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.
調査の概要
状態
積極的、募集していない
詳細な説明
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).
研究の種類
介入
入学 (予想される)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New York
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Syracuse、New York、アメリカ、13210
- Syracuse VA Medical Center
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Texas
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Houston、Texas、アメリカ、77030
- Michael E. DeBakey VA Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in actual engagement with social resource services and mental health treatment
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Veteran satisfaction
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Therapeutic alliance
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Ellen Poleshuck, PhD、Syracuse VA Medical Center
- 主任研究者：Derrecka Boykin, PhD、Michael E. DeBakey Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Shrout PE, Bolger N. Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychol Methods. 2002 Dec;7(4):422-45.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年10月1日
一次修了 (予想される)
2024年1月1日
研究の完了 (予想される)
2024年10月1日
試験登録日
最初に提出
2022年7月6日
QC基準を満たした最初の提出物
2022年7月25日
最初の投稿 (実際)
2022年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2022年7月28日
QC基準を満たした最後の更新が送信されました
2022年7月25日
最終確認日
2022年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- H-50334
- 1652536 (その他の識別子：Syracuse VA Medical Center IRB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
The data will be available once the database is finalized and will remain available in the future.
IPD 共有アクセス基準
Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- 臨床試験報告書（CSR）
- 分析コード
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Personalized Support for Progress (PSP)の臨床試験
-
Johns Hopkins Bloomberg School of Public HealthNational Heart, Lung, and Blood Institute (NHLBI); Oakland University募集平時および緊急事態における食糧不安の人々における健康的な食糧アクセスの改善アメリカ