NCT06060535

Brief Summary

The goal of this clinical trial is to evaluate a suicide risk model in patients receiving behavioral health care treatment. The main question it aims to answer is: Does the implementation of the suicide risk model reduce suicide attempts? Researchers will compare the outcomes of patients identified by the model to those in a usual care group.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
394,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 15, 2025

Status Verified

October 1, 2025

Enrollment Period

3.2 years

First QC Date

August 13, 2023

Last Update Submit

December 11, 2025

Conditions

Keywords

Suicide Prevention

Outcome Measures

Primary Outcomes (1)

  • Suicide attempt, 90 days post-index encounter

    The number and proportion of visits followed by any suicide attempt (ICD-10 diagnosis codes) occurring within 90 days of an index visit.

    90 days post-index encounter

Secondary Outcomes (4)

  • Identification

    Through study completion, an average of 18 months

  • Recognition

    Through study completion, an average of 18 months

  • Evidence-based suicide care

    Through study completion, an average of 18 months

  • Any 14-day follow-up care in behavioral health

    14 days post-index encounter

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care suicide prevention pathway

Behavioral: Suicide Attempt Risk Model Care Pathway

Intervention

EXPERIMENTAL

Implementation of the suicide risk model

Behavioral: Suicide Attempt Risk Model Care Pathway

Interventions

The suicide attempt risk model uses documented histories of medical and psychiatric diagnoses, medications, and health service utilization to predict risk of a suicide attempt in the 90 days following an outpatient visit in behavioral health clinics.

InterventionUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years old
  • + visit to a behavioral health clinic at participating sites

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

HealthPartners

Bloomington, Minnesota, 55425, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (11)

  • Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.

    PMID: 24567199BACKGROUND
  • Simon GE, Johnson E, Lawrence JM, Rossom RC, Ahmedani B, Lynch FL, Beck A, Waitzfelder B, Ziebell R, Penfold RB, Shortreed SM. Predicting Suicide Attempts and Suicide Deaths Following Outpatient Visits Using Electronic Health Records. Am J Psychiatry. 2018 Oct 1;175(10):951-960. doi: 10.1176/appi.ajp.2018.17101167. Epub 2018 May 24.

    PMID: 29792051BACKGROUND
  • Hedegaard H, Curtin SC, Warner M. Increase in Suicide Mortality in the United States, 1999-2018. NCHS Data Brief. 2020 Apr;(362):1-8.

    PMID: 32487287BACKGROUND
  • Yarborough BJH, Ahmedani BK, Boggs JM, Beck A, Coleman KJ, Sterling S, Schoenbaum M, Goldstein-Grumet J, Simon GE. Challenges of Population-based Measurement of Suicide Prevention Activities Across Multiple Health Systems. EGEMS (Wash DC). 2019 Apr 12;7(1):13. doi: 10.5334/egems.277.

    PMID: 30993146BACKGROUND
  • Rossom RC, Richards JE, Sterling S, Ahmedani B, Boggs JM, Yarborough BJH, Beck A, Lloyd K, Frank C, Liu V, Clinch SB, Patke LD, Simon GE. Connecting Research and Practice: Implementation of Suicide Prevention Strategies in Learning Health Care Systems. Psychiatr Serv. 2022 Feb 1;73(2):219-222. doi: 10.1176/appi.ps.202000596. Epub 2021 Jun 30.

    PMID: 34189931BACKGROUND
  • Simon GE, Shortreed SM, Johnson E, Rossom RC, Lynch FL, Ziebell R, Penfold ARB. What health records data are required for accurate prediction of suicidal behavior? J Am Med Inform Assoc. 2019 Dec 1;26(12):1458-1465. doi: 10.1093/jamia/ocz136.

    PMID: 31529095BACKGROUND
  • Simon GE, Rutter CM, Peterson D, Oliver M, Whiteside U, Operskalski B, Ludman EJ. Does response on the PHQ-9 Depression Questionnaire predict subsequent suicide attempt or suicide death? Psychiatr Serv. 2013 Dec 1;64(12):1195-202. doi: 10.1176/appi.ps.201200587.

    PMID: 24036589BACKGROUND
  • Yarborough BJH, Stumbo SP. Patient perspectives on acceptability of, and implementation preferences for, use of electronic health records and machine learning to identify suicide risk. Gen Hosp Psychiatry. 2021 May-Jun;70:31-37. doi: 10.1016/j.genhosppsych.2021.02.008. Epub 2021 Mar 4.

    PMID: 33711562BACKGROUND
  • Coleman KJ, Stewart CC, Bruschke C, et al. Identifying people at risk for suicide: Implementation of screening for the Zero Suicide Initiative in large health systems. Advances in Psychiatry and Behavioral Health. 2021;1(1):67-76.

    BACKGROUND
  • National Action Alliance for Suicide Prevention. A prioritized research agenda for suicide prevention: An action plan to save lives. Rockville, MD. 2014.

    BACKGROUND
  • Stumbo SP, Hooker SA, Rossom RC, Miley K, Ahmedani BK, Lockhart E, Yeh HH, Yarborough BJH. Study protocol for a stepped-wedge, randomized controlled trial to evaluate implementation of a suicide risk identification model among behavioral health patients in three large health systems. BMC Psychiatry. 2025 Apr 8;25(1):344. doi: 10.1186/s12888-025-06760-0.

Related Links

MeSH Terms

Conditions

Suicide, AttemptedSuicide, CompletedSuicide Prevention

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Bobbi Jo Yarborough, PsyD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Clinics are the unit of randomization, all behavioral health clinics will be randomized, over the course of three waves, to cross over from usual care to intervention (implementation of the suicide risk model).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2023

First Posted

September 29, 2023

Study Start

October 4, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

We will make our documentation, research methods and protocol, data collection tools, and a de-identified dataset of data that underlie results in publications freely available, upon request, to interested researchers beginning 6 months after publication of the main analyses. Materials will be shared through the MHRN website or a secure file transfer. Creation of a deidentified dataset for sharing may include redaction of some information to prevent re-identification or because the data is proprietary. The de-identified dataset will be available for non-commercial research use to external investigators via a data-sharing agreement and under the auspices of the Site-PIs. Users must agree to the conditions of use governing access to the data. The study team will be available for support. Information related to errors in the data, future releases, and publication lists will also be shared with users.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Materials will be shared, upon request, to interested researchers beginning 6 months after publication of the main analyses for up to one year.
Access Criteria
Materials will be shared with interested researchers through the MHRN website, data may be shared for secondary analyses through a secure file transfer site.

Locations