NCT05307432

Brief Summary

The purpose of this study is to evaluate the effectiveness and implementation of a suicide prevention strategy delivered via telehealth in Emergency Departments. We will compare implementation of the Safety Planning Intervention plus follow-up calls (SPI+) delivered by Emergency Department (ED) staff to SPI+ delivered via ED referral to an off-site Suicide Prevention Consultation Center (SPCC).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,814

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
May 2022Jul 2026

First Submitted

Initial submission to the registry

March 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

4.3 years

First QC Date

March 2, 2022

Last Update Submit

July 11, 2025

Conditions

Keywords

Safety PlanningEmergency DepartmentRisk AssessmentFollow-up ContactImplementation StrategiesTelehealth

Outcome Measures

Primary Outcomes (7)

  • Suicide Behavior Composite

    Number of patients who had a documented suicide attempt or death by suicide

    6 months after index ED visit

  • Outpatient Treatment Engagement - Count

    Number of behavioral healthcare visits following discharge from index ED visit

    6 months after index ED visit

  • Outpatient Treatment Engagement - Type

    Types of behavioral healthcare visits following discharge from index ED visit

    6 months after index ED visit

  • Safety Planning Intervention Scoring Algorithm (SPISA)

    Fidelity of written safety plans post-discharge from index ED visit

    At index ED visit

  • Fidelity of Follow-up Calls

    Number of patients who had 2 or more follow-up calls post-discharge from index ED visit

    1 month after index ED visit

  • Reach/Penetration of Safety Plans

    Proportion of patients with a completed safety plan documented in the medical record out of all patients identified as at risk for suicide by the ED staff

    At index ED visit

  • Reach/Penetration of Follow-up Calls

    Proportion of patients who receive 2 or more telephone follow-up attempts out of all patients who received a safety plan

    1 month after index ED visit

Secondary Outcomes (9)

  • Suicide-related ED Visits and Psychiatric Hospitalizations

    6 months after index ED visit

  • Suicide Attempts

    6 months after index ED visit

  • Adoption

    At index ED visit

  • Utilization of Screening of Suicide Risk Among ED Patients

    At index ED visit

  • Index ED Visit Inpatient Admission Disposition

    At index ED visit

  • +4 more secondary outcomes

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

ED staff deliver SPI+ (Safety Planning Intervention plus 2 or more post-discharge telephone calls) to suicidal patients who are not admitted to an inpatient unit.

Behavioral: SPI+ Delivered by ED Staff

Suicide Prevention Consultation Center

EXPERIMENTAL

ED staff refer suicidal patients not admitted to an inpatient unit to the off-site Suicide Prevention Consultation Center (SPCC). SPCC clinicians will deliver SPI+ (Safety Planning Intervention plus 2 or more post-discharge telephone calls) to patients via telehealth.

Behavioral: SPI+ Delivered by SPCC Clinicians

Interventions

ED staff will deliver SPI+ (Safety Planning Intervention plus follow-up phone calls) to patients at risk for suicide in the ED who are not admitted to an inpatient unit.

Enhanced Usual Care

The Suicide Prevention Consultation Center (SPCC) will be located external to the Emergency Department (ED). ED staff will be able to refer patients at risk for suicide to the SPCC. Licensed and credentialed mental health clinicians will deliver SPI+ (Safety Planning Intervention plus follow-up phone calls) via telehealth to patients at risk for suicide in the ED who are not admitted to an inpatient unit.

Suicide Prevention Consultation Center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ED visit at one of our participating sites for a suicide-related event or determined to be at risk for suicide per the Electronic Health Record (EHR) and ED clinical staff
  • years of age or older
  • Not admitted to an inpatient hospital following the index ED visit as documented in the EHR

You may not qualify if:

  • \- Inpatient admission following the index ED visit per the EHR
  • Aim 2:
  • ED clinician or leader at one of our participating sites, or ED patient who was referred to the SPCC
  • years of age or older
  • Able to communicate in English
  • Willing to give informed consent
  • Patients who are at imminent risk of suicide or acutely psychotic at the time of the interview, requiring emergency services and/or precluding ability to provide informed consent
  • Patients without a phone for contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

SuicideSuicidal IdeationEmergencies

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory K Brown, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped-wedge cluster-randomized controlled design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

April 1, 2022

Study Start

May 1, 2022

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations