Evaluating chronic disease approaches to ameliorate tobacco-related health disparities: Study protocol of a hybrid type 1 implementation-effectiveness trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-10-16 DOI:10.1016/j.conctc.2024.101380

Steven S. Fu , Patrick Hammett , David Nelson , Andrew Busch , Warren McKinney , Pravesh Sharma , Christi A. Patten , Nathalia Gutierrez Sacasa , Lynn Andreae , Sandra Japuntich

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引用次数: 0

Abstract

Background

Black, Indigenous, and People of Color (BIPOC) communities experience higher prevalence of cardiovascular disease and related chronic conditions compared to White communities due to disparities in tobacco exposure. Smoking can be effectively treated but evidence-based treatments are less likely to be offered to or used by BIPOC patients. We present the study protocol of the Smoking Cessation Outreach for Racial Equity (SCORE) trial that tests the effect of adding longitudinal care coordination to current standard of care for smoking cessation to promote health equity among BIPOC patients.

Methods

Longitudinal Proactive Outreach (LPO; 4 culturally tailored outreach call cycles over one year by motivational interviewing trained counselors to connect patients to cessation counseling and medication) will be added to the current standard of care, Ask-Advise-Connect (AAC; primary care providers asking all patients if they smoke, and if smoking, advising to quit and connecting to treatment). We will conduct a hybrid type 1 implementation-effectiveness trial to examine the direct effect of AAC + LPO (a multilevel health system intervention) vs. AAC on population-level combustible tobacco abstinence at 18 months and treatment utilization among 2000 BIPOC adults who smoke across two healthcare systems in Minnesota. Participants will be surveyed at 6, 12, and, 18 months post-enrollment to assess outcomes. The primary outcome is biochemically confirmed combustible cigarette abstinence at 18 months.

Discussion

LPO has potential to promote health equity by addressing barriers caused by structural racism, including access to care, care fragmentation, and provider racism, by systematically reaching out to all BIPOC patients who smoke.

Clinicaltrialsgov

NCT05671380.

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评估改善烟草相关健康差异的慢性病方法：混合型 1 类实施效果试验研究方案

背景黑人、原住民和有色人种（BIPOC）社区与白人社区相比，由于烟草接触方面的差异，心血管疾病及相关慢性病的发病率更高。吸烟可以得到有效治疗，但以证据为基础的治疗方法却较少提供给有色人种患者或被他们使用。我们介绍了 "促进种族公平的戒烟推广"（SCORE）试验的研究方案，该试验测试了在目前的戒烟标准护理中增加纵向护理协调以促进 BIPOC 患者健康公平的效果。方法将在现行标准护理 "询问-建议-连接"（AAC；初级保健提供者询问所有患者是否吸烟，如果吸烟，则建议戒烟并连接到治疗）的基础上增加 "纵向主动外展"（LPO；由受过动机访谈训练的咨询师在一年内进行 4 次文化定制的外展呼叫周期，为患者提供戒烟咨询和药物治疗）。我们将在明尼苏达州的两个医疗系统中对 2000 名吸烟的 BIPOC 成年人进行混合型 1 类实施效果试验，研究 AAC + LPO（多层次医疗系统干预）与 AAC 相比，对 18 个月后人群可燃烟草戒断率和治疗利用率的直接影响。参与者将在加入后 6 个月、12 个月和 18 个月接受调查，以评估结果。讨论LPO具有促进健康公平的潜力，它通过系统地接触所有BIPOC吸烟患者，解决了结构性种族主义造成的障碍，包括获得医疗服务、医疗服务的分散性和医疗服务提供者的种族主义。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles 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 a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.