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Clinical Trials/NCT05307432
NCT05307432
Enrolling By Invitation
Not Applicable

A Safety Planning Intervention and Follow-up Telehealth Service Model for Suicidal Individuals in Emergency Department Settings

University of Pennsylvania1 site in 1 country2,814 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide
Sponsor
University of Pennsylvania
Enrollment
2814
Locations
1
Primary Endpoint
Outpatient Treatment Engagement - Count
Status
Enrolling By Invitation
Last Updated
9 months ago

Overview

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).

Detailed Description

Individuals at high risk for suicide often present to acute care settings, such as emergency departments (EDs), and then typically are hospitalized or referred for outpatient mental health treatment. Patients are at increased risk of suicide attempts and suicide following an ED visit and nearly half do not attend outpatient treatment. Brief, evidence-based clinical interventions, such as the Safety Planning Intervention with post-discharge telephone follow-up (SPI+), can reduce suicide risk, decrease hospitalizations, and increase engagement in outpatient services for suicidal patients discharged from the ED. Leveraging insights from implementation science and collaborative care, we propose a model in which ED staff will connect patients at risk for suicide to ED-credentialed mental health clinicians who are located external to the ED. These off-site clinicians will provide SPI+ via telehealth for ED patients prior to discharge and provide follow-up services after ED discharge as part of an innovative Suicide Prevention Consultation Center (SPCC). All participating EDs will begin in the Enhanced Usual Care phase, in which ED staff will deliver SPI+ to suicidal patients. EDs will then be randomized in pairs to begin referral to the SPCC in 3 month intervals. We will also conduct a cost evaluation to help determine scalability and sustainability.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
July 31, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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
  • 18 years of age or older
  • Not admitted to an inpatient hospital following the index ED visit as documented in the EHR

Exclusion Criteria

  • Inpatient admission following the index ED visit per the EHR
  • Inclusion Criteria:
  • ED clinician or leader at one of our participating sites, or ED patient who was referred to the SPCC
  • 18 years of age or older
  • Able to communicate in English
  • Willing to give informed consent
  • Exclusion Criteria:
  • 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

Outcomes

Primary Outcomes

Outpatient Treatment Engagement - Count

Time Frame: 6 months after index ED visit

Number of behavioral healthcare visits following discharge from index ED visit

Reach/Penetration of Safety Plans

Time Frame: At index ED visit

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

Outpatient Treatment Engagement - Type

Time Frame: 6 months after index ED visit

Types of behavioral healthcare visits following discharge from index ED visit

Reach/Penetration of Follow-up Calls

Time Frame: 1 month after index ED visit

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

Suicide Behavior Composite

Time Frame: 6 months after index ED visit

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

Safety Planning Intervention Scoring Algorithm (SPISA)

Time Frame: At index ED visit

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

Fidelity of Follow-up Calls

Time Frame: 1 month after index ED visit

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

Secondary Outcomes

  • Feasibility of SPCC(9-12 months after ED crosses over to SPCC condition)
  • Acceptability of SPCC(9-12 months after ED crosses over to SPCC condition)
  • Cost to Emergency Department of SPCC(After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years))
  • Cost to Emergency Department of EUC(Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years))
  • 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)

Study Sites (1)

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