Alcohol Screening and Preoperative Intervention Research Study - 2 (ASPIRE-2)

University of Michigan

Status: Enrolling

Conditions: Alcohol Drinking

Treatments: Behavioral: Enhanced Usual Care (pre-operative); Behavioral: Postoperative Virtual Health Coaching; Behavioral: Usual surgical care (post-operative); Behavioral: Preoperative Virtual Health Coaching; Behavioral: On-Track (Post-operative)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05783635

R01AA029666 (U.S. NIH Grant/Contract)

HUM00208317

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completed consent form, baseline survey, and enrollment phone call
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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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440 participants in 10 patient groups

Enhanced Usual Care then Usual Surgical Care

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

Treatment:

Behavioral: Usual surgical care (post-operative)

Behavioral: Enhanced Usual Care (pre-operative)

Enhanced Usual Care then Post-operative Health Coaching

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

Treatment:

Behavioral: Postoperative Virtual Health Coaching

Behavioral: Enhanced Usual Care (pre-operative)

Enhanced Usual Care then On-Track

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

Treatment:

Behavioral: On-Track (Post-operative)

Behavioral: Enhanced Usual Care (pre-operative)

Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

Treatment:

Behavioral: On-Track (Post-operative)

Behavioral: Postoperative Virtual Health Coaching

Behavioral: Enhanced Usual Care (pre-operative)

Enhanced Usual Care alone

Other group

Description:

Only completed first randomization. Study withdrawal prior to re-randomization

Treatment:

Behavioral: Enhanced Usual Care (pre-operative)

Preoperative Virtual Health Coaching then Usual Surgical Care

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

Treatment:

Behavioral: Preoperative Virtual Health Coaching

Behavioral: Usual surgical care (post-operative)

Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

Treatment:

Behavioral: Preoperative Virtual Health Coaching

Behavioral: Postoperative Virtual Health Coaching

Preoperative Virtual Health Coaching then On-Track

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

Treatment:

Behavioral: On-Track (Post-operative)

Behavioral: Preoperative Virtual Health Coaching

Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)

Experimental group

Description:

Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

Treatment:

Behavioral: On-Track (Post-operative)

Behavioral: Preoperative Virtual Health Coaching

Behavioral: Postoperative Virtual Health Coaching

Preoperative Virtual Health Coaching only

Other group

Description:

Only completed first randomization. Study withdrawal prior to re-randomization.

Treatment:

Behavioral: Preoperative Virtual Health Coaching