothesize that 
 will improve 
My Telederm
established patients’ ability to follow-up with dermatology care remotely, while opening up 
dermatology clinic space for other patients. 
8.2  
List the specific aims:
AIMS: 
Aim 1. Measure impact of apps on access to dermatology care.  San Francisco VA Health Care
System's involvement is limited in Aim 1.  All data related to this aim is collected by the VA’
s Center for Access Policy, Evaluation Research (CAPER) located at the Boston VA Health Care 
System.  All data collected from the Corporate Data Warehouse, or any other databases as 
approved by the Boston VA Health Care System IRB will be anonymously recorded, aggregated, 
and shared with investigators and study staff at the San Francisco VA Health Care System and 
other sites.  No analysis of the primary data will occur at San Francisco VA. 
Both apps will be made available over a 2 year period in a randomized, stepped-wedge design to 
Veterans Health Administration (VHA) facilities, after each app becomes available.  The VA 
 app will be distributed to 36 eligible VHA facilities that currently have low 
Telederm
teledermatology activity and thus have had relatively poor adoption of basic consultative 
teledermatology.  The 
 app will be distributed to 24 facilities with dermatology clinics 
My Telederm
that currently have relatively high teledermatology activity and thus already have relatively mature 
teledermatology programs ready for advanced operations.
By using health factors and stop codes unique to each app, we will use the VA Corporate Data 
Warehouse (CDW) to measure the impact of both apps on the following outcomes reflecting 
dermatology access: 1) Consult and appointment completion times for both teledermatology and in-
person consults, stratified by new and established patients (primary outcome); 2) Instances of 

dermatologic care (associated with either teledermatology or in-person dermatology encounters); and 
3) Travel costs for VA, as well as non-VA care consult rates and associated costs.  In addition, the
following outcomes will be measured specifically for the 
 app:  1) Proportions of new
My Telederm
patient encounters in-person dermatology clinics; and 2) “No-show” rates and timeliness of follow-
up.  Results of each of these access measures will be stratified to examine the effect on rural/highly
rural Veterans, as well as to determine whether a differential effect occurs for facilities with some pre-
existing teledermatology relative to those that had none.
Aim 2. Determine the factors that affect personal and organizational adoption of mobile apps.  
Using the Replicating Effective Programs framework, we will work with OCC to implement and 
measure the deployment, adoption and utilization of both teledermatology apps throughout all 
eligible VA sites. 
, we 
 In one sub-aim, which is the principal focus of the current IRB application
will conduct a formative evaluation of the implementation process at 3 early adopter sites to develop 
implementation strategies to guide subsequent nationwide deployment and research.  Surveys and 
semi-structured interviews will assess Organizational Readiness for Change (ORC) at these sites 
regarding the apps, and link ORC to stages of implementation, barriers and facilitators to 
implementation, and implementation effectiveness as measured by uptake of the apps and actual use 
of teledermatology. 
In the second sub-aim, we will also monitor deployment, adoption and utilization of both 
teledermatology apps nationally by analyzing remotely accessible data from the CDW and OCC.  The
primary data will be collected by CAPER under its own IRB approval, and aggregate data will be 
.  We will then correlate the degree of adoption with reach of 
shared with the PIs and co-investigators
the program (i.e., number of Veterans served) and stratify analyses of primary outcomes from Aim 1 
based on degree of adoption. 
At the conclusion of the project, we expect to document important indicators of mobile 
teledermatology’s effects on patient access in the nation’s largest healthcare system and to 
comprehensively understand the implementation of mobile teledermatology.  These novel 
achievements will guide future mobile telemedicine endeavors in VA, and will inform other large 
healthcare organizations interested in telehealth.
8.3  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
DESIGN: 
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  
 is anticipated to be ready for national release in January 2017 and My Telederm in the spring of 
VA Telederm
2018, as part of VA's Office of Connected Care operations. Beforehand, technical field testing will occur at San 
Francisco, Providence and Denver VHA facilities.  For national rollout, each app will be targeted to sites that are 
clinically appropriate and best positioned to benefit from the app.  Within these sites, the apps will be released in 
three month intervals according to allow a cross-sectional stepped-wedge cluster randomized trial for each 
app.  We anticipate the affected population will represent VA’s as a whole.
The impact of teledermatology apps depends not only on their intrinsic effectiveness, but also on successful 
implementation and adoption by as many target sites and end-users as possible who then maintain the 
practice.  Outcomes may be organized within the RE-AIM Framework, which encompasses multiple domains 
necessary for translating innovation into real-world practice.  The Reach and Effectiveness domains are 
addressed in Aim 1; The Adoption, Implementation and Maintenance domains are the focus of Aim 2.
Aim 1 will assess each app’s effect on Veterans’ access to dermatology in a stepped-wedge cluster randomized 
trial. Corporate Data Warehouse (CDW) data pertaining to access will be collected remotely by the Center for 
Access Policy, Evaluation and REsearch (CAPER) under its own IRB approval.  Multiple measures reflecting 
different aspects of access will be evaluated to achieve a comprehensive and accurate evaluation of each app’s 
impact.  Aim 2 will focus on measuring the degree to which each app was implemented.  Using semi-quantitative 
interviews and surveys of key VA  staff members at the three early adopter sites (San Francisco, Denver and 
Providence VA Medical Centers) involved in technical testing as well as data in CDW and OCC databases, we 
will monitor implementation and identify organizational, individual, and app-specific factors that affect each app’s 
overall impact. 

8.4  
 Briefly provide the background and significance of this study (e.g. 
BACKGROUND AND SIGNIFICANCE:
 
why is this study needed) (space limit: one half page):
Telehealth and mobile health are rapidly growing segments of healthcare in VA and other government agencies 
such as the Department of Defense, as well as in the private sector.  Teledermatology has been adopted by 
both large non-profit health care organizations as well as by for-profit companies and individual practices.  The 
use of mobile apps in teledermatology is in a relatively early phase and it is important to validate their 
effectiveness in promoting teledermatology in diverse populations, and understand how best to integrate them 
into clinical operations.  The proposed research is expected to have the following impacts:
Tele
Assess the ability of mobile teledermatology to bring expert dermatologic care to new populations.  
dermatology has been well-studied with respect to its diagnostic and management reliability, and clinical 
outcomes.  Its ability to enhance access to skin care has also been documented.  However, little is known about 
the ability of teledermatology to expand the number of patients served, especially to those in underserved 
areas.  Less is known about the effect of teledermatology on the performance of a healthcare system.  The 
integrated nature and size of VA’s teledermatology program offers an unparalleled opportunity to study the effect 
of the teledermatology intervention on patient access in the largest healthcare system in the United States, as 
well as to study implementation of apps on a large scale.  The proposed project will document the ability of VA 
 to expand consultative teledermatology within existing programs and to new VA CBOCs.  This 
Telederm
information will be particularly important to health care organizations responsible for large, geographically 
diverse populations in rural or otherwise remote areas.
.  Historically, teledermatology has been principally 
Validate a new model for enhancing access to patients
practiced as a consultative tool where a PCP requests guidance from a dermatologist.  The preponderance of 
published research has similarly focused on consultative teledermatology.  However, with the widespread 
availability of digital cameras and internet access, the ability to accept teledermatology consultations directly 
from patients has increasingly emerged in commercial ventures but with little scientific validation of their actual 
impact on healthcare. Within VA, there has also recently been an evolution toward delivering healthcare 
centered in patients’ homes, and OCC has begun live-interactive telehealth encounters with patients in their 
homes.  The effect of this type of telehealth is unknown.  The 
 app will be VA’s first attempt to bring 
My Telederm
store-and-forward telehealth into patients homes and may have significant impacts on not only the patients that 
it directly serves, but also indirect effects on new patients who need to be seen in person in clinics and who may 
benefit from the additional capacity created by allowing established patients to follow-up remotely.  The 
proposed research seeks to measure the magnitude of this effect.
.  Implementation and adoption of 
Understand factors affecting successful implementation of mobile apps
telehealth, including teledermatology, in the VHA has proven to be a slow and heterogeneous effort, having 
taken over 8 years since the program was nationally disseminated by VA, with no systematic effort to collect 
data that would inform VA as to the reasons why teledermatology has been actively adopted and thriving at 
some sites, while being neglected or failing at others.  It is thus significant that the proposed research will be the 
first large-scale attempt to understand the implementation science associated with a teledermatology program, 
and it will be the first to study VA apps that are intended to interface directly with existing clinical care 
pathways.  The research will have strategic importance for VA and OCC as additional mobile apps serving other 
clinical needs, particularly those that directly interact with clinical care of patients, are rolled out in the 
future.  Additionally, we believe that studying the process within the paradigm of OTIE and the REP framework 
will allow the findings to be broadly applicable to other healthcare organizations.
8.5  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
The proposed research is to assess the implementation and impact of mobile apps that are in the final stages of 
development, validation and checks for compliance with VA's privacy and safety requirements.  In anticipation of 
the stepped-wedge cluster randomized trial, all VA facilities were examined for teledermatology activity relative 
to total dermatology activity.  
The inclusion criterion for the first trial (
) was that a site had a minimum of 0.1% and < 8.8% of its 
VA Telederm
total FY2016 dermatology encounters under secondary stop codes 695/696 (teledermatology readings).  VA 

