Suicidal Ideation, Suicide Attempt, Suicide Prevention, Suicide Safety Planning
Conditions
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
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.
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.
Interventions
BEHAVIORALLocal Care Continuity
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.
BEHAVIORALCentralized Care Navigation
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.
Sponsors
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Cluster-randomized controlled trial with observational usual care cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. 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 3. Nine months of enrollment in the year prior to index visit, allowing for 1-month gaps
Exclusion criteria
1\) None specified for the overall CE-RCT population
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicide attempt | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTEsti Iturralde, PhD
CONTACTMonique Buffler Project Manager, MPH
PRINCIPAL_INVESTIGATOREsti M Iturralde, PhD
Kaiser Permanente Northern California Division of Research
Outcome results
None listed