SBIR Phase II New Risk Assessment/Intervention For Pregnant Woman

SBIR 第二阶段针对孕妇的新风险评估/干预

• 批准号: 7108740
• 负责人: Robin Inlander
• 金额: $ 39.8万
• 依托单位: BEHAVIORAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-01 至 2008-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7108740
• 关键词: behavior; clinical research; computers; interview; pregnancy; questionnaires

DESCRIPTION (provided by applicant): Drug use is common among pregnant women, yet only an estimated 32 percent to 42 percent of prenatal care providers routinely ask patients about their use of drugs. Prenatal visits afford a unique opportunity for providers to educate women about prevention, and to detect drug use during pregnancy. To facilitate efficient use of provider resources, we developed a computerized interactive survey interview, the Pregnancy Information Program (PIP) that has been extensively tested in non-Hispanic white, Hispanic, and American Indian populations. Earlier studies demonstrated that the PIP was well received in multiple ethnic/racial pregnant populations. More importantly, the PIP evoked more honest responses regarding drug use and other socially stigmatized behaviors than paper-and-pencil questionnaires. In Phase I we updated the program, integrated current diagnostic standards, added a tailored motivational intervention, and incorporated audio and video elements to the program. For this Phase II project, we propose to further enhance the software capabilities, expand the domains of use to clinicians, and develop a commercial quality CD ROM prototype of the entire instrument. We will beta test the completed instrument in 6 community women's clinics, to determine its acceptability and ease of use, through anonymous clinician surveys and rates of completion. We will also conduct a randomized, controlled clinical trial of 346 pregnant women to determine PIP's ability to promote behavior change from the initial to the third trimesters of pregnancy. Primary outcomes evaluated in this trial include self-reported changes in nutrition, drug use, alcohol use, cigarette smoking, HIV risk behavior, and partner abuse avoidance. We will also assess stages of readiness to change, where change is not yet manifest. Subjects in their first trimester will be randomized to complete the PIP or a computer questionnaire minus the educational and customized motivational feedback. Both groups also will receive printed educational information. In their third trimesters, subjects will complete a second computer-based questionnaire to determine current behaviors, and will participate in a personal interview regarding their reaction to PIP. Paired data will be analyzed using generalized linear mixed models to estimate differences between and within groups over time. This study will reveal the potential of the PIP to enhance prenatal healthy behaviors, and improve birth outcomes, while saving providers time.

描述（由申请人提供）：药物使用在孕妇中很常见，但估计只有32%至42%的产前护理提供者常规询问患者的药物使用情况。产前检查为提供者提供了一个独特的机会，教育妇女预防和发现怀孕期间的药物使用情况。为了促进有效利用提供者资源，我们开发了一种计算机交互式调查访谈，即妊娠信息计划（PIP），该计划已在非西班牙裔白人、西班牙裔和美洲印第安人中进行了广泛的测试。早期的研究表明，PIP在多个民族/种族的怀孕人群中得到了很好的接受。更重要的是，与纸笔问卷相比，PIP唤起了关于吸毒和其他社会污名行为的更诚实的回答。在第一阶段，我们更新了程序，整合了当前的诊断标准，增加了量身定制的动机干预，并在程序中加入了音频和视频元素。对于这个二期项目，我们建议进一步增强软件功能，将使用领域扩展到临床医生，并开发整个仪器的商业质量CD ROM原型。我们将在6个社区妇女诊所测试完成的仪器，通过匿名临床医生调查和完成率来确定其可接受性和易用性。我们还将对346名孕妇进行随机对照临床试验，以确定PIP在妊娠初期至妊娠晚期促进行为改变的能力。本试验评估的主要结局包括自我报告的营养、药物使用、酒精使用、吸烟、艾滋病毒风险行为和避免伴侣虐待的变化。我们还将评估准备改变的阶段，其中变化尚未显现。在他们的头三个月的受试者将随机完成PIP或电脑问卷减去教育和定制的动机反馈。两组还将收到印刷的教育信息。在孕晚期，受试者将完成第二份基于计算机的问卷，以确定他们当前的行为，并将参加关于他们对PIP反应的个人访谈。配对数据将使用广义线性混合模型进行分析，以估计组间和组内随时间的差异。这项研究将揭示PIP在提高产前健康行为和改善分娩结果方面的潜力，同时节省提供者的时间。