Back to resultsWritten vs Electronic Safety Planning Study
Primary Purpose
Suicidal Ideation, Suicide Attempt, Mental Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Net App
Sponsored by
About this trial
This is an interventional prevention trial for Suicidal Ideation focused on measuring Suicide, Suicide Prevention, Safety Planning, Safety Net App
Eligibility Criteria
Inclusion Criteria:
- Patients presenting for suicidal ideation (SI) or after a suicide attempt to the UAMS ED
- 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:
- <18 or >89 years of age
- Incarcerated or in police custody
- Non-English-speaking or Non-English-writing (as translators will not be available for this study)
- Critically-ill (or appear to be critically-ill)
- Intoxicated with alcohol or other substance(s)
- ED staff objection to patient enrollment in study
- Unwilling or unable to complete the safety plan electronically
- Unwilling or unable to use a tablet device to complete the safety plan
- Unwilling or unable to show/email the safety plan to clinical and research staff
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Written Safety Plan
Electronic Safety Plan
Arm Description
Participants will complete a traditional written suicide safety plan.
Participants will complete a suicide safety plan in the Safety Net app using a tablet.
Outcomes
Primary Outcome Measures
Acceptability of Intervention
The number of patients approached who agree to allow trained non-clinical staff to assist with safety planning.
Length of Stay
The length of stay in the ED for patients approached who agree to allow trained non-clinical staff to assist with safety planning.
Satisfaction With Safety Planning
Evaluate patient satisfaction with safety planning. This will be assessed by having the patient rate their experience with the safety planning process on a 7-point Likert scale (1 - strongly disagree; 2 - disagree; 3 - moderately disagree; 4 - neutral; 5 - moderately agree; 6 - agree; 7 - strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04026308
Brief Title
Written vs Electronic Safety Planning Study
Official Title
Written Safety Planning vs the Safety Net App: A Prospective Randomized Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. In one popular version of the safety plan developed by Stanley et al, 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.
This study aims to find out how valuable an electronic safety plan is compared to a traditional paper safety plan. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.
Detailed Description
This project has 3 aims: (1) Will ED patients with suicidal ideation/attempt accept coaching on safety planning from non-clinical personnel (i.e., medical students or peer supporters); (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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide Attempt, Mental Health
Keywords
Suicide, Suicide Prevention, Safety Planning, Safety Net App
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Written Safety Plan
Arm Type
No Intervention
Arm Description
Participants will complete a traditional written suicide safety plan.
Arm Title
Electronic Safety Plan
Arm Type
Experimental
Arm Description
Participants will complete a suicide safety plan in the Safety Net app using a tablet.
Intervention Type
Other
Intervention Name(s)
Safety Net App
Other Intervention Name(s)
Stanley-Brown Safety Plan App
Intervention Description
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 the 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.
Primary Outcome Measure Information:
Title
Acceptability of Intervention
Description
The number of patients approached who agree to allow trained non-clinical staff to assist with safety planning.
Time Frame
Up to 12 hours
Title
Length of Stay
Description
The length of stay in the ED for patients approached who agree to allow trained non-clinical staff to assist with safety planning.
Time Frame
Up to 12 hours
Title
Satisfaction With Safety Planning
Description
Evaluate patient satisfaction with safety planning. This will be assessed by having the patient rate their experience with the safety planning process on a 7-point Likert scale (1 - strongly disagree; 2 - disagree; 3 - moderately disagree; 4 - neutral; 5 - moderately agree; 6 - agree; 7 - strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.
Time Frame
Up to 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting for suicidal ideation (SI) or after a suicide attempt to the UAMS ED
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:
<18 or >89 years of age
Incarcerated or in police custody
Non-English-speaking or Non-English-writing (as translators will not be available for this study)
Critically-ill (or appear to be critically-ill)
Intoxicated with alcohol or other substance(s)
ED staff objection to patient enrollment in study
Unwilling or unable to complete the safety plan electronically
Unwilling or unable to use a tablet device to complete the safety plan
Unwilling or unable to show/email the safety plan to clinical and research staff
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Wilson, M.D., Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Written vs Electronic Safety Planning Study
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