Written Safety Planning vs the Safety Net App: A Prospective Randomized Pilot Trial
Phase: NA
Conditions: Suicidal Ideation, Suicide Attempt, Mental Health
Sponsor: University of Arkansas

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 1 
 
 
 
Study Title: 
Written safety planning vs the Safety Net app: A 
prospective randomized pilot trial 
 
Principal Investigator: 
Michael Wilson, MD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 584 
Little Rock, AR 72205 
Telephone: 501-686-7000 
Email: MPWilson@uams.edu 
 
Sub-Investigator(s): 
Angie Waliski, PhD 
Psychiatric Research Institute 
University of Arkansas for Medical Sciences 
4301 West Markham Street, #554 
Little Rock, Arkansas 72205 
Telephone: 501-686-7000 
Email: ADWaliski@uams.edu 
 
Ronald Thompson, Jr, PhD 
Psychiatric Research Institute 
University of Arkansas for Medical Sciences 
4301 West Markham Street, #554 
Little Rock, Arkansas 72205 
Telephone: 501-686-7000 
Email: RGThompson@uams.edu 
 
Carly Eastin, MD 
University of Arkansas for Medical Sciences 
 4301 W. Markham Street, Slot # 584 
Little Rock, AR 72205 
Telephone: 501-686-7000 
Email: CDEastin@uams.edu 
 
Manuel Alvarez Romero 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 584 
Little Rock, AR 72205 
Telephone: 501-686-7000 
Email: MAlvarezromero@uams.edu 
 
Study location: 
University of Arkansas For Medical Sciences 
 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 2 
Background and Rationale 
Scientific rationale: Suicide deaths are at an all-time high 
Suicide is a leading – and growing – cause of death in the United States.1 From 
2008-2017, suicide was ranked the 10th leading cause of death for all ages combined, 
and from 1999-2017, the age-adjusted suicide rate rose by 33%.2 Thus, suicide is a 
large problem nationwide.3 
Safety planning is a brief, ED-feasible intervention which has been demonstrated to 
save lives,4,5 and has been universally recommended by every recent expert consensus 
panel on suicide prevention strategies.3,6-8 In one popular version of the safety plan 
developed by Stanley et al,4 the patient is encouraged to write out the following items: 
identifying personal signs of a crisis; helpful internal coping strategies; social contacts or 
settings which may distract from a crisis; using family members or friends for help when 
in crisis; mental health professionals who can be contacted when in crisis; and 
restricting access to lethal means.4 In most emergency departments, safety-planning is 
done by clinical personnel such as psychologists or social workers, but these providers 
are often too busy to perform safety-planning well or have multiple other patient care 
responsibilities. 
This project aims to answer the following three research questions: (1) Will ED 
patients with suicidal ideation/attempt accept coaching on safety planning from non-
clinical personnel; (2) Are these safety plans of high-enough quality for clinical 
personnel; and finally, (3) Will ED patients with suicidal ideation/attempt complete safety 
plans electronically? 
Please note that the study will not otherwise alter usual & customary care in the 
emergency department. 
 
Concerns about peer vulnerability to relapse 
Anecdotally, there have been concerns that peer-delivered interventions may not be 
effective in the ED, since peers may be vulnerable to relapse in the stress of the acute-
care environment. As some authors have noted, working in acute care is stressful for 
many individuals, not just peers.9 However, it is not true that peers are too “fragile” for a 
study of this type. Findings from peers in non-ED environments have generally indicated 
that peers receive positive benefit from the experience,10 including increased confidence 
and self-esteem.11 Nonetheless, peers will be given the opportunity to experience the 
ED environment before committing to this project (please see “Recruitment of peers for 
this project” and “Training of peers” below). In addition, peers will be closely monitored 
and debriefed by the sub-investigator of this project (Dr. Waliski), who is a licensed 
clinical counselor (please also see “Supervision and debriefing of peers” below). While 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 3 
adverse events are not expected as a result of this intervention, the PI will carefully 
monitor for any such event and report any adverse event to the IRB. In addition, if a 
peer has a relapse or any psychiatric emergency during the course of the intervention, 
they may contact Dr. Waliski using the contact information provided during peer training. 
After this initial contact, Dr. Waliski will debrief 
the peer by meeting with them and further 
discussing the situation. 
Please note that although peers will receive 
mandatory confidentiality training required at 
the study institution, there is little concern that 
peers will “say the wrong thing” or break a 
patient’s confidentiality. Given that these peers 
have personal experience of hospitalization, it 
is more likely that they will be willing to guard 
the patient’s confidentiality and less likely than 
clinical staff to make insensitive remarks to a 
patient. However, all peers will be CITI-certified, 
with periodic reminders about patient confidentiality from the investigators. 
 
