Suicide PreventionSTAYNCT07783490
Suicide Safety Planning
A study testing Local Care Continuity and Centralized Care Navigation in people with Suicide Prevention and Suicide Safety Planning, run by Kaiser Permanente at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn the best way to provide suicide prevention care to adults receiving outpatient mental health care. The study compares two approaches based on the Zero Suicide Framework: Local Care Continuity and Centralized Care Navigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention, Suicide Safety Planning, Suicidal Ideation
- What is being tested?
- Local Care Continuity and Centralized Care Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 28 Feb 2031
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Attending an intake or follow-up outpatient mental health visit at a participating Kaiser Permanente Northern California mental health clinic during the study eligibility period
- Nine months of enrollment in the year prior to index visit, allowing for 1-month gaps
Who cannot join
- 1) None specified for the overall CE-RCT population
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 Northern California Division of Research
Pleasanton, California, 94588
About this study
Official title: Comparing Two Approaches for Assessment and Safety Planning With Adults at Risk for Suicide
The goal of this clinical trial is to learn the best way to provide suicide prevention care to adults receiving outpatient mental health care. The study compares two approaches based on the Zero Suicide Framework: Local Care Continuity and Centralized Care Navigation.
The main questions the study aims to answer are:
Read more
- Does adding support from a centralized telehealth care navigation team reduce suicide attempts compared with providing additional tools and support to local mental health clinicians?
- Does the centralized approach help more patients receive recommended suicide prevention care, including safety planning, and connect with follow-up mental health treatment?
- How do patients experience the two approaches, including their ability to cope with difficult situations and their experiences with their mental health care?
Researchers will compare Local Care Continuity, in which suicide prevention care is delivered by patients' local mental health clinicians with additional implementation support, with Centralized Care Navigation, which adds support from a centralized telehealth team of clinicians and care navigators. The researchers expect that Centralized Care Navigation will result in better suicide prevention care, greater connection to follow-up treatment, and fewer suicide attempts than Local Care Continuity.
Read the detailed description
This is a pragmatic, two-arm, parallel, cluster-randomized comparative effectiveness trial evaluating two approaches for delivering systematic suicide prevention care to adults receiving outpatient mental health care. The study is based on the Zero Suicide Framework and addresses an important question for health care systems: whether evidence-based suicide prevention practices can be effectively delivered by patients' existing local mental health clinicians with enhanced implementation support, or whether outcomes can be improved by adding a centralized telehealth team that provides specialized suicide prevention and care navigation services.
Geographic service areas will be randomized to Local Care Continuity or Centralized Care Navigation. Randomization occurs at the geographic service-area level rather than the individual patient level because the interventions are health care delivery approaches that are integrated into routine clinical workflows. The cluster-randomized design also reduces the potential for contamination between the two study approaches within the same service area.
Outcomes for the overall comparative effectiveness trial will primarily be assessed using electronic health record and claims data.
The randomized trial will be supplemented by an observational usual-care cohort from geographic service areas where the two study care pathways have not been implemented. This comparison will provide additional information about outcomes associated with the study approaches relative to ongoing health system quality-improvement efforts.
Finally, the study will examine whether the relative effects of Local Care Continuity and Centralized Care Navigation vary across prespecified patient subgroups. These analyses will help identify whether the effectiveness of the two approaches differs according to patient demographic, socioeconomic, and clinical characteristics.
- Being tested
- Local Care Continuity, Centralized Care Navigation
- Keywords
- Suicide Safety Planning, Treatment Engagement, Suicide Prevention, Mixed Methods Research, Implementation Science, Cluster Randomized Trial, Comparative Effectiveness Research, Care Navigation, Telemedicine, Zero Suicide, Caring Contacts, Suicide Risk Assessment
- Medical subject headings
- Suicide Prevention, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Care ContinuityBehavioural
Local Care Continuity uses implementation strategies to support existing specialty mental health clinicians in delivering evidence-based suicide prevention care. Implementation strategies include electronic health record tools for suicide risk assessment, safety planning, and follow-up; practice facilitation, including training and troubleshooting; and audit and feedback on delivery of suicide prevention practices. When suicide risk is identified, the local mental health clinician conducts suicide risk assessment, develops a safety plan as clinically indicated, and plans appropriate follow-up care.
