Shared Decision Making In Pediatric Chronic Conditions: Biologics in IBD and JIA

描述（由申请人提供）：Ellen Lipstein，MD，MPH是一名初级保健儿科医生，其首要职业目标是通过根本改变家庭和护理提供者如何共同做出困难的治疗决定来改善慢性病儿童的结局。她在这里提出的研究使用决定开始治疗肿瘤坏死因子-β抑制剂（TNF-α i）作为一个复杂的儿科治疗决策的模型。这一决定发生在炎症性肠病（IBD）和幼年特发性关节炎（JIA）中，是复杂儿科决策的理想模型，因为疾病和治疗风险之间存在重大权衡，关于理想治疗时机的数据有限，以及在两种不同条件下比较决策的机会。候选人：Lipstein博士是辛辛那提儿童医院医学中心青少年医学部慢性病护理创新中心的儿科助理教授。她完成了公共卫生硕士学位，这是她儿科健康服务研究奖学金的一部分。利用这些初步培训，她进行了多项研究，重点关注父母对儿科医疗保健的偏好和医疗保健的利用。拟议的K23职业发展计划将建立在她的奖学金培训和早期职业发展的基础上，重点关注三个需要额外培训的领域，以增强她成为独立研究者的轨迹：1）儿科慢性疾病的医疗决策; 2）决策辅助开发和实施; 3）定性，调查和试验研究的高级方法学技能。Lipstein博士建议开展培训活动，包括课程、研讨会和体验式学习，使她能够获得研究和开发儿科慢性疾病决策支持干预措施的必要技能。导师/环境：Lipstein博士和她的主要导师Maria Britto，医学博士，公共卫生硕士，组建了一个强大的共同导师和顾问团队，指导Lipstein博士完成拟议的培训和研究活动。拟议的职业发展计划利用了辛辛那提大学和辛辛那提儿童学校提供的智力资源 医院，以及国家认可的研讨会和课程时，最佳培训是不提供当地。作为一个机构，辛辛那提儿童医院致力于通过内部赠款、行政支持和教师网络和教育的结构化机会来支持朱尼尔教师。此外，Lip- stein博士的研究将在胃肠病学和流变学部门进行，她的共同导师也来自该部门，这些部门都是各自领域的领导者，并为了解儿科慢性病决策的背景提供了关键机会。这两个部门还提供了大量的患者人群，允许进行拟议的研究。调研：了解决策过程和改善家庭决策是美国儿科学会医学研究所和健康人2020年目标的关键。然而，为了实现这些目标，儿科决策研究必须超越回顾性和横断面工作，并向决策过程和理论驱动的干预措施的详细了解。该提案将开始填补差距，提供所需的前瞻性数据，并产生易于适用于临床实践的信息和干预措施。目标1将使用创新的视频观察和采访，以了解目前的，纵向的决策过程，为家庭作出决定的肿瘤坏死因子。目标2将确定高质量决策的潜在可修改的障碍和促进因素。目标3将利用先前目标的结果，通过开发和试点测试一种决策支持干预措施，解决决策的关键可修改方面，来改善有关TNF i治疗的决策。这种决策支持的发展可能会提高决策的及时性，从而减少治疗的延误和更快的疾病控制。如果父母能够做出高质量的决定，减少决策的遗憾，家庭可能会得到更好的照顾，减少与决定相关的父母压力，提高家庭生活质量。总结：拟议的普通儿科、风湿病学和胃肠病学之间的创新合作将使人们能够充分了解决策背景，并最大限度地提高决策支持干预的临床适用性和未来实施。Lipstein博士的研究和临床培训，试点工作，调查-tagating ths的决定和承诺，经验丰富的导师团队，使她非常适合追求这一行的研究。该奖项将为她提供培训和研究所需的成功，在未来的大规模试验的决策支持家庭作出决定有关TNF-α i治疗IBD和JIA。此外，这项职业发展奖将促进Lipstein博士发展成为一名全国公认的独立调查员和领导者，开展研究，改善与慢性病儿童治疗相关的决策过程。

DESCRIPTION (provided by applicant): Ellen Lipstein, MD, MPH is a primary care pediatrician whose overarching career goal is to improve outcomes for children with chronic conditions through fundamental changes in how families and care providers work to- gether to make difficult treatment decisions. The research she proposes here uses the decision to initiate treatment with tumor necrosis factor-� inhibitors (TNF�i) as a model of complex pediatric treatment decisions. This decision, which occurs in both inflammatory bowel disease (IBD) and juvenile idiopathic arthritis (JIA), is an ideal model of complex pediatric decisions due to significant trade-offs between disease and treatment risks, limited data regarding the ideal timing of treatment, and the opportunity to compare the decision in two different conditions. Candidate: Dr. Lipstein is an Assistant Professor of Pediatrics in the Center for Innovation in Chronic Disease Care within the Division of Adolescent Medicine at Cincinnati Children's Hospital Medical Center. She com- pleted a Master's in Public Health as part of her fellowship in pediatric health services research. Using that ini- tial training, she has conducted multiple studies focused on parents' preferences in pediatric health care and on health care utilization. The proposed K23 career development plan will build upon her fellowship training and early career development to focus on three areas that require additional training to enhance her trajectory toward becoming an independent investigator: 1) Medical decision making in pediatric chronic disease; 2) De- cision aid development and implementation; and 3) Advanced methodologic skills in qualitative, survey, and trials research. Dr. Lipstein proposes training activities that include coursework, seminars and experiential learning to enable her to gain the necessary skills for research and development of decision support interven- tions in