medical centers with no 695/696 activity in FY2016 or with zero full-time equivalent dermatologists were 
excluded since these sites likely lack the expertise, support and infrastructure to feasibly adopt teledermatology 
during the study period. In total, we identified 36 sites eligible for 
, teledermatology constituting 
VA Telederm
between 0.1% and 8.8% of all dermatology encounters.
Conversely, the inclusion criterion for the second trial with 
was that a site had ≥8.8% of all FY2016 
My Telederm 
dermatology encounters under secondary stop codes 695/696.  This indicated considerable pre-existing 
experience with consultative teledermatology and the likely presence of dermatology reader and support 
personnel needed to implement 
. We identified 24 sites where teledermatology constituted 8.8% to 
My Telederm
100% of total encounters. 
In Aim 1, apps will be disseminated according to the stepped-wedge cluster randomization scheme 
determined by this research project, but otherwise is under the control of VA's Office of Connected Care as 
part of its operational plan to disseminate the apps to the clinical field.  The main outcomes are measures 
that serve as proxies for access to dermatology services, and these are stored in VA's Corporate Data 
Warehouse (CDW) which is remotely accessbie.
8.6  
Is this a treatment study, i.e. does this study intend to provide treatment
* TREATMENT PROTOCOL: 
to individuals with a medical or psychological condition: (REQUIRED)
  Yes   
  No
8.7  
 Does this study involve any procedures, lab tests or imaging studies that
* BILLABLE PROCEDURES:
have a CPT code and could be billable to patients, their insurance, Medi-Cal, Medicare, or any other
entity (answer 'Yes' even if the study is going to pay for all the procedures): (REQUIRED)
  Yes   
  No
, send an 
If you are not sure if your study involves billable procedures
email to the 
 for help answering this 
UCSF Office of Clinical Research (OCR)
question.
8.8  
Types of research activities that will be carried out. Check all that
COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Social media-based research activities
Observation
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, etc.)
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-guided 
biopsies, DEXA scans, MUGA or PET scan)
Administration of contrast agent
Randomization to one intervention versus another
Use of placebo
Biopsy conducted solely for research purposes
Sham surgical procedure
None of the above
8.9  
PROCEDURES / METHODS: 
*
(REQUIRED)

1.  
2.  
3.  
Describe the research methods and study activities taking place at each site (e.g. 
what will participants be asked to do and what will members of the study team 
do?). If there will be multiple participant groups or study sites, explain what will 
happen with each group or study sites.
If some of the activities would occur even if the person were not in the study, as in 
the case of treatment or tests performed for diagnostic purposes, 
clearly differentiate between those activities that will be done solely for 
research purposes and those that are happening as part of routine care.
Please call our office at 415-476-1814 and ask to speak to someone on the 
Expedited Review team if you need help differentiating between what parts are 
research and what parts aren't.
In 
, no patient contact is required for the research activity of this aim.  Primary data for this Aim will 
Aim 1
be obtained by VA's CAPER under its own IRB authorization and will be stored at the CAPER's Boston VA 
facility.  Aggregate data will be shared by CAPER with the PIs and co-investigators.  
In
, technical field-testing prior to the start of the proposed study is a planned necessary step for 
 Aim 2
VA's Office of Connected Care's clinical operations.  Both 
 and 
 will be field-tested 
VA Telederm
My Telederm
by OCC at San Francisco, Denver and Providence VHA facilities and thus these sites cannot participate in 
the randomized study of Aim 1.  However, as early adopters, these sites will be designated for formative 
evaluation in Sub-Aim 2.1.  While these intensive studies cannot be conducted at all sites, we will monitor 
enterprise-wide implementation, adoption and maintenance using remotely accessible measures in Sub-
Aim 2.2.
Sub-Aim 2.1:  Formative Evaluation
This Sub-Aim's activities are the principal focus of the current IRB application.  We will conduct an in-
depth, theory-based formative evaluation of the three early adopter sites (same as technical field-testing 
sites), with the goals of understanding: 1) Factors that may impact ORC and implementation of the 
teledermatology apps; 2) Changes in these factors over the course of one year; and 3) Association 
between ORC to both successful implementation and sustainability over time.  We will utilize a mixed 
methods approach to measure ORC and change in related components over time.  The ultimate goal is to 
inform the process of implementing both teledermatology apps during the randomized implementation and 
among sites not part of the randomization process.  Further, we will inform the implementation of future 
mobile clinical applications.
Survey data will be collected centrally using REDCap, hosted by the VA Information Resource Center 
(VIReC) and housed on a VA Informatics and Computing Infrastructure (VINCI) server at VA's Austin 
Infomration Techology Center.  Interview data will be collected by recording phone conversations directly 
onto secure VA networked servers or encrypted computers, using MS Teams and Phillips recorder.
Site Selection for Formative Evaluation.  In addition to their initial roles in field-testing, the three early 
adopter sites—San Francisco, Denver and Providence VA Medical Centers—are appropriate for evaluation 
since their primary care and dermatology leadership as well as CBOCs are willing to participate.  These 
sites may have specific qualities that impact implementation.  However, since they vary in terms of both 
organization and location, lessons learned will likely translate to the mix of other VA facilities with 
dermatology programs.
Formative evaluation process 
Brief summary
The formative evaluation will begin by identifying baseline characteristics of the organization and team 
that may impact implementation (Site Process Guide is attached to this application).  This will be followed 
by:
Assessment of readiness to implement teledermatology (to be determined by survey and by 
interviews; the email consent script and ORC survey, and telephone consent script and 
initial interview guide are attached to this application).
Bi-monthly (every other month) monitoring of the implementation process and progress (Bi-
monthly Site Report is attached to this application).
Qualitative interviews addressing implementation factors suggested by the OTIE 6-8 months 
following initial implementation of teledermatology (The follow-up interview guide will be developed 
based on the initial evaluations in (1) and (2) and will be submitted as a modification to this 
protocol).