Description of interventions 
Written safety plan: Please see separate upload for the Stanley et al version of the 
safety plan. This safety plan contains 6 components, and is completed by the patient 
themselves. This intervention takes approximately 20-40 minutes to complete. As a 
former site for the ED-SAFE study,12 the UAMS ED typically has patients complete 
safety plans if being discharged. This is typically done by the psychiatric nurse or social 
worker if they are available, and this individual then places a progress note in the 
electronic medical record (EMR). These clinical providers must approve all safety plans 
in this study as peer support specialists and other research staff do not have the ability 
to place notes in the EMR. 
Stanley-Brown Safety Plan app (i.e., Safety Net app): The Safety Net app is an 
electronic version of a safety plan and it is available for download in Apple’s App Store. 
A preview of this app is available at: https://apps.apple.com/us/app/stanley-brown-
safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was 
developed in partnership with the New York State Office of Mental Health. Unlike the 
paper version, the Safety Net app allows participants to email a copy of their safety plan 
to whomever they wish. It also allows patients to dial 911 or the National Suicide 
Prevention Lifeline from the app. 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 4 
Please see Figure 2 below for study flow. The app only stores deidentified data 
locally on UAMS secured tablets. Thus, the safety plan will have to be shown or emailed 
to clinical staff in order to be entered into the electronic medical record. Please note that 
peers and other research staff do not have the ability to place notes in the EMR. 
Study Design and Procedures 
This is an effectiveness-implementations randomized controlled trial which will be 
conducted in the emergency department (ED) at the University of Arkansas for Medical 
Sciences (UAMS) in Little Rock, Arkansas. The UAMS ED is an urban emergency 
department which sees approximately 60,000 patients per year, including more than 
1,200 suicidal patients. 
This clinical trial will compare the intervention of ED patients completing an 
electronic safety plan with a peer or other research staff member to completing a 
traditional written safety plan with a peer or other research staff member. Patients 
triaged and flagged with the chief complaint of “SI”, “suicidal ideation”, “suicide attempt”, 
or “Psychiatric BEE” on the ED trackboard when a peer or other research staff member 
is available will be approached to participate. Patients will be approached after 
evaluation by an emergency physician. 
Study flow: Utilizing trained nonclinical staff (i.e., peers or other research staff 
directed by the investigator team), staff will approach patients identified from the ED 
trackboard as being at risk for suicide until as many as 30 patients have been enrolled. 
Please see Figure 2 above for study flow. Patients are typically triaged by UAMS 
nursing staff as being “at-risk” after questions about self-harm. If so triaged, patients are 
then flagged with the chief complaint “SI”, “suicidal ideation”, “suicide attempt”, or 
“Psychiatric BEE” on the ED trackboard and placed in a special area of the ED for 
evaluation. A partial waiver of HIPAA for recruitment purposes is requested to allow 
peers and other research staff to visualize the ED trackboard, and is appropriate for the 
following reasons: 
• The PHI use or disclosure involves no more than minimal risk to the privacy of 
individuals based on the fact that no PHI will be recorded, reused, or 
Figure 2. Study flow. 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 5 
disclosed to any other person or entity except as required by law or for 
authorized oversight of the research study. 
• The research could not practicably be conducted without the requested 
waiver or alteration, as it would be difficult or impossible to identify ED 
patients at risk of self-harm in any other manner. 
• The research could not practicably be conducted without access to and use of 
the PHI. 
The trained peers and other research staff are UAMS nonclinical staff members who 
are participating in ED clinical research and who have received extensive training in 
safety planning (see below), data collection techniques, how to operate REDCap data 
collection software, and how to obtain informed consent. All are CITI certified and 
receive periodic reminders about confidentiality. 
Upon approach by peers or other research staff, patients will be asked if they would 
like to participate in the study and if they would allow peers or other research staff to 
help them with safety planning. If the answer to both questions is yes, patients will be 
offered a brief screening procedure: 
 
