- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05307432
Safety Planning Intervention Telehealth Service Model in Emergency Departments
July 5, 2023 updated by: University of Pennsylvania
A Safety Planning Intervention and Follow-up Telehealth Service Model for Suicidal Individuals in Emergency Department Settings
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).
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
2814
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enhanced Usual Care
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 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.
|
Experimental: Suicide Prevention Consultation Center
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide Behavior Composite
Time Frame: 6 months after index ED visit
|
Number of patients who had a documented suicide attempt or death by suicide
|
6 months after index ED visit
|
Outpatient Treatment Engagement - Count
Time Frame: 6 months after index ED visit
|
Number of behavioral healthcare visits following discharge from index ED visit
|
6 months after index ED visit
|
Outpatient Treatment Engagement - Type
Time Frame: 6 months after index ED visit
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Types of behavioral healthcare visits following discharge from index ED visit
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6 months after index ED visit
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Safety Planning Intervention Scoring Algorithm (SPISA)
Time Frame: At index ED visit
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Fidelity of written safety plans post-discharge from index ED visit
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At index ED visit
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Fidelity of Follow-up Calls
Time Frame: 1 month after index ED visit
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Number of patients who had 2 or more follow-up calls post-discharge from index ED visit
|
1 month after index ED visit
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Reach/Penetration of Safety Plans
Time Frame: At index ED visit
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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
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At index ED visit
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Reach/Penetration of Follow-up Calls
Time Frame: 1 month after index ED visit
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Proportion of patients who receive 2 or more telephone follow-up attempts out of all patients who received a safety plan
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1 month after index ED visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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6 months after index ED visit
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Suicide Attempts
Time Frame: 6 months after index ED visit
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Number of patients who had a documented suicide attempt
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6 months after index ED visit
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Adoption
Time Frame: At index ED visit
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Proportion of clinicians with eligible patients who refer the patient to the SPCC
|
At index ED visit
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Utilization of Screening of Suicide Risk Among ED Patients
Time Frame: At index ED visit
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Proportion of ED patients who received the Columbia Suicide Severity Rating Scale or equivalent evidence-based measure of suicide risk during index ED visit
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At index ED visit
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Index ED Visit Inpatient Admission Disposition
Time Frame: At index ED visit
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Proportion of patients admitted for inpatient hospitalization out of all patients identified as at risk for suicide
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At index ED visit
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Feasibility of SPCC
Time Frame: 9-12 months after ED crosses over to SPCC condition
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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)
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9-12 months after ED crosses over to SPCC condition
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Acceptability of SPCC
Time Frame: 9-12 months after ED crosses over to SPCC condition
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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)
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9-12 months after ED crosses over to SPCC condition
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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)
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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
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After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years)
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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)
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We will assess average personnel and non-personnel costs to Emergency Department practices of delivering EUC strategies, using Time-Driven Activity-Based Costing
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Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory K Brown, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
March 2, 2022
First Submitted That Met QC Criteria
March 23, 2022
First Posted (Actual)
April 1, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 5, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 850636
- 1P50MH127511-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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