Safety Planning Intervention Telehealth Service Model in Emergency Departments

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05307432
• Other study ID #: 850636
• Secondary ID: 1P50MH127511-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2814
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Suicidal Ideation
• Suicide

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide Behavior Composite	Number of patients who had a documented suicide attempt or death by suicide	6 months after index ED visit
Primary	Outpatient Treatment Engagement - Count	Number of behavioral healthcare visits following discharge from index ED visit	6 months after index ED visit
Primary	Outpatient Treatment Engagement - Type	Types of behavioral healthcare visits following discharge from index ED visit	6 months after index ED visit
Primary	Safety Planning Intervention Scoring Algorithm (SPISA)	Fidelity of written safety plans post-discharge from index ED visit	At index ED visit
Primary	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
Primary	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
Primary	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	Suicide-related ED Visits and Psychiatric Hospitalizations	Number of ED visits and/or inpatient psychiatric admissions for suicidal ideation/behavior	6 months after index ED visit
Secondary	Suicide Attempts	Number of patients who had a documented suicide attempt	6 months after index ED visit
Secondary	Adoption	Proportion of clinicians with eligible patients who refer the patient to the SPCC	At index ED visit
Secondary	Utilization of Screening of Suicide Risk Among ED Patients	Proportion of ED patients who received the Columbia Suicide Severity Rating Scale or equivalent evidence-based measure of suicide risk during index ED visit	At index ED visit
Secondary	Index ED Visit Inpatient Admission Disposition	Proportion of patients admitted for inpatient hospitalization out of all patients identified as at risk for suicide	At index ED visit
Secondary	Feasibility of SPCC	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)	9-12 months after ED crosses over to SPCC condition
Secondary	Acceptability of SPCC	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)	9-12 months after ED crosses over to SPCC condition
Secondary	Cost to Emergency Department of SPCC	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	After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years)
Secondary	Cost to Emergency Department of EUC	We will assess average personnel and non-personnel costs to Emergency Department practices of delivering EUC strategies, using Time-Driven Activity-Based Costing	Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years)