Integrating health informatics in a scalable stepped care self-management program for survivors after hematopoietic cell transplantation

7.项目总结/摘要 到2030年，估计美国将有50万造血细胞移植（HCT）幸存者。HCT 与其他癌症治疗相比，幸存者的晚期死亡率和不良反应率更高。长- 长期并发症包括心血管疾病、代谢综合征和新癌症的高发病率沿着 有心理社会困难，包括癌症相关的痛苦和抑郁。这项建议 整合、扩展和改善了两个成功的HCT生存率计划， 这项研究将填补HCT幸存者护理方面的关键空白， 幸存者护理计划，提供个性化的自我管理技能和互动支持。的 建议的RCT将在HCT幸存者过渡到最需要的时候提供给他们， 在他们的移植中心进行密切监测它将结合联合收割机的在线，社会媒体和移动的应用程序 INSPIRE计划，包括个性化和HCT特异性治疗总结和生存护理计划 （SCP）。信息学将整合国际血液中心的数据和研究执行资源， 骨髓移植研究（CIBMTR）和国家骨髓捐赠者计划（NMDP）。具体目标 1）在对心脏代谢或新发癌症的医疗保健依从性较差的HCT幸存者中 监测和/或升高的癌症相关的痛苦，确定以病人为中心的，自我的， 与活性对照组相比，管理阶梯式护理方案提供了HCT存活率 最佳做法; 2）确定需要远程保健阶梯式护理的干预参与者的特征， 1个月; 3）确定维持干预措施作为国家HCT所需的资源 生存计划，如果通过CIBMTR//NMDP实施（即，费用、专门知识水平和 相对于成本的干预成分）。这些目标将在N=980的多中心RCT中实现 2-5一年HCT幸存者随机分配到一个自我管理，阶梯式护理计划开始与在线 INSPIRE程序加上个性化SCP（以电子方式填充现有CIBMTR数据资源） 并为1个月后未能改善的人增加远程健康自我管理，而不是积极控制 组提供对个性化SCP和控制网站的访问。主要结局将得到改善 在12个月时坚持心脏代谢和第二癌症监测指南和痛苦。的 拟议的干预措施使用可持续的信息管理系统进行研究管理， 干预交付，并通过增加更大的“剂量”， 通过为那些对在线方案没有反应的人增加远程保健阶梯式护理进行干预 一个人如果该计划证明有效，它可以很容易地实施，以提高护理标准 通过利用CIBMTR/NMDP的现有基础设施，在全国范围内为HCT幸存者提供服务。

7. PROJECT SUMMARY/ABSTRACT By 2030, there will be an estimated half a million hematopoietic cell transplant (HCT) survivors in the US. HCT survivors have higher rates of late mortality and adverse effects compared to other cancer treatments. Long- term complications include high rates of cardiovascular disease, metabolic syndrome, and new cancers along with psychosocial difficulties including elevated cancer-related distress and depression. This proposal integrates, extends, and improves two successful HCT survivorship programs tested in randomized controlled trials (RCTs) and will fill a critical gap in care for HCT survivors by providing a novel, technology based survivorship care program to provide personalized self-management skills and interactive support. The proposed RCT will be offered to HCT survivors at the point of their greatest need as they transition away from close monitoring at their transplant centers. It will combine an online, social media and mobile application INSPIRE program, with a personalized and HCT-specific treatment summary and survivorship care plan (SCP). Informatics will integrate the data and study conduct resources of the Center for International Blood and Marrow Transplant Research (CIBMTR) and the National Marrow Donor Program (NMDP). The specific aims are to: 1) Among HCT survivors with poor health care adherence to cardiometabolic or new cancer surveillance and/or elevated cancer-related distress, determine the impact of a patient-centered, self- management stepped care program compared to an active control group provided access to HCT survivorship best practices; 2) Determine characteristics of intervention participants who require telehealth stepped care at 1-month; and 3) Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR//NMDP (i.e., costs, level of expertise, and use of intervention components relative to costs). These aims will be accomplished in a multicenter RCT of N=980 2-5 year HCT survivors randomized to a self-management, stepped care program beginning with the online INSPIRE program plus a personalized SCP (electronically populated with existing CIBMTR data resources) and adding telehealth self-management for those who fail to improve after 1 month, versus an active control group provided access to the personalized SCP and a control website. Primary outcomes will be improved adherence to cardiometabolic and second cancer surveillance guidelines and distress at 12 months. The proposed intervention uses a sustainable informatics administration system for study management and intervention delivery, and potentially improves effect sizes of earlier studies by adding a larger ‘dose’ of the intervention through the addition of telehealth stepped care for those who do not respond to the online program alone. If the program demonstrates efficacy it could be readily implemented to improve the standard of care nationally for HCT survivors by leveraging the existing infrastructure of the CIBMTR/NMDP.