A pragmatic pre-post intervention trial to address adherence to lung cancer screening follow-up in community settings (the ACCELL trial): Study protocol

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-10-10 DOI:10.1016/j.cct.2025.108106

Tinnie Louie , Madison Snidarich , Daniel S. Hippe , Karen J. Wernli , Lorella Palazzo , Laurel Hansell , Meagan Brown , Gloria D. Coronado , Saba Lodhi , Richard Leone , Katie DeCell , Kelly Mardesich , Nicholas Wysham , Matthew Triplette

{"title":"A pragmatic pre-post intervention trial to address adherence to lung cancer screening follow-up in community settings (the ACCELL trial): Study protocol","authors":"Tinnie Louie , Madison Snidarich , Daniel S. Hippe , Karen J. Wernli , Lorella Palazzo , Laurel Hansell , Meagan Brown , Gloria D. Coronado , Saba Lodhi , Richard Leone , Katie DeCell , Kelly Mardesich , Nicholas Wysham , Matthew Triplette","doi":"10.1016/j.cct.2025.108106","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Lung cancer remains the leading cause of cancer death in the United States. Annual lung cancer screening (LCS) with low-dose chest CT (LDCT) can prevent lung cancer deaths in high-risk individuals; However, these benefits are tempered by low adherence to annual screening and low rates of follow-up for those with abnormal findings.</div></div><div><h3>Objective</h3><div>To evaluate the impact of centralized approaches to care coordination on LCS follow-up in community settings through a hybrid implementation-effectiveness trial.</div></div><div><h3>Methods</h3><div>This is a pre-post intervention trial of a pragmatic and flexible approach to LCS care coordination delivered at the system-level at two community LCS programs based at regional hospitals in Washington state. Care coordination approaches include standardized LCS follow-up workflows incorporating universal tracking of LCS results, universal results delivery to patients, stepped approaches to follow-up reminders and personalized approaches to positive findings. Participants who are eligible for and undergo LCS during either period (n ∼ 6750) will be included. Primary outcomes include adjusted changes in screening adherence to annual follow-up and follow-up for positive findings between the pre- (August 2022–March 2025) and post- (March 2025–September 2027) intervention period. Secondary outcomes include assessing the impact of interventions by community site, patient ethnicity, socioeconomic status, and rurality. We will also assess the implementation of the intervention with attention to adaptation, sustainability and equity.</div></div><div><h3>Discussion</h3><div>Implementing centralizing care coordination models may decrease barriers and improve adherence to LCS in community settings and serve as a model to improve LCS follow-up in clinical care settings.</div><div>Registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID <span><span>NCT06324110</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108106"},"PeriodicalIF":1.9000,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425003003","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Lung cancer remains the leading cause of cancer death in the United States. Annual lung cancer screening (LCS) with low-dose chest CT (LDCT) can prevent lung cancer deaths in high-risk individuals; However, these benefits are tempered by low adherence to annual screening and low rates of follow-up for those with abnormal findings.

Objective

To evaluate the impact of centralized approaches to care coordination on LCS follow-up in community settings through a hybrid implementation-effectiveness trial.

Methods

This is a pre-post intervention trial of a pragmatic and flexible approach to LCS care coordination delivered at the system-level at two community LCS programs based at regional hospitals in Washington state. Care coordination approaches include standardized LCS follow-up workflows incorporating universal tracking of LCS results, universal results delivery to patients, stepped approaches to follow-up reminders and personalized approaches to positive findings. Participants who are eligible for and undergo LCS during either period (n ∼ 6750) will be included. Primary outcomes include adjusted changes in screening adherence to annual follow-up and follow-up for positive findings between the pre- (August 2022–March 2025) and post- (March 2025–September 2027) intervention period. Secondary outcomes include assessing the impact of interventions by community site, patient ethnicity, socioeconomic status, and rurality. We will also assess the implementation of the intervention with attention to adaptation, sustainability and equity.

Discussion

Implementing centralizing care coordination models may decrease barriers and improve adherence to LCS in community settings and serve as a model to improve LCS follow-up in clinical care settings.

Registration: ClinicalTrials.gov ID NCT06324110

查看原文本刊更多论文

一项旨在解决社区环境中肺癌筛查随访依从性的实用的干预前后试验（ACCELL试验）：研究方案。

背景：肺癌仍然是美国癌症死亡的主要原因。低剂量胸部CT （LDCT）每年肺癌筛查（LCS）可预防高危人群肺癌死亡；然而，这些益处受到年度筛查依从性低和异常结果随访率低的影响。目的：通过一项实施-有效性混合试验，评估集中护理协调方法对社区LCS随访的影响。方法：这是一项干预前试验，在华盛顿州地区医院的两个社区LCS项目中，采用实用和灵活的方法在系统层面提供LCS护理协调。护理协调方法包括标准化的LCS随访工作流程，包括LCS结果的普遍跟踪、向患者提供的普遍结果、后续提醒的分步方法和积极发现的个性化方法。符合资格并在任何一段时间内接受LCS的参与者（ ~ 6750）将被包括在内。主要结局包括在干预前（2022年8月- 2025年1月）和干预后（2025年1月- 2027年7月）期间筛查依从性和阳性结果随访的调整变化。次要结局包括根据社区地点、患者种族、社会经济地位和农村状况评估干预措施的影响。我们还将评估干预措施的实施情况，关注适应性、可持续性和公平性。讨论：实施集中护理协调模式可以减少障碍，提高社区环境中LCS的依从性，并可作为改善临床护理环境中LCS随访的模式。注册：ClinicalTrials.gov编号NCT06324110。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.