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Completed

NCT Number: NCT03929562

Alcohol Screening and Pre-Operative Intervention Research Study

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Advice

Behavioral

One 10-minute brief advice session

Health Coaching

Behavioral

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.

Primary outcomes

  1. 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

  1. Acceptability of Intervention as Measured by the Post-intervention Evaluation.

    Time frame: 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

    • Quite dissatisfied
    • Mildly dissatisfied
    • Mostly satisfied
    • Very satisfied

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: ASPIRE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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