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| ID | Type | Description | Link |
|---|---|---|---|
| CDA 18-006 | Other Grant/Funding Number | VA HSR&D | |
| IK2HX002610 | U.S. NIH Grant/Contract | View source |
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In this study, the investigators are interested in learning how patients feel about and are impacted by a new approach for the primary care team to use to talk to patients about heart disease and health behaviors. The investigators were looking to recruit around 40 Veterans from Buffalo and Syracuse to be in this study. What it entailed is being randomly assigned to one of two conditions. If patients are assigned to the first condition, their upcoming primary care appointment will be extended by about 5 minutes because a Health Educator will join the end of that appointment. If they are assigned to the second condition they would have their typical primary care appointment. Beyond that, both conditions are quite similar. They will have an individual meeting following the primary care appointment with the Health Educator, two phone booster meetings at 2 and 4 weeks, and information about an optional app that they have the choice to use to help them track some health behaviors.
Many Veterans (30.4%) with cardiovascular diseases (CVDs) continue to engage in behaviors that increase risk of cardiovascular events and early mortality, such as smoking or hazardous drinking. While the VA has several programs designed to help Veterans quit smoking or quit/reduce drinking, there is a gap in service for Veterans who are not ready for change-based treatments but continue to smoke or drink hazardously. VA Patient Aligned Care Teams (PACTs) screen all patients annually for alcohol and tobacco use, and thus the PACT platform is an ideal way to reach Veterans with CVDs who smoke and/or drink hazardously. Through the Primary Care Mental Health Integration (PCMHI) initiative, mental and behavioral health providers are embedded to provide effective, evidence-based, Veteran-centered, behavioral health interventions for a variety of co-occurring behavioral health concerns and medical problems. Educational and self-monitoring interventions are evidence-based and increase substance users' intentions to make a behavior change, and additionally improve patient factors including engagement, willingness to accept behavioral health referrals, and self-management strategies. This research proposal focuses on adapting elements of these evidence-based interventions specifically for a PACT-based VA setting to appeal to Veterans not yet ready to change smoking and/or drinking. This intervention aims to increase intention to change and may improve rates of cessation and engagement with change-based programs. The intervention will fill a gap in care and potentially improve the health and longevity of Veterans seen in PACT. The intervention, called CARE, will be piloted in two formats: 1) that includes a conjoint meeting between a PACT medical provider and a behavioral health provider; and 2) only with a behavioral health provider.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARE-PACT | Experimental | Brief (5 minute) meeting between the PACT medical provider and a behavioral health educator (in person or virtual using VA's VA Video Connect (VVC) system) -followed by- 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator |
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| CARE-PCMHI | Experimental | 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARE | Behavioral | Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
| Measure | Description | Time Frame |
|---|---|---|
| Readiness to Change Drinking OR Smoking | Readiness to Change Questionnaire. This is a standardized measure (Heather and Rollnick, 1993) with 12 items measuring how ready an individual is to make a change to a behavior (e.g., drinking, smoking). The scale contains subscales that can indicate which Stage of Change (Precontemplation, Contemplation, or Action) an individual is in during the time of measurement. It is scored by seeing which subscale an individual is highest on at the time of measurement (i.e., their highest subscale score among the three stages; if two subscale scores are equal then the higher stage is chosen). | 6 weeks post intervention |
| Readiness to Change Drinking OR Smoking | This is a 1-10 scale wherein participants are asked to rate their readiness to change drinking or smoking from 1-10 with 1 being not ready/not considering change up to 10, being taking steps toward change. This scale is based off of numerous "Readiness Rulers" published in the motivational interviewing literature. | 6 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes Per Day | This is one item from a two-item smoking quantity-frequency measure. Veterans were asked (1) on how many days of the last 28 did they smoke any cigarettes; and (2) on the days they smoked, how many they smoked. The second of those is reported here. The number corresponds directly to the average of how many cigarettes they smoked per smoking day in the past 28. 1=1 cigarettes per day, 2=2 cigarettes per day, etc. |
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Inclusion Criteria:
Veteran patients age 18 seen in PACT at the Buffalo and Syracuse VA Medical Center (VAMCs) and catchment areas
Upcoming PACT appointment
A diagnosis of cardiac disease, including coronary artery disease, hypertension, hyperlipidemia, OR ischemia
Positive alcohol or tobacco use screen for at least two consecutive years (including most recent) for:
Currently smokes at least one cigarette per day OR currently scores in a range indicating hazardous drinking on the Alcohol Use Disorders Identification Test (AUDIT) OR both [telephone screen]
Currently reports on 1 to 10 scale having no greater than high-moderate (defined as 8) intention (i.e., 7) to change their drinking and/or smoking behavior [telephone screen]
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Christina Gass, PhD | VA Western New York Healthcare System, Buffalo, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215-1129 | United States | ||
| Syracuse VA Medical Center, Syracuse, NY |
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Recruitment began in May 2022 for the clinical trial and ended September of 2023. Veterans were identified via data pull/chart review for potential inclusion with inclusion criteria including having an upcoming primary care appointment, having a cardiovascular condition or risk factor, and screening positive on the last two annual tobacco use or alcohol use screens performed in primary care.
