SuicideNCT05307432
Safety Planning Intervention Telehealth Service Model in Emergency Departments
A study testing SPI+ Delivered by ED Staff and SPI+ Delivered by SPCC Clinicians in people with Suicide and Suicidal Ideation, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Suicidal Ideation
- What is being tested?
- SPI+ Delivered by ED Staff and SPI+ Delivered by SPCC Clinicians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,814 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- Inpatient admission following the index ED visit per the EHR
- Aim 2:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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).
Read the 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.
- Conditions
- Suicide, Suicidal Ideation
- Being tested
- SPI+ Delivered by ED Staff, SPI+ Delivered by SPCC Clinicians
- Keywords
- Safety Planning, Emergency Department, Risk Assessment, Follow-up Contact, Implementation Strategies, Telehealth
- Medical subject headings
- Suicide, Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI+ Delivered by ED StaffBehavioural
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 CliniciansBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Active comparator | 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. Receives: Behavioral: SPI+ Delivered by ED Staff |
| Suicide Prevention Consultation Center | Experimental | 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. Receives: Behavioral: SPI+ Delivered by SPCC Clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Behavior Composite
Number of patients who had a documented suicide attempt or death by suicide
Measured: 6 months after index ED visit
Outpatient Treatment Engagement - Count
Number of behavioral healthcare visits following discharge from index ED visit
Measured: 6 months after index ED visit
Outpatient Treatment Engagement - Type
Types of behavioral healthcare visits following discharge from index ED visit
Measured: 6 months after index ED visit
Safety Planning Intervention Scoring Algorithm (SPISA)
Fidelity of written safety plans post-discharge from index ED visit
Measured: At 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
Measured: 1 month after 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
Measured: At index ED visit
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
Measured: 1 month after index ED visit
Secondary outcomes (9)
Suicide-related ED Visits and Psychiatric Hospitalizations
Number of ED visits and/or inpatient psychiatric admissions for suicidal ideation/behavior
Measured: 6 months after index ED visit
Suicide Attempts
Number of patients who had a documented suicide attempt
Measured: 6 months after index ED visit
Adoption
Proportion of clinicians with eligible patients who refer the patient to the SPCC
Measured: At index ED visit
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
Measured: At 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
Measured: At index ED visit
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)
Measured: 9-12 months after ED crosses over to SPCC condition
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)
Measured: 9-12 months after ED crosses over to SPCC condition
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
Measured: After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years)
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
Measured: Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 May 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster-randomized controlled design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,814 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gregory K Brown, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307432
- Sponsor's protocol ID
- 850636
- Other IDs
- 1P50MH127511-01
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Planning Intervention and Follow-up Telehealth Service Model for Suicidal Individuals in Emergency Department Settings
- ClinicalTrials.gov ID
- NCT05307432
- Acronym / sponsor ID
- 850636
- Conditions
- Suicide, Suicidal Ideation
- Keywords
- Safety Planning, Emergency Department, Risk Assessment, Follow-up Contact, Implementation Strategies, Telehealth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,814 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster-randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Active comparator | Behavioral: SPI+ Delivered by ED StaffED 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. |
| Suicide Prevention Consultation Center | Experimental | Behavioral: SPI+ Delivered by SPCC CliniciansED 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- Inpatient admission following the index ED visit per the EHR
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPI+ Delivered by ED StaffED 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. | Behavioural | Enhanced Usual Care |
| SPI+ Delivered by SPCC CliniciansThe 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. | Behavioural | Suicide Prevention Consultation Center |
Primary outcome
Suicide Behavior Composite
Time frame: 6 months after index ED visit
Number of patients who had a documented suicide attempt or death by suicide
Outpatient Treatment Engagement - Count
Time frame: 6 months after index ED visit
Number of behavioral healthcare visits following discharge from index ED visit
Outpatient Treatment Engagement - Type
Time frame: 6 months after index ED visit
Types of behavioral healthcare visits following discharge from index ED visit
Safety Planning Intervention Scoring Algorithm (SPISA)
Time frame: At index ED visit
Fidelity of written safety plans post-discharge from index ED visit
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
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
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
9 secondary outcomes
Suicide-related ED Visits and Psychiatric Hospitalizations
Time frame: 6 months after index ED visit
Suicide Attempts
Time frame: 6 months after index ED visit
Adoption
Time frame: At index ED visit
Utilization of Screening of Suicide Risk Among ED Patients
Time frame: At index ED visit
Index ED Visit Inpatient Admission Disposition
Time frame: At index ED visit
Feasibility of SPCC
Time frame: 9-12 months after ED crosses over to SPCC condition
Acceptability of SPCC
Time frame: 9-12 months after ED crosses over to SPCC condition
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory K Brown, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPI+ Delivered by ED Staff and SPI+ Delivered by SPCC Clinicians in people with Suicide and Suicidal Ideation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Behavior Composite (time frame: 6 months after index ED visit). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.