Alcohol Screening and Preoperative Intervention Research Study - 2
NCT ID: NCT05783635
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
440 participants
INTERVENTIONAL
2023-04-17
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Enhanced Usual Care then Usual Surgical Care
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
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.
Usual surgical care (post-operative)
This group will receive standard post-operative care.
Enhanced Usual Care then Post-operative Health Coaching
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
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.
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.
Enhanced Usual Care then On-Track
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
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.
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.
Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
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.
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.
Enhanced Usual Care alone
Only completed first randomization. Study withdrawal prior to re-randomization
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 then Usual Surgical Care
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
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.
Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
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.
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.
Preoperative Virtual Health Coaching then On-Track
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
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.
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.
Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
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.
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.
Preoperative Virtual Health Coaching only
Only completed first randomization. Study withdrawal prior to re-randomization.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. History of severe alcohol withdrawal
3. Unable to speak, understand, or read English
21 Years
75 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Michigan
OTHER
Responsible Party
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Anne Fernandez
Associate Professor of Psychiatry
Principal Investigators
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Anne Fernandez
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00208317
Identifier Type: -
Identifier Source: org_study_id
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