NCT04068142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 27, 2022

Completed
Last Updated

January 27, 2022

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

August 22, 2019

Results QC Date

August 30, 2021

Last Update Submit

November 22, 2021

Conditions

Keywords

SuicideSuicide PreventionSafety Planning

Outcome Measures

Primary Outcomes (4)

  • 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.

    approach in the ED (typically <1 hour)

  • Proportion of Eligible Patients

    Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.

    Up to 12 hours

  • 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.

    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

Study Arms (2)

Clinical Personnel Safety Planning

NO INTERVENTION

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

Peer Supporter Safety Planning

EXPERIMENTAL

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

Other: Peer Supporter Safety Planning

Interventions

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

Peer Supporter Safety Planning

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicidal IdeationSuicide, AttemptedSuicideSuicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Dr Michael Wilson
Organization
UAMS

Study Officials

  • Michael P Wilson, M.D., Ph.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

November 6, 2019

Primary Completion

September 1, 2020

Study Completion

January 1, 2021

Last Updated

January 27, 2022

Results First Posted

January 27, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations