Written vs Electronic Safety Planning Study

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026308
• Other study ID #: 239731
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 28, 2020

Study information

• Verified date: February 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health
• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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