Alcohol Use Disorders, Depressive Disorders, Post-traumatic Stress Disorder (PTSD)
Conditions
Keywords
depressive disorder, alcohol-related disorders, telemedicine, rural health, collaborative care, post-traumatic stress disorder (PTSD)
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* The investigators will enroll Veterans who screen positive on routinely administered VA mental health screens for depressive disorders, alcohol use disorders, and PTSD at the 6 study CBOCs.
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: * schizophrenia * bipolar disorder * other psychotic disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VR-12 Mental Component Summary Scores | Six months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PHQ-9 Scores | Six months | 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. |
| Change in AUDIT-C Scores | Baseline, Six months | 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. |
Countries
United States
Contacts
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 279 |
| 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. | 39 |
| Total | 318 |
Baseline characteristics
| Characteristic | Total | Usual Care (Pre-Implementation) Cohort | Blended Telemedicine-Based Care (Post-Implementation) Cohort |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 15 | 53.6 years STANDARD_DEVIATION 14.8 | 48.9 years STANDARD_DEVIATION 16.6 |
| AUDIT-C Total Score | 3.8 units on a scale STANDARD_DEVIATION 3.4 | 3.6 units on a scale STANDARD_DEVIATION 3.5 | 4.6 units on a scale STANDARD_DEVIATION 2.9 |
| BRFSS Tobacco Use | 119 Participants | 109 Participants | 10 Participants |
| Clinical Alcohol Screening Test - Positive | 128 Participants | 106 Participants | 22 Participants |
| Clinical Depression Screen Positive | 133 Participants | 116 Participants | 17 Participants |
| Clinical PTSD Screening - Positive | 106 Participants | 105 Participants | 1 Participants |
| CSQ-8 | 27.0 units on a scale | 27.0 units on a scale | 28.0 units on a scale |
| Education College Degree or More | 72 Participants | 54 Participants | 18 Participants |
| Education High School or Less | 115 Participants | 107 Participants | 8 Participants |
| Education Some College | 131 Participants | 118 Participants | 13 Participants |
| Employment Full-Time or Part-Time | 119 Participants | 98 Participants | 21 Participants |
| Employment Other | 120 Participants | 108 Participants | 12 Participants |
| Employment Retired | 79 Participants | 73 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 6 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 310 Participants | 272 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| GAD-7 | 9.3 units on a scale STANDARD_DEVIATION 6 | 9.1 units on a scale STANDARD_DEVIATION 6 | 10.4 units on a scale STANDARD_DEVIATION 6.1 |
| Hoge Barriers Assessment | 33.8 units on a scale STANDARD_DEVIATION 8.9 | 33.9 units on a scale STANDARD_DEVIATION 8.8 | 33.1 units on a scale STANDARD_DEVIATION 9.9 |
| Jenkins Sleep Scale | 14.0 units on a scale | 14.0 units on a scale | 16.0 units on a scale |
| Marital Status | 187 Participants | 164 Participants | 23 Participants |
| Non-VA Health Insurance Status | 184 Participants | 163 Participants | 21 Participants |
| Pain Scale | 5.1 units on a scale STANDARD_DEVIATION 2.7 | 5.1 units on a scale STANDARD_DEVIATION 2.7 | 4.8 units on a scale STANDARD_DEVIATION 2.9 |
| PCL-5 | 30.3 units on a scale STANDARD_DEVIATION 17.6 | 30.4 units on a scale STANDARD_DEVIATION 17.6 | 29.2 units on a scale STANDARD_DEVIATION 17.4 |
| PHQ-9 | 11.2 units on a scale STANDARD_DEVIATION 6.3 | 11.2 units on a scale STANDARD_DEVIATION 6.3 | 11.3 units on a scale STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 100 Participants | 93 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 17 Participants | 17 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 197 Participants | 165 Participants | 32 Participants |
| Readiness Ruler Readiness 1 | 6.0 units on a scale | 6.0 units on a scale | 7.0 units on a scale |
| Readiness Ruler Readiness 2 | 8.0 units on a scale | 8.0 units on a scale | 8.0 units on a scale |
| Readiness Ruler Readiness 3 | 7.0 units on a scale | 7.0 units on a scale | 8.0 units on a scale |
| Region of Enrollment United States | 318 Participants | 279 Participants | 39 Participants |
| Severity Measure for Panic - Adult | 11.9 units on a scale STANDARD_DEVIATION 8.6 | 12.1 units on a scale STANDARD_DEVIATION 8.6 | 10.6 units on a scale STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 29 Participants | 22 Participants | 7 Participants |
| Sex: Female, Male Male | 289 Participants | 257 Participants | 32 Participants |
| VR-12 MCS | 39.5 units on a scale STANDARD_DEVIATION 13.5 | 39.7 units on a scale STANDARD_DEVIATION 13.5 | 38.2 units on a scale STANDARD_DEVIATION 13.7 |
| VR-12 PCS | 33.2 units on a scale STANDARD_DEVIATION 13.6 | 32.7 units on a scale STANDARD_DEVIATION 13.6 | 36.8 units on a scale STANDARD_DEVIATION 13.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 279 | 0 / 39 |
| other Total, other adverse events | 0 / 279 | 0 / 39 |
| serious Total, serious adverse events | 0 / 279 | 0 / 39 |
Outcome results
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.
Time frame: Six months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Pre-Implementation) Cohort | Change in VR-12 Mental Component Summary Scores | 2.9 score on a scale | Standard Deviation 11.8 |
| Blended Telemedicine-Based Care (Post-Implementation) Cohort | Change in VR-12 Mental Component Summary Scores | 5.1 score on a scale | Standard Deviation 9.6 |
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.
Time frame: Baseline, Six months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Pre-Implementation) Cohort | Change in AUDIT-C Scores | Baseline assessment | 6.8 units on a scale | Standard Deviation 2.8 |
| Usual Care (Pre-Implementation) Cohort | Change in AUDIT-C Scores | 6-month follow-up assessment | 6.4 units on a scale | Standard Deviation 2.7 |
| Blended Telemedicine-Based Care (Post-Implementation) Cohort | Change in AUDIT-C Scores | Baseline assessment | 6.5 units on a scale | Standard Deviation 1.7 |
| Blended Telemedicine-Based Care (Post-Implementation) Cohort | Change in AUDIT-C Scores | 6-month follow-up assessment | 6.1 units on a scale | Standard Deviation 2 |
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.
Time frame: Six months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Pre-Implementation) Cohort | Change in PHQ-9 Scores | -2.3 score on a scale | Standard Deviation 6 |
| Blended Telemedicine-Based Care (Post-Implementation) Cohort | Change in PHQ-9 Scores | -3.2 score on a scale | Standard Deviation 3.8 |
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.
Time frame: 12-24 months
Reach of Intervention
Proportion of patients having any mental health encounter in the six month follow-up period.
Time frame: Six months