Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

适应性干预以最大限度地提高安全网人群的结直肠筛查率

基本信息

批准号：
9898331
负责人：
K ALLEN GREINER
金额：
$ 86.47万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-08 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9898331
关键词：
Accounting Address Adherence African American Age Baseline Surveys Bayesian Modeling Behavior Behavior Therapy Behavioral Belief Burmese Cancer Etiology Cessation of life Client Clinic Clinical Colonoscopy Colorectal Colorectal Cancer Computers Cost Analysis Custom Dose Educational Intervention Evidence based intervention Failure Focus Groups Health Health Care Reform Health education Healthcare Healthcare Systems Incidence Individual Informed Consent Insurance Insurance Coverage Intervention Latino Linguistics Low Income Population Low income Measures Mediating Mediation Medicaid Multimedia Outcome Outcome Study Participant Pathway interactions Patient Preferences Patients Phase Population Primary Health Care Privatization Process Protocols documentation Provider Randomized Refugees Reporting Research Resources Sampling Sequential Multiple Assignment Randomized Trial Subgroup Surveillance Program Surveys Tablets Techniques Telephone Testing Time Uninsured Variant adaptive intervention arm base breast and cervical cancer screening cancer health disparity cohort colorectal cancer screening comparative effectiveness cost cost effective cost estimate design effective intervention follow-up improved innovation intervention cost mortality patient oriented primary outcome program costs programs public health relevance safety net satisfaction screening secondary outcome stool sample success theories touchscreen uptake

项目摘要

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.

描述（由适用提供）：结直肠癌（CRC）筛查相关的发病率和死亡率降低并不能使所有人口亚组受益。在临床环境中，随着时间的流逝，与同一患者的重复尝试通常需要进行促进筛查。很少有研究评估在服务不足的组中反复使用干预措施是否可以产生更大的筛查。可能需要进行多种“剂量”干预措施，以将筛查率提高到乳腺癌和宫颈癌筛查的水平。这项研究将利用在高度多样化的安全网诊所人群中研究CRC筛查的贝叶斯自适应设计。尽管越来越多的研究发现基于实施意图的干预措施有效，但没有研究对此类技术进行了两次测试以增强CRC筛查的吸收。 CRC筛选实施意图解决了粪便样本或结肠镜检查筛查的详细信息的“何时”，“ where”和“ where”。随机设计将测试通用健康教育（HE）与实施意图（I2）的比较条件（I2），对于在六个月内未完成筛选的参与者将再次重新授予这两种策略之一。所有干预材料将通过低成本触摸屏计算机和平板电脑进行交付，用于用于英语，西班牙语，尼泊尔，缅甸和阿拉伯语的索马里人（以容纳安全网难民客户）。试点测试和形成阶段焦点小组将对每个组中的每个组测试触摸屏音频，视频和图形材料的显着性和适当性（尼泊尔除外，最近开发了材料并进行了试点测试）。这项研究将与500名有资格在9个安全净初级保健诊所中进行CRC筛查的患者进行。所有参与者将完成触摸屏管理筛选表，知情同意，基线调查以及接收有关测试选项的信息。由于服务不足的保险格局迅速变化，因此我们不会承担超出已经到位或为每个参与者获得的测试费用。在6个月内完成筛查的参与者只会接受一次HE或I2。那些不筛选的人将获得第二次干预剂量和对保险状态的重新评估，以测试He + He，He + I2，I2 + I2或I2 + HE的各种组合效果。健康覆盖范围的变化或变化将被分析为共同变化。所有参与者将完成六个月和12个月的电话调查。主要结果将是CRC筛查在12个月时完成。次要结果将来自对主要结果和共同变化的调解分析。我们将对干预及其可变成分进行成本分析。这项研究将提供有关将基于低成本，实施意图嵌入基于实施意图的效用和可行性的重要信息 “现实世界”的初级保健，它们可能会随着时间的推移重复应用具有成本效益，并且难以促进CRC筛查等行为。