Zero Suicide Implementation in Outpatient Mental Health Clinics (R56)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
OVERVIEW
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 investigators' prior grant (#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. These findings are consistent with several studies that found outpatient behavioral health clients, irrespective of suicide status, are difficult to retain in care. At the same time, disengagement has negative consequences (e.g., symptom worsening, suicide attempts, hospitalizations and emergency visits, and death). Therefore, improving client retention in the high risk population is crucial and has the potential to reduce suicide deaths and attempts as well as hospitalizations and emergency department visits.
This project has two phases; only the second phase is considered a clinical trial, but since the first stage will inform development of the second, both will be described herein. In the first phase, the investigators will conduct qualitative interviews with suicidal client stakeholders, as well as outpatient behavioral health staff (peer specialists and clinicians) with experience working with suicidal clients, 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.
RESEARCH STRATEGY
- PHASE 1 - QUALITATIVE INTERVIEWS AND SECONDARY DATA ANALYSIS TO INFORM TREATMENT DEVELOPMENT. The investigators will conduct qualitative participatory research that explores preferences for mental health treatment, how treatment engagement and retention can be improved, and perceptions of current suicide prevention efforts. Interviews will be conducted with two stakeholder groups: 1) suicidal clients enrolled in outpatient behavioral health and
- outpatient behavioral health staff (peer specialists and clinicians) working with suicidal clients. Prior to conducting interviews, interview guides will be developed based on topics of interest and will be reviewed and revised by a steering committee that will be formed in the initial stage of this project. The results of these interviews will be used for developing the treatment approach in the pilot intervention study (phase 2).
The investigators will recruit participants for qualitative interviews from programs that participated in the previously-funded project. Potential client participants will be recruited in two ways: either ward-off letters sent to clients who were placed on the suicide care pathway in the original project (whose data on service utilization and self-harm is available from the prior project) or identify suicidal clients as they are newly-admitted to treatment at two representative clinics (rural, suburban, urban; racially/ethnically diverse) that participated in our original project. Potential behavioral health staff (clinicians and peer specialists) will be recruited from any program that participated in the previously-funded project.
For potential client participants, a brief phone screen assessing inclusion/exclusion criteria will be administered; to ensure safety, callers' contact information and location will be requested at the beginning of the call and all callers will be briefed as to limits of confidentiality, including noting that interviews will be recorded and the researchers' obligation to ensure safety in the case of imminent risk. All potential participants (clients and staff) will be provided with further information about the purpose/procedures of the study and any questions will be answered. All potential participants will provide verbal consent before any screening questions are asked and documented informed consent will be provided via a HIPAA-compliant telehealth platform prior to the beginning of the qualitative interview. All interviews will be conducted by trained staff experienced with the assessment, treatment, and management of suicidality.
The investigators will administer semi-structured qualitative interviews about their experiences with treatment and obtain feedback from them about the proposed approaches to enhance engagement and retention, including: demographic information; suicidal thoughts and behaviors in the past 90 days, as assessed by the C-SSRS (client participants only); and client, clinician and situational facilitators and barriers of suicidal clients' engagement in ongoing care, including factors they believe influence suicidal clients' decision to drop out, remain in care, or frequency of outpatient visits. Interviews will also assess aspects of care clients find desirable, inappropriate or undesirable, and/or alternatives to outpatient care that clients consider helpful. 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.
Behavioral health staff and clients who participated in the previously-funded project will complete one interview; clients recruited as they are newly-admitted to treatment will complete two interviews (baseline interview on treatment expectations and suicidality and 3-month follow-up on their experiences in treatment). All interviews will be transcribed, de-identified and coded by two independent coders. To check reliability of codes, inter-rater reliability will be calculated using kappa-coefficients. Coded NVivo data will then be analyzed through descriptive statistics. With respect to secondary data analysis of administrative data from the previously-funded project, the investigators will analyze four data sets: Suicide Care Pathway (SCP) data; all participating clinic data; retrospective data (data from the six months prior to study implementation); and non-participating clinic data (data from clinics that did not participate in the project). These data sets provide complementary information to examine potential demographic and clinical moderators of who did not engage or remain in treatment and/or had self-harm/suicidal behavior during the implementation period. These analyses will inform strategies to identify clients who may benefit from additional support or assistance at the outset of treatment and during ongoing care to incorporate into the manualized treatment protocol.
- PHASE 2 - PILOT STUDY. Based on data derived from qualitative interviews and secondary data analysis in phase 1, the investigators will develop a manualized treatment engagement and retention protocol for suicidal outpatient clients. Stakeholders will review the proposed manual and training materials and revisions will be made iteratively. A small pilot study (N=15 suicidal clients across 1-2 clinics) will be conducted to assess the protocol's: a. feasibility and acceptability to clients and staff (peer specialists and clinicians), and b. preliminary effectiveness, as indicated by client satisfaction and engagement.
Clients will be recruited from 1-2 clinics that participated in our previous grant, allowing for comparison with historical treatment engagement and retention data. The clinic(s) will be chosen to reflect diversity in terms of age, diagnosis, and sociodemographic factors and serve a large enough number of suicidal outpatients to meet recruitment requirements. Training and clinical implementation assistance will be provided to staff in participating clinics, and peer specialists and 1-2 designated clinicians at each site will work closely with the research team to facilitate staff training, implementation and fidelity to protocols, and recruitment. Following training via webinars and in person/phone conference to ensure fidelity across sites, peer specialists in participating clinics will implement the manualized treatment engagement and retention program with their suicidal outpatient clients. Outcome measures will focus on feasibility, acceptability, satisfaction, and perceived effectiveness of the treatment engagement and retention intervention, as rated by clients (1 month after receiving the intervention) and peer specialists (pre-training, post-training, and 1-month after delivering the intervention). Peer specialists delivering the intervention will also complete an assessment of knowledge, attitudes, self-efficacy, and barriers and facilitators of implementation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment engagement and retention intervention for suicidal clients 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). |
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.
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Outcome Measures
Primary Outcome Measures
- Acceptability (adapted from the Treatment Acceptability and Preference Questionnaire) [1 month]
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) [1 month]
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) [1 month]
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 [1 month]
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 [1 month]
Rate of return after the first OBH visit for clients assigned to the suicide care pathway, as assessed by Medicaid claims
Eligibility Criteria
Criteria
Inclusion Criteria (clients receiving pilot intervention):
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Age range 18-64 years
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Medicaid eligible
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Currently receiving outpatient behavioral healthcare for suicide-related reasons
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Willingness to participate in the pilot intervention
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Willingness to complete a 1-month follow-up assessment
Inclusion Criteria (peer specialists delivering pilot intervention):
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Any adult participant (18+) is acceptable, though most will be expected to be working age (e.g., 18-65 years old)
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Certified peer specialists working in an outpatient behavioral health setting
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Has experience working with clients enrolled in behavioral healthcare for suicide-related reasons
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Willingness to participate in training and deliver the pilot intervention
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Willingness to complete the pre-training, post-training, and 1-month follow-up assessment
Exclusion criteria (all participants):
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Lacks capacity to consent
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Not fluent to read, write, and/or speak in English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York State Psychiatric Institute | New York | New York | United States | 10032 |
Sponsors and Collaborators
- New York State Psychiatric Institute
- Columbia University
- Research Foundation for Mental Hygiene, Inc.
Investigators
- Principal Investigator: Barbara Stanley, PhD, Columbia University
- Principal Investigator: Christa Labouliere, PhD, New York State Psychiatric Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R56MH112139