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NCT Number: NCT07783490

Suicide Safety Planning

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.

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Key information

Conditions

Suicide Prevention Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Suicide Attempt Suicide Safety Planning Suicide, Attempted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California Division of Research

Pleasanton, California, 94588, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • None specified for the overall CE-RCT population

Treatment and study plan

Local Care Continuity

Behavioral

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 Navigation

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esti Iturralde, PhD

CONTACT

[email protected]

925-520-1768

Monique Buffler Project Manager, MPH

CONTACT

[email protected]

510-410-5459

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparing Two Approaches for Assessment and Safety Planning With Adults at Risk for Suicide

Acronym: STAY

Important dates

Study start
2027
Primary completion
2030
Study completion
2031
First posted
Aug 24, 2026
Registry last updated
Aug 24, 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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