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Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs (EMBER)

Primary Purpose

Psychological Distress, Depression, PTSD

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Personalized Support for Progress (PSP)

Tailored Referral (TR)

About this trial

This is an interventional supportive care trial for Psychological Distress focused on measuring Peer-delivered Intervention, Psychological Distress, Unmet social needs, Rural Women Veterans, PTSD, Depression, Suicide risk, Telehealth, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Syracuse VA Medical Center
Michael E. DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized Support for Progress (PSP)

Tailored Referral (TR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

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.

Secondary Outcome Measures

Veteran satisfaction

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.

Change in depression symptoms

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.

Change in social needs

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.

Change in greater perceived progress on needs

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.

Change in functioning

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.

Change in Perception of Quality of Life

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.

Stigma-related beliefs about mental health

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.

Change in perceived stress

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.

Change in anxiety symptoms

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.

Change in Post-Traumatic Stress Disorder (PTSD) symptoms

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.

Full Information

NCT ID

NCT05477706

First Posted

July 6, 2022

Last Updated

July 25, 2022

Sponsor

Syracuse VA Medical Center

Collaborators

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT05477706

Brief Title

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

Acronym

EMBER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syracuse VA Medical Center

Collaborators

US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychological Distress, Depression, PTSD, Anxiety

Keywords

Peer-delivered Intervention, Psychological Distress, Unmet social needs, Rural Women Veterans, PTSD, Depression, Suicide risk, Telehealth, Anxiety

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized clinical trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Personalized Support for Progress (PSP)

Arm Type

Experimental

Arm Description

Arm Title

Tailored Referral (TR)

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Personalized Support for Progress (PSP)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Tailored Referral (TR)

Intervention Description

TR consists of detailed resource information and referral, consistent with standard practice.

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

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

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Veteran satisfaction

Description

Time Frame

6 Months (post-intervention) and 9 Months (3 Months post-intervention)

Title

Change in depression symptoms

Description

Time Frame

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

Title

Change in social needs

Description

Time Frame

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

Title

Change in greater perceived progress on needs

Description

Time Frame

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

Title

Change in functioning

Description

Time Frame

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

Title

Change in Perception of Quality of Life

Description

Time Frame

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

Title

Stigma-related beliefs about mental health

Description

Time Frame

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

Title

Change in perceived stress

Description

Time Frame

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

Title

Change in anxiety symptoms

Description

Time Frame

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

Title

Change in Post-Traumatic Stress Disorder (PTSD) symptoms

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Therapeutic alliance

Description

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.

Time Frame

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

Title

Perceived Confidence

Description

The Perceived Confidence Scale will be used to assess each participants' feelings of confidence in engaging in tasks independently.

Time Frame

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

Title

Autonomy Support

Description

The Autonomy Support Questionnaire will be used to assess each participants perceptions of autonomy support from their provider or peer.

Time Frame

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Self-identification as woman or gender fluid

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ellen Poleshuck, PhD

Organizational Affiliation

Syracuse VA Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Derrecka Boykin, PhD

Organizational Affiliation

Michael E. DeBakey Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Syracuse VA Medical Center

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Michael E. DeBakey VA Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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 Sharing Time Frame

The data will be available once the database is finalized and will remain available in the future.

IPD Sharing Access Criteria

Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.

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

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