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| ID | Title | Description |
|---|---|---|
| FG000 | CARE-PACT | Brief (5 minute) meeting between the patient-aligned care team (PACT) medical provider and a behavioral health educator (in person or virtual using VA's Virtual Care (VVC) system) -followed by- 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
| 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 | Nov 20, 2023 |
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The CARE intervention will be piloted in two formats: 1) that includes a conjoint meeting between a Patient Aligned Care Team (PACT) medical provider and a behavioral health provider; and 2) does not include the conjoint meeting with the medical provider. All other elements of the treatment are identical.
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The outcomes assessor will not know which version of CARE that the patient receives.
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| 6 weeks post intervention |
| Drinking Days | This is one item from a two-item drinking quantity-frequency measure. Veterans were asked on how many days of the last 28 did they have at least one standard drink of alcohol. The number corresponds directly to the average of how many days they had a standard drink of alcohol in the past 28 days. 1=1 day out of 28 that they drank alcohol, 2=2 days per week that they drank alcohol, etc. | 6 weeks post intervention |
| Drinks Per Drinking Day | This is one item from a two-item drinking quantity-frequency measure. Veterans were asked (1) on how many days of the last 28 did they drink a standard drink of alcohol; and (2) on the days they drank, how many standard drinks they had. The second of those is reported here. The number corresponds directly to the average of how many drinks they consumed per drinking day in the past 28. 1=1 drink per drinking day, 2=2 drinks per drinking day, etc. | Six weeks post intervention |
| Patient Satisfaction Survey | This was a Patient Satisfaction Survey that assess for satisfaction with the healthcare system assessing satisfaction, quality, sense of care and concern, courtesy, and abilities of their providers. The scores reported are averages of the 7 items, with scores ranging from 1-5 with a 1 generally corresponding to poor and a 5 to excellent. One item is scaled as yes/maybe/no ("would you recommend the medical center to your friends/relatives) with a yes=5, maybe=3, and no=1. | 6 months post intervention |
| Syracuse |
| New York |
| 13210 |
| United States |
| FG001 | CARE-PCMHI | 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CARE-PACT | Brief (5 minute) meeting between the PACT medical provider and a behavioral health educator (in person or virtual using VA's VVC system) -followed by- 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
| BG001 | CARE-PCMHI | 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Substance Targeted (Tobacco or Alcohol) | Count of Participants | Participants |
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| Readiness to Change Drinking or Smoking | This is a 1-10 scale wherein participants are asked to rate their readiness to change drinking or smoking from 1-10 with 1 being not ready/not considering change up to 10, being taking steps toward change. This scale is based off of numerous "Readiness Rulers" published in the motivational interviewing literature. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Readiness to Change Questionnaire | Readiness to Change Questionnaire. This is a standardized measure (Heather and Rollnick, 1993) with 12 items measuring how ready an individual is to make a change to a behavior (e.g., drinking, smoking). The scale contains subscales that can indicate which Stage of Change (Precontemplation, Contemplation, or Action) an individual is in during the time of measurement. It is scored by seeing which subscale an individual is highest on at the time of measurement (i.e., their highest subscale score among the three stages; if two subscale scores are equal then the higher stage is chosen). | Count of Participants | Participants |
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| Cigarettes per Smoking Day | This is one item from a two-item smoking quantity-frequency measure. Veterans were asked (1) on how many days of the last 28 did they smoke any cigarettes; and (2) on the days they smoked, how many they smoked. The second of those is reported here. The number corresponds directly to the average of how many cigarettes they smoked per smoking day in the past 28. 1=1 cigarettes per day, 2=2 cigarettes per day, etc. | Only those in the sample who were tobacco smokers were included in this analysis. | Mean | Standard Deviation | cigarettes/smoking day |
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| Drinking Days | This is one item from a two-item drinking quantity-frequency measure. Veterans were asked on how many days of the last 28 did they have at least one standard drink of alcohol. The number corresponds directly to the average of how many days they had a standard drink of alcohol in the past 28 days. 1=1 day out of 28 that they drank alcohol, 2=2 days per week that they drank alcohol, etc. | Only those who screened positive for alcohol use were included in this measure. | Mean | Standard Deviation | Days |
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| Drinks per Drinking Day | This is one item from a two-item drinking quantity-frequency measure. Veterans were asked (1) on how many days of the last 28 did they drink a standard drink of alcohol; and (2) on the days they drank, how many standard drinks they had. The second of those is reported here. The number corresponds directly to the average of how many drinks they consumed per drinking day in the past 28. 1=1 drink per drinking day, 2=2 drinks per drinking day, etc. | Only those who screened positive for alcohol use were included in this measure. | Mean | Standard Deviation | drinks/drinking day |
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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 | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Readiness to Change Drinking OR Smoking | Readiness to Change Questionnaire. This is a standardized measure (Heather and Rollnick, 1993) with 12 items measuring how ready an individual is to make a change to a behavior (e.g., drinking, smoking). The scale contains subscales that can indicate which Stage of Change (Precontemplation, Contemplation, or Action) an individual is in during the time of measurement. It is scored by seeing which subscale an individual is highest on at the time of measurement (i.e., their highest subscale score among the three stages; if two subscale scores are equal then the higher stage is chosen). | While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 34, as one participant missed the 6 week assessment. | Posted | Count of Participants | Participants | 6 weeks post intervention |