4.  
1.  
2.  
3.  
4.  
5.  
6.  
1.  
2.  
3.  
4.  
1.  
Qualitative and quantitative evaluation of program sustainability for each app 1 year after the first 
use of each of the teledermatology applications.  (Program Sustainability Index survey attached to 
this application, the sustainability interview guide will be developed based on (1), (2), and (3) and 
will be submitted as a modification to this protocol.)
     Each section of the formative evaluation is independent of the other, except when specifically 
noted.  We are examining the perceptions of specific groups of individuals based on their roles within VA 
medical centers, as opposed to being based on the individual person.   Furthermore since the apps are 
being released at different times, aside from the site information report the steps will be done separately 
for each app. The staff using the two teledermatology mobile apps are different. Steps of the formative 
evaluation process are summarized below.
Collection of Baseline Characteristics that may impact implementation.  The three VA sites at San 
Francisco, Denver and Providence will be asked by research staff at San Francisco, Providence, and 
Durham VA sites using the Site Information Report to identify individuals (research subjects) directly 
involved in planning and execution of app implementation.  These individuals make up the core 
 which may vary among the sites, and has not yet been exactly defined at each 
implementation team
site, including San Francisco VA, but may include those that function in the following roles:
Facility Telemedicine Coordinators
Primary Care Clinical Champions
Dermatology Clinical Champions
Imaging Master Preceptors
Clinical Applications Coordinators (CACs)
Teledermatology Readers
Additionally, the three sites will identify 
 whose work or clinical decision-making may 
other staff
change as a result of app implementation.  These individuals are:
Primary Care Clinicians
Telehealth Clinical Technicians/Telehelath Imagers
Dermatology Clinicians
Other staff at the three early adopter sites whose work may be affected by teledermatology.
Detailed description of formative evaluation
The Principal Investigators will be asked to complete and provide San Francisco VA HCS research staff with 
a 
 for each of the early adopter sites.  This document will be used to 
baseline site information document
identify core implementation team members and other staff involved in teledermatology and their 
relationships among each other, as well as teledermatology processes, size and composition of each 
medical centers, and impacted clinical services.  We may supplement this information be examining 
organizational-level information (e.g., number of patients, number of providers) that is normally available 
to all VA employees through the VHA Reports and Measures Portal (RAMP) and/or VHA Report Services 
Center (VSSC).
Upon completion of the baseline site information document, the following specific steps will be 
overseen by the San Francisco VA Health Care system research staff.
Measurement of ORC.  At each site, core implementation team members and other staff from 
impacted services will receive the validated Organization Readiness for Implementing Change 
, a 12-item computer-based ORC survey which examines perceptions of organizational-
measure
level change efficacy and commitment to newly implemented interventions.  The ORC survey is 
submitted in its entirety as an attachment to application, along with the email consent script that 
will introduce the research subject to it and the consent process.  In brief, survey questions ask 
participants to indicate their perceptions on the level of confidence that organizational 
members have in effecting changes in teledermatology operations using each of the mobile 
apps.  Survey responses will objectively examine ORC as a two-dimensional construct 
encompassing change commitment and change efficacy.  This instrument was developed specifically 
to measure aspects of the Weiner Theory of ORC.  In addition, San Francisco research staff will 
conduct 
 of the core implementation 
semi-structured qualitative telephone individual interviews
team, 3 PCPs, 3 dermatologists, 2 dermatology staff members, as well as leadership positions 
overseeing and supporting teledermatology operations at the site (e.g., Network telehealth lead, 
Chief of Dermatology, Associate Chief of Staff for Ambulatory Care, informatics leads, IT specialists) 
at each site to assess ORC and factors that are hypothesized to predict ORC (i.e. change valance
/value place on the apps and assessment of what it will take to implement the apps).  These semi-
structured interviews following the initial guide will allow us to study implementation processes, 
which tend to be fluid, non-linear, and context sensitive and will permit us to compare patterns 

2.  
3.  
4.  
5.  
1.  
2.  
across cases.  The telephone consent script and initial interview guide are attached to this 
application.
Bi-monthly Monitoring of Implementation – Process of Implementation.  At the start of 
each app implementation, the research team will interview the core implementation team as a 
group during a conference call after obtaining verbal consent (the telephone consent script and Site 
Process Guide are attached to this application).  Baseline information on the site's process of 
implementing each app and related clinical workflow will be collected through a series of questions 
based on expected workflow, such as identifying essential tasks in IT and informatics as well as 
staff training that need to occur.  Additionally, we will collect baseline information on the 
organization of dermatology services, the referral process from PCPs, number of providers, and 
perceived volume of patients.  Components of the workflow process will be stored in an Excel 
spreadsheet to be sent to the sites for updates every two months. 
Bi-monthly Monitoring of Implementation – Implementation Progress.  We will also 
measure the implementation process by 
 from the three 
bi-monthly site reports
sites.  Implementation progress will be assessed utilizing the Stages of Implementation Completion 
(SIC).  SIC enumerates key pre-implementation, implementation and sustainability milestones. 
Dates by which specific implementation milestones were reached will be identified.  Bi-monthly 
(every other month) reports will also include assessment of barriers and facilitators identified 
through the ORC measurement process.  Bi-monthly information will be fed back to project and 
OCC leadership so that program adjustments can be made.  The Bi-Monthly Site Report survey is 
attached to this application.
Evaluation of the Implementation Process – Qualitative Interviews.  At 6-8 months 
following the start of the implementation process of each app at the 3 early adopter sites, we will 
conduct 
 among the core 
follow-up semi-structured qualitative telephone individual interviews
implementation team, 3 PCPs, 3 dermatologists, 2 dermatology staff members, as well as 
leadership positions overseeing and supporting teledermatology operations at each site to assess 
OTIE factors suggestive of implementation success. The goal will be to interview the same 
individuals interviewed at baseline. The follow-up guide to be used for these interviews has not yet 
been developed as it will necessarily need to reflect the information obtained in the initial baseline 
studies above, but will in general allow participants to expand on the same areas covered by the bi-
monthly site report survey that is attached, and described in (3) above.  The follow-up interview 
will be introduced by the telephone consent script attached to this application.
Assessment of Sustainability.  At one year, we will assess the sustainability of use of each of the 
mobile apps. 
The Mancini & Marek Model of Community-based Program Sustainability will be used to 
conceptually guide the evaluation of sustainability.  Mancini & Marek propose that six 
elements are important to achieve long-term sustainability:  Leadership competence, 
effective collaboration, demonstrating program results, strategic funding, staff involvement 
and integration, and program responsivity.  The validated Program Sustainability Index (PSI)
measures each of the 6 sustainability elements, and is attached to this application.  Each 
core implementation team member and director of primary care and dermatology will be 
surveyed for each app.  
Using the 
 above, each core implementation team 
semi-structured interview methods
member, director of primary care, Chief of Dermatology, FTC, imager, and other staff 
members participating in processing or supporting teledermatology at each site will be 
interviewed.  The sustainability interview will explore in more depth the areas surveyed in 
the PSI (Leadership, Collaboration, Demonstrating Program Results, Funding, and Program 
Responsivity.  We have previously used the combination of PSI and qualitative interviews to 
evaluate the sustainability of a multi-facility program for the Office of Patient Centered Care 
and Cultural Transformation.  This  program sustainability interview guide will be introduced 
by the telephone consent script attached to this application.
Sub-Aim 2.2
Implementation of field sites will also be assessed at all participating sites by monitoring intermediate 
milestones and quantitative indicators of implementation that are available in CDW as well as from OCC’s 
own telehealth database and Web and Mobile Solutions (WMS) device procurement program. 
To understand how rapidly sites meet key milestones as a result of the OCC implementation process, and 
if the apps are more effective among sites that have reached more implementation milestones, 
randomized sites will be asked to complete a bi-monthly implementation site report monitoring key 
milestones, collected electronically via REDCAP on the VA intranet.  This bi-monthly report is based on 
the bi-monthly site report utilized as part of the formative evaluation described above.  Sites will be sent 
email reminders two weeks and one week prior to, and one week after the due date, with follow up via 
phone call, if necessary.  Four of these randomized sites will be recruited to participate in semi-structured 
sustainability interviews using the same guides used in the formative evaluation and will be introduced by 
the telephone consent script attached to this application. These Interview data will be collected by 

