Pragmatic Trial

务实试用

• 批准号: 10454673
• 负责人: MICHAEL J MORRIS
• 金额: $ 22.31万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10454673
• 关键词: Agonist; Ambulatory Care Facilities; Breast Cancer Patient; COVID-19 pandemic; Cancer Center; Cancer Patient; Caring; Clinic Visits; Clinical; Cluster randomized trial; Communication; Complex; County; Custom; Data; Data Analyses; Data Science; Development; Dimensions; Economics; Effectiveness; Electronic Health Record; Emergency Situation; Ethnic Origin; GNRH1 gene; Geography; Goals; Health system; Home; Home Care Services; Informatics; Internet; Intervention; Intramuscular; Laboratories; Long Island; Malignant Neoplasms; Malignant neoplasm of prostate; Medicine; Mission; Modeling; Motivation; New Jersey; Nurses; Oncology; Oral; Outpatients; Patient Care; Patients; Perception; Persons; Policies; Population; Process; Protocols documentation; Quality of Care; Race; Randomized; Reporting; Research Methodology; Research Personnel; Resources; Safety; Services; Site; Site Visit; Supervision; Surveys; System; Testing; Time; Training; Venous blood sampling; Vertebral column; Visit; Visiting Nurse; Visual; arm; asynchronous encounter; base; cancer care; cancer clinical trial; capecitabine; care delivery; clinical biomarkers; data streams; design; digital; effectiveness implementation study; effectiveness outcome; effectiveness study; effectiveness trial; evidence base; experience; hormone therapy; implementation facilitators; implementation outcomes; implementation process; improved; inhibitor; innovation; mHealth; malignant breast neoplasm; multi-component intervention; patient engagement; patient portal; pragmatic trial; preservation; primary outcome; programs; prostate cancer model; routine care; secondary outcome; stem; subcutaneous; synchronous contact; telehealth; tool; treatment as usual; virtual visit

PROJECT SUMMARY/ABSTRACT The centerpiece of the MATCHES Center is a pragmatic trial, MATCH-UP (MAking Telehealth-delivery of Cancer Care at Home—Upscaled Services Protocol), which we will conduct across MSK’s network of outpatient practices. MATCH-UP will be a Type I hybrid implementation-effectiveness study with a two-arm cluster-randomized design across eight clusters. It will assess a multi-component intervention, MSK@Home, which supports the ability of patients receiving select therapies to receive routine oncology care at home via telehealth and a suite of enabling strategies. MSK@Home includes capacity for at-home phlebotomy, vital signs, and treatment administration or supervision by nurses. The motivation for MSK@Home stems from the COVID-19 pandemic: although telehealth was feasible under emergency conditions, patients were still required to visit the clinic for labwork or to receive therapy. To make care delivery more efficient and convenient for patients, experts in oncology, clinical trials, informatics, health system transformation, and data science have joined forces to develop the expanded telehealth model, MSK@Home. This intervention includes telehealth training and, to avoid deepening the digital divide, support for web and hardware access for patients lacking these resources. Seven outpatient clinic sites in MSK’s network will make up eight clusters to be randomized to MSK@Home or to usual care for breast and prostate cancers. A minimum of 400 patients per cluster, for a total of 3200 patients split between breast and prostate cancer, will power us to detect meaningful effects in the primary outcome (proportion of visits at home) as well as an array of secondary outcomes. This three-year trial’s effectiveness outcomes span multiple dimensions of care quality: efficiency, safety, timeliness, equity, and the patient and clinician experience. Implementation outcomes include feasibility, acceptability, appropriateness, and sustainability from the diverse perspectives. The Research & Methods Core will integrate the multiple data streams from synchronous and asynchronous encounters and patient and clinician surveys, enabling analysis and interpretation of the data and building the evidence base for telehealth-delivery in routine cancer care. MATCH-UP’s specific aims are: Aim 1: to determine if MSK@Home is efficient, reducing the need for in-person visits by at least 20%; Aim 2: to assess whether MSK@Home improves the patient experience; Aim 3: to determine if MSK@Home is non-inferior to usual care based on clinicians’ experiences and perceptions of quality; Aim 4: to characterize the barriers and facilitators to implementation of telehealth in oncology. Eligible patients will be prostate and breast cancer patients treated at MSK with non-intravenous therapy. This includes many of the most commonly administered therapies such as GnRH agonists, hormonal therapies, capecitabine, and the PARP inhibitors; therefore, the results of this pragmatic study are expected to be broadly generalizable for these two common malignancies and could transform how thousands of patients each year in the U.S., and many more worldwide, receive their care.

项目总结/摘要 MATCHES中心的核心是一项务实的试验，MATCH-UP（制造远程医疗-提供 家庭癌症护理-升级服务协议），我们将在MSK的网络中进行， 门诊实践。MATCH-UP将是一项I型混合实施有效性研究， 8个群集的群集随机化设计。它将评估一个多组成部分的干预，MSK@Home， 它支持接受选定治疗的患者在家中接受常规肿瘤护理的能力， 远程保健和一套扶持战略。MSK@Home包括家庭静脉切开术、重要 体征和治疗管理或护士的监督。MSK@Home的动机源于 2019冠状病毒病大流行：尽管远程医疗在紧急情况下是可行的，但仍需要患者 去诊所做实验或接受治疗。为了使护理服务更有效和方便， 患者，肿瘤学，临床试验，信息学，卫生系统转型和数据科学专家， 联手开发扩展的远程保健模式MSK@Home。这种干预措施包括远程保健 培训，并为避免加深数字鸿沟，支持缺乏网络和硬件的患者访问 这些资源。MSK网络中的七个门诊诊所将组成八个集群， 对于乳腺癌和前列腺癌，MSK@Home或常规护理。每个群集至少400名患者， 总共有3200名患者分为乳腺癌和前列腺癌，将使我们能够检测到有意义的影响， 主要结局（在家访视的比例）以及一系列次要结局。这个为期三年 试验的有效性结果涵盖了护理质量的多个方面：效率，安全性，及时性，公平性， 以及患者和临床医生的经验。实施结果包括可行性、可接受性、 从不同的角度来看，可持续性。研究与方法核心将整合 来自同步和异步就诊以及患者和临床医生调查的多个数据流， 能够对数据进行分析和解释，并为日常远程保健服务建立证据库 癌症护理MATCH-UP的具体目标是：目标1：确定MSK@Home是否有效， 目标2：评估MSK@Home是否改善了患者体验; 目的3：根据临床医生的经验，确定MSK@Home是否不劣于常规护理， 目标4：描述在非洲实施远程保健的障碍和促进因素， 肿瘤学合格的患者将是在MSK接受非静脉注射治疗的前列腺癌和乳腺癌患者。 疗法这包括许多最常用的治疗方法，如GnRH激动剂、激素 治疗，卡培他滨和PARP抑制剂;因此，这项务实研究的结果预计将 对于这两种常见的恶性肿瘤， 每年在美国，以及世界各地更多的人，接受他们的护理。