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评估改善烟草相关健康差异的慢性病方法:1型混合实施-有效性试验的研究方案

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

作者信息

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

机构信息

Department of Medicine, University of Minnesota, Minneapolis, MN, USA.

Hennepin Healthcare Research Institute, Minneapolis, MN, USA.

出版信息

Contemp Clin Trials Commun. 2024 Oct 16;42:101380. doi: 10.1016/j.conctc.2024.101380. eCollection 2024 Dec.

DOI:10.1016/j.conctc.2024.101380
PMID:39498443
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11533523/
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.

摘要

背景

与白人社区相比,黑人、原住民和有色人种(BIPOC)社区由于烟草暴露方面的差异,心血管疾病及相关慢性病的患病率更高。吸烟可以得到有效治疗,但循证治疗方案较少提供给BIPOC患者,或较少被他们采用。我们介绍了种族平等戒烟外展(SCORE)试验的研究方案,该试验旨在测试在当前戒烟标准治疗中增加纵向护理协调,以促进BIPOC患者的健康公平。

方法

将纵向主动外展(LPO;由接受动机性访谈培训的咨询师在一年内进行4个针对不同文化的外展电话周期,将患者与戒烟咨询和药物联系起来)添加到当前的标准治疗方案“询问-建议-联系”(AAC;初级保健提供者询问所有患者是否吸烟,如果吸烟,建议戒烟并联系治疗)中。我们将进行一项混合型1类实施-有效性试验,以检验AAC + LPO(一种多层次卫生系统干预措施)与AAC相比,在18个月时对明尼苏达州两个医疗系统中2000名吸烟的BIPOC成年人的总体可燃烟草戒断率和治疗利用率的直接影响。参与者将在入组后的6个月、12个月和18个月接受调查,以评估结果。主要结果是18个月时经生化确认的可燃香烟戒断情况。

讨论

LPO有可能通过系统地联系所有吸烟的BIPOC患者,解决结构性种族主义造成的障碍,包括获得医疗服务的机会、医疗服务碎片化和提供者种族主义,从而促进健康公平。

临床试验注册

NCT05671380

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbf3/11533523/8f4dd8c73a19/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbf3/11533523/6ebc62e35e71/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbf3/11533523/8f4dd8c73a19/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbf3/11533523/6ebc62e35e71/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbf3/11533523/8f4dd8c73a19/gr2.jpg

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