recording phone conversations directly onto secure VA networked servers or encrypted computers, 
using MS Teams and Phillips recorder.
8.11  
List all questionnaires, surveys, interview, or focus group guides that will be used for 
INSTRUMENTS: 
this study:
If the instruments are not complete or not available because they will be 
developed as part of this study, describe the basic content or include an outline 
and submit the final versions to the IRB with a modification for approval prior to 
use.
1) Site Information Report (revision attached)
2) Site Process Guide (attached)
3) Organizational Readiness for Change (ORC) Survey (revision attached)
4) Initial Interview Guide (attached)
5) Bi-Monthly Site Report (survey revision attached)
6) Follow-up Interview Guide (Allows participants to expand on the same areas covered by the bi-monthly
site report)
7) Program Sustainability Index (survey revisions attached) Now VA T Program Sustainabiltiy index
(attached) and My T Program Sustainability index (attached)
8) Sustainability Interview Guide (attached-Allows participants to expand on the same areas covered by
the PSI survey)
9) Bi-Monthly Site Report for National Sites (attached)
Telephone/Email Consent Scripts for Contacting Subjects:
1) Email consent script (introduction and consent to ORC, both Bi-monthly reports, and Program
Sustainability Index surveys)
2) Telephone consent script (introduction and consent to Site Process Guide, Initial Guide, Follow-up
Guide, and Sustainability Guide)
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after completing the 
study application. Published instruments should NOT be attached.
8.12  
Are you drawing any blood or collecting other biosamples (e.g. tissue,
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.) for analysis under this protocol and/or storage for future
research: (REQUIRED)
  Yes   
  No
8.13  
Briefly summarize the methods and types of analyses that will be 
STATISTICAL METHODS: 
performed:
Aim 1-Due to a lack of participation by sites during the study which was in part conducted during the novel 
coronavirus (COVID-19) pandemic, we were not ale to follow the analysis plan for Aim 1 described below.  
Instead we focused on understanding factors associated with successful completion of consults with the mobile 
apps, examining differences between rural and urban Veteran users. 
Data analysis. Primary data will be collected and analyzed by CAPER and shared in aggregate with the 
PIs and other investigators.  Stepped wedge - cluster randomized trials (SW-CRTs) need to employ data 
analysis strategies that account for the causal structure implied by this design and mitigate its potential 
shortcomings. Two related issues which may confound the treatment effect are the within-cluster correlation and 
potentially significant secular trends in the outcomes of interest given the long duration of the trials (2.5 years). 
In fact, the exposure of each cluster to both the control and intervention allows the researcher to partially exploit 
the within cluster variance towards estimation, which renders this type of trial less sensitive to the intra-cluster 
correlation coefficient. To further ensure that these confounding factors are properly handled, we will analyze 
the data using mixed models that allow for time fixed effects and cluster random effects.

Second, we are interested in the average effect of the treatment among compliers (patients who only receive the 
treatment as a direct result of their exposure to the intervention), referred to as the Local Average Treatment 
Effect (LATE). This effect better reflects the efficacy of teledermatology compared to regular practice. In order to 
estimate LATE, we will follow an instrumental variable (IV)-based two-stage residual inclusion (2SRI) procedure. 
Finally, we will also conduct an intent-to-treat analysis, yielding an estimate of the average effect of being 
randomized to receive one of the telederm apps (average treatment effect). From a policy perspective, this 
effect can be interpreted as the efficacy of deploying an app in real-world outpatient clinics, where overall uptake 
to clinical practice is likely less than 100%. 
Aim 2
.  Core to the concept of formative evaluation is continual analysis of 
Sub-Aim 2.1:  Formative Data Analysis
results and feedback to stakeholders.  That will be done in this formative evaluation.  Key data sources are 
qualitative interviews, surveys to assess ORC, and collection of detail about organizational characteristics and 
implementation process and progress.  All qualitative interviews will be transcribed in full.  Rapid analysis 
approaches will generate preliminary findings to share among the research team.  This effort will involve an 
initial review of factors identified as directly impacting the process of supporting app implementation and impact 
of the apps on clinical workflow.  Rapid analysis will be followed by in-depth content analysis.  Content analysis 
to examine the telephone interviews will involve three phases: data coding, within-case analysis, and between-
case analysis.  In the 
, we will use qualitative data analysis software (ATLAS.ti 5.0) to code 
data coding phase
the study data. The OTIE will provide a starting list of codes, which we will supplement with emergent codes as 
analysis proceeds. Using a common codebook, two investigators will conduct a preliminary test of codes by 
independently coding five transcripts. Based on the preliminary test, the investigators will sharpen the coding 
manual’s definitions, decision rules, and examples. Research assistants will code the remaining documents. 
In the second phase, we will conduct a 
 of each VA using ATLAS.ti to generate reports of all 
within-case analysis
text segments for each code. We will assess the degree to which the construct emerges in the data (its 
“strength”), the degree to which the construct positively or negatively affects implementation (its “valence”), and 
the degree to which relationships among constructs are consistent with the hypothesized model.  We will assess 
support for the hypothesized relationships by using three criteria proposed by Trochim and Miles and 
Huberman.  First, we will look for the overall covariance of the constructs (e.g., whether VA clinics exhibiting 
strong implementation climate have supportive administration).  Second, we will look for explicit attributions or 
the identification of plausible mechanisms to link the two constructs (e.g., participants attribute a strong 
implementation climate to the deployment of appropriate implementation policies and practices). 
In the third phase, we will apply the same criteria across the cases to determine if 
 variation in 
cross-case
implementation is consistent with the hypothesized relationships in the model. Consistent with the organization-
level focus of the model, we will aggregate and analyze quantitative data on implementation policies and 
practices (e.g. staffing levels) and other study constructs using simple statistics. In addition, we will create within-
case and between-case data displays that cross-tabulate the quantitative and qualitative data in order to 
facilitate the use of pattern-matching logic.
:  Collection of this data will be descriptively summarized to understand how rapidly sites meet key 
Sub-Aim 2.2
milestones as a result of the OCC implementation process, correlate the milestones to the number of patients 
serviced via the apps (i.e., reach), and allow for stratified analyses of main quantitative study results by degree 
of implementation based on reaching milestones to determine if the apps are more effective among sites that 
have reached more implementation milestones. We will analyze the qualitative data from the interviews in the 
same manner as described above for the formative evaluations using direct content analysis to examine themes 
within each case and to determine cross-case variation.
8.14  
List only the 5-10 most relevant references (a separate bibliography can be attached 
REFERENCES: 
 
for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with):
1. Landow, S.M., D.H. Oh, and M.A. Weinstock, Teledermatology within the Veterans Health Administration,
 Telemed E Health, 2015. 
(10): p. 769-773.
2002-2014.
21
2. Kilbourne, A.M., M.S. Neumannn, H.A. Pincus, et al., Implementing evidence-based interventions in health
 Implement. Sci., 2007. : p. 42.
care: application of the replicating effective programs framework.
2

3. Neumann, M.S. and E.D. Sogolow, 
 
Replicating effective programs:  HIV/AIDS prevention technology transfer.
AIDS Educ. Prev., 2000. 
(5 Suppl.): p. 35-48.
12
4. Moullin, J.C., D. Sabater-Hernandez, F. Fernandez-Llimos, et al., A systematic review of implementation 
 Health Res. Policy Syst., 
frameworks of innovations in healthcare and resulting generic implementation.
2015. 
: p. 16.
13
5. Klein, K. and J. Sorra, 
 Academy of. Management Review, 1996. 
The challenge of innovation implementation.
: p. 1055-1080.
4
6. Weiner, B.J., M.A. Lewis, and L.A. Linnan, Using organization theory to understand the determinants of 
 Health Educ Res, 2009. 
(2): p. 292-305.
effective implementation of worksite health promotion programs.
24
7. Copas, A.J., J.J. Lewis, J.A. Thompson, et al., Designing a stepped wedge trial:  three main designs, carr-
 Trials, 2015. 
(1).
over effects and randomisation approaches.
16
8. Pizer, S.D., M.L. Davies, and J.C. Prentice, 
 Am. J. 
Consult timeliness strongly predicts patient satisfaction.
Accountable Care, 2016. in press.
9. Prentice, J.C., M.L. Davies, and S.D. Pizer, Which outpatient wait-time measures are related to patient 
 Am. J. Med. Qual., 2014. 
(3): p. 227-235.
satisfaction?
29
10. Shaw, R.J., M.A. Kaufman, H.B. Bosworth, et al., Organizational factors associated with readiness to 
 
implement and translate a primary care based telemedicine behavioral program to improve blood pressure.
Implement. Sci., 2013. (1): p. 106.
8
9.0
 Drugs and Devices
9.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
  Yes   
  No
9.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
  Yes   
  No
10.0
 Sample Size and Eligibility Criteria
10.1  
 
