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

Developing a Team-Delivered Intervention for Smoking and Hazardous Drinking for Primary Care Veterans With Cardiovascular Diseases (CDA 18-006)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cigarette Use; Alcohol Use Above Recommended Limits; Cardiovascular Risk Factors (e.g., Hypertension)
• Intervention / Treatment: Behavioral: CARE

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215-1129
      • VA Western New York Healthcare System, Buffalo, NY
    • Syracuse, New York, United States, 13210
      • Syracuse VA Medical Center, Syracuse, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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; Other Names: CARE-PACT, CARE-PCMHI
Experimental: CARE-PACT; 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	Behavioral: 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; Other Names: CARE-PACT, CARE-PCMHI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Julie Christina Gass, PhD, VA Western New York Healthcare System, Buffalo, NY

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Smoking; Cardiovascular diseases; Drinking, alcohol; Heart disease risk factors
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CDX 22-006; CDA 18-006 (Other Grant/Funding Number: VA HSR&D); IK2HX002610 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No