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The purpose of this study is to investigate health problems among rural Veterans. The research project also aims to test a new telephone-based approach for helping Veterans who need treatment connect with the appropriate care. This study will help us to better understand the kinds of problems Veterans experience. The study will also help us to find better ways to help Veterans get the help they may need.
Project Background: One in five Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) Veterans resides in rural areas and primarily receives care from VA Community-Based Outpatient Clinics (CBOCs). Compared to their urban counterparts, rural Veterans experience a significantly greater MH burden and poorer outcomes. Nevertheless, less than 10% of OEF/OIF/OND Veterans with a new PTSD diagnosis attend a minimum number of sessions required for evidence-based treatment, with rurality being one of the strongest predictors of poor engagement. The investigators' pilot study in urban OEF/OIF/OND Veterans demonstrated that telephone Motivational Interviewing (MI) delivered by research staff significantly improved MH treatment initiation and retention in care. However, the investigators do not know whether telephone MI will have as strong an effect on MH treatment engagement when implemented by VA staff in CBOCs serving rural Veterans.
Project Objectives: As a part of the Center for Mental Healthcare and Outcomes Research (CeMOHR) CREATE application to improve rural Veterans' access to evidence-based mental healthcare, the overall goal of this project is to adapt, implement and test an MI-based coaching intervention to improve MH services engagement at CBOCs serving rural Veterans. The specific aims of this project are: (1) Conduct a developmental formative evaluation of perceived barriers to MH treatment engagement and adapt the MI-based treatment engagement intervention and implementation strategy to the needs of stakeholders; (2) Conduct a randomized multi-site pragmatic effectiveness trial comparing MH Referral alone with MH Referral plus MI-based coaching; and (3) Conduct an implementation-focused formative evaluation and use this information to make mid-course corrections to the implementation strategy based on stakeholder and key informant input.
Methods: The investigators will conduct the pragmatic effectiveness trial of the telephone motivational coaching intervention to determine whether, in comparison to MH Referral alone, telephone MI coaching improves MH treatment initiation and retention, the use of e-health MH resources, and perceived need and readiness for and access to MH treatment among rural Veterans who use CBOCs (Aim 2).
Impact: This research will help close the knowledge gap about barriers to care and preferences for MH services among rural Veterans. In addition, information from this project will be used to develop implementation toolkits for MH treatment engagement interventions for rural Veterans. Finally, this project will determine the effectiveness of a telephone Motivational Interviewing engagement intervention using e-health adjuncts, thereby filling a gap in the scientific literature about whether novel interventions can be used by VA staff in CBOCs to overcome rural-urban disparities in MH treatment engagement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Coaching | Experimental | Telephone based Motivational Coaching sessions |
|
| Referral alone | No Intervention | This is the current standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Coaching | Behavioral | Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health (MH) Treatment Engagement | Motivational Coaching (vs. Control) on MH treatment initiation. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates | 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health (MH) Treatment Retention | Motivational Coaching (vs. Control) on MH treatment retention. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates | 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. | Depression, anxiety, panic, PTSD, tobacco, alcohol, cannabis, cocaine, amphetamine, inhalants, sedatives, hallucinogen, opioid, and QOL domains: physical health, psychological health, social relationships, and environment. Ranges of scores: depression: 0-27, anxiety: 0-4, panic: 0-4, PTSD: PTSD: 0-80., tobacco: 0-31, alcohol: 0-39, cannabis use: 0-39, cocaine: 0-39, amphetamine: 0-39, inhalants: 0-39, sedatives: 0-39, hallucinogen: 0-39, opioid: 0-39, QOL physical health: 4-20, QOL psychological health: 4-20, QOL social relationships: 4-20, QOL environment: 4-20. Higher scores mean worse outcomes for mental health symptoms and substance use scores; higher scores mean worse outcomes for quality of life measures. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen H Seal, MD MPH | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | North Little Rock | Arkansas | 72114-1706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27509291 | Result | Koenig CJ, Abraham T, Zamora KA, Hill C, Kelly PA, Uddo M, Hamilton M, Pyne JM, Seal KH. Pre-Implementation Strategies to Adapt and Implement a Veteran Peer Coaching Intervention to Improve Mental Health Treatment Engagement Among Rural Veterans. J Rural Health. 2016 Sep;32(4):418-428. doi: 10.1111/jrh.12201. Epub 2016 Aug 10. | |
| 28755653 |
| Label | URL |
|---|---|
| Click here for more information about this study: Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans | View source |
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Baseline assessment was used to determine mental health eligibility. Those who did not score high enough on mental health symptoms AND/OR had recently had recently had a mental health visit and/or a schedule mental health visit were excluded.
(1) CBOC providers will refer veterans; (2) VA administrative data will be used to identify veterans; (3) veteran self-referral; (4) "snowball sampling"
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Coaching | Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment |
| FG001 | Referral Alone | This is the current standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We baselined 418 participants, 280 were eligible for the study and randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Coaching | Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment |
| BG001 | Referral Alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mental Health (MH) Treatment Engagement | Motivational Coaching (vs. Control) on MH treatment initiation. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates | Including 272 patients who provided primary outcome data (excluding those who withdrew). | Posted | Count of Participants | Participants | 26 months |
|
2 years and 9 months
Adverse events were collected during telephone interactions only if reported by the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Coaching | Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization from Car Accident | Injury, poisoning and procedural complications | Non-systematic Assessment | He was involved in a car accident and hospitalized, suffering a broken arm and a facial injury. He said he was too upset with the VA to continue in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Cancer Diagnosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant stated that he had been diagnosed with lung cancer a few months prior |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Seal | San Francisco VA Healthcare System | 415-2214810 | 24852 | karen.seal@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 | Apr 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| 26 months |
| Self-care Activities | Five types of self-care activities to relieve stress: internet or mobile applications, community groups (church groups, gun clubs), community classes (Yoga, cooking), alternative treatments (acupuncture, chiropractor, massage), and other self-care activities (meditation, fishing, walking). | 26 months |
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121 | United States |
| Abraham TH, Koenig CJ, Zamora K, Hill C, Uddo M, Kelly AP, Hamilton MF, Curran GM, Pyne JM, Seal KH. Situating mental health work in place: Qualitative findings from interviews with Veterans in Southeastern Louisiana and Northern California. Health Place. 2017 Sep;47:63-70. doi: 10.1016/j.healthplace.2017.07.001. Epub 2017 Jul 26. |
This is the current standard of care
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Count of Participants | Participants |
|
| Region of Enrollment | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Count of Participants | Participants |
|
| WHOQOL-BREF | The WHOQOL BREF is a shorter version of the WHO Quality of Life measure that includes four domains: physical health, psychological health, social relationships, and environment domains. The theoretical scale ranges of all 4 domains are the same: 4-20. Higher scores indicate better quality of life. | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Mean | Standard Deviation | units on a scale |
|
| Mental Health Treatment Experiences in the last 5 years | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Count of Participants | Participants |
|
| Readiness Ruler: Assessment of Motivation for Treatment | All 3 measures have a range of 0-10 for both arms. The higher scores are the better. | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Mean | Standard Deviation | units on a scale |
|
| Severity Measure for Depression-Adult (PHQ-9) | The theoretical scale range is 0-27, with higher scores indicating greater severity of depression. | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Mean | Standard Deviation | units on a scale |
|
| Severity Measure for Generalized Anxiety Disorder-Adult | The investigators used the averaged total score calculated by dividing the raw total score by number of items in the measure. The theoretical scale range is 0-4, with higher scores indicating greater severity of anxiety disorder. | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Mean | Standard Deviation | units on a scale |
|
| Severity Measure for Panic Disorder-Adult | The investigators used the averaged total score calculated by dividing the raw total score by number of items in the measure. The theoretical scale range is 0-4, with higher scores indicating greater severity of panic disorder. | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Mean | Standard Deviation | units on a scale |
|
| PCL-5 | PCL-5 is the PTSD Checklist for DSM-5. It is a 20-item self-report measure that assesses 20 symptoms of PTSD. Each item is on a 5-point Likert scale ranging from 0-4, and the total score range is 0-80, with the higher scores indicating more severe PTSD symptoms. A cut-point score of 33 is considered as a diagnostic criterion for PTSD. In our study, we did not intend to diagnose PTSD. Instead, we simply compared total scores of PCL-5 between two arms. | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Mean | Standard Deviation | units on a scale |
