Alcohol Use Above Recommended Limits, Cardiovascular Diseases, Cardiovascular Risk Factors (e.g., Hypertension), Cigarette Use
Conditions
Keywords
Smoking, Drinking, alcohol, Cardiovascular diseases, Heart disease risk factors
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCARE
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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will not know which version of CARE that the patient receives.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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: * a.Smoking (i.e., Answered Yes on the Annual Veteran's Health Administration (VHA) Tobacco Use Screening Questionnaire) AND/OR * b.Hazardous drinking (Alcohol Use Disorders-Consumption \[AUD-C\] 4 for men or 3 for women) * 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
* Disorientation at time of eligibility (i.e., delirium, acute psychosis, dementia, severe intoxication) \[from the electronic medical record (EMR), telephone screen, or clinical judgment at the time of the in person appointment\] * Unable to read or understand English \[telephone screen\] * Non-Veteran status \[EMR\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readiness to Change Drinking OR Smoking | 6 weeks post intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes Per Day | 6 weeks post intervention | 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. |
| Drinking Days | 6 weeks post intervention | 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. |
| Drinks Per Drinking Day | Six weeks post intervention | 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. |
| Patient Satisfaction Survey | 6 months post intervention | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 19 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Did not/could not complete primary care appointment for various reasons | 4 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | CARE-PCMHI | CARE-PACT |
|---|---|---|---|
| Age, Continuous | 62.7 Years STANDARD_DEVIATION 13 | 63.1 Years STANDARD_DEVIATION 14.1 | 62.4 Years STANDARD_DEVIATION 12.1 |
| Cigarettes per Smoking Day | 12.9 cigarettes/smoking day STANDARD_DEVIATION 9.6 | 17.6 cigarettes/smoking day STANDARD_DEVIATION 12.7 | 10.1 cigarettes/smoking day STANDARD_DEVIATION 6 |
| Drinking Days | 19.8 Days STANDARD_DEVIATION 11 | 17.9 Days STANDARD_DEVIATION 9.8 | 21.2 Days STANDARD_DEVIATION 12.3 |
| Drinks per Drinking Day | 3.9 drinks/drinking day STANDARD_DEVIATION 2.2 | 3.6 drinks/drinking day STANDARD_DEVIATION 2.2 | 4.1 drinks/drinking day STANDARD_DEVIATION 2.3 |
| Race/Ethnicity, Customized Race Alaskan/Indigenous | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black | 11 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 32 Participants | 14 Participants | 18 Participants |
| Readiness to Change Drinking or Smoking | 4.4 units on a scale STANDARD_DEVIATION 3.4 | 3.6 units on a scale STANDARD_DEVIATION 2.9 | 5.0 units on a scale STANDARD_DEVIATION 3.7 |
| Readiness to Change Questionnaire Action | 10 Participants | 3 Participants | 7 Participants |
| Readiness to Change Questionnaire Contemplation | 23 Participants | 10 Participants | 13 Participants |
| Readiness to Change Questionnaire Precontemplation | 11 Participants | 6 Participants | 5 Participants |
| Region of Enrollment United States | 44 Participants | 19 Participants | 25 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 43 Participants | 19 Participants | 24 Participants |
| Substance Targeted (Tobacco or Alcohol) Alcohol | 16 Participants | 7 Participants | 9 Participants |
| Substance Targeted (Tobacco or Alcohol) Tobacco | 28 Participants | 12 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 19 |
| other Total, other adverse events | 0 / 25 | 0 / 19 |
| serious Total, serious adverse events | 1 / 25 | 2 / 19 |
Outcome results
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).
Time frame: 6 weeks post intervention
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CARE-PACT | Readiness to Change Drinking OR Smoking | Precontemplation | 2 Participants |
| CARE-PACT | Readiness to Change Drinking OR Smoking | Contemplation | 4 Participants |
| CARE-PACT | Readiness to Change Drinking OR Smoking | Action | 11 Participants |
| CARE-PCMHI | Readiness to Change Drinking OR Smoking | Precontemplation | 4 Participants |
| CARE-PCMHI | Readiness to Change Drinking OR Smoking | Contemplation | 8 Participants |
| CARE-PCMHI | Readiness to Change Drinking OR Smoking | Action | 5 Participants |
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.
Time frame: 6 weeks post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARE-PACT | Readiness to Change Drinking OR Smoking | 5.9 units on a scale | Standard Deviation 3.4 |
| CARE-PCMHI | Readiness to Change Drinking OR Smoking | 4.6 units on a scale | Standard Deviation 3.5 |
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.
Time frame: 6 weeks post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARE-PACT | Cigarettes Per Day | 6.4 cigarettes/smoking day | Standard Deviation 7.4 |
| CARE-PCMHI | Cigarettes Per Day | 16.0 cigarettes/smoking day | Standard Deviation 16.6 |
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.
Time frame: 6 weeks post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARE-PACT | Drinking Days | 19.1 Days | Standard Deviation 12 |
| CARE-PCMHI | Drinking Days | 22.3 Days | Standard Deviation 10.1 |
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.
Time frame: Six weeks post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARE-PACT | Drinks Per Drinking Day | 3.4 drinks/drinking day | Standard Deviation 1.7 |
| CARE-PCMHI | Drinks Per Drinking Day | 3.5 drinks/drinking day | Standard Deviation 2.3 |
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.
Time frame: 6 months post intervention
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARE-PACT | Patient Satisfaction Survey | 4.4 units on a scale | Standard Deviation 0.7 |
| CARE-PCMHI | Patient Satisfaction Survey | 3.8 units on a scale | Standard Deviation 1.2 |