Inclusion criteria 
• Presenting to the UAMS ED for suicidal ideation (SI) or after suicide attempt; 
• Willingness to engage in safety planning with trained non-clinical staff; 
• Have not already filled out a safety plan at the current visit 
 
Exclusion criteria 
• Prospective participants <18-years or >89-years of age; 
• Presently incarcerated or in police custody; 
• Non-English speaking; 
• Critically-ill; 
• Intoxicated with alcohol or other substances; 
• ED staff objected against entering room; 
• Unwilling or unable to complete the safety plan electronically; 
• Unwilling or unable to use a tablet; 
• Unwilling or unable to show/email this safety plan to clinical and research staff. 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 6 
If participants indicate interest in the study and meet all inclusion/exclusion criteria, 
informed consent will be obtained using IRB-approved consent forms & processes. If 
they provide consent, participants (n=30) will be randomized in a 1:1 fashion to either 
the traditional written safety plan group, in which they will complete a written safety plan 
with a peer support specialist or other research staff member, or the electronic “Safety 
Net” safety plan group, in which they will complete an electronic safety plan with a peer 
support specialist or other research staff member (please see Figure 2 above). 
Participants will be randomized using the randomization function in REDCap. All 
participants will be allowed to complete the safety plan in the privacy of their ED 
treatment room. Please note that participants will be given a $25 gift card for 
participating regardless of which group they are randomized into for the study. 
After completing the safety planning process, participants will then be asked to 
answer a short questionnaire concerning their demographics (e.g., age, biological sex), 
any history of previous suicidal ideation, suicide attempts, or related behaviors, and 
satisfaction with the safety planning process. 
Regardless of whether the safety plan is completed in the traditional paper format or 
electronically, this will be shown to the UAMS ED psychiatric registered nurse or social 
worker for approval and entry into the EMR. Please note that the study will not 
otherwise modify care in the ED. It is possible, although not likely, that psychiatry 
consultants could choose to revise, edit, or otherwise start anew with safety planning for 
a particular patient. If so, the patient will be withdrawn from the study. 
Other measures: All participants will complete a brief questionnaire regarding their 
demographics, history of suicidal behaviors, and satisfaction with the safety planning 
process. After the visit, the electronic medical record will be searched for the following 
data: date/time of ED triage and disposition; length of ED stay; ED chief complaint or 
reason for visit; patient disposition (observation/admission/discharge/transfer); 
psychiatric diagnoses; and frequency of ED visits 3 months before and after the 
intervention. Length of ED stay will be compared against two control groups (obtained 
using AR-CDR): a) length of stay of all ED patients during a similar time period; and b) 
length of stay of ED patients who presented for SI during a similar time period. No PHI 
will be recorded for either of these deidentified control groups. Peers and other research 
staff will also be asked to record the total amount of time that they spent performing the 
safety plan intervention. 
Study retention: The study duration is limited to the ED visit (typically <6 hours for SI 
patients), with participation in the study limited to the interventions mentioned above. 
Consequently, no special measures designed to increase retention are planned. 
 
