- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068142
The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention
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. 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 study aims to find out if ED patients prefer to complete a safety plan with a peer supporter or clinical personnel. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients presenting for suicidal ideation (SI) or after a suicide attempt to the University of Arkansas for Medical Sciences (UAMS) Emergency Department (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 with a peer supporter
- Unwilling or unable to show the safety plan to clinical staff
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Clinical Personnel Safety Planning
Patients will complete a traditional written suicide safety plan with clinical personnel.
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Experimental: Peer Supporter Safety Planning
Patients will complete a traditional written suicide safety plan with peer supporters.
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The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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.
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Up to 12 hours
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Number of Suicidal Ideology (SI) Participants Who Agree to Receive a Safety Plan
Time Frame: approach in the ED (typically <1 hour)
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Evaluate the number of suicidal ideology (SI) patients approached in the ED who agree to receive a safety plan.
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approach in the ED (typically <1 hour)
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Proportion of Eligible Patients
Time Frame: Up to 12 hours
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Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.
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Up to 12 hours
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Quality of Safety Plans
Time Frame: Up to 12 hours
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Evaluate the quality of the completed safety plans.
This will be done by retrospective review after the patient has left the ED.
Safety plans will be graded individually, then resolved by consensus, for quality (0=blank, 1=boilerplate, 2=some evidence of personalization, 3=highly personalized; range=0-24) by the investigators using materials developed by Brown and Stanley for this purpose.
Using a "safety checklist," responses for each of the 6 safety plan steps will be classified according to the personalization of the information in each step.
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Up to 12 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 239486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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