Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

 描述(由申请人提供)：结直肠癌(CRC)筛查相关发病率和死亡率的降低并不是使所有人口亚组受益。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人群中重复使用干预措施是否可以产生更大的筛查效果。为了将筛查率提高到乳腺癌和宫颈癌筛查的水平，多剂量干预可能是必要的。这项研究将利用 贝叶斯适应性设计在高度多样化的安全网临床人群中研究结直肠癌筛查。尽管越来越多的研究发现以实施意向为基础的干预措施是有效的，但还没有研究连续两次测试这种技术来提高结直肠癌筛查的接受度。CRC筛查的实施意向涉及粪便样本或结肠镜筛查的“何时”、“何处”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，对于在六个月内没有完成筛查的参与者，将再次随机选择这两种策略之一。所有干预材料将通过为索马里人定制的英语、西班牙语、尼泊尔语、缅甸语和阿拉伯语的低成本触摸屏计算机和平板电脑提供(以容纳安全网难民客户)。试点测试和形成阶段焦点小组将测试触摸屏音频、视频和图形材料对每一组的显着性和适当性(尼泊尔除外，尼泊尔材料是最近开发和试点测试的)。这项研究将在9个安全网初级保健诊所的500名符合CRC筛查条件的患者中进行。所有参与者将完成一份触摸屏管理的筛查表、知情同意、基线调查，并收到有关测试选项的信息。由于服务不足者的保险格局迅速变化，我们将不会覆盖超过已有或为每个参与者获得的保险范围的测试费用。在6个月内完成筛查的参与者将只接受一次HE或I2。那些没有筛查的人将接受第二次干预剂量和保险状况的重新评估，以测试HE+HE、HE+I2、I2+I2或I2+HE对结直肠癌筛查完成的不同组合效果。健康覆盖范围的变化或变化将作为协变量进行分析。为期6个月和12个月的电话调查将与所有参与者一起完成。初步结果将是在12个月内完成结直肠癌筛查。次要结果将来自对主要结果和协变量的调解分析。我们将对干预措施及其可变组成部分进行成本分析。这项研究将提供关于嵌入低成本、基于实施意图的干预措施的效用和可行性的重要信息 “现实世界”的初级保健，随着时间的推移，它们可能对重复应用具有成本效益，而难以促进诸如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.