Alcohol Screening and Pre-Operative Intervention Research Study

Not Applicable

Completed

• Conditions: Alcohol Drinking
• Interventions: Behavioral: Health coaching; Behavioral: Brief advice

• Registration Number: NCT03929562
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-29
• Study Start: 2019-08-20
• Primary Completion: 2021-07-19
• Study Completion: 2021-08-17
• Results First Submitted: 2022-07-18
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Results First Posted: 2022-11-15
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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Exclusion Criteria

• Displays or shows evidence of psychotic symptoms
• Undergoing surgeries that commonly require local anesthesia only

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health coaching	Health coaching	Two health coaching sessions, resource brochure, standard of care
Brief advice	Brief advice	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States