Safety Planning Intervention to Reduce Short Term Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-10

Study Completion Date

2020-06-30

Brief Summary

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This study will determine the efficacy of Safety Planning Intervention (SPI) compared to receiving risk factors and warning sign information (RWI) in recent suicide attempters during the 6 months following an acute care visit on: (1) suicidal behaviors; (2) mental health/substance use treatment engagement; (3) suicide-related coping strategies; (4) suicidal ideation; and (5) use of means restriction.

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Detailed Description

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There is a pressing need for improved acute care setting suicide prevention interventions. The Safety Planning Intervention (SPI) is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings (i.e., emergency departments (ED) and inpatient units). The SPI involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis. It is easy to learn and administer, acceptable to patients, brief, firmly rooted in an empirical base and has preliminary studies supporting its feasibility and potential to impact patient outcomes, including suicidal behavior and treatment engagement. However, while it is being adopted widely, it lacks a randomized controlled trial (RCT) to definitively determine its efficacy. The purpose of this study to conduct a randomized control trial of the Safety Planning Intervention (SPI) compared with receiving risk factors and warning sign information (RWI) in acute care settings.

All participants in this study will complete some baseline assessments, following which they will be randomly assigned to one of two study conditions: Safety Plan Intervention (SPI) or receiving risk factors and warning sign information (RWI). If assigned to SPI, participants will receive the assigned intervention by the research clinician. They will receive a paper copy of their safety plan while in the ED or on the inpatient unit and a back-up copy will be sent approximately 1 week after discharge to participants. For RWI participants, ED and inpatient unit care will be delivered as usual, with the addition of a printed information sheet listing suicide risk factors and crisis hotlines. In addition to the baseline assessment, multi-method outcome assessment will be conducted at 1, 3, and 6 months. This will include telephone evaluations by a blinded assessor (not the research clinician), medical record review, and vital statistics registry review.

Conditions

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Suicide, Attempted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Safety Planning Intervention

SPI is a personalized approach that focuses on early identification of warning signs and execution of systematic steps to manage suicidal thoughts, created collaboratively by the patient and clinician.

Group Type ACTIVE_COMPARATOR

Safety Planning Intervention

Intervention Type BEHAVIORAL

The Safety Planning Intervention is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings. It involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis.

Risk factors and Warning signs

Patients will receive a generic suicide risk factors and warning signs information handout.

Group Type ACTIVE_COMPARATOR

Risk factors and Warning signs

Intervention Type BEHAVIORAL

Printed information sheet listing suicide risk factors and crisis hotlines

Interventions

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Safety Planning Intervention

The Safety Planning Intervention is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings. It involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis.

Intervention Type BEHAVIORAL

Risk factors and Warning signs

Printed information sheet listing suicide risk factors and crisis hotlines

Intervention Type BEHAVIORAL

Other Intervention Names

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SPI RWI

Eligibility Criteria

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Inclusion Criteria

1. Presented for an acute care visit within 8 weeks of a suicide attempt, interrupted or aborted attempt, or suicidal ideation with intent and plan within 4 weeks.
2. Are 18 years of age or older
3. Able to speak and read English
4. Able to understand the nature of the study, provide written informed consent, and complete study procedures
5. Have been evaluated by a health care professional who provides permission for research staff to approach the patient.

Exclusion Criteria

1. Under 18 years of age
2. Cannot speak or read English
3. Unable to understand the nature of the study, provide written informed consent, or complete study procedures
4. Unable or unwilling to provide a personal phone number for follow up purposes.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No