Study protocol for a sequential multiple assignment randomized trial to decrease alcohol use before and after surgery

Abstract

Background: High-risk alcohol consumption in the weeks before and after surgery poses significant risks for postoperative recovery. Despite this, elective surgical patients are rarely offered alcohol-focused education, interventions, or treatment. This paper describes the protocol of a research study designed to evaluate the effectiveness of brief, non-pharmacological, therapeutic approaches to reduce alcohol use before and after surgery.

Methods: The Alcohol Screening and Preoperative Intervention Research (ASPIRE-2) study trial includes 440 elective, non-cancer, surgery patients ages 21-75 years-old who report high-risk alcohol use. This trial uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to test the effectiveness of adaptive interventions that include preoperative Virtual Health Coaching (VHC) or Enhanced Usual Care (EUC) followed by postoperative intervention strategies tailored to participant response to the preoperative study condition. Intervention "response" is defined as achieving low-risk alcohol use following the preoperative intervention. The primary aims of this study are to: 1) examine the effectiveness of adaptive interventions that begin with preoperative VHC compared to EUC in reducing high-risk alcohol use among elective surgical patients; and 2) identify the most effective postoperative strategy for lasting alcohol use reduction over a period of 12 months. Secondary and exploratory aims will identify the best performing pre-specified adaptive interventions, identify baseline and time-varying moderators of intervention effectiveness, and evaluate surgical outcomes.

Conclusion: The ASPIRE-2 study is an innovative approach to develop adaptive interventions to reduce alcohol use proximal to elective surgery when alcohol use poses short- and long-term risks to surgery and health.

Keywords: Adaptive intervention; Alcohol use; Elective surgery; Postoperative recovery; Sequential multiple assignment randomized trial (SMART).