Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs (EMBER)
25. juli 2022 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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Syracuse, New York, Forenede Stater, 13210
- Syracuse VA Medical Center
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Texas
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Houston, Texas, Forenede Stater, 77030
- Michael E. DeBakey VA Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in actual engagement with social resource services and mental health treatment
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Veteran satisfaction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Therapeutic alliance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ellen Poleshuck, PhD, Syracuse VA Medical Center
- Ledende efterforsker: Derrecka Boykin, PhD, Michael E. DeBakey Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2021
Primær færdiggørelse (Forventet)
1. januar 2024
Studieafslutning (Forventet)
1. oktober 2024
Datoer for studieregistrering
Først indsendt
6. juli 2022
Først indsendt, der opfyldte QC-kriterier
25. juli 2022
Først opslået (Faktiske)
28. juli 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-50334
- 1652536 (Anden identifikator: Syracuse VA Medical Center IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
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-delingstidsramme
The data will be available once the database is finalized and will remain available in the future.
IPD-delingsadgangskriterier
Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
- Klinisk undersøgelsesrapport (CSR)
- Analytisk kode
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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