Alcohol Screening and Pre-Operative Intervention Research Study (ASPIRE)

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Brief advice; Behavioral: Health coaching

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Brief advice; One 10-minute brief advice session
Experimental: Health coaching; Two health coaching sessions, resource brochure, standard of care	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Anne Fernandez, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): August 17, 2021

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Elective Surgery
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: HUM00156743; 5K23AA023869 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The researchers will plan to share individual participant data that underlies the results reported in an article, after deidentification (text, tables, figures, and appendices), Study protocol, and Informed Consent Form.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No