ClinicalTrials.gg
Enrolling by invitationNCT05307432Updated Jul 28, 2026

Safety Planning Intervention Telehealth Service Model in Emergency Departments

An interventional study of SPI+ Delivered by ED Staff and SPI+ Delivered by SPCC Clinicians in Suicide and Suicidal Ideation, sponsored by University of Pennsylvania. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Primary conditionSuicidal IdeationRegistry: SuicideReclassifiedWhy we changed it
Registry
Suicide — the first condition term the registry derived for this study.
ClinicalTrials.gg
Suicidal Ideation
Why
  1. Suicide is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Suicidal Ideation, a narrower term within Suicide.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,814
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Suicide
  • Suicidal Ideation

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Keywords

  • Safety Planning
  • Emergency Department
  • Risk Assessment
  • Follow-up Contact
  • Implementation Strategies
  • Telehealth
03

In context

Suicidal Ideation Reclassified

569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.

This study's planned enrollment of 2,814 is above the median of 80 across 469 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Compared within Suicidal Ideation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
2,814 participants (estimated)

Study arms

  • 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.

    Behavioral: SPI+ Delivered by ED Staff

  • 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.

    Behavioral: SPI+ Delivered by SPCC Clinicians

Interventions

  • BehavioralSPI+ 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.

  • BehavioralSPI+ 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.

06

What researchers measure

Primary outcomes

  1. Suicide Behavior Composite

    Number of patients who had a documented suicide attempt or death by suicide

    Time frame: 6 months after index ED visit

  2. Outpatient Treatment Engagement - Count

    Number of behavioral healthcare visits following discharge from index ED visit

    Time frame: 6 months after index ED visit

  3. Outpatient Treatment Engagement - Type

    Types of behavioral healthcare visits following discharge from index ED visit

    Time frame: 6 months after index ED visit

  4. Safety Planning Intervention Scoring Algorithm (SPISA)

    Fidelity of written safety plans post-discharge from index ED visit

    Time frame: At index ED visit

  5. Fidelity of Follow-up Calls

    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

  6. 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

    Time frame: At index ED visit

  7. 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

    Time frame: 1 month after index ED visit

Secondary outcomes

  1. Suicide-related ED Visits and Psychiatric Hospitalizations

    Number of ED visits and/or inpatient psychiatric admissions for suicidal ideation/behavior

    Time frame: 6 months after index ED visit

  2. Suicide Attempts

    Number of patients who had a documented suicide attempt

    Time frame: 6 months after index ED visit

  3. Adoption

    Proportion of clinicians with eligible patients who refer the patient to the SPCC

    Time frame: At index ED visit

  4. 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

    Time frame: At index ED visit

  5. Index ED Visit Inpatient Admission Disposition

    Proportion of patients admitted for inpatient hospitalization out of all patients identified as at risk for suicide

    Time frame: At index ED visit

  6. 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)

    Time frame: 9-12 months after ED crosses over to SPCC condition

  7. 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)

    Time frame: 9-12 months after ED crosses over to SPCC condition

  8. 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

    Time frame: After ED crosses over to SPCC condition (2.25 - 3 year range, average of 2.625 years)

  9. 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

    Time frame: Before ED crosses over to SPC condition (1 - 1.75 year range, average of 1.375 years)

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Jan 2027, 56 months after the start.

Of 281 non-industry interventional studies with no phase under Suicidal Ideation, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 56 months is above that.

Counting every sponsor, half of 290 studies reached it within 29 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2022
First posted
Apr 1, 2022
StartActual
May 1, 2022
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2027
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05307432
Responsible party
Sponsor
First posted
Apr 1, 2022
Start date
May 1, 2022
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Jul 28, 2026

Study contacts

Gregory K Brown, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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