Newborn Screening for Critical Congenital Heart Disease in U.S.: Assessment of implementation obstacles and application of cost-effectiveness to gauge if action needed for improved implementation

美国新生儿危重先天性心脏病筛查：评估实施障碍并应用成本效益来衡量是否需要采取行动来改进实施

• 批准号: 10200880
• 负责人: Rie Sakai-Bizmark
• 金额: $ 13.75万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10200880
• 关键词: Adherence; Adoption; Affect; Anxiety; Area; Attitude; Belief; Biomedical Research; Blood; Blood Circulation; Blood flow; California; Cardiac; Catheters; Characteristics; Clinical; Code; Consolidated Framework for Implementation Research; Cost Effectiveness Analysis; Data Analyses; Data Collection; Development; Diagnosis; Diffusion; Effectiveness; Eligibility Determination; Ensure; Environment; Face; Family; Funding; Future; Goals; Guidelines; Health Services Research; Hospitals; Individual; Infant; Institution; Intervention; Interview; Investments; Knowledge; Lead; Left; Life; Live Birth; Los Angeles; Medical; Medical center; Mentors; Methodology; Methods; Morbidity - disease rate; Neonatal Screening; Newborn Infant; Nurseries; Nurses; Observational Study; Operative Surgical Procedures; Oxygen; Parents; Patients; Positioning Attribute; Process; Protocols documentation; Published Comment; Pulse Oximetry; Qualitative Research; Quality of Care; Questionnaires; Research; Research Institute; Research Personnel; Research Project Grants; Resources; Screening procedure; Self Efficacy; Source; Structure; Surveys; Techniques; Time; Training; Translational Research; Unconscious State; Universities; base; career; congenital heart disorder; cost; cost effective intervention; cost effectiveness; design; follow-up; implementation cost; implementation framework; implementation science; implementation study; improved; infant outcome; innovation; meetings; mortality; professor; response; screening; screening panel; skills; uptake

This proposed study focuses on newborn screening for Critical Congenital Heart Disease (CCHD) using Pulse Oximetry, which was added to the recommended uniform screening panel (RUSP) in 2011. Challenges often face implementation of new medical screenings into the patient environment, in spite of proven effectiveness in research. Low implementation levels of screening can greatly diminish outcomes for infants, as undiagnosed CCHD can lead to greater mortality and morbidities, including developmental problems. Infants without CCHD will also be affected by low implementation because incorrect screening procedures can lead to false positive results, causing families to face anxiety and unnecessary costs for transport and further examination. Currently, over 99% of U.S. newborns are born in states that have individually mandated CCHD screening in the last 3 years, yet implementation levels in many states are low or unknown. In the study’s first aim, barriers and facilitators in the current CCHD screening implementation will be assessed through: (1) observation of CCHD screening practices at hospitals in the local area, (2) nationwide one-on-one interviews among nurse managers in nursery units, and (3) nationwide surveys of nursery nurses. A systematic assessment of multilevel implementation will be guided by the Consolidated Framework for Implementation Research (CFIR), serving as an organizational construct. Results will help tailor interventions to improve implementation. In order to estimate future implementation levels, the nurses’ survey will be conducted at two time points (years three and five). For our second aim, we will use cost-effectiveness analysis (CEA). With CEA, the difference in cost-effectiveness between current and future years will be calculated. Results will determine whether diffusion (natural adoption of a technique over time) is enough to bring about desired levels of implementation, or if investment is needed to accomplish desired levels of cost-effective interventions. The Parent K01 is an important mechanism for reaching my career goal to become an independent investigator in health services research. Support will allow me to extend my research acumen into my primary focus of implementation science, from both a qualitative and quantitative approach. Up until this point, my focus and practice has been clinical and quantitative. K01 provides me with training in skills I have not had time or the opportunity to develop, including qualitative research interview methodologies, survey design and administration, and cost-effectiveness analysis. I hold an Assistant Professor position at Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, with access to many resources at UCLA Westwood, Charles R. Drew University, and RAND. Moreover, I have the support of an incredible team of outstanding mentors from these UCLA-associated institutions. Research in implementation science and cost- effectiveness analysis will drive my future career direction when I seek funding through an R01 mechanism.

这项拟议的研究重点是使用脉冲的新生儿筛查（CCHD） 血氧蛋白法，在2011年添加到推荐的统一筛选面板（RUSP）中。 尽管有公认的有效性，但面对患者环境的新医疗检查 研究。筛查的实施水平较低，可以大大减少婴儿的结果，因为未诊断 CCHD可以导致更大的死亡率和病态，包括发育问题。没有CCHD的婴儿 也将受到低实施的影响，因为错误的筛选程序会导致假阳性 结果，导致家庭面临动画和不必要的运输成本和进一步检查。 目前，超过99％的美国新生儿出生于已在 最近三年，但是在许多州的实施水平较低或未知。 在研究的第一个目标中，将评估当前CCHD筛查实施中的障碍和促进者 通过：（1）在当地医院观察CCHD筛查实践，（2）全国一对一的 护士单位护士经理的访谈，以及（3）对护士护士的国家调查。系统 多层次实施的评估将由合并框架进行指导 研究（CFIR），作为组织结构。结果将有助于裁缝干预措施改善 执行。为了估计未来的实施水平，护士的调查将在两个 时间点（第三年和五年）。为了我们的第二个目标，我们将使用成本效益分析（CEA）。和 CEA将计算当前和未来几年之间成本效益的差异。结果将 确定扩散（随着时间的时间的自然采用）是否足以实现所需的水平 实施，或者需要投资以达到具有成本效益的干预措施的水平。 家长K01是实现我的职业目标的重要机制 卫生服务研究研究者。支持将使我能够将研究敏锐度扩展到主要 实施科学的重点，来自定性和定量方法。到目前为止，我 重点和实践是临床和定量的。 K01为我提供了我没有时间的技能培训 或有机会开发的机会，包括定性研究访谈方法，调查设计和 管理和成本效益分析。我在洛杉矶担任助理教授职位 Harbour-UCLA医疗中心生物医学研究所，在UCLA获得许多资源 Westwood，Charles R. Drew University和Rand。而且，我得到了一支令人难以置信的团队的支持 来自这些与加州大学洛杉矶分校相关的机构的杰出导师。实施科学和成本研究 当我通过R01机制寻求资金时，有效性分析将推动我未来的职业发展。