Centralized Care NavigationBehavioural
Centralized Care Navigation uses the same implementation strategies as Local Care Continuity and adds a centralized telehealth suicide prevention service. The centralized team includes clinicians and non-clinician care navigators who work with local mental health clinicians to provide or facilitate suicide risk assessment and safety planning. When clinically indicated, patients receive a digital safety plan supported by a care navigator. Care navigators provide telehealth follow-up to support safety plan completion and connection to follow-up mental health care and send Caring Contacts from the care team.
| Study group | Role | What they receive |
|---|---|---|
| Local care continuity | Active comparator | Existing specialty mental health clinicians deliver suicide prevention care, including suicide risk assessment, safety planning, and connection to follow-up care, supported by implementation strategies designed to increase delivery of recommended suicide prevention practices. Receives: Behavioral: Local Care Continuity |
| Centralized care navigation | Experimental | A centralized telehealth suicide prevention team works with existing specialty mental health clinicians to provide or facilitate suicide risk assessment, safety planning, and connection to follow-up care. This arm includes the implementation strategies used in Local Care Continuity plus additional support from clinicians and care navigators. Receives: Behavioral: Centralized Care Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide attempt
Suicide attempts will be identified from EHR and claims data using ICD-10 diagnosis codes for intentional self-harm (X60-X84 and Y87.0). Encounter diagnoses for injury or poisoning with modifiers indicating self-harm intent will be classified as suicide attempts. Fatal and non-fatal suicide attempts occurring during the 18-month follow-up period will be included.
Measured: From the index outpatient mental health visit through 18 months
Receipt of a safety plan
Receipt of a safety plan will be assessed using text processing of structured and unstructured electronic health record (EHR) documentation. The outcome will indicate whether a patient received a safety plan during the 3-month follow-up period.
Measured: From the index outpatient mental health visit through 3 months
Treatment initiation/follow-up
Treatment initiation/follow-up will be assessed using EHR data to determine whether a patient attended a subsequent outpatient mental health visit during the 6-month follow-up period.
Measured: From the index outpatient mental health visit through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized controlled trial with observational usual care cohort
- Masking
- None (open label)
- Enrolment
- 176,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Esti Iturralde, Kaiser Permanente
- Investigators
- Esti M Iturralde, PhD, Principal investigator, Kaiser Permanente Northern California Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783490
- Sponsor's protocol ID
- 2405957
- Other IDs
- MBH-2025C1-43946
- Acronym
- STAY
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study's individual participant data sharing plan is currently under development and will be finalized as part of the study protocol. Decisions regarding the availability and conditions for sharing individual participant data will consider participant privacy and confidentiality, the sensitive nature of the study data, risk of participant re-identification, and restrictions related to proprietary health system data.
Publications
Hsin H, Papini S, Lu Y, Clancy H, Erion M, Lee C, Brochard-Des Roches K, Ju J, Girard K, Koshy M, Awsare S, Sterling SA, Liu VX, Iturralde E. Predicting and Preventing Suicide at Entry to Mental Health Care: A Community-Engaged, Machine Learning Model Implementation. NEJM Catal Innov Care Deliv. 2026 Mar;7(3):CAT250298. doi: 10.1056/CAT.25.0298. Epub 2026 Feb 18.
PubMed 42418608Ahmedani BK, Penfold RB, Frank C, Richards JE, Stewart C, Boggs JM, Coleman KJ, Sterling S, Yarborough BJH, Clarke G, Schoenbaum M, Aguirre-Miyamoto EM, Barton LJ, Yeh HH, Westphal J, McDonald S, Beck A, Beidas RS, Richardson L, Ryan JM, Buckingham ET 4th, Buttlaire S, Bruschke C, Flores J, Simon GE. Zero Suicide Model Implementation and Suicide Attempt Rates in Outpatient Mental Health Care. JAMA Netw Open. 2025 Apr 1;8(4):e253721. doi: 10.1001/jamanetworkopen.2025.3721.
PubMed 40193074Angerhofer Richards J, Cruz M, Stewart C, Lee AK, Ryan TC, Ahmedani BK, Simon GE. Effectiveness of Integrating Suicide Care in Primary Care : Secondary Analysis of a Stepped-Wedge, Cluster Randomized Implementation Trial. Ann Intern Med. 2024 Nov;177(11):1471-1481. doi: 10.7326/M24-0024. Epub 2024 Oct 1.
