Pragmatic Trial

务实试用

基本信息

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
项目类别：
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

项目摘要

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 MATCH-UP 将是一项采用两臂的 I 型混合实施效果研究。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包括至关重要的家庭静脉切开术的能力。 MSK@Home 的动机来自于护士的体征、治疗管理或监督。 COVID-19 大流行：尽管在紧急情况下可以进行远程医疗，但仍然需要患者前往诊所进行实验室检查或接受治疗，使护理服务更加高效和方便。患者、肿瘤学、临床试验、信息学、卫生系统转型和数据科学领域的专家联手开发扩展的远程医疗模型 MSK@Home 该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将由 MSK 斯隆网络中的 7 个门诊诊所组成，并被随机分配到 8 个集群中。 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这三年的主要成果（回家访视的比例）以及一系列次要成果。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、患者和临床医生的经验包括可行性、可接受性、研究与方法核心将整合不同角度的适当性和可持续性。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 MATCH-UP 的具体目标是：目标 1：确定 MSK@Home 是否有效，从而减少需求。亲自就诊至少提高 20%；目标 2：评估 MSK@Home 是否改善了患者体验；目标 3：根据民众的经验和经验确定 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符合条件的患者是在 MSK 斯隆接受非静脉注射治疗的前列腺癌和乳腺癌患者。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广泛适用于这两种常见的恶性肿瘤，并可能改变数千名患者的治疗方式每年在美国以及世界各地有更多的人都会得到他们的照顾。