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

7.项目摘要/摘要 到2030年，美国估计将有50万造血细胞移植(HCT)幸存者。血细胞比容 与其他癌症治疗相比，幸存者的晚期死亡率和不良反应更高。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生率。 有心理社会困难，包括癌症相关的痛苦和抑郁加剧。这项建议 整合、扩展和改进两个在随机对照试验中测试的成功的HCT生存计划 试验(RCT)，并将通过提供一种基于技术的新颖技术来填补HCT幸存者护理方面的关键空白 生存护理计划，提供个性化的自我管理技能和互动支持。这个 拟议的随机对照试验将在HCT幸存者最需要的时候提供给他们，因为他们正在从 他们的移植中心进行了密切的监控。它将结合在线、社交媒体和移动应用程序 INSPIRE计划，具有个性化和针对HCT的治疗总结和生存护理计划 (SCP)。信息学将整合国际血液和研究中心的数据和研究行为资源 骨髓移植研究(CIBMTR)和国家骨髓捐献计划(NMDP)。具体目标 是：1)在医疗保健较差的HCT幸存者中，坚持心脏代谢性癌症或新的癌症 监测和/或提升癌症相关的痛苦，确定以患者为中心的影响，自我 与积极控制组相比，管理分级护理计划提供了获得HCT存活率的途径 最佳实践；2)确定需要远程医疗分级护理的干预参与者的特征 1个月；以及3)确定作为国家艾滋病毒/艾滋病持续干预所需的资源 如果通过CIBMTR//NMDP实施生存计划(即成本、专业知识水平和使用 与成本相关的干预组成部分)。这些目标将在N=980的多中心随机对照试验中实现 2-5年的HCT幸存者随机参加自我管理的分级护理计划，从在线开始 INSPIRE计划和个性化SCP(以电子方式填充现有CIBMTR数据资源) 对于那些在1个月后没有改善的人，添加远程健康自我管理，而不是主动控制 小组提供了对个性化SCP和控制网站的访问。初步结果将得到改善 坚持心脏代谢和第二癌症监测指南，并在12个月时感到痛苦。这个 拟议的干预措施使用可持续的信息学管理系统进行研究管理和 干预传递，并潜在地改善早期研究的效果大小，通过添加更大剂量的 通过为那些对在线计划没有反应的人增加远程医疗分步护理进行干预 独自一人。如果该方案显示出有效性，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幸存者提供援助。

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.