Faro Jamie M, Orvek Elizabeth A, Blok Amanda C, Nagawa Catherine S, McDonald Annalise J, Seward Gregory, Houston Thomas K, Kamberi Ariana, Allison Jeroan J, Person Sharina D, Smith Bridget M, Brady Kathleen, Grosowsky Tina, Jacobsen Lewis L, Paine Jennifer, Welch James M, Sadasivam Rajani S
Division of Health Informatics and Implementation Science, Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.
Center for Healthcare Organization and Implementation Research, Bedford Veterans Affairs Medical Center, Bedford, MA, United States.
JMIR Res Protoc. 2019 Jul 23;8(7):e14814. doi: 10.2196/14814.
Smoking continues to be the leading preventable cause of death. Digital Interventions for Smoking Cessation (DISCs) are health communication programs accessible via the internet and smartphones and allow for greater reach and effectiveness of tobacco cessation programs. DISCs have led to increased 6-month cessation rates while also reaching vulnerable populations. Despite this, the impact of DISCs has been limited and new ways to increase access and effectiveness are needed.
We are conducting a hybrid effectiveness-dissemination study. We aim to evaluate the effectiveness of a machine learning-based approach (recommender system) for computer-tailored health communication (CTHC) over a standard CTHC system based on quit rates and risk reduction. In addition, this study will assess the dissemination of providing access to a peer recruitment toolset on recruitment rate and variability of the sample.
The Smoker-to-Smoker (S2S) study is a 6-month hybrid effectiveness dissemination trial conducted nationally among English-speaking, current smokers aged ≥18 years. All eligible participants will register for the DISC (Decide2quit) and be randomized to the recommender system CTHC or the standard CTHC, followed by allocation to a peer recruitment toolset group or control group. Primary outcomes will be 7-day point prevalence and risk reduction at the 6-month follow-up. Secondary outcomes include recruitment rate, website engagement, and patient-reported outcomes collected via the 6-month follow-up questionnaire. All primary analyses will be conducted on an intent-to-treat basis.
The project is funded from 2017 to 2020 by the Patient Centered Outcomes Research Institute. Enrollment was completed in early 2019, and 6-month follow-ups will be completed by late 2019. Preliminary data analysis is currently underway.
Conducting a hybrid study with both effectiveness and dissemination hypotheses raises some unique challenges in the study design and analysis. Our study addresses these challenges to test new innovations and increase the effectiveness and reach of DISCs.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14814.
吸烟仍然是主要的可预防死因。戒烟数字干预措施（DISC）是可通过互联网和智能手机获取的健康传播项目，能提高戒烟项目的覆盖面和效果。DISC使6个月戒烟率有所提高，同时也惠及了弱势群体。尽管如此，DISC的影响有限，需要新的方法来增加其可及性和有效性。
我们正在开展一项有效性与传播相结合的研究。我们旨在基于戒烟率和风险降低情况，评估基于机器学习的方法（推荐系统）用于计算机定制健康传播（CTHC）相对于标准CTHC系统的有效性。此外，本研究将评估提供同伴招募工具集对招募率和样本变异性的传播效果。
吸烟者对吸烟者（S2S）研究是一项为期6个月的有效性与传播相结合的试验，在全国范围内针对年龄≥18岁、讲英语的当前吸烟者开展。所有符合条件的参与者将注册DISC（决定戒烟），并随机分为推荐系统CTHC组或标准CTHC组，然后再分为同伴招募工具集组或对照组。主要结局指标将是6个月随访时的7天点患病率和风险降低情况。次要结局指标包括招募率、网站参与度以及通过6个月随访问卷收集的患者报告结局。所有主要分析将基于意向性分析原则进行。
该项目由患者为中心的结局研究所在2017年至2020年期间提供资助。2019年初完成了入组，2019年底将完成6个月随访。目前正在进行初步数据分析。
开展一项包含有效性和传播假设的混合研究在研究设计和分析方面带来了一些独特挑战。我们的研究应对这些挑战，以测试新的创新方法，并提高DISC的有效性和覆盖面。
国际注册报告识别号（IRRID）：DERR1-10.2196/14814