 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 7 
Recruitment of peers for this project 
Peers will be recruited through existing relationships with community suicide 
prevention organizations (i.e., Arkansas Foundation for Suicide Prevention, Arkansas 
Governor’s Suicide Prevention Council, Veterans Service Organizations, etc.). Eligible 
recruits will complete an interview with Dr. Waliski where they will be informed about the 
responsibilities and expectations of working with this project. Training and supervision of 
peers and other research staff will be used to further monitor the appropriateness of the 
individual to assist patients in providing the intervention. 
 
Training of peers and other nonclinical individuals 
As this project utilizes peers that have lived through suicidal ideation or attempts and 
other nonclinical individuals, albeit ones with strong interest in suicide prevention, the 
training, debriefing, and supervision of research staff are paramount (please see 
“Supervision and debriefing of peers” below). Training will follow constructivism learning 
theory,13 which posits that individuals learn best when they actively construct their own 
meaning of new information by relating it to their experiences, attitudes, and beliefs.14,15 
In this mode of instruction, instructors facilitate learning by asking guiding questions and 
providing individualized feedback, utilizing role play and role modeling, and providing a 
safe learning environment that promotes self-exploration and self-evaluation.14-16 
As shown in the Suicide Safety Planning Training Cycle (please see figure 1), 
training conducted by sub-investigator Waliski, sub-investigator Thompson, and PI 
Wilson will extend over approximately 12 hours (please see “Training agenda” uploaded 
to the IRB as a separate document). Training will involve a four-step cycle that starts 
with exploring personal experiences about suicide and suicide prevention. Using videos, 
presentation slides, and active learning techniques, peers and other nonclinical 
individuals will be provided education about suicide and the safety planning intervention 
using training materials originally developed by Drs. Stanley and Brown.17 The 
information presented to the peers or other nonclinical individuals may be new or 
previously known by them, but will be presented in a way that encourages deeper 
examination of the topic and how it relates to their experiences. The instructor will then 
facilitate the revision of beliefs and skills using guiding questions and individualized 
feedback based on comments from the peers and other nonclinical individuals. 
Examination and exploration will promote the revision of their knowledge and beliefs 
about suicide and the safety planning intervention. Finally, role modeling and role play 
will be used to allow the peers and other nonclinical individuals the opportunity to test 
their now-revised beliefs and skills related to suicide and safety planning intervention. 
This is an iterative process and will be performed as many times as needed for each 
member of the team. 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 8 
Specific training will be conducted about how to conduct the safety plan intervention, 
using materials developed by Brown & Stanley. Five learning objectives will guide the 
development of the training structure (please see Table I below). The instructor (Drs. 
Thompson & Waliski) will present information using various didactic and technological 
methods, and will take place over approximately 12 hours. During initial topics, the 
focus will be on building a safe learning environment that utilizes the peers’ and other 
nonclinical individuals’ personal life experiences to understand empirical evidence of 
suicide and suicide prevention. Later topics will provide more specific training on the 
safety plan using materials from Brown and Stanley.17 This portion of the training will 
also use videos, presentation slides, and role-playing. While lists of examples of 
warning signs, strategies for internal and external distractions, methods for restricting 
lethal means, and mental health treatment providers will be provided, peers and other 
nonclinical individual will be encouraged to provide input based on their own 
experiences. Finally, training will also involve a general orientation to the emergency 
department. This part of the orientation will be provided by Dr. Wilson, and will involve 
already- developed training materials for orienting new research staff to the UAMS ED. 
Follow-up trainings will be provided depending on identified need. 
Special training about COVID-19: all patients presenting to the UAMS ED are 
universally screened for COVID-19 signs or symptoms (fever, cough, recent travel) and 
are placed into specially-marked isolation rooms. As part of training, research staff must 
demonstrate awareness of ED policies regarding the marking of these isolation rooms 
for suspected COVID-19 patients; must understand the importance of not entering these 
rooms; must understand and agree to use hand sanitizers when entering and leaving a 
patient’s room (“foam in/foam out”); must demonstrate awareness of UAMS policies 
regarding screening of employees when they arrive for work; and must agree to stay 
home if they are feeling sick. 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 9 
Please note that safety planning is a process that requires in-person interaction with 
participants due to the setting involved and confidentiality concerns. Having the special 
training detailed above in place reduces the health risk to potential participants and 
research staff. In addition to using the special training about COVID-19 detailed above, 
research staff will further minimize health risk by maintaining a safe social distance from 
participants during all study procedures and properly sanitizing all study equipment 
(pens, tablets, etc.) by using sanitizing wipes after use by each participant. 
 
