Written vs Electronic Safety Planning Study

Written Safety Planning vs the Safety Net App: A Prospective Randomized Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Mental Health; Suicide Attempt
• Intervention / Treatment: Other: Safety Net App

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?

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Written Safety Plan; Participants will complete a traditional written suicide safety plan.
Experimental: Electronic Safety Plan; Participants will complete a suicide safety plan in the Safety Net app using a tablet.	Other: 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 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.; Other Names: Stanley-Brown Safety Plan App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention	The number of patients approached who agree to allow trained non-clinical staff to assist with safety planning.	Up to 12 hours
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.	Up to 12 hours
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.	Up to 12 hours

Collaborators and Investigators

• Sponsor: University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Suicide; Suicide Prevention; Safety Planning; Safety Net App
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: 239731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No