Suicide Risk Model for Suicide Prevention

Recruiting at 2 trial locations

Overseen By Bobbi Jo H Yarborough, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

394000 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Suicide Attempt Risk Model Care Pathway?

The Zero Suicide model, which is similar to the Suicide Attempt Risk Model Care Pathway, has been shown to improve suicide prevention in healthcare settings by using a systematic approach that includes risk assessment, direct intervention, and ongoing monitoring. Additionally, structured interventions like the Attempted Suicide Short Intervention Program (ASSIP) and Brief Cognitive Behavioral Therapy (CBT) have been found to enhance outcomes when added to standard care for individuals who have attempted suicide. ^{1 2 3 4 5}

Is the Suicide Risk Model for Suicide Prevention generally safe for humans?

The research highlights challenges in defining and reporting adverse events (unintended negative effects) in suicide prevention trials, which makes it difficult to evaluate the safety of such interventions. However, using multiple methods to detect adverse events can improve safety monitoring in suicide research. ^{6 7 8 9 10}

How does the Suicide Attempt Risk Model Care Pathway treatment differ from other treatments for suicide prevention?

The Suicide Attempt Risk Model Care Pathway is unique because it incorporates a structured safety planning intervention, which is a personalized plan developed collaboratively between the patient and provider to manage suicidal crises. This approach is flexible, allowing for both face-to-face and digital delivery, and can be adapted to individual needs, unlike traditional no-suicide contracts. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Bobbi Jo Yarborough, PsyD

Principal Investigator

Kaiser Permanente

Eligibility Criteria

This trial is for adults over the age of 18 who have visited a behavioral health clinic at one of the participating sites. There are no specific exclusion criteria, meaning it's open to anyone meeting the inclusion conditions.

Inclusion Criteria

You have made at least one visit to a behavioral health facility affiliated with the program.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the suicide risk model in behavioral health clinics

18 months

Ongoing visits as per usual care schedule

Follow-up

Participants are monitored for suicide attempts and other outcomes post-index encounter

90 days

Regular follow-up visits

Long-term follow-up

Monitoring of secondary outcomes such as identification and recognition through study completion

18 months

Treatment Details

Interventions

• Suicide Attempt Risk Model Care Pathway

Trial Overview The study is testing whether a suicide risk model can help reduce suicide attempts when implemented in patients receiving behavioral health care. It compares outcomes between those identified by this model and those receiving usual care without the model.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Implementation of the suicide risk model

Group II: Usual Care Active Control 1 Intervention

Usual care suicide prevention pathway

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

HealthPartners Institute

Collaborator

Trials

196

Recruited

3,721,000+

Findings from Research

The study analyzed responses from 49 patients regarding helpful aspects of their treatment for suicidal risk, leading to the development of a reliable coding system to identify major themes in their experiences.

Insights gained from 52 patients on what they learned from their clinical care can inform future suicide-specific treatments, highlighting the importance of patient feedback in improving therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. Schembari, BC., Jobes, DA., Horgan, RJ.[2022]

Suicide is a major public health crisis, with over 44,000 deaths in the US alone in 2015, highlighting the urgent need for effective suicide prevention strategies that integrate research into practice.

The article introduces the Assess, Intervene and Monitor for Suicide Prevention (AIM-SP) model, which provides a structured approach to implementing evidence-based practices in clinical settings, focusing on ongoing risk assessment and support for individuals at high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Zero Suicide Model: Applying Evidence-Based Suicide Prevention Practices to Clinical Care. Brodsky, BS., Spruch-Feiner, A., Stanley, B.[2023]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Zero Suicide Model: Applying Evidence-Based Suicide Prevention Practices to Clinical Care. [2023]

3. Norway pubmed.ncbi.nlm.nih.gov

"Zero Suicide" - A model for reducing suicide in United States behavioral healthcare. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A lived experience co-designed study protocol for a randomised control trial: the Attempted Suicide Short Intervention Program (ASSIP) or Brief Cognitive Behavioural Therapy as additional interventions after a suicide attempt compared to a standard Suicide Prevention Pathway (SPP). [2021]

5. United States pubmed.ncbi.nlm.nih.gov

An implementation evaluation of "Zero Suicide" using normalization process theory to support high-quality care for patients at risk of suicide. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Measurement as a Performance Driver: The Case for a National Measurement System to Improve Patient Safety. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Association of preventable adverse drug events with inpatients' length of stay-A propensity-matched cohort study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

A systematic review of validated suicide outcome classification in observational studies. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Therapeutic risk management of the suicidal patient: safety planning. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The Emergency Department: Challenges and Opportunities for Suicide Prevention. [2023]

14. New Zealand pubmed.ncbi.nlm.nih.gov

A multidisciplinary approach to therapeutic risk management of the suicidal patient. [2020]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Suicide Safety Planning: Clinician Training, Comfort, and Safety Plan Utilization. [2020]