Supervision and debriefing of peers 
Although anecdotally peers may be vulnerable to stress-induced relapse in the ED 
clinical environment, scant support for this idea is noted in the literature (please see 
above). Nonetheless, all peers will receive close supervision and debriefing during the 
study. Supervision will be provided using the discrimination model.18 
As a licensed clinical counselor, Dr. Waliski will assess the provider’s skill level and 
will become the role of a teacher, counselor, or consultant based on need. In other 
words, peers and mental health staffs will be provided with either instruction and direct 
feedback (i.e., the teacher role), support for reflection and processing of personal 
experiences (i.e., the counselor role), or encouraging confidence in required skills (i.e., 
the counselor role) depending on need. 
In terms of direct supervision, Dr. Waliski will be on site during the first week of the 
intervention to observe performance and operation. She will ensure that the safety plan 
is being administered, documented, and managed appropriately by each provider (see 
also “Fidelity of the intervention” below). If deficits are identified, she will work with 
individuals to make needed improvements. During the first week of intervention 
implementation, Dr. Waliski will also conduct an individual face-to-face interview with 
each peer. Interview questions will be guided by the Consolidated Framework for 
Implementation Research (CFIR)19 and focus on identifying and overcoming perceived 
barriers to implementation of the intervention. 
Peers will also be provided with clear instructions on how to obtain help during any 
difficult or uncomfortable situations during the intervention. After the first week of the 
intervention, peers may inform ED clinical staff (social worker or psychiatric nurse) on 
site of such situations so that the staff may continue working on the safety plan with the 
participant. ED clinical staff are available 24/7 so peers would not have much trouble in 
finding and asking someone for help with a participant during these situations. 
Participants who do not complete the safety planning with a peer will be withdrawn from 
the study, but peers will be informed that their safety and well-being remains a priority 
when completing the intervention and so they should not hesitate to ask clinical staff for 
help. Peers may also contact Dr. Waliski using the contact information provided during 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 10 
peer training in order to schedule an in-person meeting. Dr. Waliski will debrief the peer 
at these meetings by further discussing the difficult or uncomfortable situations. 
Once the pilot project is underway, periodic debriefing of providers will be provided 
by Dr. Waliski. This debriefing will provide an opportunity to identify areas of needed 
improvement in the study protocol or in training (please also see “Fidelity of the 
intervention” below). Given this study utilizes individuals that have lived through serious 
suicide ideations and/or attempts, peers will likely have their own preconceived opinions 
about suicide and how to encourage survival. Debriefing will allow an opportunity to 
monitor how past experiences could be impacting the delivery of the intervention or how 
participating in the study could be impacting the provider. Dr. Waliski will also use this 
time to review personal safety plans and encourage providers to participate in 
appropriate self-care. 
Please note that training on other aspects of the proposed research has been 
provided by Dr. Wilson. All research staff are trained on relevant IRB regulations & 
procedures, and required to be CITI-certified. 
Measurement of safety plan quality: All safety plans will be evaluated by existing ED 
clinical staff for approval. If it needs to be modified, it will be documented that the 
research staff had to gather more information from the participant. Safety plans will also 
later be graded on a numerical rating scale (0-2 or 0-3, depending on grading 
component) by the investigators using materials developed by Gamarra et al for this 
purpose.20 Using a “safety checklist,” responses for each of the 6 safety plan steps (with 
step 3 divided into two parts) and the “most important thing worth living for” section will 
be rated according to the personalization of the information in each section. In addition, 
each section will be independently rated for “completeness” (0=not complete, 1=partially 
complete, 2=complete) and “quality” (0=blank, 1=boilerplate, 2=some evidence of 
personalization, 3=highly personalized and specific). For instance, in the answer to the 
question “Warning signs (list 3 items),” patients may simply list “sad” which reflects a 
low-quality answer. Alternatively, the patient may answer “Feeling like I can’t stop crying 
or can’t stop being sad” which reflects a higher-quality more personalized answer. Each 
of the sections in a participant’s safety plan will be graded in this manner, with 
completeness having a maximum score of 16 and quality having a maximum score of 
24. An overall score for the safety plan will be derived by adding the scores for all 
sections in a participant’s safety plan. Peers and other nonclinical individuals will be 
trained to coach participants towards higher-quality answers (please see above). 
 
Monitoring: Adverse events or in case of psychiatric emergency 
By definition, all patients have presented to the ED for an acute mental health crisis 
and will be under the care of trained ED physicians, trained ED nurses, trained 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 11 
psychiatric ED nurses who typically complete the safety plan, and other psychiatric 
personnel as appropriate. In the unlikely event of psychiatric decompensation, peers will 
be instructed to stop the intervention and seek help from qualified personnel in the ED. 
The intervention will then not be continued. 
Although adverse events (AEs) are not expected and are unlikely, the peers and 
mental health personnel who are responsible for approving the safety plan will 
nonetheless be instructed to communicate any and all AEs to the PI (Wilson). The PI 
will communicate any adverse events to the UAMS IRB, consistent with IRB policies & 
regulations. 
 
Risks and Benefits 
The main potential risk to study participants is loss of confidentiality. The 
researchers take confidentiality very seriously, and measures to protect the 
confidentiality of study participants will be implemented as described in the Data 
Handling and Recordkeeping section below. Adverse events will be handled as above 
(please see “Monitoring: Adverse events or in case of psychiatric emergency” above). 
 
Data Handling and Recordkeeping 
The Principal Investigators will carefully monitor study procedures to protect the 
safety of research subjects, the quality of the data, and the integrity of the study. All 
study subject material will be assigned a unique identifying code or number in REDCap. 
Only Dr. Wilson, the study statistician, and select study staff will have access to the 
code and information that identifies the subject in this study. Safety plan material of 
patients will also be kept in a locked file in the office of the PI or co-investigator. Access 
will be strictly limited to study staff. Safety plans that are emailed contain no identifying 
information about the patient unless the patient has themselves listed this information. 
However, to guard against the very real possibility that these safety plans may allow 
identification of a particular patient despite having no identifying information, electronic 
safety plans will not take place on the patient’s cellphone. Instead, the patient will 
complete the safety plan on a UAMS research tablet and use this device to email the 
plan to clinical staff. This email will be sent directly from the “Safety Net” app, will utilize 
the secured UAMS wireless network, and this information will be erased before every 
patient. If patients would like a copy of their own safety plan, they may email it to 
themselves. If they are randomized to a written safety plan intervention, they will be 
given a copy of this document without their name. 
Records will be maintained for 7 years per IRB requirements. At the discretion of the 
PI, records may be scanned and maintained in electronic format instead of paper format 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 12 
once the study is complete. If so, electronic records will be audited to ensure high 
fidelity with the originals. These electronic copies will also be maintained on secure 
password-protected UAMS servers. When eventually destroyed, copies will be 
shredded per UAMS disposal guidelines. 
Data collection will be performed through the Research Electronic Data Capture 
(REDCap) system on a secured UAMS wireless network, and it will be set up in 
cooperation with the UAMS Translational Research Institute (TRI) in order to assure 21 
CFR Part 11 and HIPAA compliance. 
 