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| Primary | Readiness to Change Drinking OR Smoking | This is a 1-10 scale wherein participants are asked to rate their readiness to change drinking or smoking from 1-10 with 1 being not ready/not considering change up to 10, being taking steps toward change. This scale is based off of numerous "Readiness Rulers" published in the motivational interviewing literature. | While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 34, as one participant missed the 6 week appointment. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks post intervention |
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| Secondary | Cigarettes Per Day | This is one item from a two-item smoking quantity-frequency measure. Veterans were asked (1) on how many days of the last 28 did they smoke any cigarettes; and (2) on the days they smoked, how many they smoked. The second of those is reported here. The number corresponds directly to the average of how many cigarettes they smoked per smoking day in the past 28. 1=1 cigarettes per day, 2=2 cigarettes per day, etc. | While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 19 total, as one participant missed the 6 week appointment, and we only included those who smoked in the sample, and two who attended the 6-week appointment had missing data for this item. | Posted | Mean | Standard Deviation | cigarettes/smoking day | 6 weeks post intervention |
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| Secondary | Drinking Days | This is one item from a two-item drinking quantity-frequency measure. Veterans were asked on how many days of the last 28 did they have at least one standard drink of alcohol. The number corresponds directly to the average of how many days they had a standard drink of alcohol in the past 28 days. 1=1 day out of 28 that they drank alcohol, 2=2 days per week that they drank alcohol, etc. | While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 15 total, as one participant missed the 6 week appointment, and we only included those who smoked in the sample. | Posted | Mean | Standard Deviation | Days | 6 weeks post intervention |
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| Secondary | Drinks Per Drinking Day | This is one item from a two-item drinking quantity-frequency measure. Veterans were asked (1) on how many days of the last 28 did they drink a standard drink of alcohol; and (2) on the days they drank, how many standard drinks they had. The second of those is reported here. The number corresponds directly to the average of how many drinks they consumed per drinking day in the past 28. 1=1 drink per drinking day, 2=2 drinks per drinking day, etc. | While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 15 total, as one participant missed the 6 week appointment, and we only included those who smoked in the sample. | Posted | Mean | Standard Deviation | drinks/drinking day | Six weeks post intervention |
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| Secondary | Patient Satisfaction Survey | This was a Patient Satisfaction Survey that assess for satisfaction with the healthcare system assessing satisfaction, quality, sense of care and concern, courtesy, and abilities of their providers. The scores reported are averages of the 7 items, with scores ranging from 1-5 with a 1 generally corresponding to poor and a 5 to excellent. One item is scaled as yes/maybe/no ("would you recommend the medical center to your friends/relatives) with a yes=5, maybe=3, and no=1. | While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35) | Posted | Mean | Standard Deviation | units on a scale | 6 months post intervention |
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Adverse event data were collected over the full period of data collection for the study (~2 years). For participants, they were monitored from their initial time in the study until their final assessment (~6 months).
Serious Adverse Events were categorized as "related to study" or "unrelated to study" as determined by the respective Institutional Review Boards after review. "Unrelated to study" indicated that, while the serious adverse occurred during the study period, was determined by the review board to not be caused by or related to the study in any appreciable way.
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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 | CARE-PACT | Brief (5 minute) meeting between the PACT medical provider and a behavioral health educator (in person or virtual using VA's VVC system) -followed by- 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator | 1 | 25 | 1 | 25 | 0 | 25 |
| EG001 | CARE-PCMHI | 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator | 0 | 19 | 2 | 19 | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious adverse event | Vascular disorders | Non-systematic Assessment | unrelated to study |
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| serious adverse event | Injury, poisoning and procedural complications | Non-systematic Assessment | unrelated to study |
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| Serious adverse event | General disorders | Non-systematic Assessment | unrelated to study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Gass | VA Center for Integrated Healthcare | 716-834-9200 | 25429 | julie.gass@va.gov |
| Jan 30, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2023 | Jun 12, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D012907 | Smoking |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator
CARE: Behavioral intervention including
-30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator
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| OG001 | CARE-PCMHI | 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
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30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
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| OG001 |
| CARE-PCMHI |
30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
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30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator CARE: Behavioral intervention including -30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app of substance use behavior, mood, other behavioral processes 2 optional 15-minute phone calls with behavioral health educator |
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