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The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention

Primary Purpose

Suicidal Ideation, Suicide, Attempted, Mental Health Issue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Supporter Safety Planning
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Suicide, Suicide Prevention, Safety Planning

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Clinical Personnel Safety Planning

Peer Supporter Safety Planning

Arm Description

Patients will complete a traditional written suicide safety plan with clinical personnel.

Patients will complete a traditional written suicide safety plan with peer supporters.

Outcomes

Primary Outcome Measures

Number of Suicidal Ideology (SI) Participants Who Agree to Receive a Safety Plan
Evaluate the number of suicidal ideology (SI) patients approached in the ED who agree to receive a safety plan.
Proportion of Eligible Patients
Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.
Quality of Safety Plans
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.
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

First Posted
August 22, 2019
Last Updated
November 22, 2021
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT04068142
Brief Title
The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention
Official Title
The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (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. 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.
Detailed Description
This project aims to answer the following three research questions: (1) In general, do ED patients with suicidal ideation/attempt prefer to interact with/receive support from peers with life experiences of suicide or clinical professionals who might have such life experiences or not? (2) Will patients with suicidal ideation/attempt accept a peer-delivered safety planning intervention as opposed to one delivered by clinical personnel? (3) Are peer-delivered safety plans of equal quality as those delivered by clinical personnel?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide, Attempted, Mental Health Issue
Keywords
Suicide, Suicide Prevention, Safety Planning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Personnel Safety Planning
Arm Type
No Intervention
Arm Description
Patients will complete a traditional written suicide safety plan with clinical personnel.
Arm Title
Peer Supporter Safety Planning
Arm Type
Experimental
Arm Description
Patients will complete a traditional written suicide safety plan with peer supporters.
Intervention Type
Other
Intervention Name(s)
Peer Supporter Safety Planning
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Suicidal Ideology (SI) Participants Who Agree to Receive a Safety Plan
Description
Evaluate the number of suicidal ideology (SI) patients approached in the ED who agree to receive a safety plan.
Time Frame
approach in the ED (typically <1 hour)
Title
Proportion of Eligible Patients
Description
Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.
Time Frame
Up to 12 hours
Title
Quality of Safety Plans
Description
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.
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 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
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
Citations:
PubMed Identifier
35502515
Citation
Wilson MP, Waliski A, Thompson RG Jr. Feasibility of Peer-Delivered Suicide Safety Planning in the Emergency Department: Results From a Pilot Trial. Psychiatr Serv. 2022 Oct 1;73(10):1087-1093. doi: 10.1176/appi.ps.202100561. Epub 2022 May 3.
Results Reference
derived

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The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention

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