Alcohol Screening and Preoperative Intervention Research Study - 2
ASPIRE-2
Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions
2 other identifiers
interventional
440
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
May 5, 2026
January 1, 2026
3.9 years
March 13, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
World Health Organization Drinking (WHO) Risk Level
10 months after surgical discharge
Alcohol Use Disorder Identification test (AUDIT)
Up to 10 months after surgical discharge
Study Arms (10)
Enhanced Usual Care then Usual Surgical Care
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
Enhanced Usual Care then Post-operative Health Coaching
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
Enhanced Usual Care then On-Track
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
Enhanced Usual Care alone
OTHEROnly completed first randomization. Study withdrawal prior to re-randomization
Preoperative Virtual Health Coaching then Usual Surgical Care
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
Preoperative Virtual Health Coaching then On-Track
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)
EXPERIMENTALRandomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
Preoperative Virtual Health Coaching only
OTHEROnly completed first randomization. Study withdrawal prior to re-randomization.
Interventions
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 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.
This group will receive standard post-operative care.
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Exclude participants enrolled in another research study focused on alcohol use
- History of severe alcohol withdrawal
- Unable to speak, understand, or read English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Fernandez
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
April 17, 2023
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
May 5, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The research team will share data with NIAAA data archive (NIAAADA) biannually per funder requirements. The data in the NIAAADA are catalogued and made available to the general research community at the time of an associated publication or end of the award/support period, whichever comes first. Data in the NIAAADA is available indefinitely.
- Access Criteria
- Community of scientists interested in the study of alcohol use and related interventions. Additionally, data submitted to National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) will be accessible by the general research community via NIAAADA.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded investigators conducting applicable human subjects research are expected to submit de-identified, individual-level data to this data archive. The data generated in this grant will also be presented at national or international meetings (e.g., Research Society on Alcoholism, Addiction Health Services Research, etc.) and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive in PubMed Central.