PubMed 39348695
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Approaches for Assessment and Safety Planning With Adults at Risk for Suicide
- ClinicalTrials.gov ID
- NCT07783490
- Acronym / sponsor ID
- STAY / 2405957
- Keywords
- Suicide Safety Planning, Treatment Engagement, Suicide Prevention, Mixed Methods Research, Implementation Science, Cluster Randomized Trial, Comparative Effectiveness Research, Care Navigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 24 Aug 2026 (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 clinical trial is to learn the best way to provide suicide prevention care to adults receiving outpatient mental health care. The study compares two approaches based on the Zero Suicide Framework: Local Care Continuity and Centralized Care Navigation.
The main questions the study aims to answer are:
- Does adding support from a centralized telehealth care navigation team reduce suicide attempts compared with providing additional tools and support to local mental health clinicians?
- Does the centralized approach help more patients receive recommended suicide prevention care, including safety planning, and connect with follow-up mental health treatment?
- How do patients experience the two approaches, including their ability to cope with difficult situations and their experiences with their mental health care?
Researchers will compare Local Care Continuity, in which suicide prevention care is delivered by patients' local mental health clinicians with additional implementation support, with Centralized Care Navigation, which adds support from a centralized telehealth team of clinicians and care navigators. The researchers expect that Centralized Care Navigation will result in better suicide prevention care, greater connection to follow-up treatment, and fewer suicide attempts than Local Care Continuity.
Detailed description
This is a pragmatic, two-arm, parallel, cluster-randomized comparative effectiveness trial evaluating two approaches for delivering systematic suicide prevention care to adults receiving outpatient mental health care. The study is based on the Zero Suicide Framework and addresses an important question for health care systems: whether evidence-based suicide prevention practices can be effectively delivered by patients' existing local mental health clinicians with enhanced implementation support, or whether outcomes can be improved by adding a centralized telehealth team that provides specialized suicide prevention and care navigation services.
Geographic service areas will be randomized to Local Care Continuity or Centralized Care Navigation. Randomization occurs at the geographic service-area level rather than the individual patient level because the interventions are health care delivery approaches that are integrated into routine clinical workflows. The cluster-randomized design also reduces the potential for contamination between the two study approaches within the same service area.
Outcomes for the overall comparative effectiveness trial will primarily be assessed using electronic health record and claims data.
The randomized trial will be supplemented by an observational usual-care cohort from geographic service areas where the two study care pathways have not been implemented. This comparison will provide additional information about outcomes associated with the study approaches relative to ongoing health system quality-improvement efforts.
Finally, the study will examine whether the relative effects of Local Care Continuity and Centralized Care Navigation vary across prespecified patient subgroups. These analyses will help identify whether the effectiveness of the two approaches differs according to patient demographic, socioeconomic, and clinical characteristics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial with observational usual care cohort
| Arm | Type | Receives |
|---|---|---|
| Local care continuity | Active comparator | Behavioral: Local Care ContinuityExisting specialty mental health clinicians deliver suicide prevention care, including suicide risk assessment, safety planning, and connection to follow-up care, supported by implementation strategies designed to increase delivery of recommended suicide prevention practices. |
| Centralized care navigation | Experimental | Behavioral: Centralized Care NavigationA centralized telehealth suicide prevention team works with existing specialty mental health clinicians to provide or facilitate suicide risk assessment, safety planning, and connection to follow-up care. This arm includes the implementation strategies used in Local Care Continuity plus additional support from clinicians and care navigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Attending an intake or follow-up outpatient mental health visit at a participating Kaiser Permanente Northern California mental health clinic during the study eligibility period
- Nine months of enrollment in the year prior to index visit, allowing for 1-month gaps
Key exclusion criteria (1 listed)
- 1) None specified for the overall CE-RCT population
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 |
|---|---|---|
| Local Care ContinuityLocal Care Continuity uses implementation strategies to support existing specialty mental health clinicians in delivering evidence-based suicide prevention care. Implementation strategies include electronic health record tools for suicide risk assessment, safety planning, and follow-up; practice facilitation, including training and troubleshooting; and audit and feedback on delivery of suicide prevention practices. When suicide risk is identified, the local mental health clinician conducts suicide risk assessment, develops a safety plan as clinically indicated, and plans appropriate follow-up care. | Behavioural | Local care continuity |
| Centralized Care NavigationCentralized Care Navigation uses the same implementation strategies as Local Care Continuity and adds a centralized telehealth suicide prevention service. The centralized team includes clinicians and non-clinician care navigators who work with local mental health clinicians to provide or facilitate suicide risk assessment and safety planning. When clinically indicated, patients receive a digital safety plan supported by a care navigator. Care navigators provide telehealth follow-up to support safety plan completion and connection to follow-up mental health care and send Caring Contacts from the care team. | Behavioural | Centralized care navigation |
Primary outcome
Suicide attempt
Time frame: From the index outpatient mental health visit through 18 months
Suicide attempts will be identified from EHR and claims data using ICD-10 diagnosis codes for intentional self-harm (X60-X84 and Y87.0). Encounter diagnoses for injury or poisoning with modifiers indicating self-harm intent will be classified as suicide attempts. Fatal and non-fatal suicide attempts occurring during the 18-month follow-up period will be included.