Data Analysis 
Outcome measures: Number of patients approached who agree to allow trained 
non-clinical staff to assist them with safety planning (if they do not agree, no other 
information about the patient will be recorded); the number of patients approached who 
meet all inclusion/exclusion criteria (if patients are not eligible for the study, no other 
information about the patient will be recorded); the number of participant safety plans 
which must be redone either by the peer support specialist, other nonclinical individuals, 
or clinical staff; the quality of completed safety plans; and patient satisfaction with each 
method. 
Outcome 1: Evaluate the proportion of SI patients approached in the UAMS ED who 
agree to allow trained non-clinical staff to assist with safety planning. This number is 
currently unknown. 
Outcome 2: Evaluate the proportion of patients approached who meet all 
inclusion/exclusion criteria. This number may be lower than the number of patients 
willing to participate in safety planning. 
Outcome 3: Evaluate the quality of the completed safety plans. This will be done by 
retrospective review after the patient has left the ED. The number of safety plans that 
must be repeated or redone by clinical providers will also be tracked. 
Outcome 4: Patient satisfaction with each method. This will be assessed by having 
the patient rate their experience with the safety planning process on a 7-point Likert 
scale (strongly disagree; disagree; moderately disagree; neutral; moderately agree; 
agree; strongly agree). 
Power calculations and sample size: As this is a pilot study, no formal sample size 
calculation is planned. The investigators plan a priori to enroll 30 patients. The 
investigators therefore ask for permission to approach a maximum of 100 patients. 
Initially, the randomization scheme will be validated by comparing the groups on key 
variables that could be associated with outcome (e.g., age, biological sex, prior suicide 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 13 
attempts, prior completion of safety plan). Where we identify significant differences 
between groups, we will either adjust for these variables in analysis or conduct stratified 
analyses. Categorial variables will be analyzed with chi-square. Continuous variables 
will be analyzed by ANOVAs. Sub-analyses of potential prognosticators, including 
biological variables such as sex, will be descriptively presented, as the sample size will 
not likely permit sufficient testing of these variables. 
 
Ethical Considerations 
Written consent will be required for any study procedures. (please see “consent 
form.”). Please note that all study procedures will be conducted in accordance with all 
applicable government regulations and University of Arkansas for Medical Sciences 
research policies and procedures. This protocol and any amendments will be submitted 
and approved by the UAMS Institutional Review Board (IRB) to conduct the study. 
Potential participants will be identified from the ED track board and/or patient triage 
note. This requires a partial waiver of HIPAA for recruitment purposes only. No PHI will 
be recorded or disclosed without patient consent. Please see study flow above. 
Peers or other research staff will approach the patient in an ED treatment room only 
if this can be done privately and safely (please see “Training of peers” above). The 
consent process will also be done privately in the same room. No patients will be 
approached in the waiting room or in a hall bed. The formal consent of each subject, 
using the IRB-approved consent form, will be obtained before that subject is submitted 
to any study procedure. All subjects for this study will be provided a consent form 
describing this study and providing sufficient information in language suitable for 
subjects to make an informed decision about their participation in this study. The person 
obtaining consent will thoroughly explain each element of the document and outline the 
risks and benefits, alternate treatment(s), and requirements of the study. The consent 
process will take place as described above, and subjects may take as much time as 
needed to make a decision about their participation. 
Participation privacy will be maintained and questions regarding participation will be 
answered. No coercion or undue influence will be used in the consent process, 
including the fact that the PI will not be involved in the recruitment process if he is 
working in the ED at the time as an attending physician. This consent form must be 
signed by the subject and the individual obtaining the consent. A copy of the signed 
consent will be given to the participant, and the informed consent process will be 
documented in each subject’s research record. 
 
 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 14 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The 
publications will not contain any identifiable information that could be linked to a 
participant. 
 
