Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

Study Overview
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Brief Summary
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The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to increase the ambulatory follow-up in american war veterans. This study evaluates the implementability and effectiveness in a significantly different population in a real world setting.

Detailed Description
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We will perform a Effectiveness-implementation Hybrid Design (Curran et al. 2012) to study firstly the feasibility of implementing the SPI in our clinical setting and secondly its effectiveness. The experimental arm will consist in a group of patients who visit the ED for a suicide-related concern in which the SPI is performed. This will be in the Emergency Department , unless for clinical reasons, the ED psychiatrist decide to postpone it to the first psychiatric appointment (which will be before one week of the ED visit as part of the treatment as usual). Right after the SPI is performed, both the patient and the clinician will complete questionnaire with satisfaction and acceptability measures. Subjects will be followed for 6 months. At this time medical records will be consulted to obtain suicide reattempts rates and follow-up adherence. At all times, the anonymity of the participants will be preserved and will require heading of informed consent, as well as other ethical aspects indicated by the Ethics Committee.

Official Title
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Safety-Planning Intervention for Suicidal Behavior in an Emergency Department: an Effectiveness-implementation Hybrid Design

Conditions
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Suicide, Suicide, Attempted, Suicidal Ideation

Intervention / Treatment
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* Behavioral: Safety Plan Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Suicide attempt or presence of severe suicidal ideation Signed Informed Consent Form Exclusion criteria: Less than 18 years old Hospitalization in the Psychiatry Department Inability to understand the Safety Planning Intervention Withdrawal criteria: 1) Participant's decision to withdraw from the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional cohort (Safety Plan Intervention)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety Plan Intervention<br>The Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment | Behavioral: Safety Plan Intervention<br>* The SPI has 6 key steps: (1) identify personalized warning signs for an impending suicide crisis; (2) determine internal coping strategies that distract from suicidal thoughts and urges; (3) identify family and friends who are able to distract from suicidal thoughts and urges and social places that provide the opportunity for interaction; (4) identify individuals who can help provide support during a suicidal crisis; (5) list mental health professionals and urgent care services to contact during a suicidal crisis; and (6) lethal means counseling for making the environment safer (Stanley & Brown, 2012)<br>* Other names: Security Plan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Safety Plan Implementation | Percentage of SPIs performed in ED from total number of suicide related ED visits. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for the performance of the SPI | Minutes required for the performance of the SPI | Baseline | 
| Satisfaction of the patient with the Safety Plan | Likert-type scales with 5 levels of response will be measured through questions: To what extent do the Safety Plan can help you to avoid a new situation of suicidal risk? | t0 (Safety Plan Performance ) | 
| Satisfaction of the Professional with the Safety Plan | Likert-type with 5 levels of response will be measured through questions: To what extent do the Safety Plan can help you to avoid a new situation of suicidal risk? Likert-type with 5 levels of response will be measured through questions: To what extent the Safety Plan did you useful for the patient?. Open questions can be explained where contributions and obstacles encountered in its implementation will also be formulated. | Baseline | 
| Presence of suicide reattempt | Percentage of patients that commit suicide reattempt. | Month 6 | 
| Time to suicide reattempt | Days from suicide attempt attended in the ED to the next suicide reattempt. | Month 6 | 
| Adherence to psychiatric ambulatory follow-up | Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide, Suicidal behavior, Suicidal attempt, Suicide prevention, Safety Planning Intervention