SPARC: Suicide Prevention Among Recipients of Care

Sponsor

St. Luke's Health System, Boise, Idaho (Other)

Overall Status

Recruiting

CT.gov ID

NCT04893447

Collaborator

Patient-Centered Outcomes Research Institute (Other), Idaho Suicide Prevention Hotline (Jannus, Inc.) (Other), University of Washington (Other), Columbia University (Other), University of Pennsylvania (Other)

1,382

Enrollment

Location

Arms

29.8

Anticipated Duration (Months)

46.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Behavioral: SPI+ Behavioral: SP+CC (Caring Contacts)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1382 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Individual-level randomization to one of two treatment armsIndividual-level randomization to one of two treatment arms

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Nov 14, 2023

Anticipated Study Completion Date :

Nov 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPI+: Safety Planning Intervention plus structured phone-based follow-up 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+ 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. Other Names: phone-based follow-up, brief contact intervention
Experimental: Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC) 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) 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. Other Names: Brief contact intervention, text-based follow-up, email follow-up

Arm

Intervention/Treatment

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

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+

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.

Other Names:

phone-based follow-up, brief contact intervention

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

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)

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.

Other Names:

Brief contact intervention, text-based follow-up, email follow-up

Outcome Measures

Primary Outcome Measures

Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment) [6 months]
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 [6 months]
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 [12 months]
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 [6 months]
Measured through self-report
Utilization of Emergency Department for Suicidality [12 months]
Measured through self-report
Attendance at Outpatient Behavioral Health Appointments [6 months]
Measured through self-report
Attendance at Outpatient Behavioral Health Appointments [12 months]
Measured through self-report
Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment) [12 months]
6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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
Completed, Revised, or Reviewed Safety Plan or Connection & Support Plan as part of current visit
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