Alcohol Screening and Pre-Operative Intervention Research Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alcohol Screening and Pre-Operative Intervention Research Study

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Behavioral: Brief advice
* Behavioral: Health coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief advice<br>One brief advice session, resource brochure, standard of care, and an infographic about alcohol and surgical health at patient's pre-existing pre-operative clinical visit. | Behavioral: Brief advice<br>* One 10-minute brief advice session<br>|
| Experimental: Health coaching<br>Two health coaching sessions, resource brochure, standard of care | Behavioral: Health coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Quite dissatisfied Mildly dissatisfied Mostly satisfied Very satisfied | Weeks 1-6, Immediately following intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective Surgery