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Integrating mental health treatments into the primary care delivered at Community Based Outpatient Clinics(CBOCs) that are geographically accessible to rural Veterans is a major priority for the Department of Veterans Affairs. However, there is no scientific evidence that integrating mental health and primary care is clinically effective at smaller CBOCs that have limited mental health staffing. The goal of this proposed project is to implement a "blended" combination of integrated care models that have been adapted for smaller CBOCs using telemedicine technologies, and evaluate the acceptability and effectiveness of the blended, telemedicine-based, integrated care model. If clinical outcomes are improved compared to usual care, findings will be used to justify and facilitate the implementation of this telemedicine-based integrated care model at smaller CBOCs in order to increase rural Veterans' access to effective mental health treatments.
Background: Providing mental health care to rural Veterans in geographically accessible Community Based Outpatient Clinics (CBOCs) is a major priority of the Office of Rural Health. Likewise, integrating mental health into primary care is one of the highest priorities of the Office of Mental Health Services and the Office of Mental Health Operations. The Uniform Mental Health Services Handbook mandates the blending of the two predominant, evidence-based models of integrated care (the Care Management model and the Co-Located model) at VAMCs, very large CBOCs, and large CBOCs. Because there is no scientific evidence to support its implementation, the "Blended model" is not mandated at medium CBOCs or small CBOCs that serve rural Veterans. At most smaller CBOCs, on-site mid-level providers and/or off-site tele-psychiatrists and tele-psychologists deliver traditional referral-based specialty treatment (Referral model) rather than integrated care.
Objective: This project contributes to Specific Aim 3 (Test clinical interventions to improve quality and outcomes of mental health care at CBOCs) of the Little Rock CREATE application. The goal of this proposed Hybrid Type 2 pragmatic effectiveness-implementation trial is to generate the scientific evidence needed to justify the national dissemination of the Blended model adapted using telemedicine technologies to accommodate the clinical context of smaller CBOCs that lack on-site psychiatrists and PhD psychologists. The resulting Telemedicine Blended model will be compared to usual care (Referral model) in a pragmatic trial, where the intervention will be delivered via interactive video by centrally located clinical staff and fidelity will be monitored but not controlled. Specific Aim 1: Use an expert panel comprised of clinical providers and managers who are applying telemedicine to provide a Blended model for CBOCs lacking on-site PhD psychologists and psychiatrists to document the core components of a Telemedicine Blended model and using a PDSA process, implement this model in six CBOCs. Specific Aim 2: Conduct a Hybrid Type 2 pragmatic effectiveness-implementation trial of the adapted Telemedicine Blended model by assessing RE-AIM outcomes including: provider Reach into the patient population, Effectiveness at improving clinical outcomes, Adoption by providers and Implementation Fidelity.
Methods: In conjunction with national, regional and local partners, including providers and managers who have experience with the Telemedicine Blended model, the Blended model will be adapted for smaller CBOCs using telemedicine technologies and pilot tested to generate a standardized treatment protocol. We will use a stepped wedge design with randomization of sites to sequential implementation steps, and CBOC patients who screen positive for depression or alcohol disorders will be recruited and consented to participate in the Hybrid Type 2 pragmatic effectiveness-implementation trial. Data about Reach and Adoption will be obtained from the Corporate Data Warehouse. Data about Implementation Fidelity will be obtained from chart review. Data about clinical Effectiveness will be obtained from telephone survey.
Impact: If the Telemedicine Blended model improves clinical outcomes compared to usual care, results will be used to justify and facilitate the implementation of the Telemedicine Blended model at smaller CBOCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Implementation Cohort | Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs. |
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| Post-Implementation Cohort | Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VR-12 Mental Component Summary Scores | Change in overall mental health functioning from study enrollment (after screening positive for depressive disorder or alcohol use disorder) to six-month follow-up on the Mental Component Summary scale of the Veterans Rand 12-item Health Survey. Measure Description: The Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) is a normed scale, presented as a T-score that is standardized to the US population. The population mean MCS score is 50 and standard deviation is 10, with scores ranging from 0-100. A higher (positive) change score represents greater improvement in mental health-related quality of life from study enrollment to follow-up. The VR-12 was developed from the Veterans RAND 36-Item Health Survey (VR-36), which was developed from the Medical Outcomes Study RAND SF-36(TM) Version 1.0. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PHQ-9 Scores | Change in depressive symptoms as measured by Patient Health Questionnaire (PHQ-9) from study enrollment to six-month follow-up, for patients screening positive for depressive disorders at baseline. The possible range of scores on the PHQ-9 is 0-27, with higher scores indicating more severe depressive symptoms. A negative change score represents improvement in depressive symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Adoption of Intervention by Primary Care Providers | Proportion of primary care providers with at least one patient with a Primary Care-Mental Health Integration encounter following implementation of the blended, integrated care model. The time frame is variable due to the stepped wedge design. | 12-24 months |
| Reach of Intervention |
Inclusion Criteria:
Exclusion Criteria:
Patients receiving specialty mental health treatment in the 6 months prior to recruitment and those who have a diagnosis of PTSD
Those with a diagnosis of substance dependence
Those with a psychotic disorder diagnosis:
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Patients will be Veterans receiving care at 6 Community-Based Outpatient Clinics (primary care clinics) affiliated with the Central Arkansas Veterans Healthcare System or the Overton Brooks VA Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Richard R. Owen, MD | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | Principal Investigator |
