Alcohol Drinking
Conditions
Keywords
Elective Surgery
Brief summary
This study aims to learn more about how to improve patients' health before and after a scheduled surgery by examining acceptability and initial efficacy of pre-operative alcohol use reduction interventions.
Detailed description
The study is a randomized clinical pilot trial that assesses preliminary intervention efficacy of a two-session health coaching intervention relative to brief advice among pre-operative elective surgical patients and evaluates intervention acceptability. Study subjects will be outpatients at a large health system in the midwestern United States and fulfill the study's inclusion criteria. Subjects will be randomized to one of two intervention conditions: Health Coaching or Brief Advice.
Interventions
BEHAVIORALBrief advice
One 10-minute brief advice session
BEHAVIORALHealth coaching
Two 45-minute health coaching sessions will use a non-confrontation motivational interviewing (MI) style. Intervention delivery will include expressing concern about unhealthy drinking, 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 is ready to change. We will also include a personalized feedback component to address the links between pre-operative alcohol use and postoperative morbidity/mortality.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Referred for elective or semi-elective surgery or pre-operative assessment in the next 120 days * Meet criteria for risky drinking as defined by study staff
Exclusion criteria
* Displays or shows evidence of psychotic symptoms * Undergoing surgeries that commonly require local anesthesia only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Alcohol Weekly Use | Baseline through 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Weeks 1-6, Immediately following intervention | 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 |
Countries
United States
Participant flow
Pre-assignment details
14 of 65 enrolled participants were not assigned to groups because they did not meet eligibility requirements after enrollment (i.e. surgery cancelation).
Participants by arm
| Arm | Count |
|---|---|
| Brief Advice One 10-minute brief advice session. | 26 |
| 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. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1 Month Follow Up to 4 Month Follow Up | Lost to Follow-up | 2 | 0 |
| 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 |
Baseline characteristics
| Characteristic | Brief Advice | Health Coaching | Total |
|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 13.9 | 49.4 years STANDARD_DEVIATION 14.4 | 47.7 years STANDARD_DEVIATION 14.1 |
| Alcohol Use Disorders Identification Test (AUDIT-C) Score | 6.4 units on a scale STANDARD_DEVIATION 1.4 | 6.2 units on a scale STANDARD_DEVIATION 1.5 | 6.3 units on a scale STANDARD_DEVIATION 1.5 |
| Drinks consumed per week | 13.8 Drinks consumed/week STANDARD_DEVIATION 12.5 | 10.7 Drinks consumed/week STANDARD_DEVIATION 7.8 | 12.3 Drinks consumed/week STANDARD_DEVIATION 10.5 |
| Highest Education College graduate | 15 Participants | 11 Participants | 26 Participants |
| Highest Education High school/GED | 3 Participants | 2 Participants | 5 Participants |
| Highest Education Post college | 4 Participants | 5 Participants | 9 Participants |
| Highest Education Some college | 4 Participants | 6 Participants | 10 Participants |
| Highest Education Some high school | 0 Participants | 1 Participants | 1 Participants |
| Marital Status Married | 16 Participants | 12 Participants | 28 Participants |
| Marital Status Not Married | 10 Participants | 13 Participants | 23 Participants |
| Percentage of Days Abstinent | 47.8 Percentage STANDARD_DEVIATION 33.8 | 52.8 Percentage STANDARD_DEVIATION 32.8 | 50.3 Percentage STANDARD_DEVIATION 33 |
| Percentage of Weeks Exceeding Moderate Drinking | 54.1 Percentage STANDARD_DEVIATION 39.6 | 43.7 Percentage STANDARD_DEVIATION 38.9 | 49.0 Percentage STANDARD_DEVIATION 39.2 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic Ethnicity | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Other Race | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 20 Participants | 44 Participants |
| Region of Enrollment United States | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
| Surgical Service Colorectal | 1 Participants | 0 Participants | 1 Participants |
| Surgical Service Endocrine | 1 Participants | 1 Participants | 2 Participants |
| Surgical Service Gynecology | 1 Participants | 1 Participants | 2 Participants |
| Surgical Service Hepatobiliary | 0 Participants | 1 Participants | 1 Participants |
| Surgical Service Minimally Invasive | 5 Participants | 2 Participants | 7 Participants |
| Surgical Service Orthopedic | 6 Participants | 7 Participants | 13 Participants |
| Surgical Service Plastic | 11 Participants | 12 Participants | 23 Participants |
| Surgical Service Urology | 1 Participants | 1 Participants | 2 Participants |
| Surgical Stay Inpatient | 4 Participants | 6 Participants | 10 Participants |
| Surgical Stay Outpatient | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 0 / 26 | 0 / 25 |
| serious Total, serious adverse events | 1 / 26 | 3 / 25 |
Outcome results
Primary
Mean Alcohol Weekly Use
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.
Time frame: Baseline through 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Advice | Mean Alcohol Weekly Use | 4-Month Follow Up | 8.15 Drinks consumed/week | Standard Deviation 3.08 |
| Brief Advice | Mean Alcohol Weekly Use | 1-Month Follow Up | 7.01 Drinks consumed/week | Standard Deviation 3.12 |
| Health Coaching | Mean Alcohol Weekly Use | 1-Month Follow Up | 6.07 Drinks consumed/week | Standard Deviation 2.13 |
| Health Coaching | Mean Alcohol Weekly Use | 4-Month Follow Up | 6.44 Drinks consumed/week | Standard Deviation 1.91 |
Secondary
Acceptability of Intervention as Measured by the Post-intervention Evaluation.
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
Time frame: Weeks 1-6, Immediately following intervention
Population: Among the Brief Advice participants only 23 completed this survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brief Advice | Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Very Satisfied (4) | 15 Participants |
| Brief Advice | Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Mostly Satisfied (3) | 8 Participants |
| Health Coaching | Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Mostly Satisfied (3) | 4 Participants |
| Health Coaching | Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Very Satisfied (4) | 20 Participants |
| Health Coaching Session 2 | Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Mostly Satisfied (3) | 1 Participants |
| Health Coaching Session 2 | Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Very Satisfied (4) | 23 Participants |