Pragmatic Trial

务实试用

• 批准号: 10674001
• 负责人: MICHAEL J MORRIS
• 金额: $ 31.91万
• 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/10674001
• 关键词: Acceleration; Agonist; Ambulatory Care Facilities; Blood; Breast Cancer Patient; COVID-19 pandemic; Cancer Center; Cancer Patient; Caring; Clinic Visits; Clinical; Clinical Trials; Cluster randomized trial; Collaborations; Communication; Complex; County; Custom; Data; Data Analyses; Data Science; Development; Digital biomarker; Dimensions; Economics; Effectiveness; Electronic Health Record; Eligibility Determination; Emergency Situation; Equity; 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; Poly(ADP-ribose) Polymerase Inhibitor; Population; Productivity; Protocols documentation; Quality of Care; Race; Randomized; Reporting; Research Methodology; Research Personnel; Resources; Safety; Selection for Treatments; Services; Site; Site Visit; Supervision; Surveys; System; Testing; Venous blood sampling; Vertebral column; Visit; Visiting Nurse; Visual; Work; arm; asynchronous encounter; cancer care; capecitabine; care delivery; clinical biomarkers; cluster randomized design; data streams; digital; digital platform; effectiveness outcome; effectiveness trial; effectiveness/implementation hybrid; effectiveness/implementation study; evidence base; experience; forging; health training; hormone therapy; implementation facilitators; implementation outcomes; implementation process; improved; innovation; mHealth; malignant breast neoplasm; multi-component intervention; patient engagement; patient portal; pragmatic study; pragmatic trial; preservation; primary outcome; process improvement; 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.

项目概要/摘要 MATCHES 中心的核心是一项务实的试验 MATCH-UP（MAking Telehealth-delivering of 家庭癌症护理 — 升级服务协议），我们将在 MSK 斯隆的网络中进行 门诊实践。 MATCH-UP 将是一项采用两臂研究的 I 型混合实施有效性研究 跨八个集群的集群随机设计。它将评估多成分干预措施 MSK@Home， 支持接受特定治疗的患者在家中接受常规肿瘤护理的能力 远程医疗和一套支持策略。 MSK@Home 包括家庭静脉切开术的能力，这一点至关重要 体征、治疗管理或护士的监督。 MSK@Home 的动机源于 COVID-19 大流行：尽管在紧急情况下远程医疗是可行的，但仍然需要患者 前往诊所进行实验室工作或接受治疗。让护理服务更加高效、便捷 患者、肿瘤学、临床试验、信息学、卫生系统转型和数据科学领域的专家 联手开发扩展的远程医疗模式 MSK@Home。这种干预措施包括远程医疗 培训，并为避免加深数字鸿沟，为缺乏网络和硬件访问的患者提供支持 这些资源。 MSK 斯隆网络中的 7 个门诊诊所将组成 8 个集群，并被随机分配到 MSK@Home 或乳腺癌和前列腺癌的常规护理。每个集群至少有 400 名患者， 总计 3200 名乳腺癌和前列腺癌患者的研究将使我们能够检测到有意义的影响 主要结果（回家访视的比例）以及一系列次要结果。这三年 试验的有效性结果涵盖护理质量的多个维度：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、 从不同的角度考虑适当性和可持续性。研究与方法核心将整合 来自同步和异步接触以及患者和临床医生调查的多个数据流， 实现数据分析和解释，并为日常远程医疗服务建立证据基础 癌症护理。 MATCH-UP 的具体目标是： 目标 1：确定 MSK@Home 是否有效，减少需求 亲自拜访至少 20%；目标 2：评估 MSK@Home 是否改善患者体验； 目标 3：根据临床医生的经验和经验确定 MSK@Home 是否不劣于常规护理 对质量的看法；目标 4：描述远程医疗实施的障碍和促进因素 肿瘤学。符合条件的患者将是在 MSK 斯隆接受非静脉注射治疗的前列腺癌和乳腺癌患者 治疗。这包括许多最常用的疗法，例如 GnRH 激动剂、激素 疗法、卡培他滨和 PARP 抑制剂；因此，这项务实研究的结果预计将 可广泛应用于这两种常见的恶性肿瘤，并可能改变成千上万患者的治疗方式 每年，美国以及世界各地的许多人都会得到他们的照顾。