References 
1. 
United States Centers for Disease Control. Web-based injury statistics query and 
reporting system (WISQARS): Leading causes of death reports, 1981-2016.  
https://webappa.cdc.gov/sasweb/ncipc/leadcause.html. Accessed August 19, 
2018. 
2. 
Hedegaard H, Curtin SC, Warner M. Suicide mortality in the United States, 1999-
2017. Hyattsville, MD: National Center for Health Statistics; 2018. 
3. 
Betz ME, Boudreaux ED. Managing Suicidal Patients in the Emergency 
Department. Ann Emerg Med. 2016;67(2):276-282. 
4. 
Stanley B, Brown GK. Safety planning intervention: A brief intervention to 
mitigate suicide risk. Cog Beh Pract. 2012;19:256-264. 
5. 
Stanley B, Brown GK, Brenner LA, et al. Comparison of the Safety Planning 
Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the 
Emergency Department. JAMA Psychiatry. 2018;75(9):894-900. 
6. 
Suicide Prevention Resource Center. Caring for adult patients with suicide risk: A 
consensus guide for emergency departments. 2015; 
http://www.sprc.org/sites/default/files/EDGuide_full.pdf. Accessed May 30, 2018. 
7. 
Betz ME, Wintersteen M, Boudreaux ED, et al. Reducing Suicide Risk: 
Challenges and Opportunities in the Emergency Department. Ann Emerg Med. 
2016;68(6):758-765. 
8. 
National Action Alliance for Suicide Prevention Transforming Health Systems 
Initiative Work Group. Recommended standard care for people with suicide risk: 
Making health care suicide safe. Washington, DC: Education Development 
Center, Inc.; 2018. 
9. 
Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with 
severe mental illnesses: A review of evidence and experience. World Psychiatry. 
2012;11(2):123-128. 
10. 
Chinman M, George P, Dougherty RH, et al. Peer support services for individuals 
with serious mental illnesses: assessing the evidence. Psychiatr Serv. 
2014;65(4):429-441. 

Title: 
Written safety planning vs the Safety Net app: A prospective randomized pilot trial 
PI: 
Michael Wilson, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 5 
IRB# 239731 
Date: 08/28/2020 
Page 15 
11. 
Walker G, Bryant W. Peer support in adult mental health services: a 
metasynthesis of qualitative findings. Psychiatr Rehabil J. 2013;36(1):28-34. 
12. 
Miller IW, Camargo CA, Jr., Arias SA, et al. Suicide Prevention in an Emergency 
Department Population: The ED-SAFE Study. JAMA Psychiatry. 2017;74(6):563-
570. 
13. 
David L. Constructivism in learning theories. 2015; https://www.learning-
theories.com/constructivism.html. Accessed Mar 1, 2019. 
14. 
Ertmer PA, NewbyT.J. Behaviorism, cognitivism, constructivism: comparing 
critical features from an instructional design perspective. Perform Improv Q. 
2013;26(2):43-71. 
15. 
Pritchard A. Ways of Learning – Learning Theories and Learning Styles in the 
Classroom. 3rd ed. New York, New York: Routledge; 2014. 
16. 
Clark KR. Learning theory: Constructivism. Radiol Technol. 2018;90(2):180-182. 
17. 
Stanley B, Brown GK. Safety Plan Treatment Manual to Reduce Suicide Risk: 
Veteran Version. 2008; 
www.mentalhealth.va.gov/docs/VA_Safety_planning_manual.doc. Accessed Feb 
7, 2019. 
18. 
Bernard JM, Goodyear RK. Fundamentals of clinical supervision (5th ed.). 
Boston, MA: Allyn & Bacon; 2014. 
19. 
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. 
Fostering implementation of health services research findings into practice: a 
consolidated framework for advancing implementation science. Implement Sci. 
2009;4:50. 
20. 
Gamarra JM, Luciano MT, Gradus JL, Stirman SW. Assessing variability and 
implementation fidelity of suicide prevention safety planning in a regional VA 
Healthcare System. Crisis. 2015;36(6):433-439.