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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05275582
Collaborator
(none)
40
2
2
25.6
20
0.8

Study Details

Study Description

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 are looking to recruit around 40 Veterans from Buffalo and Syracuse to be in this study. What it will entail 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The CARE intervention will be piloted in two formats: 1) that includes a conjoint meeting between a 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.The CARE intervention will be piloted in two formats: 1) that includes a conjoint meeting between a 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.
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcomes assessor will not know which version of CARE that the patient receives.
Primary Purpose:
Prevention
Official Title:
Developing a Team-Delivered Intervention for Smoking and Hazardous Drinking for Primary Care Veterans With Cardiovascular Diseases (CDA 18-006)
Actual Study Start Date :
May 13, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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-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
  • Outcome Measures

    Primary Outcome Measures

    1. Readiness to Change drinking OR smoking [6 weeks post intervention]

      Intention to Change subscale of the Theory of Planned Behavior Scale

    2. Readiness to Change drinking OR smoking [6 weeks post intervention]

      Readiness to Change Questionnaire

    3. Readiness to change drinking OR smoking [6 weeks post intervention]

      Visual analog scale (ruler) rating their readiness to change smoking and/or drinking behaviors

    Secondary Outcome Measures

    1. Cigarettes per day [6 weeks post intervention]

      A quantity/frequency measure of cigarettes per day for smokers in the study

    2. Alcohol Use Disorders Identification Test (AUDIT) [6 weeks post intervention]

      A brief measure examining alcohol use disorder symptom severity for drinkers in the study

    3. Patient Satisfaction Survey [6 months post intervention]

      Subscales of the Patient Satisfaction Survey that assess for satisfaction with the healthcare system.

    4. Nicotine dependence [6 weeks post intervention]

      The Nicotine Dependence Symptom Severity scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Veteran patients age 18 seen in PACT at the Buffalo VAMC

    • 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 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) [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]

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Western New York Healthcare System, Buffalo, NY Buffalo New York United States 14215
    2 Syracuse VA Medical Center, Syracuse, NY Syracuse New York United States 13210

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Julie Christina Gass, PhD, VA Western New York Healthcare System, Buffalo, NY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05275582
    Other Study ID Numbers:
    • CDX 22-006
    • CDA 18-006
    • IK2HX002610
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 17, 2022