pediatric chronic conditions. Mentors/Environment: Dr. Lipstein and her primary mentor, Maria Britto, MD, MPH, have assembled a strong team of co-mentors and advisors to guide Dr. Lipstein through the proposed training and research activities. The proposed career development plan utilizes the intellectual resources available through the University of Cincinnati and Cincinnati Children's Hospital, as well as nationally recognized seminars and courses when op- timal training is not available locally. As an institution Cincinnati Children's Hospital is committed to supporting junir faculty members through internal grants, administrative support and structured opportunities for faculty networking and education. Additionally, the divisions of gastroenterology and rheumatology, where Dr. Lip- stein's research will be conducted and from which her co-mentors are drawn, are each leaders in their respec- tive fields and provide key opportunities for understanding the context of decision making in pediatric chronic conditions. The two divisions also provide large patient populations allowing for the conduct of the proposed research. Research: Understanding the decision process and improving family decision making are key to goals of the Institute of Medicine, American Academy of Pediatrics and Healthy People 2020. However, to achieve these goals, pediatric decision-making research must move beyond retrospective and cross-sectional work and to- wards a detailed understanding of the decision-making process and theory-driven interventions. This proposal will begin to fill the gap, provide the needed prospective data and produce information and interventions that are readily applicable to clinical practice. Aim 1 will use innovative video observation and interviews to under- stand the current, longitudinal decision process for families making decisions about TNF�i. Aim 2 will identify potentially modifiable barriers to and facilitators of high quality deciion making. Aim 3 will use the results of the prior aims to improve decision making about TNF�i treatment by developing and pilot testing a decision sup- port intervention that addresses key modifiable aspects of decision making. The development of such decision support may improve the timeliness of decision making, thus leading to decreased delays in treatment and more rapid disease control. If parents are able to make high-quality decisions with less decisional regret, fami- lies will likely experience improved care, less parental stress associated with the decision and better family quality of life. Summary: The proposed innovative collaboration between general pediatrics, rheumatology and gastroenter- ology will allow for a full understanding of the decision context and maximize the clinical applicability and future implementation of decision support interventions. Dr. Lipstein's research and clinical training, pilot work inves- tigating ths decision and committed, experienced mentorship team make her ideally suited to pursue this line of research. This award will provide her with the training and research needed to be successful in a future, large-scale trial of decision support for families making decisions about TNF�i treatment in IBD and JIA. Fur- thermore, this career development award will facilitate Dr. Lipstein's development into a nationally-recognized independent investigator and leader conducting research that improves the decision making process related to treatments for children with chronic conditions.