Suicide Prevention Among Recipients of Care

NCT04893447 | Completed DMC

• 1 other identifier: 2019-0026
• Study Type: interventional
• Target: 1,520
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)

  6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)

  6 months

Secondary Outcomes (7)

• Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale

  6 months

• Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale

  12 months

• Utilization of Emergency Department for Suicidality

  6 months

• Utilization of Emergency Department for Suicidality

  12 months

• Attendance at Outpatient Behavioral Health Appointments

  6 months

Study Arms (2)

SPI+: Safety Planning Intervention plus structured phone-based follow-up

EXPERIMENTAL

The Safety Planning Intervention (SPI+) includes safety planning (moderate or high risk for suicide) or connection \& support planning (low risk for suicide) at the clinic or ED, plus a structured telephone-based intervention from a suicide prevention hotline

Behavioral: SPI+

Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC)

EXPERIMENTAL

SP+CC will include safety planning (moderate or high risk for suicide) or connection \& support planning (low risk for suicide) at the clinic or ED, plus caring text messages or emails from a suicide prevention hotline.

Behavioral: SP+CC (Caring Contacts)

Interventions

SPI+ BEHAVIORAL

Suicide prevention hotline follow-up specialists will call participants to (1) conduct a brief suicide risk assessment; (2) review and discuss the participant's connection and support plan or safety plan; and (3) provide referrals to social services or other support with treatment engagement, if indicated. Participants will receive at least one and optional additional phone calls, generally delivered according to the following schedule: days 3, 7, 14, 30, 60, 90. Modifications may be made to the schedule due to weekends, holidays, or participant availability, and additional calls may be scheduled as desired by the participant. The follow-up will stop once the participant is successfully engaged in outpatient treatment or does not desire further follow-up support.

Also known as: phone-based follow-up, brief contact intervention

SPI+: Safety Planning Intervention plus structured phone-based follow-up

SP+CC (Caring Contacts) BEHAVIORAL

SP+CC follow-up includes one phone conversation with a suicide prevention hotline follow-up specialist and a series of personalized caring messages sent over the course of 12 months via text or email (based on participant preference). Caring contacts will generally be sent according to the following schedule: 3 in the first week, 6 weekly, 6 bi-weekly, 4 monthly; 2 bi-monthly, and one each for the participant's birthday, Thanksgiving, Christmas, and New Year's (total of 25 over 12 months). Slight variation in the schedule is allowed. There is no expectation that participants respond to the text messages; if they do, follow-up specialists reply to any incoming texts. Replies are individually-tailored and caring.

Also known as: Brief contact intervention, text-based follow-up, email follow-up

Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at St. Luke's Health System Emergency Department or Primary Care Clinic
• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Luke's Health System, Boise, Idaho: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Idaho Crisis & Suicide Hotline: collaborator
• University of Washington: collaborator
• Columbia University: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

St. Luke's Health System

Boise, Idaho, 83712, United States

Location

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation; Psychological Well-Being; Mental Disorders; Emergencies; Depressive Disorder; Depression; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Personal Satisfaction; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mood Disorders

Study Officials

• Anna K Radin, DrPH, MPH

  St. Luke's Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Applied Research Scientist

Model Details: Individual-level randomization to one of two treatment arms

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 19, 2021
• Study Start: May 20, 2021
• Primary Completion: July 7, 2024
• Study Completion: July 7, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data are estimated to become available in 2026.
• Access Criteria: A data access committee will review and make decisions on all requests to access data.

Locations

US (1)