NCT07783490

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176,000

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Feb 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2031

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

3.3 years

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

Suicide AttemptSuicide PreventionSuicide Safety PlanningSuicidal Ideation

Keywords

Suicide Safety PlanningTreatment EngagementSuicide PreventionMixed Methods ResearchImplementation ScienceCluster Randomized TrialComparative Effectiveness ResearchCare NavigationTelemedicineZero SuicideCaring ContactsSuicide Risk Assessment

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    From the index outpatient mental health visit through 6 months

Study Arms (2)

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.

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.

Behavioral: Centralized Care Navigation

Interventions

Local Care ContinuityBEHAVIORAL

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.

Local care continuity
Centralized Care NavigationBEHAVIORAL

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.

Centralized care navigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) None specified for the overall CE-RCT population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California Division of Research

Pleasanton, California, 94588, United States

Location

Related Publications (3)

  • 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.

    PMID: 42418608BACKGROUND

  • Ahmedani 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.

    PMID: 40193074BACKGROUND

  • Angerhofer 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.

    PMID: 39348695BACKGROUND

MeSH Terms

Conditions

Suicide PreventionSuicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Esti M Iturralde, PhD

    Kaiser Permanente Northern California Division of Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esti Iturralde, PhD

CONTACT

925-520-1768Estibaliz.M.Iturralde@kp.org

Monique Buffler Project Manager, MPH

CONTACT

510-410-5459monique.does@kp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized controlled trial with observational usual care cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Investigator II

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 24, 2026

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

February 28, 2031

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations

US(1)