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Safety Planning Intervention Telehealth Service Model in Emergency Departments

Primary Purpose

Suicide, Suicidal Ideation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPI+ Delivered by ED Staff
SPI+ Delivered by SPCC Clinicians
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide focused on measuring Safety Planning, Emergency Department, Risk Assessment, Follow-up Contact, Implementation Strategies, Telehealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced Usual Care

Suicide Prevention Consultation Center

Arm Description

ED staff deliver SPI+ (Safety Planning Intervention plus 2 or more post-discharge telephone calls) to suicidal patients who are not admitted to an inpatient unit.

ED staff refer suicidal patients not admitted to an inpatient unit to the off-site Suicide Prevention Consultation Center (SPCC). SPCC clinicians will deliver SPI+ (Safety Planning Intervention plus 2 or more post-discharge telephone calls) to patients via telehealth.

Outcomes

Primary Outcome Measures

Suicide Behavior Composite
Number of patients who had a documented suicide attempt or death by suicide
Outpatient Treatment Engagement - Count
Number of behavioral healthcare visits following discharge from index ED visit
Outpatient Treatment Engagement - Type
Types of behavioral healthcare visits following discharge from index ED visit
Safety Planning Intervention Scoring Algorithm (SPISA)
Fidelity of written safety plans post-discharge from index ED visit
Fidelity of Follow-up Calls
Number of patients who had 2 or more follow-up calls post-discharge from index ED visit
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
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

Secondary Outcome Measures

Suicide-related ED Visits and Psychiatric Hospitalizations
Number of ED visits and/or inpatient psychiatric admissions for suicidal ideation/behavior
Suicide Attempts
Number of patients who had a documented suicide attempt
Adoption
Proportion of clinicians with eligible patients who refer the patient to the SPCC
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
Index ED Visit Inpatient Admission Disposition
Proportion of patients admitted for inpatient hospitalization out of all patients identified as at risk for suicide
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)
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)
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
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

Full Information

First Posted
March 2, 2022
Last Updated
July 5, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05307432
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation
Keywords
Safety Planning, Emergency Department, Risk Assessment, Follow-up Contact, Implementation Strategies, Telehealth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped-wedge cluster-randomized controlled design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2814 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
ED staff deliver SPI+ (Safety Planning Intervention plus 2 or more post-discharge telephone calls) to suicidal patients who are not admitted to an inpatient unit.
Arm Title
Suicide Prevention Consultation Center
Arm Type
Experimental
Arm Description
ED staff refer suicidal patients not admitted to an inpatient unit to the off-site Suicide Prevention Consultation Center (SPCC). SPCC clinicians will deliver SPI+ (Safety Planning Intervention plus 2 or more post-discharge telephone calls) to patients via telehealth.
Intervention Type
Behavioral
Intervention Name(s)
SPI+ Delivered by ED Staff
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SPI+ Delivered by SPCC Clinicians
Intervention Description
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 Measure Information:
Title
Suicide Behavior Composite
Description
Number of patients who had a documented suicide attempt or death by suicide
Time Frame
6 months after index ED visit
Title
Outpatient Treatment Engagement - Count
Description
Number of behavioral healthcare visits following discharge from index ED visit
Time Frame
6 months after index ED visit
Title
Outpatient Treatment Engagement - Type
Description
Types of behavioral healthcare visits following discharge from index ED visit
Time Frame
6 months after index ED visit
Title
Safety Planning Intervention Scoring Algorithm (SPISA)
Description
Fidelity of written safety plans post-discharge from index ED visit
Time Frame
At index ED visit
Title
Fidelity of Follow-up Calls
Description
Number of patients who had 2 or more follow-up calls post-discharge from index ED visit
Time Frame
1 month after index ED visit
Title
Reach/Penetration of Safety Plans
Description
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
Time Frame
At index ED visit
Title
Reach/Penetration of Follow-up Calls
Description
Proportion of patients who receive 2 or more telephone follow-up attempts out of all patients who received a safety plan
Time Frame
1 month after index ED visit
Secondary Outcome Measure Information:
Title
Suicide-related ED Visits and Psychiatric Hospitalizations
Description
Number of ED visits and/or inpatient psychiatric admissions for suicidal ideation/behavior
Time Frame
6 months after index ED visit
Title
Suicide Attempts
Description
Number of patients who had a documented suicide attempt
Time Frame
6 months after index ED visit
Title
Adoption
Description
Proportion of clinicians with eligible patients who refer the patient to the SPCC
Time Frame
At index ED visit
Title
Utilization of Screening of Suicide Risk Among ED Patients
Description
Proportion of ED patients who received the Columbia Suicide Severity Rating Scale or equivalent evidence-based measure of suicide risk during index ED visit
Time Frame
At index ED visit
Title
Index ED Visit Inpatient Admission Disposition
Description
Proportion of patients admitted for inpatient hospitalization out of all patients identified as at risk for suicide
Time Frame
At index ED visit
Title
Feasibility of SPCC
Description
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)
Time Frame
9-12 months after ED crosses over to SPCC condition
Title
Acceptability of SPCC
Description
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)
Time Frame
9-12 months after ED crosses over to SPCC condition
Title
Cost to Emergency Department of SPCC
Description
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
Time Frame
After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years)
Title
Cost to Emergency Department of EUC
Description
We will assess average personnel and non-personnel costs to Emergency Department practices of delivering EUC strategies, using Time-Driven Activity-Based Costing
Time Frame
Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory K Brown, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Safety Planning Intervention Telehealth Service Model in Emergency Departments

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