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Clinical Trials/NCT03929562
NCT03929562CompletedNot Applicable

Alcohol Screening and Pre-Operative Intervention Research Study

University of Michigan2 sites in 1 country65 target enrollmentStarted: August 20, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
65
Locations
2
Primary Endpoint
Mean Alcohol Weekly Use

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Mean Alcohol Weekly Use

Time Frame: 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 Outcomes

  • Acceptability of Intervention as Measured by the Post-intervention Evaluation.(Weeks 1-6, Immediately following intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne Fernandez

Assistant Professor of Psychiatry, Medical School

University of Michigan

Study Sites (2)

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