|
| WHO - ASSIST V3 | Ranges of scores: tobacco: 0-31, alcohol: 0-39, cannabis: 0-39, cocaine: 0-39, amphetamine: 0-39, inhalants: 0-39, sedatives: 0-39, hallucinogens: 0-39, opioid: 0-39. The higher scores indicate worse outcome. | One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis. | Mean | Standard Deviation | units on a scale |
|
This is the current standard of care |
|
|
|
| Secondary | Mental Health (MH) Treatment Retention | Motivational Coaching (vs. Control) on MH treatment retention. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates | Including patients who provided primary outcome data. | Posted | Count of Participants | Participants | 26 months |
|
|
|
| Other Pre-specified | Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. | Depression, anxiety, panic, PTSD, tobacco, alcohol, cannabis, cocaine, amphetamine, inhalants, sedatives, hallucinogen, opioid, and QOL domains: physical health, psychological health, social relationships, and environment. Ranges of scores: depression: 0-27, anxiety: 0-4, panic: 0-4, PTSD: PTSD: 0-80., tobacco: 0-31, alcohol: 0-39, cannabis use: 0-39, cocaine: 0-39, amphetamine: 0-39, inhalants: 0-39, sedatives: 0-39, hallucinogen: 0-39, opioid: 0-39, QOL physical health: 4-20, QOL psychological health: 4-20, QOL social relationships: 4-20, QOL environment: 4-20. Higher scores mean worse outcomes for mental health symptoms and substance use scores; higher scores mean worse outcomes for quality of life measures. | Including patients who reported mental health symptoms, substance use, and quality of life. | Posted | Mean | Standard Deviation | score on a scale | 26 months |
|
|
|
| Other Pre-specified | Self-care Activities | Five types of self-care activities to relieve stress: internet or mobile applications, community groups (church groups, gun clubs), community classes (Yoga, cooking), alternative treatments (acupuncture, chiropractor, massage), and other self-care activities (meditation, fishing, walking). | Including participants who responded to survey questions during follow-up. | Posted | Count of Participants | Participants | 26 months |
|
|
|
| 0 |
| 140 |
| 3 |
| 140 |
| 4 |
| 140 |
| EG001 | Referral Alone | This is the current standard of care | 0 | 140 | 2 | 140 | 2 | 140 |
|
| Hospitalization from Stomach Flu | Gastrointestinal disorders | Non-systematic Assessment | She's been having a stomach illness, was totally out of it and had to go to urgent care/hospital get to get fluids etc. It sounded like a pure stomach virus, with all the sxs. |
|
| Hospitalization for Lung Transplant | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | The veteran was in the hospital for a lung transplant. She self reported that she has been in the hospital for about 3 weeks. At a future interview she was hospitalized again due to complication related to the lung transplant. |
|
| Hospitalization for Abdominal Surgery | Surgical and medical procedures | Non-systematic Assessment | Participant had abdominal surgery |
|
| Hospitalization due to injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant stated that he had been assaulted/beaten by another veteran. This assault required a 4-day hospitalization. |
|
|
| Hurt Shoulder | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant stated that he hurt his should in previous week and had to have an MRI |
|
| Recently illness | Infections and infestations | Non-systematic Assessment | Participant self reported that he has been ill the last three weeks. He did not see the doctor for this event, and says it is starting to break away from him now. He said he was not sure if it was cold or flu, but is not running a fever. |
|
| Adverse Events related to PTSD | Psychiatric disorders | Non-systematic Assessment | Participant claims that since they have been talking about their MH issues and prior trauma, the participant's drinking and gambling has increased, and they are experiencing more dreams about her trauma. |
|
| Broken Rib | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant stated that he had broken a rib while at work |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment | Participant called PI to explain that he was very concerned about the personal information that he provided in this study and the security of that data. These concerns have caused him lots of anxiety and he has lost sleep over this. |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| panic |
|
| PTSD |
|
| tobacco |
|
| alcohol |
|
| cannabis |
|
| cocaine |
|
| amphetamine |
|
| inhalants |
|
| sedatives |
|
| halluninogens |
|
| opioid |
|
| QOL physical health domain |
|
| QOL psychological health domain |
|
| QOL social relationships domain |
|
| QOL environment domain |
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| Community classes |
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| Alternative treatments |
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| Self-care activities |
|