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临床试验/NCT05477706
NCT05477706进行中(未招募)不适用

Use of a Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs

Syracuse VA Medical Center4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
72
试验地点
4
主要终点
Change in actual engagement with social resource services and mental health treatment

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)
  • 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.
  • 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)

结局指标

主要结局

Change in actual engagement with social resource services and mental health treatment

时间窗: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

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).

Change in perceived access to social resource services and mental health treatment

时间窗: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

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.

次要结局

  • Veteran satisfaction(6 Months (post-intervention) and 9 Months (3 Months post-intervention))
  • Change in Perception of Quality of Life(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Stigma-related beliefs about mental health(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Change in functioning(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Change in perceived stress(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Change in Post-Traumatic Stress Disorder (PTSD) symptoms(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Change in depression symptoms(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Change in social needs(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Change in greater perceived progress on needs(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))
  • Change in anxiety symptoms(Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention))

研究者

发起方
Syracuse VA Medical Center
申办方类型
Fed
责任方
Sponsor

研究点 (4)

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