search
Back to results

Zero Suicide Implementation in Outpatient Mental Health Clinics

Primary Purpose

Suicide

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment engagement and retention intervention for suicidal clients
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide Prevention, Engagement, Retention, Outpatient behavioral health

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment engagement and retention intervention for suicidal clients

Arm Description

Participants will receive the manualized treatment engagement and retention protocol for suicidal outpatient clients (single-arm intervention pilot). The manualized treatment engagement and retention protocol 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).

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
Engagement
Rate of return after the first OBH visit for clients assigned to the suicide care pathway, as assessed by Medicaid claims

Full Information

First Posted
July 29, 2022
Last Updated
August 18, 2023
Sponsor
Columbia University
Collaborators
Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05587530
Brief Title
Zero Suicide Implementation in Outpatient Mental Health Clinics
Official Title
Zero Suicide Implementation and Evaluation in Outpatient Mental Health Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
The study is paused.
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Research Foundation for Mental Hygiene, Inc., 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide Prevention, Engagement, Retention, Outpatient behavioral health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Masking Description
N/A - Open pilot trial
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment engagement and retention intervention for suicidal clients
Arm Type
Experimental
Arm Description
Participants will receive the manualized treatment engagement and retention protocol for suicidal outpatient clients (single-arm intervention pilot). The manualized treatment engagement and retention protocol 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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment engagement and retention intervention for suicidal clients
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability (adapted from the Treatment Acceptability and Preference Questionnaire)
Description
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
Time Frame
1 month
Title
Feasibility (adapted from the Treatment Acceptability and Preference Questionnaire)
Description
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
Time Frame
1 month
Title
Satisfaction with the Intervention (adapted from the Treatment Acceptability and Preference Questionnaire)
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Perceived Effectiveness
Description
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
Time Frame
1 month
Title
Engagement
Description
Rate of return after the first OBH visit for clients assigned to the suicide care pathway, as assessed by Medicaid claims
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christa D. Labouliere, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Zero Suicide Implementation in Outpatient Mental Health Clinics

We'll reach out to this number within 24 hrs