Suicide Safety Planning
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Permanente
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Local Care Continuity
BehavioralLocal 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
BehavioralCentralized 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.
Treatment groups
176,000 Participants
are divided into 2 treatment groupsGroup A: Local care continuityActive comparator 1 intervention
Group B: Centralized care navigationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaiser Permanente
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: