An interventional study of Local Care Continuity and Centralized Care Navigation in Suicide Prevention, Suicide Safety Planning and Suicidal Ideation, sponsored by Kaiser Permanente. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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:
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.
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.
186 studies on the registry are indexed under Suicide Prevention; 92 are open to participants now.
This study's planned enrollment of 176,000 is above the median of 140 across 167 interventional studies indexed under Suicide Prevention.
Browse Suicide Prevention studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1) None specified for the overall CE-RCT population
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.
Behavioral: Local Care Continuity
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.
Behavioral: Centralized Care Navigation
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 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From the index outpatient mental health visit through 6 months
Plan to share: 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.
Start is estimated for Feb 2027; primary completion for Jun 2030, 40 months later.
Of 127 non-industry interventional studies with no phase under Suicide Prevention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's planned 40 months is above that.
Counting every sponsor, half of 129 studies reached it within 28 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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