Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs (EMBER)
2022年7月25日 更新者：Syracuse VA Medical Center
Use of a Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs
This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social needs.
研究概览
地位
主动，不招人
详细说明
Not only do rural women Veterans report significant psychological distress (PTSD, anxiety, depression, suicide risk) and social needs (housing, transportation, material insecurity), they also experience substantial barriers accessing services which limits the Veteran Health Administration's (VHA) ability to address their needs. Personalized Support for Progress (PSP) is a virtually delivered intervention in which a Peer Specialist supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services. This trial is investigating whether PSP with rural women Veterans is associated with improved perceived access and actual engagement to mental health and social resource services, as well as high satisfaction and improved mental health, social needs and function outcomes. Rural women Veterans of color are more likely to be coping with psychological distress and social needs, as well as experiencing barriers to engagement and retention in services. Therefore this trial is designed to ensure that PSP delivery is tailored to increase rural women Veterans of color's acceptability.
The primary study design is a randomized controlled trial of Tailored Referral Information (TR) compared to Personalized Support for Progress (PSP) intervention for rural women Veterans with psychological distress and social needs (Aim 2). Prior to implementing the trial, focus groups and individual interviews will be conducted with women Veterans, Peer Specialists, and providers/stakeholders to determine any needed adaptations to determine any needed adaptations of PSP delivery for rural women Veterans and for PSP implementation in rural primary care clinics (Aim 1).
研究类型
介入性
注册 (预期的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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Syracuse、New York、美国、13210
- Syracuse VA Medical Center
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Texas
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Houston、Texas、美国、77030
- Michael E. DeBakey VA Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Aim 1 (Focus groups and interviews with women Veterans, Peer Specialists, and Providers to assess adaptations needed for PSP prior to the intervention trial)
Inclusion Criteria:
Veteran Inclusion:
- Veteran status (non-Veterans will not be enrolled in this trial)
- Identifies as a woman or as gender fluid
- Resides in a rural or highly rural area
- Psychological distress in the past 6 months as evidenced by a diagnosis in the electronic health record or elevated score on the PHQ-9, GAD-7 and/or PCL
- At least one social need in the past 6 months on the PRAPARE
- Ability to communicate in English including reading, writing, hearing, and speaking well enough to complete research and intervention tasks.
Providers Inclusion Criteria:
• Any provider (physician, social worker, therapist, etc. with experience working with rural women Veterans) employed by the VHA
Peers inclusion criteria:
•Any peer specialist employed by the VHA who identifies as a woman or as gender fluid
Veteran Exclusion Criteria:
- Any Veteran with high suicide or homicide risk and/or evaluated by the PI or another clinician to be clinically unstable
- Veterans with impairment that would not allow them to engage in study activities including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in electronic health record or reported by a primary care clinician team member)
Aim 2 (Randomized controlled trial of PSP compared to TR)
Inclusion:
- Veteran status (non-Veterans will not be enrolled in this trial)
- Identifies as a woman or as gender fluid
- Resides in a rural or highly rural area
- Veteran must reside in Southeastern Texas, Arkansas or Louisiana
- Psychological distress in the past 6 months as evidenced by a diagnosis in the electronic health record or elevated score on the PHQ-9, GAD-7 and/or PCL
- At least one social need in the past 6 months on the PRAPARE
- Ability to communicate in English including reading, writing, hearing, and speaking well enough to complete research and intervention tasks.
Exclusion:
- Any Veteran with high suicide or homicide risk and/or evaluated by the PI or another clinician to be clinically unstable
- Veterans with impairment that would not allow them to engage in study activities including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in EMR or reported by a PACT member)
- Veterans who have current VA or non-VA peer support engagement (an appointment within the last month and/or additional follow-up scheduled)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Personalized Support for Progress (PSP)
PSP includes an initial 60-minute video or phone appointment and then follow-up tailored to the Veteran's preferences.
The Peer Specialist guides the Veteran through a card-sorting task to prioritize concerns and then create a personalized care plan.
The Peer then provides up to six months of outreach and support to implement the care plan.
At the end of the six months, the Veteran and peer review the plan, determine next steps and consider other supports and resources to sustain progress made.
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Personalized Support for Progress (PSP) is a Peer Specialist delivered intervention in which a peer supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services.
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有源比较器：Tailored Referral (TR)
The Tailored Referral (TR) comparator will be comprised of written or emailed information describing resources and contact information for VHA and local social and mental health resources.
Examples include information about the appropriate office/person to reach within the local VA or area, help scheduling an appointment, or information for a same-day Primary Care - Mental Health Integration (PCMHI) assessment.
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TR consists of detailed resource information and referral, consistent with standard practice.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in actual engagement with social resource services and mental health treatment
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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VHA Administrative data will be used to assess face-to-face and digital visits (encounters) along with self-reported number of visits on the Epidemiological Catchment Area Survey (ECA).
