Implementation of Suicide Risk Models in Health Systems

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate a suicide risk model in patients receiving behavioral health care treatment. The main question it aims to answer is: Does the implementation of the suicide risk model reduce suicide attempts? Researchers will compare the outcomes of patients identified by the model to those in a usual care group.

Detailed Description
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Suicide is a major public health concern in the United States; nearly 50,000 individuals die by suicide annually and almost 1.5 million attempt suicide. To date, identification of individuals at risk for suicide has relied on suicide risk screening practices, including using a variety of self-reported instruments. However, sensitivity of these measures is only moderate; more precise tools for identifying patients at risk for suicide are needed. Suicide risk models, developed by our team, incorporate health records data and historical self-report screening questionnaire responses to improve accuracy of risk prediction. Our models have outperformed traditional clinical screening and similar risk models for adults receiving care in outpatient mental health specialty settings. However, while statistically accurate, they have not been evaluated in real world care; whether the models actually increase identification or result in patients receiving more suicide prevention services, fewer crisis services, or making fewer suicide attempts is unknown. There is substantial clinical interest in implementing suicide risk models but little scientific evidence about the effectiveness of these models in real-world settings compared to standard screening practices alone. Additionally, there is almost no guidance for their implementation in healthcare. The proposed project leverages the NIMH-funded Mental Health Research Network (MHRN), a collaboration of large health systems with established clinical data infrastructure to support multi-site studies. MHRN members Henry Ford Health, Kaiser Permanente Northwest, and HealthPartners will participate in this project and collectively serve >170,000 behavioral health patients per year. The patient populations are diverse, including thousands of individuals with Medicaid and Medicare. Each of these systems has implemented a suicide prevention care model in their behavioral health departments, including robust suicide risk screening and assessment processes. However, none of these systems has implemented a suicide risk identification model. The proposed project includes a pragmatic trial approach with randomization of behavioral health clinics across the three participating health systems. It is innovative because it seeks to implement an MHRN suicide risk model (intervention) into each system's existing suicide prevention care model (usual care) to increase the reach and effectiveness of the suicide prevention care models. Sites will receive implementation planning support based on stakeholder feedback from preliminary studies and deliverables include an implementation planning tool kit to facilitate spread. This high-impact study has important clinical implications as health systems consider whether it makes sense to enhance their existing suicide prevention care models with a suicide risk model. It is timely because many health systems are advancing toward suicide risk model implementation without evidence to support this innovation.

Official Title
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Evaluating Effectiveness and Implementation of a Risk Model for Suicide Prevention Across Health Systems

Conditions
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Suicide, Attempted, Suicide, Fatal

Intervention / Treatment
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* Behavioral: Suicide Attempt Risk Model Care Pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years old 1+ visit to a behavioral health clinic at participating sites Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Clinics are the unit of randomization, all behavioral health clinics will be randomized, over the course of three waves, to cross over from usual care to intervention (implementation of the suicide risk model).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Usual care suicide prevention pathway | Behavioral: Suicide Attempt Risk Model Care Pathway<br>* The suicide attempt risk model uses documented histories of medical and psychiatric diagnoses, medications, and health service utilization to predict risk of a suicide attempt in the 90 days following an outpatient visit in behavioral health clinics.<br>|
| Experimental: Intervention<br>Implementation of the suicide risk model | Behavioral: Suicide Attempt Risk Model Care Pathway<br>* The suicide attempt risk model uses documented histories of medical and psychiatric diagnoses, medications, and health service utilization to predict risk of a suicide attempt in the 90 days following an outpatient visit in behavioral health clinics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide attempt, 90 days post-index encounter | The number and proportion of visits followed by any suicide attempt (ICD-10 diagnosis codes) occurring within 90 days of an index visit. | 90 days post-index encounter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification | The number and proportion of visits identified by PHQ9 item 9 or the risk model or both, stratified by race/ethnicity, where the denominator is the number of visits in the study period. | Through study completion, an average of 18 months | 
| Recognition | The number and proportion of visits with a completed risk assessment (C-SSRS), stratified by race/ethnicity, where the denominator is the number of visits in the study period. | Through study completion, an average of 18 months | 
| Evidence-based suicide care | The number and proportion of visits with a documented safety plan, lethal means counseling, or caring contacts subsequent to the index encounter, where the denominator is the number of visits in the study period. | Through study completion, an average of 18 months | 
| Any 14-day follow-up care in behavioral health | The number and proportion of visits with any contact with behavioral health within 14 days of the index encounter, where the denominator is the number of visits in the study period. | 14 days post-index encounter |