Suicide PreventionNCT07068685
Pilot Testing Suicide Risk Prediction Algorithms in Primary Care
A study testing Suicide risk prediction algorithm in people with Suicide Prevention and Suicide Risk | Patient, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide Prevention, Suicide Risk | Patient
- What is being tested?
- Suicide risk prediction algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Pilot Testing Implementation of Suicide Risk Prediction Algorithms to Support Suicide Prevention 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).
- Conditions
- Suicide Prevention, Suicide Risk | Patient
- Being tested
- Suicide risk prediction algorithm
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide risk prediction algorithmOther
Also called suicide care clinical decision support
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.
| Study group | Role | What they receive |
|---|---|---|
| Suicide risk monitoring | Experimental | Quality improvement intervention: 6 months following implementation of the suicide risk prediction algorithm in primary care to prompt extra mental health monitoring. Receives: Other: Suicide risk prediction algorithm |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Risk Safety Plan Documentation
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
Measured: 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)
Secondary outcomes (4)
Suicidal ideation symptom assessment
Indicator for whether a patient completed the Patient Health Questionnaire-9 (PHQ-9) Question 9 for primary care encounter
Measured: 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)
Prior month intent/planning for suicide attempt
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)
Measured: 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)
Suicide risk assessment
Indicator for whether a patient completed the Columbia Suicide Risk Severity Rating Scale (C-SSRS) for the primary care encounter
Measured: 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)
Frequent suicidal ideation reported (in prior 2-weeks)
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start5 Mar 2025
- Primary completion30 Apr 2026
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Retrospective pre-post design
- Masking
- None (open label)
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068685
- Sponsor's protocol ID
- 2019330
- Other IDs
- R34MH132829
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing Implementation of Suicide Risk Prediction Algorithms to Support Suicide Prevention in Primary Care
- ClinicalTrials.gov ID
- NCT07068685
- Acronym / sponsor ID
- 2019330
- Conditions
- Suicide Prevention, Suicide Risk | Patient
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Retrospective pre-post design
| Arm | Type | Receives |
|---|---|---|
| Suicide risk monitoring | Experimental | Other: Suicide risk prediction algorithmQuality improvement intervention: 6 months following implementation of the suicide risk prediction algorithm in primary care to prompt extra mental health monitoring. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suicide risk prediction algorithmAlso: suicide care clinical decision supportUse 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 | Suicide risk monitoring |
Primary outcome
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide risk prediction algorithm in people with Suicide Prevention and Suicide Risk | Patient, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.