Receipt of a safety plan
Time frame: From the index outpatient mental health visit through 3 months
Receipt of a safety plan will be assessed using text processing of structured and unstructured electronic health record (EHR) documentation. The outcome will indicate whether a patient received a safety plan during the 3-month follow-up period.
Treatment initiation/follow-up
Time frame: From the index outpatient mental health visit through 6 months
Treatment initiation/follow-up will be assessed using EHR data to determine whether a patient attended a subsequent outpatient mental health visit during the 6-month follow-up period.
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 24 Aug 2026.
- Background: PubMed 42418608Hsin H, Papini S, Lu Y, Clancy H, Erion M, Lee C, Brochard-Des Roches K, Ju J, Girard K, Koshy M, Awsare S, Sterling SA, Liu VX, Iturralde E. Predicting and Preventing Suicide at Entry to Mental Health Care: A Community-Engaged, Machine Learning Model Implementation. NEJM Catal Innov Care Deliv. 2026 Mar;7(3):CAT250298. doi: 10.1056/CAT.25.0298. Epub 2026 Feb 18.
- Background: PubMed 40193074Ahmedani BK, Penfold RB, Frank C, Richards JE, Stewart C, Boggs JM, Coleman KJ, Sterling S, Yarborough BJH, Clarke G, Schoenbaum M, Aguirre-Miyamoto EM, Barton LJ, Yeh HH, Westphal J, McDonald S, Beck A, Beidas RS, Richardson L, Ryan JM, Buckingham ET 4th, Buttlaire S, Bruschke C, Flores J, Simon GE. Zero Suicide Model Implementation and Suicide Attempt Rates in Outpatient Mental Health Care. JAMA Netw Open. 2025 Apr 1;8(4):e253721. doi: 10.1001/jamanetworkopen.2025.3721.
- Background: PubMed 39348695Angerhofer Richards J, Cruz M, Stewart C, Lee AK, Ryan TC, Ahmedani BK, Simon GE. Effectiveness of Integrating Suicide Care in Primary Care : Secondary Analysis of a Stepped-Wedge, Cluster Randomized Implementation Trial. Ann Intern Med. 2024 Nov;177(11):1471-1481. doi: 10.7326/M24-0024. Epub 2024 Oct 1.
- Individual participant dataSharing planned: Undecided. The study's individual participant data sharing plan is currently under development and will be finalized as part of the study protocol. Decisions regarding the availability and conditions for sharing individual participant data will consider participant privacy and confidentiality, the sensitive nature of the study data, risk of participant re-identification, and restrictions related to proprietary health system data.
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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.
Esti M Iturralde, PhD principal investigator
Kaiser Permanente Northern California Division of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Care Continuity and Centralized Care Navigation in people with Suicide Prevention and Suicide Safety Planning, 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 24 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?
Contact Esti Iturralde, PhD (925-520-1768, Estibaliz.M.Iturralde@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide attempt (time frame: From the index outpatient mental health visit through 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07783490, which also lists 3 linked publications.
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 24 Aug 2026.