How many people will you enroll:
ENROLLMENT TARGET: 
50
 If there are multiple participant groups, indicate how many people will be in each 
group:
Aim 1 will collect aggregate data relating to access exclusively by Veteran patients to VHA 
dermatology.  While some characteristics such as Veteran patient rurality and location will be monitored 
for individual encounters, the research has no direct or indirect patient contact or involvement.  Our 
randomized study of a total of 60 nationally distributed VA facilities will include encounter data from 
Veteran patients who are expected to generally reflect the diversity of VA’s patient population with respect 
to age, gender, race and ethnicity.  Children will be excluded since VHA does not serve pediatric 
populations and since children are not a target population for the apps.  
 
, as part of formative evaluation, will involve structured interviews and surveys of VHA staff at three 
Aim 2
early adopter sites, including VISN and facility organizational leadership (VISN Telehealth Leads, 
Dermatology Chiefs, Facility Telehealth Coordinators), support staff (Information Security Officers, Clinical 
Application Coordinators, Information Technology specialists), and clinical end-users (primary care 
providers, Telehealth Clinical Technicians, dermatologists) and clinical support staff (Medical Support 
Assistants).   Thus we anticipate 16-17 subjects will participate at each site.  Since there are 3 sites that 
will participate in the formative evaluation, we estimate that 50 subjects will participate via surveys and 
interviews overall.  For the formative evaluation, some but not all subjects may be Veterans, and will 

reflect the composition and diversity of VHA’s workforce. For sub aim 2.2, 28 site leads will receive the bi-
monthly report and 4 of these 28 sites will be asked to participate in a semi-structured interview. Two will 
have high usage of the app and two with low to no usage of the app.
10.2  
 
For multicenter studies, how many people will be enrolled in total:
TOTAL PARTICIPANTS: 
 
50
10.3  
Explain how and why the number of people was chosen. For multi-site 
SAMPLE SIZE JUSTIFICATION: 
studies, this is referring to the number that will be enrolled across all sites:
In 
, the number of participating medical center facilities (clusters) was determined as follows:  The 
Aim 1
inclusion criterion for the first trial (
) was that a site had a minimum of 0.1% and < 8.8% of 
VA Telederm
its total FY 2016 dermatology encounters were attributable to teledermatology (stop codes 695/696).  We 
also used clinical FTE data from FY 2016 and FY 2017 to make sure that they had at least some 
dermatologists on staff available. VA medical centers with no teledermatology activity in FY 2016 or with 
zero full-time equivalent dermatologists were excluded.  In total, we identified 36 sites eligible for VA 
.  Conversely, the inclusion criterion for the second trial with 
was that a site had ≥8.
Telederm
My Telederm 
8% of all FY 2016 dermatology encounters as teledermatology.  This indicated considerable pre-existing 
experience with consultative teledermatology and the likely presence of dermatology reader and support 
personnel needed to implement 
.  We determined, based on average treatment effects in the 
My Telederm
literature, that under most scenarios we are well-powered to detect conservative differences of 10% from 
baseline.
 
In 
, as described in 10.1 above, we anticipate that 16-17 subjects will be enrolled for formative 
Aim 2
evaluation at each of the three sites (San Francisco, Denver and Providence).  Each job title has been 
selected since it will either play be end-users of the mobile app program (e.g., primary care provider or 
imager or dermatologist), or be important support staff or mediators (e.g., Clinical Application Coordinator, 
program support assistants), or will be important leadership whose buy-in is necessary for successful 
implementation (clinical leadership). Sub aim 2.2 an additional 4 sites, two that have used the apps 
extensively in the last year and two that have not will provide additional insight into the facilitators and 
barriers at these sites.
10.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
10.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)
Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above
10.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)
Children / Minors
Adult subjects unable to consent for themselves

Adult subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
10.7  
 Briefly describe the population(s) that will be involved in this study. Include 
INCLUSION CRITERIA: 
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, 
providers, administrators, students, parents, family members, etc.):
For 
, the number of participating medical center facilities (clusters) was determined as follows:  The 
Aim 1
inclusion criterion for the first trial (
) was that a site had a minimum of 0.1% and < 8.8% of 
VA Telederm
its total FY 2016 dermatology encounters were attributable to teledermatology. 
Conversely, the inclusion criterion for the second trial with 
was that a site had ≥8.8% of all 
My Telederm 
FY 2016 dermatology encounters as teledermatology.  This indicated considerable pre-existing experience 
with consultative teledermatology and the likely presence of a dermatology reader and support personnel 
needed to implement 
.  We determined, based on average treatment effects in the literature, 
My Telederm
that under most scenarios we are well-powered to detect conservative differences of 10% from baseline.
 
For 
inclusion criteria are:
Aim 2, 
Job title or functional role is one of the following: Network telehealth lead, Facility Telehealth 
Coordinator, primary care leader or designee, dermatology chief or designee, master preceptor, 
Clinical Application Coordinator, teledermatology reader, primary care provider, dermatology staff 
physician, program support assistant.
VA appointment is at least 25% time
10.8  
 List any exclusion criteria (e.g. reasons why someone would not be included 
EXCLUSION CRITERIA:
in the study):
For 
, VA medical centers with no teledermatology activity in FY 2016 or with zero full-time 
Aim 1
equivalent dermatologists were excluded.  
 
For 
, exclusion criteria are:
Aim 2
Subject has no role in implementation of apps (unless subject is primary care or dermatology chief 
or designee)
Subject is a staff member who is also a Veteran patient whose care is affected by the apps
10.9  
Do any study activities take place on any 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
patient care units including inpatient wards, peri- or post-operative care units, operating rooms, or 
 
in the Emergency Department at UCSF Health medical facilities: (REQUIRED)
  Yes   
  No
10.11  
Does your protocol or study involve any of the following patient 
EMERGENCY DEPARTMENT: 
* 
related activities in the emergency department (e.g. subject identification, recruitment, consent, 
blood draws, specimen retrieval, involvement of ED staff (nursing, tech, and/or physician), or any 
other ED based procedures): (REQUIRED)
 
  Yes   
  No
11.0
 Recruitment and Consent

11.1  
Is this a competitive enrollment clinical trial? By competitive 
* COMPETITIVE ENROLLMENT: 
enrollment, we mean that sites who do not enroll participants early may not get to participate at all: 
(REQUIRED)  
  Yes   
  No
11.2  
 
What kinds of methods will be used to identify potential 
* SUBJECT IDENTIFICATION METHODS: 
participants for recruitment (check all that apply): (REQUIRED)
Review of patients' conditions, history, test results, etc. (includes patients seen in clinic, scheduled for 
surgery, a procedure, imaging, or tests, or seen in the Emergency Department as well as searching 
through medical record data for possible cohort identification)
Already approved recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials you will 
provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social media, 
presentation of the study at community events/media, etc.)
Online recruiting tool (describe below)
CTSI Recruitment Services unit
Posting on UCSF Clinical Trials, ClinicalTrials.gov or other publicly available clinical trial website
Other method (describe below)
* Provide details about the subject identification methods: (REQUIRED)
For 
, there is no subject recruitment.  
Aim 1
 
