Clinical trial NCT05307432: Safety Planning Intervention Telehealth Service Model in Emergency Departments
Official title: A Safety Planning Intervention and Follow-up Telehealth Service Model for Suicidal Individuals in Emergency Department Settings
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Suicide
Suicidal Ideation
Keywords: Safety Planning
Emergency Department
Risk Assessment
Follow-up Contact
Implementation Strategies
Telehealth
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-04-01
Enrollment: 2814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster-randomized controlled design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Suicide Behavior Composite
timeFrame: 6 months after index ED visit
measure: Outpatient Treatment Engagement - Count
timeFrame: 6 months after index ED visit
measure: Outpatient Treatment Engagement - Type
timeFrame: 6 months after index ED visit
measure: Safety Planning Intervention Scoring Algorithm (SPISA)
timeFrame: At index ED visit
measure: Fidelity of Follow-up Calls
timeFrame: 1 month after index ED visit
measure: Reach/Penetration of Safety Plans
timeFrame: At index ED visit
measure: Reach/Penetration of Follow-up Calls
timeFrame: 1 month after index ED visit
Secondary outcomes:
measure: Suicide-related ED Visits and Psychiatric Hospitalizations
timeFrame: 6 months after index ED visit
measure: Suicide Attempts
timeFrame: 6 months after index ED visit
measure: Adoption
timeFrame: At index ED visit
measure: Utilization of Screening of Suicide Risk Among ED Patients
timeFrame: At index ED visit
measure: Index ED Visit Inpatient Admission Disposition
timeFrame: At index ED visit
measure: Feasibility of SPCC
timeFrame: 9-12 months after ED crosses over to SPCC condition
measure: Acceptability of SPCC
timeFrame: 9-12 months after ED crosses over to SPCC condition
measure: Cost to Emergency Department of SPCC
timeFrame: After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years)
measure: Cost to Emergency Department of EUC
timeFrame: Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Gregory K Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: