Interactive Multimedia Intervention to Improve Colonoscopy and Bowel Prep Adhere

描述（由申请人提供）：结直肠癌（CRC）的死亡率可以通过筛查项目来降低。无论采用何种主要方法（粪便潜血检查、乙状结肠镜检查、结肠镜检查、粪便DNA检查、计算机断层结肠镜检查[虚拟结肠镜检查]），结肠镜检查都是评估阳性筛查试验并发现或切除结肠肿瘤的必要手段。结肠镜检查质量对效果至关重要，质量的一个重要组成部分是在手术前坚持清洁肠道的准备方案；此外，它已经表明，准备方案本身是一个重要的障碍，坚持筛选。非裔美国人坚持结肠镜检查的比例较低；此外，结肠镜检查准备的依从性在这一人群中特别低，这导致结直肠癌的发病率和死亡率增加。为了解决这些问题，本SBIR将评估开发交互式多媒体干预的可行性，以增加结肠镜检查肠道准备方案的依从性。我们的假设是，一种交互式的多媒体干预，向非裔美国人传递文化敏感的信息，将提高结肠镜检查的质量，增加结肠镜检查本身的依从性，从而降低该人群的CRC死亡率。该可行性项目的第一阶段有3个具体目标：1)开发一种交互式多媒体干预试点，以提高结肠镜检查准备方案的依从性；2)在非裔美国人中进行干预试点测试，并根据结果修改干预措施；3)验证结果指标（准备质量、患者满意度、重复结肠镜检查的意愿），这些指标将用于一项大型随机试验，以测试修改后的干预措施。非裔美国患者和他们的医疗保健提供者的焦点小组将进行引出关键问题，以解决互动，多媒体干预。干预的开发将基于健康信念模型和多媒体学习认知模型的构建。试点干预措施将在计划进行结肠镜检查的非裔美国患者样本中进行测试，并根据反馈和干预措施的表现进行修订。结果测量将包括准备质量，由波士顿量表定义，并通过一种新型的基于计算机的准备评估工具进行评估，患者对准备的满意度，以及将来再次进行结肠镜检查的意愿。这些措施将在样本中进行验证，以便在目标人群中进行适当的随机对照研究。该项目的第二阶段将包括完成最终干预和实施一项随机临床试验，将交互式多媒体干预与“常规护理”进行比较，以确定干预对提高结肠镜检查准备质量的有效性。第三阶段将侧重于开发商业方面，如生产、营销和向消费者（包括医生、医院、诊所、门诊手术中心和患者）分发干预措施。虽然我们最初的努力将集中在非裔美国人身上，但我们希望交互式多媒体干预的元素可以用于其他种族和民族群体，以减少目前结直肠癌死亡率的差异。

DESCRIPTION (provided by applicant): Mortality from colorectal cancer (CRC) can be reduced through screening programs. Regardless of the primary strategy (fecal occult blood testing, sigmoidoscopy, colonoscopy, fecal DNA, computed tomographic colonography [virtual colonoscopy]) colonoscopy is required to evaluate positive screening tests and to detect or remove colonic neoplasia. Colonoscopy quality is critical to effectiveness and an essential component of quality is adherence to the preparation regimen to cleanse the bowel prior to the procedure; moreover, it has been shown that the preparation regimen itself is a significant barrier to adherence to screening. Adherence to colonoscopy is low among African Americans; moreover, adherence to the colonoscopy preparation is especially low in this population, which contributes to the increased incidence and mortality from colorectal cancer. To address these issues, this SBIR will evaluate the feasibility of developing an interactive, multimedia intervention to increase adherence to the bowel preparation regimen for colonoscopy. Our hypothesis is that an interactive, multimedia intervention delivering a culturally sensitive message to African Americans will improve the quality of the colonoscopy examination and increase adherence to colonoscopy itself, thereby reducing CRC mortality in this population. Phase I of this feasibility project has 3 specific aims: 1) develop a pilot interactive, multimedia intervention to improve adherence to the preparation regimen for colonoscopy, 2) pilot test the intervention in African Americans and revise the intervention based on outcomes, 3) validate the outcome measures (preparation quality, patient satisfaction, willingness to repeat colonoscopy) that will be used in a large, randomized trial to test the revised intervention. Focus groups of African American patients and their healthcare providers will be conducted to elicit key issues to address with the interactive, multimedia intervention. Development of the intervention will be based on constructs of the Health Belief Model and the Cognitive Model of Multi-Media Learning. The pilot intervention will be tested in a sample of African American patients scheduled for colonoscopy and revised based on feedback and performance of the intervention. The outcome measures will consist of preparation quality, defined by the Boston Scale and assessed through a novel computer-based preparation assessment tool, patient satisfaction with preparation, and willingness to have another colonoscopy in the future. These measures will be validated in the sample in order for a properly powered randomized controlled study to be conducted in the target population. Phase II of this program will consist of completion of the final intervention and implementation of a randomized clinical trial to compare the interactive, multimedia intervention with "usual care" to determine the effectiveness of the intervention to improve the quality of colonoscopy preparation. Phase III will focus on developing the commercial aspects such as production, marketing, and distribution of the intervention to consumers including physicians, hospitals, clinics, ambulatory surgery centers, as well as patients. While our initial efforts will focus on African Americans we expect that the elements of the interactive multimedia intervention can be used to target other racial and ethnic groups to reduce current disparities in colorectal cancer mortality. PUBLIC HEALTH RELEVANCE: Colonoscopy quality is essential to optimize strategies to reduce mortality from colorectal cancer. Poor preparation results in higher rates of missing cancers and pre-cancerous polyps, and increases the difficulty and duration of the procedure. Adherence to the bowel cleansing necessary to prepare the patient for colonoscopy constitutes a major barrier to not only the quality of the colonoscopy examination but also adherence to the colonoscopy itself. Our prior work demonstrates low adherence to colonoscopy among African Americans, with specific low adherence to the colonoscopy preparation. This project will develop and test a novel interactive, multimedia intervention to increase understanding and adherence to the preparation regimen for colonoscopy. Although preparation quality is important for all persons, this intervention will be targeted to African Americans since they are at increased risk of non-adherence to the preparation.