Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

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

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicide, Attempted; Suicide
• Intervention / Treatment: Behavioral: Safety Plan Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28029
    • La Paz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Suicide attempt or presence of severe suicidal ideation
2. Signed Informed Consent Form

Exclusion criteria:

1. Less than 18 years old
2. Hospitalization in the Psychiatry Department
3. Inability to understand the Safety Planning Intervention

Withdrawal criteria:

1) Participant's decision to withdraw from the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Safety Plan Intervention; The Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment

Behavioral: Safety Plan Intervention; 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); Other Names: Security Plan

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive ability of the clinician in the subsequent conduct suicidal patient	is measured through a dichotomous question in which the professional will make a prognosis about the possibility that the patient may return to commit a suicidal behaviour.	Baseline

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Hospital Universitario La Paz; Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Investigators: Principal Investigator: Beatriz Rodriguez Vega, PhD, Instituto de Investigación Hospital Universitario La Paz

Publications and helpful links

General Publications

• Stanley, B., & Brown, G. K. (2012). Safety planning intervention: a brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice, 19(2), 256-264.
• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Suicide prevention; Suicidal behavior; Suicide; Safety Planning Intervention; Suicidal attempt
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: SPI-EI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared with other researchers on request
• IPD Sharing Time Frame: Data will be available one year after publishing the final results for at least 5 years
• IPD Sharing Access Criteria: Please contact PI Beatriz Rodríguez-Vega (beatrizrvega@gmail.com)
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No