Evidence map›Paper›PMID 39490767›Full record

ArticleContemporary clinical trials2024

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

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

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Xintong JuDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Jake SolkaDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Estevan PenaDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Ashley KocherDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Richard DaviesDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Jennifer WaljeeSection of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, United States; Overdose Prevention Engagement Network, University of Michigan, Ann Arbor, MI, United States.
Frederic C BlowDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Kelley M KidwellDepartment of Biostatistics, University of Michigan, School of Public Health, Ann Arbor, MI, United States.
Maureen A WaltonDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Anne C FernandezDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA. Electronic address: acfernan@umich.edu.

Funding

Reducing Alcohol use among Elective Surgical Patients using Adaptive InterventionsR01AA029666 · NIAAA · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Lara Nicole Coughlin, Anne Christie Fernandez · 2022 to 2026
$3.0M
NIAAA NIH HHS R01 AA029666
6 · The paper itself

Abstract

backgroundHigh-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.

methodsThe 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.

conclusionThe 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.

Indexed as

Alcohol DrinkingElective Surgical ProceduresAdultAgedFemaleHumansMaleMentoringMiddle AgedPreoperative CareRandomized Controlled Trials as TopicYoung AdultAdaptive interventionAlcohol useElective surgeryPostoperative recoverySequential multiple assignment randomized trial (SMART)

Identifiers

PMID39490767
PMCPMC12866601

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.