Improving Access to VA Mental Health and Suicide Prevention Services: A Randomized Clinical Trial of Intensive Case Management Between VA and Community Care (SUPERCEDE RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Functioning: Brief Inventory of Psychosocial Functioning (B-IPF)
研究概览
简要总结
The goal of this randomized clinical trial is to build the evidence base for SUPERCEDE, a suicide prevention focused intensive case management intervention to increase access, improve care coordination, provide suicide prevention monitoring, and procure a timely response of VA mental health and suicide prevention services among VA-enrolled veterans receiving VA authorized community care. This phase is a hybrid effectiveness Type 1 randomized control trial, which will include 2 arms: the treatment intervention, SUPERCEDE, and the control intervention, present centered therapy. The main questions it aims to answer are:• This RCT will continue to build the evidence base for effectiveness and determine feasibility and acceptability for the previously piloted SUPERCEDE. • This RCT will improve the understanding of implementation of this intervention, both in VA and VA authorized community care organizations in preparation for broader implementation. Researchers will compare SUPERCEDE and present centered therapy to see if SUPERCEDE results in improved functioning and a decrease in suicidal ideation. Participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan (CRP), intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions.
Detailed Description For hypothesis 3a: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and PCT. Recruitment. Eligible participants will be identified through the VA Rocky Mountain Regional (RMR) Medical Center the VA Corporate Data Warehouse (CDW), flyers and advertisements, or through clinician or community referral. A recruitment letter will be sent to participants identified in the CDW. Investigators will attempt to contact potential participants with a warm call by telephone (up to 3 times) after the letter is sent.
详细描述
For hypothesis 3a: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and PCT.
Recruitment. Eligible participants will be identified through the VA Rocky Mountain Regional (RMR) Medical Center the VA Corporate Data Warehouse (CDW), flyers and advertisements, or through clinician or community referral. A recruitment letter will be sent to participants identified in the CDW. Investigators will attempt to contact potential participants with a warm call by telephone (up to 3 times) after the letter is sent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization will be accessible only to the designated staff member who will perform the assignments, who is not involved in the protocol. Outcomes will be assessed by an assessor blind to treatment condition.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans must be:
- •enrolled in the VA Eastern Colorado Health Care System (ECHCS)
- •able to complete an online questionnaire
- •age 18-80 years
- •able to comprehend and provide virtual informed consent
- •receiving both VA care and VA authorized community care, through the MISSION Act, which is related to any physical or mental health disorder
- •Veteran's non-VA care is authorized (i.e., non-VA care/treatment approved in advance by the VA)
- •at risk for suicide, which is defined as any 1 of the following circumstances: a) prior lifetime suicide attempt; b) suicidal ideation in the past month; c) current mental health symptoms, defined as PHQ-9 >10, or PCL-5 >31
- •psychosocial challenges reported on the ACORN or Assessment of Needs measure
- •issues with VA community care coordination (i.e., Veteran reported challenges, consults canceled in medical record, appointments canceled or rescheduled in medical record, etc.)
- •receiving no or infrequent mental health services at the VA (e.g., seen less than once a month by a mental health provider).
排除标准
- •Veterans must be:
- •not at imminent risk of suicide or homicide warranting crisis intervention (will be able to participate once stabilized)
- •unable or unwilling to participate in the intervention (e.g., unwilling to provide VA community care information, etc.)
- •without access to a device capable of telephone calls or video calls
- •presenting with any situation which the principal investigator deems this type of care is inappropriate for the Veteran.
研究组 & 干预措施
SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)
SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA community care coordination.
干预措施: SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) (Behavioral)
Present centered therapy (PCT)
PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions with a safety plan if needed.
干预措施: Present centered therapy (Behavioral)
结局指标
主要结局
Functioning: Brief Inventory of Psychosocial Functioning (B-IPF)
时间窗: Baseline (Time 1), 5 weeks, 9 weeks (post-treatment), 6-month follow-up
B-IPF is a 7-item measure of interpersonal functioning. Scores range from 0 (not at all) to 6 (very much), with higher scores indicating worse functioning. Investigators will fit linear mixed models for the outcome variable of functioning with the between-subject factor of treatment (SUPERCEDE vs. PCT), the within- subject factor of time, and the interaction between two factors (treatment X time). Several correlation structures will be considered for repeated measures within individuals, and the best fitting structure based on Akaike Information Criterion (AIC) will be selected. Significant treatment by time interaction, with significant differences at follow-up on the B-IPF, will be considered supportive of our hypothesis.
Suicidal Ideation: Brief Beck Scale for Suicidal Ideation (BSSI)
时间窗: Baseline (Time 1), 5 weeks (Time 2), 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
The BSSI is a 21-item self report measure assessing suicidal ideation and behaviors. Scores range from 0 (no suicidal risk ideation/behaviors) to 2 (suicidal ideation/behaviors). Greater scores indicate greater suicidal ideation and behaviors. Responses will be dichotomized. The dichotomous variable (e.g., no suicidal ideation vs. suicidal ideation), and the continuous variable of suicidal ideation, when endorsed. To analyze the dichotomous outcome, a logistic regression for zero vs. nonzero values will be conducted. For the continuous variable, a zero-inflated negative binomial regression will be performed.
Formative evaluation of SUPERCEDE
时间窗: 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
A formative evaluation will be conducted to understand optimal conditions of implementing the intervention both within the VA and in VA community care agencies. Qualitative interviews will be conducted with stakeholders (n = 20) in VA and VA community care agencies. The formative evaluation will be focused on the following: 1) understand how the intervention could further be developed for both VA and community context; 2) improve understanding of the recipients (e.g., social workers, psychologists, etc.) and their needs; 3) gain perspectives from stakeholders regarding the innovation itself to improve implementation; 4) identify facilitators and barriers to wide-spread implementation.
次要结局
未报告次要终点
研究者
Bryann DeBeer
Clinical Psychologist
VA Eastern Colorado Health Care System