Zero Suicide Implementation in Outpatient Mental Health Clinics

Suicide Clinical Trial

Official title:

Zero Suicide Implementation and Evaluation in Outpatient Mental Health Clinics

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05587530
• Other study ID #: 8320
• Secondary ID: R56MH112139
• Status: Suspended
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to develop a manualized suicide prevention intervention to improve the retention and engagement of suicidal clients. (For the purposes of this proposal, engagement is defined as return to treatment after the initial session and retention as treatment attendance in an ongoing manner.) In the prior grant received by the investigators (#R01 MH112139) a large-scale project implementing evidence-based suicide prevention practices in 165 outpatient behavioral health clinics in New York State, it was determined that several aspects of the Zero Suicide model were successfully implemented but that treatment engagement and retention of acutely suicidal clients was far from optimal.

This project will have two phases; only the second phase is considered a clinical trial. In the first phase, the investigators will conduct qualitative interviews with clients engaged in outpatient behavioral health for suicide-related reasons, as well as outpatient behavioral health staff (peer specialists and clinicians) with experience working with suicidal clients, to determine to determine client, clinician and situational facilitators and barriers of suicidal clients' engagement in ongoing care. Specifically, interviews will assess if the proposed interventions of shared decision-making (SDM), structured phone outreach (SPO) and peer support are acceptable and feasible from both a client and staff perspective and perceived to be effective in enhancing treatment engagement and retention and decreasing suicidal ideation and behavior. The investigators will also conduct secondary quantitative data analyses with administrative data obtained during the previously-funded project to examine characteristics of those who did not engage or remain in treatment and/or had self-harm behavior during the implementation period, to identify clients who may benefit from additional support or assistance at the outset of treatment and during ongoing care.

In the second phase of the study, the investigators will use the findings from the first phase to develop a manualized treatment engagement and retention protocol and conduct a small pilot study to assess the protocol's feasibility and acceptability to clients and staff (peer specialists and clinicians) and preliminary effectiveness, as indicated by client satisfaction and engagement.

Description:

Suicide is the 10th leading cause of death in the US, killing more than 47,000 Americans each year. US suicide deaths have increased dramatically, a staggering 62% increase over the past two decades. While suicide research has made great strides in the development of "best practices" for screening, risk assessment, suicide-specific clinical interventions, and follow-up protocols, there is a striking gap between assessment and intervention development and the implementation of these practices in typical clinical settings.Furthermore, very little research has explored if the "best practices" recommended by clinical experts and researchers are deemed feasible, acceptable, or even desirable by clients experiencing suicidal thoughts and behavior.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria (clients receiving pilot intervention):

• Age range 18-64 years

• Medicaid eligible

• Currently receiving outpatient behavioral healthcare for suicide-related reasons

• Willingness to participate in the pilot intervention

• Willingness to complete a 1-month follow-up assessment

Inclusion Criteria (peer specialists delivering pilot intervention):

• Any adult participant (18+) is acceptable, though most will be expected to be working age (e.g., 18-65 years old)

• Certified peer specialists working in an outpatient behavioral health setting

• Has experience working with clients enrolled in behavioral healthcare for suicide-related reasons

• Willingness to participate in training and deliver the pilot intervention

• Willingness to complete the pre-training, post-training, and 1-month follow-up assessment

Exclusion criteria (all participants):

• Lacks capacity to consent

• Not fluent to read, write, and/or speak in English

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Treatment engagement and retention intervention for suicidal clients
The manualized behavioral intervention for treatment engagement and retention of suicidal clients will be based on client and staff stakeholder preferences, informed by data from qualitative participatory interviews and secondary data analysis of administrative databases (conducted in phase 1). In addition to factors identified by stakeholders, if deemed feasible and acceptable during phase 1, the intervention will include structured phone outreach, shared decision-making, and peer support.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH), Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability (adapted from the Treatment Acceptability and Preference Questionnaire)	Acceptability of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from the Treatment Acceptability and Preference Questionnaire	1 month
Primary	Feasibility (adapted from the Treatment Acceptability and Preference Questionnaire)	Feasibility of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from the Treatment Acceptability and Preference Questionnaire	1 month
Primary	Satisfaction with the Intervention (adapted from the Treatment Acceptability and Preference Questionnaire)	Satisfaction with the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from Treatment Acceptability and Preference Questionnaire	1 month
Secondary	Perceived Effectiveness	Perceived effectiveness of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention	1 month
Secondary	Engagement	Rate of return after the first OBH visit for clients assigned to the suicide care pathway, as assessed by Medicaid claims	1 month