Alcohol Screening and Preoperative Intervention Research Study - 2

Alcohol Drinking Clinical Trial

— ASPIRE-2  

Official title:

Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783635
• Other study ID #: HUM00208317
• Secondary ID: R01AA029666
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Anne Fernandez
• Phone: 734-232-0313
• Email: acfernan[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: March 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Completed consent form, baseline survey, and enrollment phone call

2. Willingness to comply with all study procedures and availability for the duration of the study

3. Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks

4. Score = 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications

5. Access to a smart device or computer access with internet or wi-fi connection throughout the study period

Exclusion Criteria:

1. Exclude participants enrolled in another research study focused on alcohol use

2. History of severe alcohol withdrawal

3. Unable to speak, understand, or read English

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Enhanced Usual Care (pre-operative)
The enhanced usual care will receive standard surgical care, and a resource brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources. The resource brochure will be e-mailed to patients or sent via postal mail.
• Preoperative Virtual Health Coaching
Preoperative Virtual Coaching is based on principles of health coaching, collaborative care, and motivational interviewing. Health and educational content is framed using the Health Belief Model. During two sessions, that take place approximately 3 and 5 weeks prior to surgery, the health coach presents alcohol use reduction/abstinence as important for surgical health (rather than addiction or chronic health reasons) and engages participants in discussion and patient-centered goal-setting. Participants will also receive a brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources.
• Usual surgical care (post-operative)
This group will receive standard post-operative care.
• Postoperative Virtual Health Coaching
Postoperative Virtual Coaching uses the same framework and structure as Preoperative Virtual Coaching. These sessions will be delivered by a health coach using a collaborative, and motivational interviewing-based approach. The goal of these sessions is to promote well-being and help participants maintain alcohol abstinence or reduction long-term (or initiate change in alcohol use if they have not already). These sessions promote low-risk alcohol use, provide education on chronic health effects of heavy alcohol use, and teach skills for coping with or avoiding triggers for alcohol use including coping with stress and mood challenges. These sessions introduce skills to help participants manage alcohol, stress, and mood as they recover from surgery.
• On-Track (Post-operative)
On-Track is a mobile and web-accessible health tool that uses self-monitoring and provision of feedback on progress towards goals to engage participants in self-management of alcohol use and motivate behavior change through increased self-awareness and accountability for health. The On-Track application includes a) daily tracking of alcohol and other substance use; b) daily tracking of stress, mood, and pain; c) personalized health goals; and d) visual displays of alcohol use, stress, mood, pain, and goal achievement including graphs of trends over time. On-Track also uses novel monetary and non-monetary incentives to encourage utilization including an escalating monetary incentive schedule for self-monitoring.

Locations

Country	Name	City	State
United States	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	Alcohol consumption as measured by the timeline follow-back	Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including average drinks/day.	10 months after surgical discharge
Secondary	World Health Organization Drinking (WHO) Risk Level	WHO drinking risk levels derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).	10 months after surgical discharge
Secondary	Alcohol Use Disorder Identification test (AUDIT)	We will calculate participant's total score on the AUDIT measure. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use and presence of more alcohol use disorder symptoms.	Up to 10 months after surgical discharge