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Clinical Trials/NCT03929562
NCT03929562
Completed
Not Applicable

Alcohol Screening and Pre-Operative Intervention Research Study

University of Michigan1 site in 1 country65 target enrollmentAugust 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Drinking
Sponsor
University of Michigan
Enrollment
65
Locations
1
Primary Endpoint
Mean Alcohol Weekly Use
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2019
End Date
August 17, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Fernandez

Assistant Professor of Psychiatry, Medical School

University of Michigan

Eligibility Criteria

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)

Study Sites (1)

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