Implementation of Suicide Risk Models in Health Systems
Primary Purpose
Suicide, Attempted, Suicide, Fatal
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suicide Attempt Risk Model Care Pathway
Sponsored by
About this trial
This is an interventional prevention trial for Suicide, Attempted
Eligibility Criteria
Inclusion Criteria: 18+ years old 1+ visit to a behavioral health clinic at participating sites Exclusion Criteria: None
Sites / Locations
- Henry Ford Health System
- HealthPartners
- Kaiser Permanente Center for Health Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care
Intervention
Arm Description
Usual care suicide prevention pathway
Implementation of the suicide risk model
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT06060535
First Posted
August 13, 2023
Last Updated
September 27, 2023
Sponsor
Kaiser Permanente
Collaborators
Henry Ford Health System, HealthPartners Institute, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT06060535
Brief Title
Implementation of Suicide Risk Models in Health Systems
Official Title
Evaluating Effectiveness and Implementation of a Risk Model for Suicide Prevention Across Health Systems
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 4, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Henry Ford Health System, HealthPartners Institute, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicide, Fatal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
394000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care suicide prevention pathway
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Implementation of the suicide risk model
Intervention Type
Behavioral
Intervention Name(s)
Suicide Attempt Risk Model Care Pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicide attempt, 90 days post-index encounter
Description
The number and proportion of visits followed by any suicide attempt (ICD-10 diagnosis codes) occurring within 90 days of an index visit.
Time Frame
90 days post-index encounter
Secondary Outcome Measure Information:
Title
Identification
Description
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.
Time Frame
Through study completion, an average of 18 months
Title
Recognition
Description
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.
Time Frame
Through study completion, an average of 18 months
Title
Evidence-based suicide care
Description
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.
Time Frame
Through study completion, an average of 18 months
Title
Any 14-day follow-up care in behavioral health
Description
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.
Time Frame
14 days post-index encounter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18+ years old
1+ visit to a behavioral health clinic at participating sites
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Janoff, MPH
Phone
971-232-9340
Email
shannon.l.janoff@kpchr.org
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Stumbo, MA
Phone
503-902-6848
Email
scott.p.stumbo@kpchr.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobbi Jo Yarborough, PsyD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joslyn Westphal
Phone
313-874-3147
Email
jwestph1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Brian Ahmedani, PhD
Facility Name
HealthPartners
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jule Muegge
Phone
952-967-5668
Email
jule.m.muegge@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Rebecca Rossom, MD
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon L Janoff, MPH
Phone
971-232-9340
Email
shannon.l.janoff@kpchr.org
First Name & Middle Initial & Last Name & Degree
Bobbi Jo H Yarborough, PsyD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will make our documentation, research methods and protocol, data collection tools, and a de-identified dataset of data that underlie results in publications freely available, upon request, to interested researchers beginning 6 months after publication of the main analyses. Materials will be shared through the MHRN website or a secure file transfer. Creation of a deidentified dataset for sharing may include redaction of some information to prevent re-identification or because the data is proprietary. The de-identified dataset will be available for non-commercial research use to external investigators via a data-sharing agreement and under the auspices of the Site-PIs. Users must agree to the conditions of use governing access to the data. The study team will be available for support. Information related to errors in the data, future releases, and publication lists will also be shared with users.
IPD Sharing Time Frame
Materials will be shared, upon request, to interested researchers beginning 6 months after publication of the main analyses for up to one year.
IPD Sharing Access Criteria
Materials will be shared with interested researchers through the MHRN website, data may be shared for secondary analyses through a secure file transfer site.
Citations:
PubMed Identifier
24567199
Citation
Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.
Results Reference
background
PubMed Identifier
29792051
Citation
Simon GE, Johnson E, Lawrence JM, Rossom RC, Ahmedani B, Lynch FL, Beck A, Waitzfelder B, Ziebell R, Penfold RB, Shortreed SM. Predicting Suicide Attempts and Suicide Deaths Following Outpatient Visits Using Electronic Health Records. Am J Psychiatry. 2018 Oct 1;175(10):951-960. doi: 10.1176/appi.ajp.2018.17101167. Epub 2018 May 24.
Results Reference
background
PubMed Identifier
32487287
Citation
Hedegaard H, Curtin SC, Warner M. Increase in Suicide Mortality in the United States, 1999-2018. NCHS Data Brief. 2020 Apr;(362):1-8.
Results Reference
background
PubMed Identifier
30993146
Citation
Yarborough BJH, Ahmedani BK, Boggs JM, Beck A, Coleman KJ, Sterling S, Schoenbaum M, Goldstein-Grumet J, Simon GE. Challenges of Population-based Measurement of Suicide Prevention Activities Across Multiple Health Systems. EGEMS (Wash DC). 2019 Apr 12;7(1):13. doi: 10.5334/egems.277.
Results Reference
background
PubMed Identifier
34189931
Citation
Rossom RC, Richards JE, Sterling S, Ahmedani B, Boggs JM, Yarborough BJH, Beck A, Lloyd K, Frank C, Liu V, Clinch SB, Patke LD, Simon GE. Connecting Research and Practice: Implementation of Suicide Prevention Strategies in Learning Health Care Systems. Psychiatr Serv. 2022 Feb 1;73(2):219-222. doi: 10.1176/appi.ps.202000596. Epub 2021 Jun 30.
Results Reference
background
PubMed Identifier
31529095
Citation
Simon GE, Shortreed SM, Johnson E, Rossom RC, Lynch FL, Ziebell R, Penfold ARB. What health records data are required for accurate prediction of suicidal behavior? J Am Med Inform Assoc. 2019 Dec 1;26(12):1458-1465. doi: 10.1093/jamia/ocz136.
Results Reference
background
PubMed Identifier
24036589
Citation
Simon GE, Rutter CM, Peterson D, Oliver M, Whiteside U, Operskalski B, Ludman EJ. Does response on the PHQ-9 Depression Questionnaire predict subsequent suicide attempt or suicide death? Psychiatr Serv. 2013 Dec 1;64(12):1195-202. doi: 10.1176/appi.ps.201200587.
Results Reference
background
PubMed Identifier
33711562
Citation
Yarborough BJH, Stumbo SP. Patient perspectives on acceptability of, and implementation preferences for, use of electronic health records and machine learning to identify suicide risk. Gen Hosp Psychiatry. 2021 May-Jun;70:31-37. doi: 10.1016/j.genhosppsych.2021.02.008. Epub 2021 Mar 4.
Results Reference
background
Citation
Coleman KJ, Stewart CC, Bruschke C, et al. Identifying people at risk for suicide: Implementation of screening for the Zero Suicide Initiative in large health systems. Advances in Psychiatry and Behavioral Health. 2021;1(1):67-76.
Results Reference
background
Citation
National Action Alliance for Suicide Prevention. A prioritized research agenda for suicide prevention: An action plan to save lives. Rockville, MD. 2014.
Results Reference
background
Links:
URL
https://theactionalliance.org/sites/default/files/agenda.pdf
Description
A Prioritized Research Agenda for Suicide Prevention: An Action Plan to Save Lives
URL
https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/suicide-prevention/general_suicide_reduction_tools.pdf
Description
The Joint Commission. General Suicide Reduction Tools. The Zero Suicide Toolkit.
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Implementation of Suicide Risk Models in Health Systems
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