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

NCT05275582 | Completed Results

• 3 other identifiers: CDX 22-006CDA 18-006IK2HX002610
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Smoking; Drinking, alcohol; Cardiovascular diseases; Heart disease risk factors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Cigarettes Per Day

  6 weeks post intervention

• Drinking Days

  6 weeks post intervention

• Drinks Per Drinking Day

  Six weeks post intervention

• Patient Satisfaction Survey

  6 months post intervention

Study Arms (2)

CARE-PACT

EXPERIMENTAL

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

CARE-PCMHI

EXPERIMENTAL

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

Interventions

CARE 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

Also known as: CARE-PACT, CARE-PCMHI

CARE-PACT; CARE-PCMHI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[telephone screen\]

You may not qualify if:

• 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 \[EMR\]

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Smoking; Alcohol Drinking

Condition Hierarchy (Ancestors)

Vascular Diseases; Behavior; Drinking Behavior

Results Point of Contact

• Title: Dr. Julie Gass
• Organization: VA Center for Integrated Healthcare

julie.gass@va.gov

716-834-9200

Study Officials

• Julie Christina Gass, PhD

  VA Western New York Healthcare System, Buffalo, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not know which version of CARE that the patient receives.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The CARE intervention will be piloted in two formats: 1) that includes a conjoint meeting between a Patient Aligned Care Team (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.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: May 13, 2022
• Primary Completion: April 26, 2024
• Study Completion: April 30, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)