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Enrolling by invitation NCT05307432

Safety Planning Intervention Telehealth Service Model in Emergency Departments

No phase Interventional Suicide Suicidal Ideation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPI+ Delivered by ED Staff, SPI+ Delivered by SPCC Clinicians.
Who it may be relevant to
Registry conditions: Suicide, Suicidal Ideation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral SPI+ Delivered by ED Staff
    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.
  • Behavioral SPI+ Delivered by SPCC Clinicians
    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.

Primary outcome measures

  • Suicide Behavior Composite [Time frame: 6 months after index ED visit]
  • Outpatient Treatment Engagement - Count [Time frame: 6 months after index ED visit]
  • Outpatient Treatment Engagement - Type [Time frame: 6 months after index ED visit]
  • Safety Planning Intervention Scoring Algorithm (SPISA) [Time frame: At index ED visit]
  • Fidelity of Follow-up Calls [Time frame: 1 month after index ED visit]
  • Reach/Penetration of Safety Plans [Time frame: At index ED visit]
  • Reach/Penetration of Follow-up Calls [Time frame: 1 month after index ED visit]
Secondary outcome measures (9)
  • Suicide-related ED Visits and Psychiatric Hospitalizations [Time frame: 6 months after index ED visit]
  • Suicide Attempts [Time frame: 6 months after index ED visit]
  • Adoption [Time frame: At index ED visit]
  • Utilization of Screening of Suicide Risk Among ED Patients [Time frame: At index ED visit]
  • Index ED Visit Inpatient Admission Disposition [Time frame: At index ED visit]
  • Feasibility of SPCC [Time frame: 9-12 months after ED crosses over to SPCC condition]
  • Acceptability of SPCC [Time frame: 9-12 months after ED crosses over to SPCC condition]
  • Cost to Emergency Department of SPCC [Time frame: After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years)]
  • Cost to Emergency Department of EUC [Time frame: Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years)]

Eligibility criteria

Aim 1/Aim 3:

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

Aim 2:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Pennsylvania Health System — Philadelphia

Identifiers

NCT: NCT05307432 · 850636 · 1P50MH127511-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