| JoAnn E. Kirchner, MD | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | 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 |
|---|---|---|---|
| 30898129 | Result | Owen RR, Woodward EN, Drummond KL, Deen TL, Oliver KA, Petersen NJ, Meit SS, Fortney JC, Kirchner JE. Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design. Implement Sci. 2019 Mar 21;14(1):33. doi: 10.1186/s13012-019-0875-5. | |
| 26912342 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care (Pre-Implementation) Cohort | Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs. Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Apr 17, 2018 |
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| Blended Telemedicine-Based Integrated Care | Other | This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication. |
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| Six months |
| Change in AUDIT-C Scores | Change in alcohol use symptoms from study enrollment to six-month follow-up, for patients screening positive for alcohol use disorders at baseline. The analysis used the Alcohol Use Disorders Identification Test (AUDIT-C) Total Score. The possible range of scores is 0-12, with higher scores indicating greater alcohol use. | Baseline, Six months |
Proportion of patients having any mental health encounter in the six month follow-up period. |
| Six months |
| Result |
| Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell C, Henderson K, Holmes S, Seibert MN, Stolzmann K, Elwy AR, Kirchner J. Partnering with health system operations leadership to develop a controlled implementation trial. Implement Sci. 2016 Feb 24;11:22. doi: 10.1186/s13012-016-0385-7. |
| FG001 | Blended Telemedicine-Based Care (Post-Implementation) Cohort | Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model. Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care (Pre-Implementation) Cohort | Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs. Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care. |
| BG001 | Blended Telemedicine-Based Care (Post-Implementation) Cohort | Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model. Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| VR-12 MCS | The Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) is a normed scale, presented as a T-score that is standardized to the US population. The population mean MCS score is 50 and standard deviation is 10, with scores ranging from 0-100. A higher score represents better mental health-related quality of life. A score of 30 signifies that the MCS score is two standard deviations below the population mean. The VR-12 was developed from the Veterans RAND 36-Item Health Survey (VR-36), which was developed from the Medical Outcomes Study RAND SF-36(TM) Version 1.0. | Mean | Standard Deviation | units on a scale |
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| VR-12 PCS | The Veterans RAND 12-Item Health Survey (VR-12), Physical Component Summary (PCS) is a normed scale, presented as a T-score that is standardized to the US population. The population mean PCS score is 50 and standard deviation is 10, with scores ranging from 0-100. A higher score represents better health-related quality of life. A score of 30 indicates that the PCS score is two standard deviations below the population mean. The VR-12 was developed from the Veterans RAND 36-Item Health Survey (VR-36), which was developed from the Medical Outcomes Study RAND SF-36(TM) Version 1.0. | Mean | Standard Deviation | units on a scale |
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| Marital Status | Marital status - categorized dichotomously as married or living with someone; or all other statuses. | Count of Participants | Participants |
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| Education | Education - trichotomous categorical variable: (1) high school or less; (2) some college; (3) college degree or more. | Count of Participants | Participants |
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| Employment | Employment status, categorized as (1) full-time or part-time; (2) retired; (3) other. | Count of Participants | Participants |
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| Non-VA Health Insurance Status | Any health insurance reported, not including VA eligibility/enrollment. | Count of Participants | Participants |
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| Clinical Depression Screen Positive | Depression screening test, administered as part of routine clinical care, is positive. Typical depression screener is PHQ-2. | Count of Participants | Participants |
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| Clinical Alcohol Screening Test - Positive | Number of participants with a positive alcohol screening test (typically AUDIT-C) administered as part of routine clinical care. | Count of Participants | Participants |
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| Clinical PTSD Screening - Positive | Count of Participants | Participants |
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| PHQ-9 | Patient Health Questionnaire-9 (PHQ-9) total score at baseline. The possible range of scores is 0-27, with higher scores indicating more severe depressive symptoms. | Mean | Standard Deviation | units on a scale |
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| AUDIT-C Total Score | Alcohol Use Disorders Identification Test (AUDIT-C) Total Score. The possible range of scores is 0-12, with higher scores indicating greater alcohol use. | Mean | Standard Deviation | units on a scale |
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| PCL-5 | PTSD Checklist for DSM-5 Total Score. Possible scores range from 0-80, with higher scores indicating greater symptom severity. | Mean | Standard Deviation | units on a scale |
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| Hoge Barriers Assessment | Hoge Barriers Assessment Total Score. The possible range of scores is 14-70, with higher scores indicating greater barriers. | Mean | Standard Deviation | units on a scale |
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| Readiness Ruler | Readiness Ruler: Assessment of Motivation for Treatment for Any Mental Health Concern. Readiness 1: "How important...to receive treatment..."; Readiness 2: "How confident...that you would get treatment"; Readiness 3: "How ready are you to receive treatment..." Each question is rated on a scale of 0-10, with higher scores indicating greater importance, confidence, and readiness, respectively. | There were missing data for Readiness 2 and Readiness 3 measures for a few participants. | Median | Inter-Quartile Range | units on a scale |