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in perceived access to social resource services and mental health treatment
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The Assessment of Perceived Access to Care (APAC) measure will be used to assess perceived access to social resource services and mental health treatment at each time-point with a scale of 1-5 so that higher total scores equals better access.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Veteran satisfaction
大体时间：6 Months (post-intervention) and 9 Months (3 Months post-intervention)
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Veteran satisfaction will be measures using the Client Satisfaction Questionnaire-8 (CSQ-8), an 8 item measure of participant satisfaction with services.
An overall score is calculated by summing the respondent's rating (item rating) score for each scale item.
For the CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction.
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6 Months (post-intervention) and 9 Months (3 Months post-intervention)
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Change in depression symptoms
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in depression symptoms for Veteran participants will be assessed using the Patient Health Questionnaire (PHQ)-9, a self-administered depression scale.
The total score can range from 1 to 27 with a higher score indicating more severe depression.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in social needs
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in social needs will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), a standardized tool for collecting social determinants of health (SDH) data including socioeconomic and psychosocial characteristics.
The total score can range from 0 to 22 with the total cumulative score indicating presence of risk and unmet needs.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in greater perceived progress on needs
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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An adapted version of the Goal Attainment Scale (GAS) will be used to assess Veteran perceived progress on needs.
The GAS is a functional scale used to measure the extent of progress towards individual goals during the course of an intervention.
Each subject has their own outcome measures but they are scored in a standardized way.
Scale items are based on current and expected levels of performance.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in functioning
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The Brief Inventory of Psychosocial Functioning (B-IPF) will be used to measure change in functioning.
The B-IPF is an 7-item self-report instrument measuring PTSD-related functional impairment in the past 30 days by looking at seven functional domains including romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care.
Items are scored on a Likert scale from 0 to 6.
The B-IPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100.
The B-IPF represents an overall index of functioning, with higher scores indicating greater functional impairment.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in Perception of Quality of Life
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The World Health Organization Quality of Life (WHO-QOL) measure will be used to assess quality of life (QOL) for each participant in the context of culture, value systems, personal goals, standards and concerns.
The scale is scored between 0 to 100 with higher scores indicating a higher quality of life.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Stigma-related beliefs about mental health
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The Endorsed and Anticipated Stigma Inventory (EASI) is a tool for assessing beliefs about mental illness and mental health treatment among Veterans.
The scales are scored so that higher scores are indicative of greater stigma.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in perceived stress
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The Perceived Stress Scale (PSS) will be used to measure each participants subjective understanding of their psychological stress level in the past month.
Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in anxiety symptoms
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in anxiety symptoms for Veteran participants will be assessed using the Generalized Anxiety Disorder (GAD)-7, a seven-item instrument used to measure the severity of generalized anxiety disorder (GAD).
The total score can range from 0 to 21 with a higher score indicating a larger amount of anxiety symptoms.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in Post-Traumatic Stress Disorder (PTSD) symptoms
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Change in PTSD symptoms for Veteran participants will be assessed using the Post Traumatic Stress Disorder (PTSD) Checklist (PCL-5), a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual-5 symptoms of PTSD.
For this trial a score of 31 or higher indicates a positive screen for PTSD.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Therapeutic alliance
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The Kim Alliance Scale (KAS-R) will be used to assess the quality of the therapeutic alliance between the Veteran and provider along with patient empowerment and satisfaction with the relationship.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Perceived Confidence
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The Perceived Confidence Scale will be used to assess each participants' feelings of confidence in engaging in tasks independently.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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Autonomy Support
大体时间：Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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The Autonomy Support Questionnaire will be used to assess each participants perceptions of autonomy support from their provider or peer.
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Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ellen Poleshuck, PhD、Syracuse VA Medical Center
- 首席研究员：Derrecka Boykin, PhD、Michael E. DeBakey Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年10月1日
初级完成 (预期的)
2024年1月1日
研究完成 (预期的)
2024年10月1日
研究注册日期
首次提交
2022年7月6日
首先提交符合 QC 标准的
2022年7月25日
首次发布 (实际的)
2022年7月28日
研究记录更新
最后更新发布 (实际的)
2022年7月28日
上次提交的符合 QC 标准的更新
2022年7月25日
最后验证
2022年7月1日
更多信息
与本研究相关的术语
其他研究编号
- H-50334
- 1652536 (其他标识符：Syracuse VA Medical Center IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Once all data collection is complete and the coded database is finalized, individual participant data (IPD) will be shared according to PI discretion.
For instance, IPD may be shared to be used in meta-analyses or other review papers.
No identifiable participant information will be shared.
IPD 共享时间框架
The data will be available once the database is finalized and will remain available in the future.
IPD 共享访问标准
Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 临床研究报告（CSR）
- 解析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.