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

NCT ID: NCT05275582

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2024-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

CARE

Intervention Type: 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

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

Group Type: EXPERIMENTAL

CARE

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

CARE-PACT, CARE-PCMHI

Eligibility Criteria

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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Christina Gass, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Western New York Healthcare System, Buffalo, NY

Locations

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, United States

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CDA 18-006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IK2HX002610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDX 22-006

Identifier Type: -

Identifier Source: org_study_id