PRAGMATIC CLUSTER RANDOMIZED TRIAL OF AN ASTHMA INTERVENTION FOR URBAN TEENS

针对城市青少年哮喘干预的务实集群随机试验

• 批准号: 8675933
• 负责人: Christine LM Joseph
• 金额: $ 75.5万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8675933
• 关键词: Ambulatory Care Facilities; Arts; Asthma; Back; Behavior Therapy; Cancer Research Network; Caring; Case Report Form; Childhood; Cities; Clinic; Clinic Visits; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Collection; Computerized Medical Record; Computers; Conduct Clinical Trials; Consent; Cost Analysis; Coupled; Data; Data Collection; Data Coordinating Center; Databases; Decision Making; Development; Diagnosis; Effectiveness; Electronics; Elements; Eligibility Determination; Enrollment; Epidemiologist; Evaluation; Funding; Futility; Future; Goals; Head; Health; Health Sciences; Health system; Individual; Informed Consent; Intervention; Leadership; Measures; Medical; Medical Records; Methods; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Heart, Lung, and Blood Institute; Nature; Observational Study; Online Systems; Outcome; Participant; Patient Care; Patient Outcomes Assessments; Patient Recruitments; Patient Self-Report; Patients; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Physicians; Pilot Projects; Population Study; Procedures; Process; Public Health; Randomized; Recording of previous events; Regimen; Research; Research Design; Research Infrastructure; Research Personnel; Retrieval; Safety; Schools; Site; Specific qualifier value; Structure; Teenagers; Testing; Time; base; clinical infrastructure; clinical research site; comparative effectiveness; cost; cost effective; cost efficient; data management; design; effective intervention; effectiveness research; experience; follow-up; improved; innovation; meetings; member; multidisciplinary; programs; randomized trial; tool; virtual

DESCRIPTION (provided by applicant): Clinical trials are critical for medical decision making, however, under the current paradigm, clinical trials are fraught with problems, including low enrollment of eligible patients, poor study compliance and high cost for the specialized infrastructure for study conduct. Most trials are of an explanatory nature (i.e., efficacy under ideal, highly controlled conditions) rather than pragmatic (evidence of effectiveness in a real clinical situation). Comparative effectiveness methods (CEM) seek to reduce the inefficiency and high cost of clinical trials while comparing effective interventions in a real world setting wih decisions tailored to individual patient needs. CEM strategies, such as electronic initiatives, the use of centralized databases with remote data capture (RDC), and integration of the electronic medical record (EMR) with RDC for trial data collection, patient enrollment, and data management, are revolutionizing the conduct of clinical trials through cost reduction and improved efficiency. The objective of this proposal is 1) to implement a seamless clinical trial lifecycle using EMR initiatives and 2) to design and conduct a Phase II trial using EMR-RDC integration to evaluate an asthma management program for urban teens in a clinical setting. Urban clinics from Henry Ford Health System of Detroit and Kaiser Permanente of Atlanta will participate. Both are members of the HMO Research Network (HMORN) which has developed an innovative Virtual Data Warehouse (VDW) for common EMR data collection. The specific aims of this proposal are: Aim 1 Design a Phase II pragmatic cluster randomized trial of a web-based asthma management intervention in teens with asthma attending urban clinics, using adaptive approaches to plan a future Phase III trial. Aim 2: Use electronic initiatives for patient enrollment and management including EMR back-end and front-end for patient recruitment, online consent, and electronic monitoring of intervention compliance and follow-up. Aim 3: Establish and maintain a centralized Oracle Clinical infrastructure with RDC integration to EMR/VDW and electronic patient reported outcomes (ePROs). Our pragmatic approach with electronic initiatives will (a) minimize the need for new infrastructure for trial conduct; (b) maximize electronic retrieval of clinical endpoints (thereby minimizing the need for non-routine care clinic visits); (c) allow exploration of web-based patient assent/consent; (d) allow electroni monitoring of compliance to study regimen, and (e) maximize external validity. We will randomize 9 clinics with 250 teens for this Phase II trial (pilot study) to test feasibility, validty and cost of the trial. Using elements of the adaptive design for clinical trials, we will assess futility and feasibility of the proposed intervention. If no futility is observed, we will seek funing for a Phase III trial with more HMORN sites and a larger study population.

描述（由申请人提供）：临床试验对于医疗决策至关重要，然而，在当前范式下，临床试验充满了问题，包括合格患者入组率低、研究依从性差以及用于研究进行的专门基础设施成本高。大多数试验都是解释性的（即在理想、高度控制的条件下的疗效）而不是实用性的（在真实临床情况下的有效性证据）。比较有效性方法 (CEM) 旨在减少临床试验的低效率和高成本，同时将现实世界中的有效干预措施与根据患者个体需求量身定制的决策进行比较。 CEM 战略，例如电子举措、 使用带有远程数据采集 (RDC) 的集中式数据库，以及将电子病历 (EMR) 与 RDC 集成以进行试验数据收集、患者登记和数据管理，正在通过降低成本和提高效率来彻底改变临床试验的进行。该提案的目标是 1) 使用 EMR 举措实施无缝临床试验生命周期，2) 使用 EMR-RDC 集成设计和进行 II 期试验，以评估临床环境中城市青少年的哮喘管理计划。底特律亨利·福特医疗系统和亚特兰大凯撒医疗机构的城市诊所将参与其中。两者都是 HMO 研究网络 (HMORN) 的成员，该网络开发了用于常见 EMR 数据收集的创新虚拟数据仓库 (VDW)。该提案的具体目标是： 目标 1 设计一项 II 期实用整群随机试验，对到城市诊所就诊的哮喘青少年进行基于网络的哮喘管理干预，并使用适应性方法规划未来的 III 期试验。目标 2：为患者使用电子举措 登记和管理，包括用于患者招募的 EMR 后端和前端、在线同意以及干预依从性和随访的电子监控。目标 3：建立和维护集中式 Oracle Clinical 基础架构，将 RDC 集成到 EMR/VDW 和电子患者报告结果 (ePRO)。我们采用电子举措的务实方法将 (a) 最大限度地减少对进行试验的新基础设施的需求； (b) 最大限度地电子检索临床终点（从而最大限度地减少非常规护理诊所就诊的需要）； (c) 允许探索基于网络的患者同意/同意； (d) 允许对研究方案的依从性进行电子监测，并且 (e) 最大限度地提高外部有效性。我们将随机抽取 9 家诊所的 250 名青少年进行这项 II 期试验（试点研究），以测试试验的可行性、有效性和成本。利用临床试验的适应性设计要素，我们将评估所提议干预措施的无效性和可行性。如果没有观察到无效性，我们将寻求资助进行更多 HMORN 站点和更大研究人群的 III 期试验。