Trial Outcomes & Findings for Alcohol Screening and Pre-Operative Intervention Research Study (NCT NCT03929562)
NCT ID: NCT03929562
Last Updated: 2022-11-15
Results Overview
Average (i.e. mean) weekly alcohol use was assessed using the timeline followback measure. The timeline followback assesses alcohol use using a calendar format on which participants report the number of standard drinks they consumed each day during the assessment period. In the United States, one standard drink (or one alcoholic drink equivalent), is defined as any beverage containing 0.6 oz or 14 grams of pure alcohol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Baseline through 4 months
Results posted on
2022-11-15
Participant Flow
14 of 65 enrolled participants were not assigned to groups because they did not meet eligibility requirements after enrollment (i.e. surgery cancelation).
Participant milestones
| Measure |
Brief Advice
One 10-minute educational and feedback intervention delivered 4 weeks prior to surgery.
|
Health Coaching
Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change.
|
|---|---|---|
|
From Baseline to 1 Month Follow Up
STARTED
|
26
|
25
|
|
From Baseline to 1 Month Follow Up
COMPLETED
|
22
|
24
|
|
From Baseline to 1 Month Follow Up
NOT COMPLETED
|
4
|
1
|
|
1 Month Follow Up to 4 Month Follow Up
STARTED
|
22
|
24
|
|
1 Month Follow Up to 4 Month Follow Up
COMPLETED
|
20
|
24
|
|
1 Month Follow Up to 4 Month Follow Up
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Brief Advice
One 10-minute educational and feedback intervention delivered 4 weeks prior to surgery.
|
Health Coaching
Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change.
|
|---|---|---|
|
From Baseline to 1 Month Follow Up
Lost to Follow-up
|
2
|
1
|
|
From Baseline to 1 Month Follow Up
Withdrawal by Subject
|
2
|
0
|
|
1 Month Follow Up to 4 Month Follow Up
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Alcohol Screening and Pre-Operative Intervention Research Study
Baseline characteristics by cohort
| Measure |
Brief Advice
n=26 Participants
One 10-minute brief advice session.
|
Health Coaching
n=25 Participants
Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 13.9 • n=99 Participants
|
49.4 years
STANDARD_DEVIATION 14.4 • n=107 Participants
|
47.7 years
STANDARD_DEVIATION 14.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic Ethnicity
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Marital Status
Married
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Marital Status
Not Married
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Highest Education
Some high school
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Highest Education
High school/GED
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Highest Education
Some college
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Highest Education
College graduate
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Highest Education
Post college
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Surgical Stay
Inpatient
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Surgical Stay
Outpatient
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Surgical Service
Plastic
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Surgical Service
Orthopedic
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Surgical Service
Minimally Invasive
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Surgical Service
Endocrine
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Surgical Service
Gynecology
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Surgical Service
Urology
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Surgical Service
Colorectal
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Surgical Service
Hepatobiliary
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Alcohol Use Disorders Identification Test (AUDIT-C) Score
|
6.4 units on a scale
STANDARD_DEVIATION 1.4 • n=99 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 1.5 • n=107 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 1.5 • n=206 Participants
|
|
Drinks consumed per week
|
13.8 Drinks consumed/week
STANDARD_DEVIATION 12.5 • n=99 Participants
|
10.7 Drinks consumed/week
STANDARD_DEVIATION 7.8 • n=107 Participants
|
12.3 Drinks consumed/week
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Percentage of Days Abstinent
|
47.8 Percentage
STANDARD_DEVIATION 33.8 • n=99 Participants
|
52.8 Percentage
STANDARD_DEVIATION 32.8 • n=107 Participants
|
50.3 Percentage
STANDARD_DEVIATION 33.0 • n=206 Participants
|
|
Percentage of Weeks Exceeding Moderate Drinking
|
54.1 Percentage
STANDARD_DEVIATION 39.6 • n=99 Participants
|
43.7 Percentage
STANDARD_DEVIATION 38.9 • n=107 Participants
|
49.0 Percentage
STANDARD_DEVIATION 39.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline through 4 monthsAverage (i.e. mean) weekly alcohol use was assessed using the timeline followback measure. The timeline followback assesses alcohol use using a calendar format on which participants report the number of standard drinks they consumed each day during the assessment period. In the United States, one standard drink (or one alcoholic drink equivalent), is defined as any beverage containing 0.6 oz or 14 grams of pure alcohol.
Outcome measures
| Measure |
Brief Advice
n=26 Participants
One 10-minute brief advice session.
|
Health Coaching
n=25 Participants
Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change.
|
Health Coaching Session 2
This 45-minute Health Coaching session was delivered 2 weeks prior to surgery. The session was based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Session 2 focused on alcohol use and surgical risk reduction in the 6 weeks after surgery. Intervention delivery included education about alcohol use and surgical risk, reviewing change since session 1, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set or maintain a drinking goal if he/she was ready to change.
|
|---|---|---|---|
|
Mean Alcohol Weekly Use
1-Month Follow Up
|
7.01 Drinks consumed/week
Standard Deviation 3.12
|
6.07 Drinks consumed/week
Standard Deviation 2.13
|
—
|
|
Mean Alcohol Weekly Use
4-Month Follow Up
|
8.15 Drinks consumed/week
Standard Deviation 3.08
|
6.44 Drinks consumed/week
Standard Deviation 1.91
|
—
|
SECONDARY outcome
Timeframe: Weeks 1-6, Immediately following interventionPopulation: Among the Brief Advice participants only 23 completed this survey.
Interventions will be considered 'acceptable' if the average acceptability rating reaches a threshold of 3 or more on a 4-point Likert scale where a score of 4 is most acceptable. Satisfaction 1. Quite dissatisfied 2. Mildly dissatisfied 3. Mostly satisfied 4. Very satisfied
Outcome measures
| Measure |
Brief Advice
n=23 Participants
One 10-minute brief advice session.
|
Health Coaching
n=24 Participants
Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change.
|
Health Coaching Session 2
n=24 Participants
This 45-minute Health Coaching session was delivered 2 weeks prior to surgery. The session was based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Session 2 focused on alcohol use and surgical risk reduction in the 6 weeks after surgery. Intervention delivery included education about alcohol use and surgical risk, reviewing change since session 1, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set or maintain a drinking goal if he/she was ready to change.
|
|---|---|---|---|
|
Acceptability of Intervention as Measured by the Post-intervention Evaluation.
Mostly Satisfied (3)
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Acceptability of Intervention as Measured by the Post-intervention Evaluation.
Very Satisfied (4)
|
15 Participants
|
20 Participants
|
23 Participants
|
Adverse Events
Brief Advice
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Coaching
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brief Advice
n=26 participants at risk
One 10-minute brief advice session.
|
Health Coaching
n=25 participants at risk
Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post-op Surgical complications, Surgical and Medical Procedures
|
3.8%
1/26 • 4 Months
|
12.0%
3/25 • 4 Months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place