减少手术前后饮酒的连续多重分配随机试验研究方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-10-28 DOI:10.1016/j.cct.2024.107732

Xintong Ju , Jake Solka , Estevan Pena , Ashley Kocher , Richard Davies , Jennifer Waljee , Frederic C. Blow , Kelley M. Kidwell , Maureen A. Walton , Anne C. Fernandez

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引用次数: 0

摘要

背景手术前后几周内的高风险饮酒会对术后恢复造成重大风险。尽管如此，择期手术患者很少接受以酒精为重点的教育、干预或治疗。本文介绍了一项研究的方案，该方案旨在评估简短、非药物治疗方法对减少手术前后饮酒的有效性。方法酒精筛查和术前干预研究（ASPIRE-2）研究试验包括 440 名年龄在 21-75 岁之间、报告有高饮酒风险的择期非癌症手术患者。该试验采用顺序、多重分配、随机试验（SMART）设计，以测试适应性干预措施的有效性，这些干预措施包括术前虚拟健康指导（VHC）或增强型常规护理（EUC），然后根据参与者对术前研究条件的反应制定术后干预策略。干预 "反应 "的定义是术前干预后达到低风险饮酒。本研究的主要目的是1）与 EUC 相比，检查术前 VHC 开始的适应性干预在减少择期手术患者高风险饮酒方面的有效性；以及 2）确定 12 个月内持续减少饮酒的最有效术后策略。ASPIRE-2研究是一种创新方法，旨在开发适应性干预措施，以减少择期手术前的饮酒，因为饮酒会给手术和健康带来短期和长期风险。

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

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.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.