Trial Outcomes & Findings for Developing a Team-Delivered Intervention for Smoking and Hazardous Drinking for Primary Care Veterans With Cardiovascular Diseases (NCT NCT05275582)

Last Updated: 2025-05-20

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

6 weeks post intervention

Results posted on

2025-05-20

Participant Flow

Recruitment began in May 2022 for the clinical trial and ended September of 2023. Veterans were identified via data pull/chart review for potential inclusion with inclusion criteria including having an upcoming primary care appointment, having a cardiovascular condition or risk factor, and screening positive on the last two annual tobacco use or alcohol use screens performed in primary care.

Participant milestones

Participant milestones
Measure	CARE-PACT Brief (5 minute) meeting between the patient-aligned care team (PACT) medical provider and a behavioral health educator (in person or virtual using VA's Virtual Care (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 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	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 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
Overall Study STARTED	25	19
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CARE-PACT Brief (5 minute) meeting between the patient-aligned care team (PACT) medical provider and a behavioral health educator (in person or virtual using VA's Virtual Care (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 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	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 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
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Did not/could not complete primary care appointment for various reasons	4	0
Overall Study Death	1	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

Only those in the sample who were tobacco smokers were included in this analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CARE-PACT n=25 Participants 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 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	CARE-PCMHI n=19 Participants 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 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	Total n=44 Participants Total of all reporting groups
Age, Continuous	62.4 Years STANDARD_DEVIATION 12.1 • n=25 Participants	63.1 Years STANDARD_DEVIATION 14.1 • n=19 Participants	62.7 Years STANDARD_DEVIATION 13.0 • n=44 Participants
Sex: Female, Male Female	1 Participants n=25 Participants	0 Participants n=19 Participants	1 Participants n=44 Participants
Sex: Female, Male Male	24 Participants n=25 Participants	19 Participants n=19 Participants	43 Participants n=44 Participants
Race/Ethnicity, Customized Race · White	18 Participants n=25 Participants	14 Participants n=19 Participants	32 Participants n=44 Participants
Race/Ethnicity, Customized Race · Black	6 Participants n=25 Participants	5 Participants n=19 Participants	11 Participants n=44 Participants
Race/Ethnicity, Customized Race · Alaskan/Indigenous	1 Participants n=25 Participants	0 Participants n=19 Participants	1 Participants n=44 Participants
Region of Enrollment United States	25 Participants n=25 Participants	19 Participants n=19 Participants	44 Participants n=44 Participants
Substance Targeted (Tobacco or Alcohol) Tobacco	16 Participants n=25 Participants	12 Participants n=19 Participants	28 Participants n=44 Participants
Substance Targeted (Tobacco or Alcohol) Alcohol	9 Participants n=25 Participants	7 Participants n=19 Participants	16 Participants n=44 Participants
Readiness to Change Drinking or Smoking	5.0 units on a scale STANDARD_DEVIATION 3.7 • n=25 Participants	3.6 units on a scale STANDARD_DEVIATION 2.9 • n=19 Participants	4.4 units on a scale STANDARD_DEVIATION 3.4 • n=44 Participants
Readiness to Change Questionnaire Precontemplation	5 Participants n=25 Participants	6 Participants n=19 Participants	11 Participants n=44 Participants
Readiness to Change Questionnaire Contemplation	13 Participants n=25 Participants	10 Participants n=19 Participants	23 Participants n=44 Participants
Readiness to Change Questionnaire Action	7 Participants n=25 Participants	3 Participants n=19 Participants	10 Participants n=44 Participants
Cigarettes per Smoking Day	10.1 cigarettes/smoking day STANDARD_DEVIATION 6.0 • n=16 Participants • Only those in the sample who were tobacco smokers were included in this analysis.	17.6 cigarettes/smoking day STANDARD_DEVIATION 12.7 • n=12 Participants • Only those in the sample who were tobacco smokers were included in this analysis.	12.9 cigarettes/smoking day STANDARD_DEVIATION 9.6 • n=28 Participants • Only those in the sample who were tobacco smokers were included in this analysis.
Drinking Days	21.2 Days STANDARD_DEVIATION 12.3 • n=9 Participants • Only those who screened positive for alcohol use were included in this measure.	17.9 Days STANDARD_DEVIATION 9.8 • n=7 Participants • Only those who screened positive for alcohol use were included in this measure.	19.8 Days STANDARD_DEVIATION 11.0 • n=16 Participants • Only those who screened positive for alcohol use were included in this measure.
Drinks per Drinking Day	4.1 drinks/drinking day STANDARD_DEVIATION 2.3 • n=9 Participants • Only those who screened positive for alcohol use were included in this measure.	3.6 drinks/drinking day STANDARD_DEVIATION 2.2 • n=7 Participants • Only those who screened positive for alcohol use were included in this measure.	3.9 drinks/drinking day STANDARD_DEVIATION 2.2 • n=16 Participants • Only those who screened positive for alcohol use were included in this measure.

PRIMARY outcome

Timeframe: 6 weeks post intervention

Outcome measures

Outcome measures
Measure	CARE-PACT n=17 Participants 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 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	CARE-PCMHI n=17 Participants 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 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
Readiness to Change Drinking OR Smoking Precontemplation	2 Participants	4 Participants
Readiness to Change Drinking OR Smoking Contemplation	4 Participants	8 Participants
Readiness to Change Drinking OR Smoking Action	11 Participants	5 Participants

PRIMARY outcome

Timeframe: 6 weeks post intervention

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.

