Clinical trial NCT05587530: Zero Suicide Implementation in Outpatient Mental Health Clinics
Official title: Zero Suicide Implementation and Evaluation in Outpatient Mental Health Clinics
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Suicide
Keywords: Suicide Prevention
Engagement
Retention
Outpatient behavioral health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Research Foundation for Mental Hygiene, Inc.
name: National Institute of Mental Health (NIMH)
First posted: 2022-10-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Informed by data from qualitative participatory interviews and secondary data analysis of administrative databases and based on client and staff stakeholder preferences, the investigators will develop a manualized treatment engagement and retention protocol for suicidal outpatient clients. To determine feasibility and acceptability of the manualized treatment engagement and retention protocol for suicidal outpatient clients, the investigators will conduct a small pilot study with 15 clients across 1-2 clinics (single arm intervention pilot).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability (adapted from the Treatment Acceptability and Preference Questionnaire)
timeFrame: 1 month
measure: Feasibility (adapted from the Treatment Acceptability and Preference Questionnaire)
timeFrame: 1 month
measure: Satisfaction with the Intervention (adapted from the Treatment Acceptability and Preference Questionnaire)
timeFrame: 1 month
Secondary outcomes:
measure: Perceived Effectiveness
timeFrame: 1 month
measure: Engagement
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Christa D. Labouliere, PhD
role: PRINCIPAL_INVESTIGATOR
References: