Pilot Studies for the Active Comparator Osteoporosis Large Simple Trial (ATLAST)

主动比较骨质疏松症大型简单试验 (ATLAST) 的初步研究

• 批准号: 8233649
• 负责人: Kenneth G Saag
• 金额: $ 23.87万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8233649
• 关键词: Academy; Address; Alabama; American; Antihypertensive Agents; Award; Bone Density; Caring; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Collaborations; Communities; Community Healthcare; Community Physician; Complex; Computer software; Confidentiality; Consent; Data; Data Collection; Data Coordinating Center; Data Security; Data Set; Drug Prescriptions; Enrollment; Exclusion Criteria; FDA approved; Family Physicians; Fracture; Future; General Practices; Grant; Head; Health; Health Personnel; Informed Consent; Institutional Review Boards; Leadership; Learning; Link; Lipids; Measures; Medical; Medicare; Methods; Musculoskeletal Diseases; Myocardial Infarction; Online Systems; Osteoporosis; Outcome; Participant; Patients; Pharmaceutical Preparations; Physicians' Offices; Pilot Projects; Prevention; Procedures; Process; Provider; Public Health; Randomized; Randomized Controlled Trials; Recovery; Recruitment Activity; Research; Research Design; Research Infrastructure; Research Project Grants; Risk Estimate; Risk Reduction; Role; Running; Safety; Sample Size; Sampling; Screening procedure; Secure; Sentinel; Site; Surveys; System; Techniques; Technology; Testing; Therapeutic; Time; Translational Research; Universities; Visit; active comparator; base; bisphosphonate; clinical decision-making; clinically relevant; cohort; community based practice; comparative; comparative effectiveness; cost; cost effective; design; effectiveness research; follow-up; meetings; mortality; patient population; population based; practice-based research network; pragmatic trial; prevent; safety study; software systems; touchscreen; trial comparing; user-friendly

DESCRIPTION (provided by applicant): Despite continued increases in the number of approved therapeutics for prevention and treatment of osteoporosis, very little is known about the comparative fracture risk reduction and long-term safety of well-established and newer anti-osteoporosis drugs. Large simple clinical trials (LSTs), also known as pragmatic trials, include randomization but use minimal inclusion/exclusion criteria, allowing for study of 'real world' patient populations who are often excluded in traditional randomized controlled trials. The Active Comparator Osteoporosis Large Simple Trial (ATLAST) will be an LST of patients randomized to FDA approved anti-osteoporosis therapies that will study comparative effectiveness and safety outcomes in diverse community-based populations. As a study design efficiency, ATLAST will include the longitudinal surveillance of patient outcomes through linkage with Medicare medical claims and Part D prescription drug data. To facilitate the successful implementation of a future ATLAST study, we propose a pilot and feasibility testing that focuses on developing and refining the infrastructure and patient enrollment process. We propose to develop and test feasibility of using web- based technology developed in collaboration with Mytrus to be used in busy community physician offices. The specific aims (SAs) of this pilot grant are: SA 1) To develop new and to modify existing materials necessary for the completion of ATLAST including: a) customizing and pilot testing of interactive enrollment, informed consent, and randomization software running on a secure web-based data collection platform, b) obtaining consent and protected health information needed for linkage to Medicare data, and c) developing a patient-based osteoporosis outcomes follow-up survey; SA 2) To complete a mini-clinical trial (i.e. pilot test) of the processes and methods developed for the ATLAST study in partnerships with a sample of six geographically diverse community general practices to test the acceptance and feasibility of informed consent processes, randomization, follow-up surveys, and creation of Medicare finder files in 36 patients. Lessons learned from the ATLAST pilot study will facilitate the full- scale rollout of ATLAST that will provide major advances in community-based LSTs and osteoporosis comparative effectiveness research. PUBLIC HEALTH RELEVANCE: A pilot study will be performed to assess the feasibility of implementing a large community-based, clinical trial comparing three approved osteoporosis therapies. Specifically, we will test our advanced, web-based techniques for patient enrollment processes including screening and informed consent. Measures of technology acceptance among providers and patients and other implementation factors will be analyzed.

描述（由申请人提供）：尽管用于预防和治疗骨质疏松症的批准疗法数量不断增加，但人们对成熟的新型抗骨质疏松药物相对骨折风险降低和长期安全性知之甚少。大型简单临床试验 (LST)，也称为实用试验，包括随机化，但使用最低限度的纳入/排除标准，允许研究经常被传统随机对照试验排除的“现实世界”患者群体。主动比较骨质疏松症大型简单试验 (ATLAST) 将是一项随机接受 FDA 批准的抗骨质疏松症治疗的患者的 LST，该试验将研究不同社区人群的有效性和安全性结果的比较。作为一项研究设计效率，ATLAST 将通过与 Medicare 医疗索赔和 D 部分处方药数据相联系，对患者结果进行纵向监测。为了促进未来 ATLAST 研究的成功实施，我们提出了一项试点和可行性测试，重点是开发和完善基础设施和患者登记流程。我们建议开发和测试使用与 Mytrus 合作开发的基于网络的技术在繁忙的社区医生办公室中使用的可行性。该试点拨款的具体目标 (SA) 为： SA 1) 开发完成 ATLAST 所需的新材料并修改现有材料，包括：a) 在安全的基于网络的数据收集平台上运行的交互式注册、知情同意和随机化软件的定制和试点测试，b) 获取与医疗保险数据链接所需的同意和受保护的健康信息，以及 c) 开展基于患者的骨质疏松症结果随访调查； SA 2) 与六个不同地区的社区一般实践样本合作，完成为 ATLAST 研究开发的流程和方法的小型临床试验（即试点测试），以测试 36 名患者的知情同意流程、随机化、随访调查和创建 Medicare finder 文件的接受度和可行性。从 ATLAST 试点研究中吸取的经验教训将促进 ATLAST 的全面推广，这将为基于社区的 LST 和骨质疏松症比较有效性研究带来重大进展。 公共卫生相关性：将进行一项试点研究，以评估实施一项大型社区临床试验的可行性，比较三种已批准的骨质疏松症疗法。具体来说，我们将测试我们先进的、基于网络的患者登记流程技术，包括筛查和知情同意。将分析提供者和患者之间的技术接受程度以及其他实施因素。