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Enrolling by Invitation

NCT Number: NCT07068685

Pilot Testing Suicide Risk Prediction Algorithms in Primary Care

The goal of this pilot study is to learn whether the use of suicide risk prediction algorithms in primary care can help identify people who may benefit from extra mental health monitoring.

Specifically, this study aims to measure how use of the suicide risk prediction algorithm to prompt extra mental health monitoring among adult primary care patients impacts proportions of patients identified at risk of suicide and engaged in safety planning. Secondarily, we plan to measure proportions of patients identified at risk of suicide via mental health monitoring (irrespective of engagement in safety planning).

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Key information

Conditions

Suicide Prevention Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide Risk | Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any type of adult primary care visit/encounter at Kaiser Permanente Washington (KPWA) between 3/5/25-10/5/25 (pre-period) and 10/6/25-4/30/26 (post-period or implementation period).

Exclusion criteria

Primary care visit/encounter among people under 18 years old.

Treatment and study plan

Suicide risk prediction algorithm

Other

Use of a suicide risk prediction algorithm, developed by the Mental Health Research Network (MHRN), will be used to prompt additional mental health monitoring. Mental health monitoring will include asking patients about suicidal thoughts (via the ninth question of the Patient Health Questionnaire-9, PHQ-9), followed by suicide risk assessment (via use of a brief self-administered version of the Columbia Suicide Risk Severity Rating Scale, C-SSRS), followed by Safety Planning with a designated member of the primary care team.

Other names: suicide care clinical decision support

Primary outcomes

  1. Suicide Risk Safety Plan Documentation

    Time frame: Rates for primary care encounters will be compared before and after implementation, during the 13 month study period 3/05/2025-4/05/2026 (implementation launch 10/6/2025)

    Indicator for whether a patient was identified at risk of suicide (using the PHQ-9 and C-SSRS) and had a safety planning intervention documented in the EMR on the day of, or in the following 14 days of a primary care encounter, using a standardized template based on the brief suicide risk safety plan intervention developed by Drs. Stanley & Brown to mitigate risk

Secondary outcomes

  1. Suicidal ideation symptom assessment

    Time frame: Rates of assessment for primary care encounters will be compared before and after implementation, during the 13 month study period 3/05/2025-4/05/2026 (implementation launch 10/6/2025)

    Indicator for whether a patient completed the Patient Health Questionnaire-9 (PHQ-9) Question 9 for primary care encounter

  2. Prior month intent/planning for suicide attempt

    Time frame: Rates for primary care encounters will be compared before and after implementation, during the 13 month study period 3/05/2025-4/05/2026 (implementation launch 10/6/2025)

    Indicator for whether a patient indicated prior-month intent or planning for suicide attempt (C-SSRS score ≥3, on the C-SSRS assessment for the primary care encounter (range 0-6; higher scores confer greater risk)

  3. Suicide risk assessment

    Time frame: Rates for primary care encounters will be compared before and after implementation, during the 13 month study period 3/05/2025-4/05/2026 (implementation launch 10/6/2025)

    Indicator for whether a patient completed the Columbia Suicide Risk Severity Rating Scale (C-SSRS) for the primary care encounter

  4. Frequent suicidal ideation reported (in prior 2-weeks)

    Time frame: Rates for primary care encounters will be compared before and after implementation, during the 13 month study period 3/05/2025-4/05/2026 (implementation launch 10/6/2025)

    Indicator for whether a patient reported suicidal ideation "more than half the days" or "nearly every day" (PHQ-9 Q9 score 2 or 3), on the assessment documented in the electronic medical record (EMR) for the primary care encounter (range 0-3, higher scores indicate more frequent suicidal ideation)

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Washington

Registry information

Official study title

Pilot Testing Implementation of Suicide Risk Prediction Algorithms to Support Suicide Prevention in Primary Care

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 16, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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