A Rapid-Throughput Feedback Intervention for Population-Scale Communication Quali

描述（由申请人提供）： 本申请涉及广泛的挑战领域（02）生物伦理学，以及特定的挑战主题02-OD（OSP）-101“新兴技术带来的独特伦理问题”。" 背景基因和分子检测技术已迅速扩展到新生儿筛查计划，几乎每个美国新生儿都使用。这些技术为一些婴儿带来了生物医学益处，但对更多具有假阳性或遗传携带者结果的婴儿造成了令人不安的心理社会危害。需要一种机制来确保筛查利大于弊，以确保新生儿筛查肺部囊性纤维化（CF）和血液镰状细胞血红蛋白病（SCH）的长期存活。由于许多心理社会问题是父母对结果意义的误解的结果，我们正在通过开发一种机制来评估和改善临床医生与父母沟通的过程和结果来应对挑战。我们以前开发了一种通信评估方法，是可行的，用于人口规模，使用排练和质量指标的方法来操作个人行为，如行话的数量和相对时间，理解的评估，和具体的内容消息。在目前的研究中，我们将开发和评估一种快速吞吐量技术，为临床医生提供有关其沟通质量指标评分的反馈和支持。 目标。(1)为了试点测试和最终设计的快速吞吐量的反馈和支持干预，旨在改善新生儿筛查CF和SCH后的沟通过程。（2）为了确定是否快速提供反馈通过“报告卡”将提高临床医生的沟通质量指标得分。该提案还响应了美国复苏和再投资法案的经济刺激目标，雇用了6名新员工，并与两家美国小企业合作，进行我们的研究转录和软件开发。 方法.我们已经调整了我们的沟通评估方法，以便在快速吞吐量的时间轴上完成，这对参与的临床医生来说应该是立即有用的。该项目包括三个时间紧迫的阶段。在第1阶段（1-2个月），我们将最终确定报告卡的信息内容和附带的支持材料，并雇用和培训新员工，以完成快速吞吐程序。在第2阶段（3-6个月），我们将与一系列住院医师一起对该程序进行试点测试。第3阶段（7-22个月）将是一项随机对照试验，对通过随机搜索AMA主文件确定的400名儿童保健提供者的报告卡和材料进行研究。参与者在一组沟通质量指标上的得分将在基线和后续行动中进行测量，之后将随机抽样，报告卡反馈和支持材料。意义改善沟通据说是解决生物伦理问题的一个重要办法，有大量的数据表明临床医生的沟通存在问题。大多数以前公布的努力，以评估和改善沟通需要更多的资源比将是可行的日常广泛使用。提高沟通质量的有效机制将有助于回答生物伦理学家关于遗传筛查安全性的挑战，并确保新生儿CF和SCH筛查利大于弊。从长远来看，我们相信，一种改善沟通的人群规模方法将使其他专业的医疗服务提供者及其患者的经验和结果受益。美国公共卫生界几乎对每一个新生儿进行先天性疾病筛查，但对检测结果意义的误解可能导致严重的心理社会问题，引起公众关注，并推迟实施新的筛查测试。这项建议是为了应对挑战，确保使用新的筛查技术利大于弊，使新生儿筛查可以扩大其服务到新的社区。该项目将实施和评估一种人口规模的方法，旨在改善临床医生对新生儿筛查结果的沟通。

DESCRIPTION (provided by applicant): and abstract This application addresses broad Challenge Area (02) Bioethics, and specific Challenge Topic 02-OD(OSP)-101, "Unique ethical issues posed by emerging technologies." BACKGROUND. Genetic and molecular testing technologies have expanded rapidly into the newborn screening programs that are used for nearly every U.S. newborn. These techniques lead to biomedical benefit for some infants but troubling psychosocial harms for far more infants who have false positive or genetic carrier results. A mechanism is needed to insure that screening lead to more good than harm, in order to insure the long-term survival of newborn screening for the lung condition cystic fibrosis (CF) and the blood condition sickle cell hemoglobinopathy (SCH). Since many psychosocial problems are the result of parent misunderstandings about the results' significance, we are responding to the challenge by developing a mechanism to assess and improve the processes and outcomes of clinicians' communication with parents. We have previously developed a communication assessment method that is feasible for use on a population scale, using rehearsals and a quality indicator approach to operationalize individual behaviors like the number and relative timing of jargon words, assessments of understanding, and specific content messages. In the current study we will develop and evaluate a rapid-throughput technique to provide feedback and support to clinicians about their communication quality indicator scores. AIMS. (1) To pilot-test and finalize design of a rapid-throughput feedback and support intervention designed to improve processes of communication after newborn screening for CF and SCH. (2) To determine whether rapid provision of feedback via a "report card" will improve clinicians' communication quality indicator scores. The proposal also responds to the economy-stimulating goals of the American Recovery and Reinvestment Act by hiring 6 new employees and engaging with two U.S. small businesses to do our research transcription and software development. METHODS. We have adapted our communication assessment method to be done on a rapid-throughput timeline that should have immediate utility for participating clinicians. The project includes 3 tightly-timed phases. In phase 1 (months 1-2) we will finalize informational content of the report card and accompanying support materials, and hire and train the new employees to accomplish the rapid-throughput procedure. In phase 2 (months 3-6) we will pilot test the procedure with a series of resident physicians. Phase 3 (months 7-22) will be a randomized controlled trial of the report card and materials over a sample of 400 child health providers identified via a random search of the AMA Masterfile. Participant scores on a panel of communication quality indicators will be measured at baseline and follow-up after sending a random sample the report card feedback and support materials. SIGNIFICANCE. Improving communication is said to be an important solution to bioethical problems, and there is ample data about problems with clinicians' communication. Most previously published efforts to assess and improve communication require more resources than would be feasible for routine widespread use. An effective mechanism to improve communication quality will help to answer bioethicist challenges about the safety of genetic screening, and insure that newborn screening for CF and SCH lead to more good than harm. In the long run, we believe that a population-scale method to improve communication will benefit health providers in other specialties and the experiences and outcomes of their patients. The U.S. public health community screens nearly every U.S. newborn for inborn diseases, but misunderstanding about the meaning of test results can lead to serious psychosocial problems, the raising of public concerns, and delays in implementing new screening tests. This proposal responds to the challenge of insuring that more good than harm comes from use of new screening technologies, so that newborn screening may expand its services to new communities. The project will implement and evaluate a population-scale method designed to improve clinicians' communication about newborn screening results.