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| Pain Scale | Single item participant rating of the average overall level of pain for the past week rated on a continuous scale from 0 to 10, with higher ratings indicating more severe pain. | Mean | Standard Deviation | units on a scale |
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| Jenkins Sleep Scale | Jenkins Sleep Scale, a four-item measure that assesses trouble falling and staying asleep. Possible scores range from 0-20, with higher ratings indicating more substantial sleep problems. | Missing data for 8 participants in the pre-implementation participant group. | Median | Inter-Quartile Range | units on a scale |
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| GAD-7 | Generalized Anxiety Disorder Scale, a 7 item inventory that yields a continuous and dichotomous assessment of generalized anxiety disorder. Possible scores range from 0-21, with scores of 10 or greater indicating a positive screen for generalized anxiety disorder. | Mean | Standard Deviation | units on a scale |
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| Severity Measure for Panic - Adult | American Psychiatric Association DSM-5 Severity Measure for Panic - Adult - 10 item inventory that yields a continuous and dichotomous assessment of panic disorder. Possible scores range from 0-28, with higher scores indicating more severe symptoms. | Total score presented here only applies to participants who reported ever having a panic attack. | Mean | Standard Deviation | units on a scale |
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| BRFSS Tobacco Use | The Behavioral Risk Factor Surveillance System (BRFSS) Tobacco Use measure was administered. It has 5 items to assess current tobacco use, with a dichotomous variable being created to indicate any tobacco use. | This item was assessed for participants who answered the first question, "Have you smoked at least 100 cigarettes in your entire life?" in the affirmative. | Count of Participants | Participants |
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| CSQ-8 | The Client Satisfaction Questionnaire-8 (CSQ-8) consists of 8 items to assess participant satisfaction with mental health services. Possible scores range from 8-32, with higher scores indicating greater client satisfaction. | One participant in the pre-implementation participant group had missing data on this scale. | Median | Inter-Quartile Range | units on a scale |
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| 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 | |||||||||||||||||||||||
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| Primary | Change in VR-12 Mental Component Summary Scores | Change in overall mental health functioning from study enrollment (after screening positive for depressive disorder or alcohol use disorder) to six-month follow-up on the Mental Component Summary scale of the Veterans Rand 12-item Health Survey. Measure Description: The Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) is a normed scale, presented as a T-score that is standardized to the US population. The population mean MCS score is 50 and standard deviation is 10, with scores ranging from 0-100. A higher (positive) change score represents greater improvement in mental health-related quality of life from study enrollment to follow-up. The VR-12 was developed from the Veterans RAND 36-Item Health Survey (VR-36), which was developed from the Medical Outcomes Study RAND SF-36(TM) Version 1.0. | The number of participants analyzed for each cohort is somewhat less than the number of total participants in each group (1) because of loss to follow-up and (2) because participants who only screened positive for PTSD were not included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | Six months |
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| Secondary | Change in PHQ-9 Scores | Change in depressive symptoms as measured by Patient Health Questionnaire (PHQ-9) from study enrollment to six-month follow-up, for patients screening positive for depressive disorders at baseline. The possible range of scores on the PHQ-9 is 0-27, with higher scores indicating more severe depressive symptoms. A negative change score represents improvement in depressive symptoms. | The numbers of participants analyzed in each cohort for this measure is less than the total number of participants (1) because this analysis only included participants who had screened positive for depression and (2) because of loss to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Six months |
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| Secondary | Change in AUDIT-C Scores | Change in alcohol use symptoms from study enrollment to six-month follow-up, for patients screening positive for alcohol use disorders at baseline. The analysis used the Alcohol Use Disorders Identification Test (AUDIT-C) Total Score. The possible range of scores is 0-12, with higher scores indicating greater alcohol use. | Participants are included in this analysis if they screened positive for alcohol use disorder (clinical screen) before enrollment. The number of participants analyzed is lower than the total enrolled in the study because many participants did not screen positive for alcohol use disorder. At 6-month follow-up assessment, some participants were lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Six months |
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| Other Pre-specified | Adoption of Intervention by Primary Care Providers | Proportion of primary care providers with at least one patient with a Primary Care-Mental Health Integration encounter following implementation of the blended, integrated care model. The time frame is variable due to the stepped wedge design. | Not Posted | 12-24 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Reach of Intervention | Proportion of patients having any mental health encounter in the six month follow-up period. | Not Posted | Six months | Participants |
Each participant was followed for 6 months after enrollment.
We are using the clinicaltrials.gov definitions.
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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) |
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| EG000 | Pre-Implementation Cohort | Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs. Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care. | 1 | 279 | 0 | 279 | 0 | 279 |
| EG001 | Post-Implementation Cohort | Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model. Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication. | 0 | 39 | 0 | 39 | 0 | 39 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard R. Owen, MD | Central Arkansas Veterans Healthcare System | 5012574802 | richard.owen2@va.gov |
| May 25, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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