Pragmatic Trial

项目总结/文摘

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.