Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068142
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.


Condition or disease Intervention/treatment Phase
Suicidal Ideation Suicide, Attempted Mental Health Issue Other: Peer Supporter Safety Planning Not Applicable

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?

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
No Intervention: Clinical Personnel Safety Planning
Patients will complete a traditional written suicide safety plan with clinical personnel.
Experimental: Peer Supporter Safety Planning
Patients will complete a traditional written suicide safety plan with peer supporters.
Other: Peer Supporter Safety Planning
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 Measures :
  1. Acceptability of intervention [ Time Frame: Up to 12 hours ]
    Evaluate the proportion of SI patients approached in the ED who agree to receive a peer-delivered safety plan.

  2. Proportion of eligible patients [ Time Frame: Up to 12 hours ]
    Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.

  3. 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. Safety plans will be graded on a 5-point scale ("poor," "mediocre," "satisfactory," "good," or "excellent") 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. The number of safety plans that must be repeated or redone by the ED mental health clinician will also be tracked.

  4. 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 somewhat; disagree a little; agree a little; agree somewhat; strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 with a peer supporter
  • Unwilling or unable to show the safety plan to clinical staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068142


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Michael P Wilson, M.D., Ph.D.    501-686-5515    MPWilson@uams.edu   
Sponsors and Collaborators
University of Arkansas
Investigators
Layout table for investigator information
Principal Investigator: Michael P Wilson, M.D., Ph.D. University of Arkansas
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT04068142    
Other Study ID Numbers: 239486
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arkansas:
Suicide
Suicide Prevention
Safety Planning
Additional relevant MeSH terms:
Layout table for MeSH terms
Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms