ASPIRE-2: Alcohol Screening and Preoperative Intervention Research Study - 2
Sponsor
University of Michigan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05783635
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
440
1
10
47
9.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
440 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
The proposed study will achieve this using a Sequential Multiple Assignment Randomized Trial (SMART) design.The proposed study will achieve this using a Sequential Multiple Assignment Randomized Trial (SMART) design.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions
Anticipated Study Start Date
:
Apr 1, 2023
Anticipated Primary Completion Date
:
Sep 1, 2026
Anticipated Study Completion Date
:
Mar 1, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Enhanced Usual Care then Usual Surgical Care Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care |
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.
Behavioral: Usual surgical care (post-operative)
This group will receive standard post-operative care.
|
| Experimental: Enhanced Usual Care then Post-operative Health Coaching Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care |
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.
Behavioral: 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.
|
| Experimental: Enhanced Usual Care then On-Track Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care |
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.
Behavioral: 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.
|
| Experimental: 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 |
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.
Behavioral: 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.
Behavioral: 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.
|
| Other: Enhanced Usual Care alone Only completed first randomization. Study withdrawal prior to re-randomization |
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.
|
| Experimental: Preoperative Virtual Health Coaching then Usual Surgical Care Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching |
Behavioral: 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.
Behavioral: Usual surgical care (post-operative)
This group will receive standard post-operative care.
|
| Experimental: Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching |
Behavioral: 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.
Behavioral: 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.
|
| Experimental: Preoperative Virtual Health Coaching then On-Track Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching |
Behavioral: 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.
Behavioral: 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.
|
| Experimental: 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 |
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
|
| Other: Preoperative Virtual Health Coaching only Only completed first randomization. Study withdrawal prior to re-randomization. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Alcohol consumption as measured by the timeline follow-back [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 Outcome Measures
- World Health Organization Drinking (WHO) Risk Level [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).
- Alcohol Use Disorder Identification test (AUDIT) [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Anne Fernandez, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Anne Fernandez,
Associate Professor of Psychiatry,
University of Michigan
ClinicalTrials.gov Identifier:
NCT05783635
Other Study ID Numbers:
- HUM00208317
- R01AA029666
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 24, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anne Fernandez,
Associate Professor of Psychiatry,
University of Michigan
Additional relevant MeSH terms: