Implementation of Suicide Risk Models in Health Systems

Sponsor
Kaiser Permanente (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06060535
Collaborator
Henry Ford Health System (Other), HealthPartners Institute (Other), National Institute of Mental Health (NIMH) (NIH)
394,000
3
2
31.9
131333.3
4121.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Suicide Attempt Risk Model Care Pathway
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
394000 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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).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)
Primary Purpose:
Prevention
Official Title:
Evaluating Effectiveness and Implementation of a Risk Model for Suicide Prevention Across Health Systems
Anticipated Study Start Date :
Oct 4, 2023
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Usual Care

Usual care suicide prevention pathway

Behavioral: Suicide Attempt Risk Model Care Pathway
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.

Experimental: Intervention

Implementation of the suicide risk model

Behavioral: Suicide Attempt Risk Model Care Pathway
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.

Outcome Measures

Primary Outcome Measures

  1. Suicide attempt, 90 days post-index encounter [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.

Secondary Outcome Measures

  1. Identification [Through study completion, an average of 18 months]

    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.

  2. Recognition [Through study completion, an average of 18 months]

    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.

  3. Evidence-based suicide care [Through study completion, an average of 18 months]

    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.

  4. Any 14-day follow-up care in behavioral health [14 days post-index encounter]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18+ years old

  • 1+ visit to a behavioral health clinic at participating sites

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henry Ford Health System Detroit Michigan United States 48202
2 HealthPartners Bloomington Minnesota United States 55425
3 Kaiser Permanente Center for Health Research Portland Oregon United States 97227

Sponsors and Collaborators

  • Kaiser Permanente
  • Henry Ford Health System
  • HealthPartners Institute
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Bobbi Jo Yarborough, PsyD, Kaiser Permanente

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT06060535
Other Study ID Numbers:
  • R01MH130548
  • 1R01MH130548-01
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023