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

Cardiovascular Diseases Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275582
• Other study ID #: CDX 22-006
• Secondary ID: CDA 18-006IK2HX0
• Status: Completed
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 30, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readiness to Change drinking OR smoking	Readiness to Change Questionnaire	6 weeks post intervention
Primary	Readiness to change drinking OR smoking	Visual analog scale (ruler) rating their readiness to change smoking and/or drinking behaviors	6 weeks post intervention
Secondary	Cigarettes per day	A quantity/frequency measure of cigarettes per day for smokers in the study	6 weeks post intervention
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	A brief measure examining alcohol use disorder symptom severity for drinkers in the study	6 weeks post intervention
Secondary	Patient Satisfaction Survey	Subscales of the Patient Satisfaction Survey that assess for satisfaction with the healthcare system.	6 months post intervention
Secondary	Nicotine dependence	The Nicotine Dependence Symptom Severity scale.	6 weeks post intervention