Clinical trial NCT04893447: Suicide Prevention Among Recipients of Care
Official title: Comparing the Effectiveness of Safety Planning Plus Follow-Up From a Suicide Prevention Hotline (SPI+) vs Safety Planning Plus Caring Contacts (SP+CC) Among Adults and Adolescents at Risk for Suicide in Primary Care or Emergency Departments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide, Attempted
Suicidal Ideation
Social Support
Secondary Prevention
Patient Care Planning
Outpatients
Outpatient Clinics, Hospital
Mental Health Services
Mental Health
Mental Disorder
Loneliness
Emergency Service, Hospital
Depressive Disorder
Depression
Continuity of Patient Care
Ambulatory Care
Adolescent
Adult
Crisis Intervention
Keywords: Brief Interventions
Caring Contacts
Care Transitions
Follow-up
Emergency Department
Primary Care
Safety Planning Intervention
Safety Plan
Suicide
Suicide Prevention
Adult
Adolescent
Brief Contact Intervention
Lead sponsor: St. Luke's Health System, Boise, Idaho
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Idaho Crisis & Suicide Hotline
name: University of Washington
name: Columbia University
name: University of Pennsylvania
First posted: 2021-05-19
Enrollment: 1520
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual-level randomization to one of two treatment arms
Primary purpose: PREVENTION

Brief summary: Randomized controlled trial to determine the best brief suicide prevention intervention for adults and adolescents who screen positive for suicidal ideation or behavior in emergency departments or primary care clinics.

Aim 1: Compare the effectiveness of two brief suicide prevention interventions (safety planning intervention plus structured phone-based follow-up from a suicide prevention hotline (SPI+), versus safety planning intervention plus caring contacts (CC)) to (a) reduce suicidal ideation and behavior, (b) reduce loneliness, (c) reduce return to care for suicidality, and (d) increase uptake of outpatient mental healthcare services over 12 months among adult and adolescent patients screening positive for suicide in emergency departments (EDs) and primary care clinics.

Aim 2: Assess the acceptability of connection and support planning and the safety planning intervention, with or without follow-up among providers and clinical staff in EDs and primary care clinics.

Aim 3: Assess the acceptability of SPI+ and SP+CC among adult and adolescent patients.


Eligibility criteria: Inclusion Criteria:

* Patient at St. Luke's Health System Emergency Department or Primary Care Clinic
* 12-17 years old (adolescents) or 18+ years old (adults)
* Screened positive for suicide risk on C-SSRS (any response of "yes") during current visit, or current visit is related to a suicide attempt
* Access to a phone for the duration of the study with the ability to receive calls
* The ability to send and receive email messages (required) and text messages (optional)
* English or Spanish speaking and reading

Exclusion Criteria:

* Unable or unwilling to provide informed consent to participate
* Inappropriate for study participation based on the clinical judgment of provider

Primary outcomes:
measure: Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)
timeFrame: 6 months
Secondary outcomes:
measure: Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale
timeFrame: 6 months
measure: Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale
timeFrame: 12 months
measure: Utilization of Emergency Department for Suicidality
timeFrame: 6 months
measure: Utilization of Emergency Department for Suicidality
timeFrame: 12 months
measure: Attendance at Outpatient Behavioral Health Appointments
timeFrame: 6 months
measure: Attendance at Outpatient Behavioral Health Appointments
timeFrame: 12 months
measure: Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)
timeFrame: 12 months
Other outcomes:
Locations:
city: Boise
country: United States
facility: St. Luke's Health System
state: Idaho
Study officials:
affiliation: St. Luke's Health System
name: Anna K Radin, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: