Developing a Team-Delivered Intervention for Smoking and Hazardous Drinking for Primary Care Veterans With Cardiovascular Diseases

Not Applicable

Completed

Conditions: Alcohol Use Above Recommended Limits
Cigarette Use
Cardiovascular Risk Factors (e.g., Hypertension)
Cardiovascular Diseases

Interventions: Behavioral: CARE

Registration Number: NCT05275582

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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]

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CARE-PACT	CARE	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-PCMHI	CARE	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

Primary Outcome Measures

Name	Time	Method
Readiness to Change Drinking OR Smoking	6 weeks post intervention	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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (2): VA Western New York Healthcare System, Buffalo, NY
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Buffalo, New York, United States
Syracuse VA Medical Center, Syracuse, NY
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Syracuse, New York, United States