University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT05783635
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.
This study is active but is not currently recruiting participants.
21 year–75 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
University of Michigan
Other
Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions
Acronym: ASPIRE-2
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.
Published trials that share one or more normalized conditions with this study.
NCT05443750
Alcohol Drinking, Behavior
Gainesville, Florida, United States
View Trial DetailsNCT06687525
Alcohol Drinking, Alcohol Intoxication
Champaign, Illinois, United States
View Trial DetailsNCT05731713
Alcohol Drinking, Behavior
Seattle, Washington, United States
View Trial DetailsNCT02345122
Alcohol Drinking, Anxiety
Toronto, Ontario, Canada
View Trial Details