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Enrolling by Invitation

NCT Number: NCT05307432

Safety Planning Intervention Telehealth Service Model in Emergency Departments

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).

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPI+ Delivered by ED Staff

Behavioral

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.

SPI+ Delivered by SPCC Clinicians

Behavioral

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 outcomes

  1. Suicide Behavior Composite

    Time frame: 6 months after index ED visit

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

  2. Outpatient Treatment Engagement - Count

    Time frame: 6 months after index ED visit

    Number of behavioral healthcare visits following discharge from index ED visit

  3. Outpatient Treatment Engagement - Type

    Time frame: 6 months after index ED visit

    Types of behavioral healthcare visits following discharge from index ED visit

  4. Safety Planning Intervention Scoring Algorithm (SPISA)

    Time frame: At index ED visit

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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. Suicide-related ED Visits and Psychiatric Hospitalizations

    Time frame: 6 months after index ED visit

    Number of ED visits and/or inpatient psychiatric admissions for suicidal ideation/behavior

  2. Suicide Attempts

    Time frame: 6 months after index ED visit

    Number of patients who had a documented suicide attempt

  3. Adoption

    Time frame: At index ED visit

    Proportion of clinicians with eligible patients who refer the patient to the SPCC

  4. Utilization of Screening of Suicide Risk Among ED Patients

    Time frame: At index ED visit

    Proportion of ED patients who received the Columbia Suicide Severity Rating Scale or equivalent evidence-based measure of suicide risk during index ED visit

  5. Index ED Visit Inpatient Admission Disposition

    Time frame: At index ED visit

    Proportion of patients admitted for inpatient hospitalization out of all patients identified as at risk for suicide

  6. Feasibility of SPCC

    Time frame: 9-12 months after ED crosses over to SPCC condition

    Will be assessed through semi-structured qualitative interviews with a randomly selected sample of clinicians, leaders, and patients, as well as by using the Feasibility of Intervention Measure (FIM)

  7. Acceptability of SPCC

    Time frame: 9-12 months after ED crosses over to SPCC condition

    Will be assessed through semi-structured qualitative interviews with a randomly selected sample of clinicians, leaders, and patients, as well as by using the Acceptability of Intervention Measure (AIM)

  8. 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)

    We will assess average personnel and non-personnel costs to Emergency Department practices of delivering SPCC and EUC strategies, using Time-Driven Activity-Based Costing

  9. 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)

    We will assess average personnel and non-personnel costs to Emergency Department practices of delivering EUC strategies, using Time-Driven Activity-Based Costing

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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