For 
, subjects will be identified from their job titles or roles in telehealth/teledermatology, as 
Aim 2
described in Section 10.  Subjects will initially be contacted through scripted emails or telephone calls (see 
attached) that describe the study goals and nature of the participation, and invite the subjects to 
participate.  
11.4  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
determined:
For 
, there is no recruitment of subjects.  
Aim 1
 
For 
, eligibility of VA staff members for recruitment is determined initially by the job title or 
Aim 2
functional role that a staff member plays in managing dermatology consults or in the telehealth 
process.  At time of initial email or phone contact, subjects will be asked to confirm their eligibility.
11.5  
Who initiates contact (check all that apply): 
INITIATION OF CONTACT: 
* 
(REQUIRED)
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
11.6  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)

Attach the recruitment letter or email template in the Other Study 
Documents section of the Initial Review Submission Packet Form.
11.7  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)
For 
, there is no recruitment of subjects.
Aim 1
 
For 
, research staff will communicate with Office of Connected Care and/or the Chief of Dermatology 
Aim 2
at each site to identify potential candidate subjects.
 
Once candidates have been identified, research staff will individually email each candidate using VA's 
internal Outlook email system (see email recruitment template).  After a week, if there is no response, 
research staff will attempt to initiate contact by phone.  
11.8  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)
Sign a consent form at the end of the consent discussion (signed consent)
Provide online 'eConsent' using an E-Signature system
Click through a link in a survey or email after reading about the study and then complete the study 
online (electronic consent)
Be told about the study and be given a handout/information sheet and be asked if they agree to 
participate (verbal consent)
Complete the study activities and turn in materials, as in the case of a completed survey that is placed 
in a drop box or mailed to the study team (implied consent)
Not be able to provide consent and will have a family member consent for them, as in the case of a 
critically ill or unconscious patient (surrogate consent)
Not be able to provide consent (emergency waiver of consent - allowed for minimal risk research or 
greater than minimal risk research with an approved community consultation plan)
Not know about the study, as in the case of chart reviews or observations of public behavior (waiver of 
consent)
Other method (describe below)
Attach your consent form, information sheet, or electronic consent text in 
the Informed Consent Documents section of the Initial Review Submission 
Packet Form.
11.9  
Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study: (REQUIRED)   We encourage researchers to review our 
.
guidance on obtaining and documenting informed consent
If there are multiple groups being consented differently, provide details about the consent 
process for each group.
If you are relying on 
, provide details about how that will happen.
verbal or implied consent
For studies using online recruitment and consent or consent via mail, provide details here.
For 
, where there is no subject contact and no retention of individually identifiable data, there is no 
Aim 1
consent process.  

 
For 
, we request a waiver of documentation of signed informed consent.  Following reply to the 
Aim 2
initial contact, if the subject agrees, arrangements will be made by the study coordinator to meet over the 
phone to review the study and discuss the informed consent process, as described in the Telephone 
Consent Script attached to this application
 It is important that the people obtaining consent are qualified to do so. Briefly 
*
describe the training and experience these individuals have in obtaining informed 
consent: (REQUIRED)
For 
, consent will be obtained by research staff who have met all the online training required by VA 
Aim 2
for employment and for human subjects research, including TMS training and CITI training.  In addition, 
research staff will be trained by the PIs and co-investigators in the key aspects of the research project, 
including obtaining consent, and role-playing prior to actual encounters with candidate subjects.
11.10  
Indicate how the study team will assess and enhance the subjects' 
CONSENT COMPREHENSION: 
* 
understanding of study procedures, risks, and benefits prior to signing the consent form (check all 
that apply): (REQUIRED)   Tip: Review the Consent Comprehension - Learning Notes in the Help 
bubble at the right for specific questions that can be asked to assess comprehension, consider 
using the UCSF Decision-Making Capacity Assesment Tool, and review our guidance on obtaining 
written or verbal informed consent for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended questions about 
the nature of the study or the experimental treatment, the risks and benefits of participating, and the 
voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their understanding of the 
study purpose, procedures, risks and benefits, as well as the voluntary nature of participation 
(especially appropriate when the consent process happens online or through a mobile health app)
Other method (describe below):
Provide details of the other approaches that will be used, if using another method 
to assess comprehension:
11.11  
Does this study rely on some deception or misinformation about what the 
* DECEPTION: 
researchers are observing to get valid data? (REQUIRED)
  Yes   
  No
11.13  
Select the regulatory category under which 
* WAIVER OF DOCUMENTATION OF SIGNED CONSENT: 
the IRB may waive the requirement to obtain 
consent for this study:
signed 
The only record linking the subject and the research would be the consent document and the principal 
risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked 
whether they want documentation linking them with the research. 46.117(c) (1)  
The research presents no more than minimal risk of harm to subjects and involves no procedures for 
which written consent is normally required outside of the research context. 46.117(c) (2)  
11.14  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
For 
, there is no time commitment.
Aim 1
 
For 
, we anticipate the following time commitments:
Aim 2
30-45 minutes per interview for the three semi-structured interviews: the intial, follow-up, and 
sustainability interviews;
15-20 minutes for the ORC Survey and the Sustainability Index, 5 minutes for the Bi-Monthly Site Report 
every 2 months for 2 years;
1-2 hours for completion of the conference call with the Site Process Guide.
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.

11.17  
Describe other alternatives to study participation, if any, that are available 
OTHER ALTERNATIVES: 
to prospective subjects:
None
12.0
 Risks and Benefits
12.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 
to participants that may need to be disclosed in the consent form:
Physical discomforts or pain
Risks to employment, or social or legal standing
Risk that the study team may observe possible evidence of child abuse, elder abuse, or a threat to self 
or others that they are required to report
For any boxes checked above, describe how you will minimize these risks and 
* 
discomforts, e.g., adding or increasing the frequency of monitoring, additional 
screening to identify and exclude people with diminished kidney or liver function, 
or modification of procedures such as changing imaging studies to avoid giving 
contrast agent to people who are more likely to suffer side effects from it, etc.: 
(REQUIRED)
For 
, the risk is minimal as there is no subject contact and data is collected in aggregate without individually-
Aim 1
identifiable information by VA's CAPER under its own IRB approval.
 
For 
,
Aim 2
There is a small risk of losing anonymity through the use of demographic or job title information.  
Some individuals may feel self-conscious or embarrassed if asked questions about something with which they are 
unfamiliar,  and they may be concerned that their responses will become known to colleagues and supervisors.
12.2  
Describe any anticipated risks and discomforts not listed above: 
RISKS: 
* 
(REQUIRED)
None
12.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation
For 
, there is no subject contact and data is collected in aggregate without 
Aim 1
individually-identifiable information.
 
For 
, 
Aim 2   
The risk of loss of anonymity will be minimized by not reporting demographic information for 
individual VA facilities participating in the study when aggregate results are provided to any VA 
administrators, colleagues, affiliated university colleagues, or affiliated university 
administrators.  No individual respondents will be identified in any presentations or reports from 
this study.

