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Written vs Electronic Safety Planning Study

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ClinicalTrials.gov Identifier: NCT04026308
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date August 29, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
  • Acceptability of intervention [ Time Frame: Up to 12 hours ]
    The proportion of patients approached who agree to allow trained non-clinical staff to assist with safety planning.
  • Proportion of eligible patients [ Time Frame: Up to 12 hours ]
    The proportion of patients approached who meet all inclusion/exclusion criteria.
  • Quality of safety plans [ Time Frame: Up to 12 hours ]
    Evaluate the quality of the completed safety plans. This will be done by retrospective review after the patient has left the ED. The assessment of quality will use the same measures as Gamarra et al, namely an assessment of how many items are filled out and to what degree the answers reflect personalization. The number of safety plans that must be repeated or redone by the ED mental health clinician will also be tracked.
  • Satisfaction with safety planning [ Time Frame: Up to 12 hours ]
    Evaluate patient satisfaction with safety planning. This will be assessed by having the patient rate their experience with the safety planning process on a 6-point Likert scale (strongly disagree; disagree; moderately disagree; moderately agree; agree; strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • The proportion of patients approached who agree to allow trained non-clinical staff to assist with safety planning. [ Time Frame: Up to 12 hours ]
  • The proportion of patients approached who meet all inclusion/exclusion criteria. [ Time Frame: Up to 12 hours ]
  • Evaluate the quality of the completed safety plans. [ Time Frame: Up to 12 hours ]
    This will be done by retrospective review after the patient has left the ED.
  • Patient satisfaction with each method. [ Time Frame: Up to 12 hours ]
    This will be assessed by having the patient rate their experience with the safety planning process on a 7-point Likert scale.
Change History Complete list of historical versions of study NCT04026308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Written vs Electronic Safety Planning Study
Official Title  ICMJE Written Safety Planning vs the My3 App: A Prospective Randomized Pilot Trial
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 patients 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 patients complete safety plans electronically?
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Suicidal Ideation
  • Mental Health
Intervention  ICMJE Other: My3 App
The My3 app is an electronic version of a safety plan, and is available for download at: http://my3app.org/. This app is owned by Link2HealthSolutions, Inc, which is the administrator for the National Suicide Prevention Lifeline. It was created in partnership with the California Mental Health Services Act. Unlike the paper version, the My3 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 Name: My3 Support Network
Study Arms  ICMJE
  • No Intervention: Written Safety Plan
    Patients will complete a traditional written suicide safety plan.
  • Experimental: Electronic Safety Plan
    Patients will complete a suicide safety plan on the My3 app using an iPad.
    Intervention: Other: My3 App
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • English-speaking and English-writing (as translators will not be available for this study)

Exclusion Criteria:

  • <18 or >89 years of age
  • Patients appearing critically-ill
  • Incarcerated or in police custody
  • Currently intoxicated with alcohol or other substance
  • ED staff objection to patient enrollment in study
  • Unwilling or unable to complete the safety plan electronically
  • Unwilling or unable to use an iPad to complete the safety plan
  • Unwilling or unable to show/email the safety plan to clinical staff
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael P Wilson, M.D., Ph.D. 501-686-5515 MPWilson@uams.edu
Contact: Manuel G Alvarez Romero, B.A. 501-214-2035 MAlvarezromero@uams.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026308
Other Study ID Numbers  ICMJE 239731
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael P Wilson, M.D., Ph.D. University of Arkansas
PRS Account University of Arkansas
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP