Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs (EMBER)
2022년 7월 25일 업데이트: 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.
연구 개요
상태
모집하지 않고 적극적으로
상세 설명
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).
연구 유형
중재적
등록 (예상)
72
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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Syracuse, New York, 미국, 13210
- Syracuse VA Medical Center
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Texas
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Houston, Texas, 미국, 77030
- Michael E. DeBakey VA Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in actual engagement with social resource services and mental health treatment
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Veteran satisfaction
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Therapeutic alliance
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ellen Poleshuck, PhD, Syracuse VA Medical Center
- 수석 연구원: Derrecka Boykin, PhD, Michael E. DeBakey Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 10월 1일
기본 완료 (예상)
2024년 1월 1일
연구 완료 (예상)
2024년 10월 1일
연구 등록 날짜
최초 제출
2022년 7월 6일
QC 기준을 충족하는 최초 제출
2022년 7월 25일
처음 게시됨 (실제)
2022년 7월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 7월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 7월 25일
마지막으로 확인됨
2022년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H-50334
- 1652536 (기타 식별자: Syracuse VA Medical Center IRB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
The data will be available once the database is finalized and will remain available in the future.
IPD 공유 액세스 기준
Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 임상 연구 보고서(CSR)
- 분석 코드
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Personalized Support for Progress (PSP)에 대한 임상 시험
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Oregon Health and Science University모집하지 않고 적극적으로상처와 부상 | 통증 관리 | 인간 공학미국
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Johns Hopkins Bloomberg School of Public HealthNational Heart, Lung, and Blood Institute (NHLBI); Oakland University모병정상 및 비상 상황에서 식량 불안 인구의 건강 식품 접근성 개선미국
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Université Catholique de LouvainKU Leuven; Epsylon, ASBL아직 모집하지 않음