Alcohol Screening and Pre-Operative Intervention Research Study

Alcohol Drinking Clinical Trial

— ASPIRE  

Official title:

Alcohol Screening and Pre-Operative Intervention Research Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929562
• Other study ID #: HUM00156743
• Secondary ID: 5K23AA023869
• Status: Completed
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: August 17, 2021

Study information

• Verified date: October 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 17, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Brief advice
One 10-minute brief advice session
• Health coaching
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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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