 
To minimize the risk that subject responses will become known to colleagues or supervisors, 
research staff will not interview or survey subjects at their own facility.  For example, San Francisco 
researchers will interview Providence staff, and 
.  In all cases, research staff is trained to 
vice versa
maintain the strict confidentiality and anonymity of subject responses in their daily interactions 
during and outside of work hours.  Subject interviews are stored on secure VA servers accessible 
only to authorized research staff approved for this specific study.  Additionally, supervisors will not 
have access to any data. 
12.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or alleviation 
of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
Briefly discuss the other possible benefits:
Participation may lead to knowledge that will help the subject and others in their jobs in the 
future.  Specifically, knowledge may be gained about organizational factors involved in the implementation 
of telehealth programs and technology that may facilitate future programs in which the subject may be 
involved.
12.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:
The formative evaluation will allow monitoring of the apps in detail at the pilot sites, and if 
safety issues are identified, will allow corrections to be made before most other sites have 
been exposed the apps.  The benefits of understanding organizational and individual factors 
that affect implementation of new processes in VA are considerable given that VA will likely 
undertake similar implementations of other interventions in the future.  The principal risk of 
inadvertently revealing employees attitudes and knowledge of the process to peers and 
supervisors is minimal in absolute terms and in relation to the potential benefit to VA.
12.7  
Do you have a Data and Safety Monitoring Plan (DSMP) for this 
DATA AND SAFETY MONITORING: 
* 
study (
): (Click the Help link for guidance 
A DSMP is 
 for Greater than Minimal Risk research
required
 
on risk determination) (REQUIRED)
 Yes   
 No
This is not required for minimal risk research but the UCSF IRB strongly recommends one to 
ensure the data collected are adequate to meet the research aims:
13.0
 
Data and Safety Monitoring Plan

13.1  
DATA AND SAFETY MONITORING PLAN (DSMP): 
* 
(REQUIRED) Provide a summary of the DSMP:
All greater than minimal risk studies are required to provide a plan. Lack 
of an adequate plan is one of the most common reasons why IRB approval 
is delayed.
 
Instructions:
Describe the plan for monitoring data quality and participant safety. Key areas that 
should be included in the plan are:
An explanation of the plan to monitor data collection, study progress, and 
safety
A description of who will perform the monitoring and at what frequency (e.g., 
the PI only, a contract research organization, a Data and Safety Monitoring 
Board or Data Monitoring Committee, etc.)
The type of data and events that will be reviewed (e.g., adverse events, 
breaches of confidentiality, unanticipated problems involving risk to 
participants or others, unblinded efficacy data, etc.)
Procedures and timeline for communicating monitoring results to the UCSF 
IRB, the study sponsor, and other appropriate entities
As appropriate:
A plan for conducting and reporting interim analysis
Clearly defined stopping rules
Clearly defined rules for withdrawing participants from study interventions
The monitoring plan consists of both local and national oversight:
 
For 
, data monitoring is done by CAPER under its own IRB approval.  Aggregate data will also be 
Aim 1
reviewed by the PIs at routine conference calls every other week and during the annual investigators' 
meeting with Office of Connected Care in Washington, DC.  However, this will be performed in consultation 
with VA's Office of Connected Care which is responsible for the overall implementation of the mobile apps 
throughout VA, and has its own independent Quality Improvement team to monitor implementation and 
safety.
 
For 
, local monitoring includes the following:
Aim 2
The consenting process informs research subjects of their ability and right to contact the local 
PI and research office should they have questions or concerns regarding their well-being, and 
provides them with contact information.  Since research subjects will be interviewed and surveyed 
remotely by research staff not associated with their facility, it will be the responsibility of the local 
PI to notify the PI responsible for the remote research staff.
The PIs and co-investigators at San Francisco, Providence and Durham, as well as CAPER 
investigators in Boston will hold phone conference calls every other week to discuss the project, 
including progress in subject recruitment, data collection, and safety. 
The PIs for each site will have first-line responsibility for ensuring that subject interactions are 
appropriate and safe, and that the data collected by their research staff is of sufficient quality and 
properly stored in REDCap.  Interview data will be collected by recording phone conversations 
directly onto secure VA networked servers or encrypted computers. Data from these interviews will 
be stored on the Research (R:) drive of the San Francsico VA Health Care System server.
Survey data will be collected centrally using REDCap, hosted by the VA Information Resource 
Center (VIReC) and housed on a VA Informatics and Computing Infrastructure (VINCI) server at 
VA's Austin Infomration Techology Center.  Data is backed up nightly and every 6 hours.  REDCap 
provides data de-identification features, and captures audit trails and logging with individualized 
user rights management.  One is able to restrict access to PHI at the user level if needed, and limit 
access between different sites' data within multi-site studies if needed.
Events triggering PI notification will include the following:  Complaints generated by research 
subjects, change in employment status of research subjects identified by research staff (e.g., 

inability to administer follow-up interviews with research subjects due to transfer to new jobs or 
lack of response), and real or suspected loss of data or breach of subject confidentiality.
If PIs identify issues with patient safety or confidentiality, the PIs will notify the local VA Research 
Office, UCSF's IRB as well as VA Office of Research and Development will be notified per VA 
protocol.  Minor issues in data quality and project progress will be addressed directly with the site
(s) involved, as well as during biweekly conference calls among all the investigators and/or during 
the annual investigators' meeting in Washington, DC.  
13.2  
DATA AND SAFETY MONITORING BOARD (DSMB): 
* 
(REQUIRED) Will a Data and Safety Monitoring 
Board (DSMB) be established:
Yes 
No 
Guidelines
  A Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee 
(DMC) is a formal, independent committee that is specifically established to 
conduct interim monitoring, oversight and analysis of study information and data 
to assure the continuing safety, efficacy, appropriateness, relevance, and integrity 
of the study.
   
  The UCSF IRB reserves the right to request a DSMB/DMC for any study. However, 
the following are factors that the IRB will consider when making this determination:
 
There is a significant likelihood of a serious adverse event to subjects
The study is conducted at multiple sites and the level of risk is greater than 
minimal
The study generates data that are blinded or randomized
The study involves a large number of patients randomized to one of two or 
more interventions
A study for which the performance of an interim analysis is crucial for the 
protection of the subjects
First use in humans
First use in children
The study involves gene therapy, stem cell therapy, or other novel 
interventions for which long-term outcome data are not known or available
14.0
 Confidentiality, Privacy, and Data Security
14.1  
Indicate how subject privacy will be protected:
PROTECTING PRIVACY: 
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be called, can 
messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added to their 
medical records or shared with others without the subject’s permission
Other methods (describe below)
14.2  
Do any of the instruments ask about illegal or stigmatized behavior:
SENSITIVE DATA: 
  Yes   
  No

14.3  
Could a breach of 
SIGNIFICANT CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
privacy or confidentiality result in any significant consequences to participants, such as criminal or 
civil liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation:
 Yes   
 No
Check all that apply:
Embarrassment
Criminal or civil liability
Loss of state or federal benefits
Damaging to the participant's financial standing, employability, or reputation
Potential risks to insurability (health, disability, or life insurance)
Describe the potential consequences:
For 
, the research will record employees' attitudes or knowledge about telehealth, mobile apps, 
Aim 2
teledermatology or broader VA-related issues.  It is possible that loss of privacy/confidentiality regarding 
this data could prove embarrassing or damaging to reputations for employees if released to peers or 
supervisors.  In such cases, some employees may feel job insecurity. 
14.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:
For 
, subjects at one site will be interviewed by research staff at another site.  For 
Aim 2
example, Providence staff will be identified, consented, and interviewed as research 
subjects by San Francisco research staff.   Interview records and contact information will 
be kept on encrypted local computers temporarily and saved on the San Francisco VA 
Medical Center's R: drive server. Survey data will also reside on the San Francisco VA 
Medical Center's R: drive server.  Study results will be reported in aggregate.  Data and 
results collected from individual VA employees will not be reported outside of individuals 
included on the study staff list.  As a result, individual-level data/results collected from 
individual VA employees will not be shared with colleagues, supervisors, or other VA 
stakeholders.  Research records will be retained in accordance with the VHA Records 
Control Schedule.
14.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others: (REQUIRED)
  Yes   
  No
14.6  
Will this study obain a Certificate of Confidentiality:
CERTIFICATE OF CONFIDENTIALITY: 
  Yes   
  No
14.7  
Will there be any sharing of 
 research test results 
SHARING OF RESEARCH RESULTS: 
EXPERIMENTAL
with subjects or their care providers:
  Yes   
  No
14.9  
Study data will be: 
* HIPAA APPLICABILITY: 
(REQUIRED)

Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service (THREDS) at 
SFGH
14.10  
Check all identifiers that will be collected and included in the research records, 
IDENTIFIERS: 
* 
even temporarily: (REQUIRED)
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
* Required for studies conducted at the VAMC
Could study records include 
 photos or images (even 'unidentifiable' ones): 
* 
ANY
(REQUIRED)
  Yes   
  No
14.11  
 
Will health information or other clinical data be accessed from UCSF Health, 
* PATIENT RECORDS: 
Benioff Children's Hospital Oakland, or Zuckerberg San Francisco General (ZSFG): (REQUIRED) 
  Yes   
  No
14.18  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)
Collection methods:
Electronic case report form systems (eCRFs), such as OnCore or sponsor-provided clinical trial 
management portal
UCSF ITS approved Web-based online survey tools: Qualtrics or RedCap
Other web-based online surveys or computer-assisted interview tool

Mobile applications (mobile or tablet-based)
Text Messaging
Wearable devices
Audio/video recordings
Photographs
Paper-based (surveys, logs, diaries, etc.)
Other:
What online survey or computer assisted interview tool will you use: 
* 
(REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
Study sponsor
UCSF data center (including OnCore, RedCap, Qualtrics, and MyResearch)
UCSF encrypted server, workstation, or laptop residing outside of UCSF data center
Personal devices, such as laptops or tablets that are not owned or managed by UCSF
SF VAMC
Zuckerberg San Francisco General Hospital
Benioff Children's Hospital Oakland
Langley Porter Psychiatric Institution
Other UCSF affiliate clinic or location (specify below)
Cloud vendor such as Amazon Web Services (AWS), Salesforce, etc. (specify below)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
Please consult with the VA's Clinical Research Office at 415-221-4810 x 2-
6425 about the VA's requirements for data storage and security.
14.20  
During the lifecycle of data collection, transmission, and storage, will identifiable 
DATA SHARING: 
* 
 
information be shared with or be accessible to anyone outside of UCSF: (REQUIRED)
  Yes   
  No
15.0
 Financial Considerations
15.1  
Will subjects be paid for participation, reimbursed for time or expenses, or receive any 
* PAYMENT: 
other kind of compensation: (REQUIRED)
  Yes   
  No
15.4  
Will subjects or their insurance be charged for any study activities:
COSTS TO SUBJECTS: 
  Yes   
  No
16.0
 Other Approvals and Registrations
16.4  
Indicate if this study involves other regulated materials and requires approval 
OTHER APPROVALS: 

and/or authorization from the following regulatory committees: 
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
17.0
 Qualifications of Key Study Personnel and Affiliated 
Personnel
 
NEW: January 2019 - Affiliated personnel who do not 
need access to iRIS no longer need to get a UCSF ID. 
Instead, add them below in the Affiliated Personnel 
table below. 
17.1    
  
  
  
Qualifications of Key Study Personnel:
 
Instructions:
 
For UCSF Key Study Personnel (KSP)* listed in 
 select the KSP from 
Section 3.0,
the drop down list and add a description of their study responsibilities, 
qualifications and training. In study responsibilities, identify every individual who 
will be involved in the consent process. Under qualifications, please include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
NOTE: This information is required and your application will be considered 
 
incomplete without it. If this study involves invasive or risky procedures, 
or procedures requiring special training or certification, please identify 
who will be conducting these procedures and provide details about their 
qualifications and training. Click the orange question mark for more 
information and examples. 
 
Training Requirements: 
The IRB requires that all Key Study Personnel complete Human Subjects Protection 
Training through 
 prior to approval of a new study, or a modification in which 
CITI
KSP are being added. More information on the CITI training requirement can be 
found on our 
. 
website  
 
* 
 UCSF 
Definition of Key Study Personnel and CITI Training Requirements (Nov, 2015):
Key Study Personnel include the Principal Investigator, other investigators and research 
personnel who are directly involved in conducting research with study participants or who are 
directly involved in using study participants’ identifiable private information during the course of 

the research. Key Personnel also include faculty mentors/advisors who provide direct oversight 
to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
   
KSP Name
Description of Study 
Responsibilities - Briefly 
describe what will each person 
be doing on the study. If there 
are procedures requiring special 
expertise or certification, 
identify who will be carrying 
these out. Also identify who will 
be obtaining informed consent.
Qualifications, Licensure, and 
Training
Oh, Dennis H
Principal Investigator
Dr. Oh is Assistant Chief of 
Dermatology at SFVAMC, co-
lead for teledermatology in 
VA's Office of Connected Care, 
and has been principal 
investigator for NIH and VA 
studies for over 20 years. He 
has completed the Human 
Subjects Training through CITI.
Peracca, Sara
Study Coordinator
Dr. Peracca is a sociologist 
with a specialization in 
demography. She is a 
research health science 
specialist in the research 
department of the SFVAMC. 
She also has an MPH and an 
MS. She has over 20 years 
experience conducting 
research using quantitative 
and qualitative methods for 
studies of varying size for 
public and private entities 
throughout the world. She has 
completed the Human 
Subjects Training through 
CITI.
Lachica, Olevie T
Research Assistant
Ms. Lachica is a program 
support assistant in the 
dermatology department of 
the SFVAMC. She has a BA in 
Health Education and is 
currently obtaining her 
masters in health informatics 
administration. She completed 
the Human Subjects Training 
through CITI.
17.2  Affiliated Personnel: 
Instructions:
 
This section is for personnel who are not listed in Section 3.0: Grant Key 
 because their names were not found in the User 
Personnel Access to the Study
Directory when 
 the iRIS Database and MyAccess directories were searched. 
both
Add any study personnel who fit 
 of the following criteria in the table below:
ALL
They meet the definition of Key Study Personnel (see above), and

They are associated with a UCSF-affiliated institution (e.g., VAMC, Gladstone, 
Institute on Aging, Vitalant, NCIRE, SFDPH, or ZSFG), and
They do 
 have a UCSF ID, 
not
and
They do 
 need access to the study application and other study materials 
not
in iRIS.
 in the 
Note: Attach a CITI Certificate for all persons listed below
Other Study 
 section of the 
 after 
Documents
Initial Review Submission Packet Form
completing the 
.
Study Application
 
Click the orange question mark icon to the right for more information on who to 
include and who not to include in this section.
 
Do 
 list personnel from outside sites/non-UCSF-affiliated institutions. Contacts 
not
for those sites (i.e. other institution, community-based site, foreign country, or 
Sovereign Native American nation) should be listed in the 
 section of 
Outside Sites
the application.
 
If there are no personnel on your study that meet the above criteria, leave 
this section blank.
 
Name
Institution
Telephone
E-mail
Role
No External Personnel has been added to this IRB Study
Please describe the study responsibilities and qualifications of each affiliated 
person listed above:
18.0
 End of Study Application
End of Study Application Form
 
:
To continue working on the Study Application
Click on the section you need to edit in the left-hand menu. Remember to save through the 
entire Study Application after making changes.
 
:
If you are done working on the Study Application
Before proceeding, please go back to Section 4.0 Initial Screening Questions and 
Important: 
 through the form to make sure all the relevant sections and questions have 
Save and Continue
been included. If you've changed any answers since you started, the branching may have 
changed. Your application will be incomplete and it will have to be returned for corrections. 
 
Once you are sure the form is complete, click 
. If this is a new study, you 
Save and Continue
will automatically enter the 
, where you can attach 
Initial Review Submission Packet Form
or other 
. Review the 
 
consent forms 
study documents
Initial Review Submission Checklist
for a list of required attachments.
 
Answer all questions and attach all required documents to speed up your approval.
 
 
 
 
 
The UCSF IRB welcomes feedback about the IRB Study Application Form. Please click the link to answer a 
 about the application form.
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