Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230434
• Other study ID #: SPI-EI
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2021
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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)

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz, Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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.0b0 — View Citation

Stanley, B., & Brown, G. K. (2012). Safety planning intervention: a brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice, 19(2), 256-264.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Feasibility of Safety Plan Implementation	Percentage of SPIs performed in ED from total number of suicide related ED visits.	Baseline
Secondary	Time required for the performance of the SPI	Minutes required for the performance of the SPI	Baseline
Secondary	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 )
Secondary	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
Secondary	Presence of suicide reattempt	Percentage of patients that commit suicide reattempt.	Month 6
Secondary	Time to suicide reattempt	Days from suicide attempt attended in the ED to the next suicide reattempt.	Month 6
Secondary	Adherence to psychiatric ambulatory follow-up	Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge	Month 6