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Suicide Prevention Among Recipients of Care (SPARC)

Primary Purpose

Suicide, Suicide, Attempted, Suicidal Ideation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPI+
SP+CC (Caring Contacts)
Sponsored by
St. Luke's Health System, Boise, Idaho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring 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

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Luke's Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale
5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).
Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale
5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).
Utilization of Emergency Department for Suicidality
Measured through self-report
Utilization of Emergency Department for Suicidality
Measured through self-report
Attendance at Outpatient Behavioral Health Appointments
Measured through self-report
Attendance at Outpatient Behavioral Health Appointments
Measured through self-report
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)

Full Information

First Posted
April 28, 2021
Last Updated
July 6, 2023
Sponsor
St. Luke's Health System, Boise, Idaho
Collaborators
Patient-Centered Outcomes Research Institute, Idaho Suicide Prevention Hotline (Jannus, Inc.), University of Washington, Columbia University, University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04893447
Brief Title
Suicide Prevention Among Recipients of Care
Acronym
SPARC
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
July 16, 2024 (Anticipated)
Study Completion Date
July 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Health System, Boise, Idaho
Collaborators
Patient-Centered Outcomes Research Institute, Idaho Suicide Prevention Hotline (Jannus, Inc.), University of Washington, Columbia University, University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individual-level randomization to one of two treatment arms
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPI+: Safety Planning Intervention plus structured phone-based follow-up
Arm Type
Experimental
Arm Description
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
Arm Title
Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SPI+
Other Intervention Name(s)
phone-based follow-up, brief contact intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SP+CC (Caring Contacts)
Other Intervention Name(s)
Brief contact intervention, text-based follow-up, email follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)
Description
6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale
Description
5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).
Time Frame
6 months
Title
Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale
Description
5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).
Time Frame
12 months
Title
Utilization of Emergency Department for Suicidality
Description
Measured through self-report
Time Frame
6 months
Title
Utilization of Emergency Department for Suicidality
Description
Measured through self-report
Time Frame
12 months
Title
Attendance at Outpatient Behavioral Health Appointments
Description
Measured through self-report
Time Frame
6 months
Title
Attendance at Outpatient Behavioral Health Appointments
Description
Measured through self-report
Time Frame
12 months
Title
Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)
Description
6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna K Radin, DrPH, MPH
Organizational Affiliation
St. Luke's Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Health System
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of the final research report, de-identified data may be shared with other researchers.
IPD Sharing Time Frame
Data are estimated to become available in 2026.
IPD Sharing Access Criteria
A data access committee will review and make decisions on all requests to access data.

Learn more about this trial

Suicide Prevention Among Recipients of Care

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