Outcome measures

Outcome measures
Measure	CARE-PACT n=17 Participants 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 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	CARE-PCMHI n=17 Participants 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 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
Readiness to Change Drinking OR Smoking	5.9 units on a scale Standard Deviation 3.4	4.6 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 6 weeks post intervention

Population: While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 19 total, as one participant missed the 6 week appointment, and we only included those who smoked in the sample, and two who attended the 6-week appointment had missing data for this item.

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.

Outcome measures

Outcome measures
Measure	CARE-PACT n=8 Participants 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 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	CARE-PCMHI n=11 Participants 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 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
Cigarettes Per Day	6.4 cigarettes/smoking day Standard Deviation 7.4	16.0 cigarettes/smoking day Standard Deviation 16.6

SECONDARY outcome

Timeframe: 6 weeks post intervention

Population: While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 15 total, as one participant missed the 6 week appointment, and we only included those who smoked in the sample.

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.

Outcome measures

Outcome measures
Measure	CARE-PACT n=9 Participants 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 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	CARE-PCMHI n=6 Participants 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 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
Drinking Days	19.1 Days Standard Deviation 12.0	22.3 Days Standard Deviation 10.1

SECONDARY outcome

Timeframe: Six weeks post intervention

Population: While the Baseline data include everyone who completed a baseline, this number reflects only those who continued in the study and received the intervention, and completed at least some outcome data (N=35). For this analysis, there are only 15 total, as one participant missed the 6 week appointment, and we only included those who smoked in the sample.

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.

Outcome measures

Outcome measures
Measure	CARE-PACT n=9 Participants 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 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	CARE-PCMHI n=6 Participants 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 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
Drinks Per Drinking Day	3.4 drinks/drinking day Standard Deviation 1.7	3.5 drinks/drinking day Standard Deviation 2.3

SECONDARY outcome

Timeframe: 6 months post intervention

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.

Outcome measures

Outcome measures
Measure	CARE-PACT n=18 Participants 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 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	CARE-PCMHI n=17 Participants 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 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
Patient Satisfaction Survey	4.4 units on a scale Standard Deviation 0.7	3.8 units on a scale Standard Deviation 1.2

Adverse Events

CARE-PACT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

CARE-PCMHI

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CARE-PACT n=25 participants at risk 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 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	CARE-PCMHI n=19 participants at risk 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 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
Vascular disorders Serious adverse event	0.00% 0/25 • Adverse event data were collected over the full period of data collection for the study (~2 years). For participants, they were monitored from their initial time in the study until their final assessment (~6 months). Serious Adverse Events were categorized as "related to study" or "unrelated to study" as determined by the respective Institutional Review Boards after review. "Unrelated to study" indicated that, while the serious adverse occurred during the study period, was determined by the review board to not be caused by or related to the study in any appreciable way.	5.3% 1/19 • Number of events 1 • Adverse event data were collected over the full period of data collection for the study (~2 years). For participants, they were monitored from their initial time in the study until their final assessment (~6 months). Serious Adverse Events were categorized as "related to study" or "unrelated to study" as determined by the respective Institutional Review Boards after review. "Unrelated to study" indicated that, while the serious adverse occurred during the study period, was determined by the review board to not be caused by or related to the study in any appreciable way.
Injury, poisoning and procedural complications serious adverse event	0.00% 0/25 • Adverse event data were collected over the full period of data collection for the study (~2 years). For participants, they were monitored from their initial time in the study until their final assessment (~6 months). Serious Adverse Events were categorized as "related to study" or "unrelated to study" as determined by the respective Institutional Review Boards after review. "Unrelated to study" indicated that, while the serious adverse occurred during the study period, was determined by the review board to not be caused by or related to the study in any appreciable way.	5.3% 1/19 • Number of events 1 • Adverse event data were collected over the full period of data collection for the study (~2 years). For participants, they were monitored from their initial time in the study until their final assessment (~6 months). Serious Adverse Events were categorized as "related to study" or "unrelated to study" as determined by the respective Institutional Review Boards after review. "Unrelated to study" indicated that, while the serious adverse occurred during the study period, was determined by the review board to not be caused by or related to the study in any appreciable way.
General disorders Serious adverse event	4.0% 1/25 • Number of events 1 • Adverse event data were collected over the full period of data collection for the study (~2 years). For participants, they were monitored from their initial time in the study until their final assessment (~6 months). Serious Adverse Events were categorized as "related to study" or "unrelated to study" as determined by the respective Institutional Review Boards after review. "Unrelated to study" indicated that, while the serious adverse occurred during the study period, was determined by the review board to not be caused by or related to the study in any appreciable way.	0.00% 0/19 • Adverse event data were collected over the full period of data collection for the study (~2 years). For participants, they were monitored from their initial time in the study until their final assessment (~6 months). Serious Adverse Events were categorized as "related to study" or "unrelated to study" as determined by the respective Institutional Review Boards after review. "Unrelated to study" indicated that, while the serious adverse occurred during the study period, was determined by the review board to not be caused by or related to the study in any appreciable way.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Gass

VA Center for Integrated Healthcare

Phone: 716-834-9200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place