Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

 描述（由申请人提供）：结直肠癌（CRC）筛查相关的发病率和死亡率降低并未使所有人群亚组受益。在临床环境中，随着时间的推移，经常需要对相同的患者重复尝试促进筛查。很少有研究评估在服务不足的群体中重复使用干预措施是否可以产生更大的筛查。多剂量干预可能是必要的，以提高筛查率的水平与乳腺癌和宫颈癌筛查。这项研究将利用一个 贝叶斯自适应设计研究在高度多样化的安全网诊所人群中进行CRC筛查。尽管越来越多的研究发现实施基于意图的干预措施是有效的，但没有研究连续两次测试这种技术以提高CRC筛查的吸收。CRC筛查实施意图解决粪便样本或结肠镜检查筛查的“何时”、“何地”和“如何”细节。随机设计将测试一般健康教育（HE）与实施意图（I2）的比较条件，对于在六个月内未完成筛选的参与者，将再次随机分配到这两种策略中的一种。所有干预材料都将通过低成本的触摸屏电脑和平板电脑提供，这些电脑和平板电脑专门为索马里人设计，有英语、西班牙语、尼泊尔语、缅甸语和阿拉伯语版本（以适应安全网难民客户）。试点测试和形成阶段重点小组将测试触摸屏音频、视频和图形材料对每个小组的突出性和适当性（尼泊尔语除外，尼泊尔语的材料是最近开发和试点测试的）。该研究将在一组9个安全网初级保健诊所中对500名符合CRC筛查条件的患者进行。所有参与者将完成触摸屏管理的筛选表、知情同意书、基线调查，并接收有关测试选项的信息。由于服务不足者的保险环境迅速变化，我们将不会支付超出已到位或为每位参与者获得的保险范围的测试费用。在6个月内完成筛选的受试者将仅接受一次HE或I2治疗。未进行筛查的患者将接受第二次干预剂量并重新评估保险状态，以测试HE +HE、HE + I2、I2 + I2或I2 + HE对CRC筛查完成的不同组合效应。健康保险的变化或变化将作为协变量进行分析。将对所有参与者进行为期6个月和12个月的电话调查。主要结局为12个月时完成CRC筛选。次要结果将来自主要结果和协变量的中介分析。我们将对干预措施及其可变组成部分进行成本分析。这项研究将提供重要的信息，说明将低成本、基于执行意图的干预措施嵌入 “现实世界”的初级保健，其中它们可能具有成本效益，随着时间的推移重复应用，难以促进诸如CRC筛查等行为。

 DESCRIPTION (provided by applicant): Colorectal cancer (CRC) screening related reductions in incidence and mortality are not benefiting all population subgroups. In clinical settings, repeat attempts at promoting screening are often required over time with the same patients. Few studies have evaluated whether repeated use of interventions in underserved groups can produce greater screening. Multi 'dose' interventions may be necessary to elevate screening rates to levels seen with breast and cervical cancer screening. This study will utilize a Bayesian adaptive design to study CRC screening in a highly diverse, safety-net clinic population. Although a growing number of studies have found implementation intentions-based interventions effective, no studies have tested such techniques twice in sequence to enhance CRC screening uptake. CRC screening implementation intentions address the "when," "where" and "how" details of stool sample or colonoscopy screening. A randomized design will test a comparison condition of generic health education (HE) versus implementation intentions (I2), and, for participants who do not complete screening within six months, will re-randomize to one of these two strategies again. All intervention materials will be delivered via low-cost touch screen computers and tablets customized for use in English, Spanish, Nepali, Burmese, and Arabic for Somalis (to accommodate safety-net refugee clients). Pilot testing and formative phase focus groups will test the salience and appropriateness of touch screen audio, video, and graphic materials for each of these groups (except Nepali, where materials were recently developed and pilot tested). The study will be conducted with 500 patients eligible for CRC screening in a group of 9 safety- net primary care clinics. All participants will complete a touch screen administered screening form, informed consent, a baseline survey, and receive information on test options. Because of the rapidly changing insurance landscape for the underserved, we will not cover test costs beyond coverage already in place or obtained for each participant. Participants who complete screening within 6 months will only receive HE or I2 once. Those who do not screen will receive a second intervention dose and re-assessment of insurance status to test varied combination effects of HE +HE, HE + I2, I2 + I2, or I2 + HE on CRC screening completion. Changes or variations in health coverage will be analyzed as a co-variate. Six and 12-month phone surveys will be completed with all participants. The primary outcome will be CRC screening completion at 12 months. Secondary outcomes will come from a mediation analysis of the main outcome and co-variates. We will conduct a cost analysis of the intervention and its variable components. This study will provide important information on the utility and feasibility of embedding low-cost, implementation intentions-based interventions in "real-world" primary care, where they may be cost effective for repeated application over time with difficult to promote behaviors such as CRC screening.