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Active, Not Recruiting

NCT Number: NCT05783635

Alcohol Screening and Preoperative Intervention Research Study - 2

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Completed consent form, baseline survey, and enrollment phone call
  • Willingness to comply with all study procedures and availability for the duration of the study
  • Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks
  • Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications
  • Access to a smart device or computer access with internet or wi-fi connection throughout the study period

Exclusion criteria

  • Exclude participants enrolled in another research study focused on alcohol use
  • History of severe alcohol withdrawal
  • Unable to speak, understand, or read English

Treatment and study plan

Enhanced Usual Care (pre-operative)

Behavioral

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

Behavioral

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)

Behavioral

This group will receive standard post-operative care.

Postoperative Virtual Health Coaching

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Alcohol consumption as measured by the timeline follow-back

    Time frame: 10 months after surgical discharge

    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.

Secondary outcomes

  1. World Health Organization Drinking (WHO) Risk Level

    Time frame: 10 months after surgical discharge

    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).

  2. Alcohol Use Disorder Identification test (AUDIT)

    Time frame: Up to 10 months after surgical discharge

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions

Acronym: ASPIRE-2

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2023
Registry last updated
May 5, 2026

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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