Patient Navigation in Medically Underserved Areas study design: A trial with implications for efficacy, effect modification, and full continuum assessment.

Patient Navigation in Medically Underserved Areas study design: A trial with implications for efficacy, effect modification, and full continuum assessment.
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患者在医疗服务不足的领域研究设计中导航:一项对功效,效果修改和完整连续体评估的试验。

DOI:
10.1016/j.cct.2016.12.001
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发表时间:
2017-02
影响因子:
2.2
通讯作者:
Calhoun EA
Calhoun EA
中科院分区:
医学4区
文献类型:
--
作者:
Molina Y;Glassgow AE;Kim SJ;Berrios NM;Pauls H;Watson KS;Darnell JS;Calhoun EA

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医疗服务不足地区的患者导航研究目的是评估导航是否改善:1)护理吸收和诊断时间; 2)取决于患者居住医疗服务不足地区(MUA)状态的结局。次要目的包括1)诊断为乳腺癌的患者中不同护理连续体点导航的有效性; 2)未获得乳腺癌诊断的患者中多次定期筛查事件。我们的随机对照试验在南芝加哥的三家社区医院进行。合格的参与者包括:1)女性,2)18岁以上,3)未怀孕,4)由初级保健提供者转介进行基于异常临床乳房检查的筛查或诊断性乳房X光检查。参与者被随机分配到1)对照护理或2)接受纵向导航,如果诊断为癌症,则通过治疗,如果无症状,则通过多年,由非专业卫生工作者进行治疗。参与者的居住区被确定为:1)已建立的MUA(1998年之前),2)新的MUA(1998年之后),3)符合/但未指定为MUA,以及4)富裕/不符合MUA。主要结果包括随机化后最初推荐治疗的天数和异常结果女性的诊断天数。次要结局涉及诊断后开始治疗的天数以及正常/良性结果后接受后续筛查的天数。这项干预措施旨在评估患者导航在整个连续体中对乳腺癌护理摄取的有效性。如果有效,该计划可能会提高早期癌症检测率和乳腺癌发病率。
The Patient Navigation in Medically Underserved Areas study objectives are to assess if navigation improves: 1) care uptake and time to diagnosis; and 2) outcomes depending on patients’ residential medically underserved area (MUA) status. Secondary objectives include the efficacy of navigation across 1) different points of the care continuum among patients diagnosed with breast cancer; and 2) multiple regular screening episodes among patients who did not obtain breast cancer diagnoses. Our randomized controlled trial was implemented in three community hospitals in South Chicago. Eligible participants were: 1) female, 2) 18+ years old, 3) not pregnant, 4) referred from a primary care provider for a screening or diagnostic mammogram based on an abnormal clinical breast exam. Participants were randomized to 1) control care or 2) receive longitudinal navigation, through treatment if diagnosed with cancer or across multiple years if asymptomatic, by a lay health worker. Participants’ residential areas were identified as: 1) established MUA (before 1998), 2) new MUA (after 1998), 3) eligible/but not designated as MUA, and 4) affluent/ineligible for MUA. Primary outcomes include days to initially recommended care after randomization and days to diagnosis for women with abnormal results. Secondary outcomes concern days to treatment initiation following a diagnosis and receipt of subsequent screening following normal/benign results. This intervention aims to assess the efficacy of patient navigation on breast cancer care uptake across the continuum. If effective, the program may improve rates of early cancer detection and breast cancer morbidity.