A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine

• Type of Material: Article
• Authors: Patricia Commiskey, Vanderbilt University; April W Armstrong, University of Southern California; Tumaini R Coker, University of Washington; Earl Ray Dorsey, University of Rochester; John C Fortney, University of Washington; Kenneth J Gaines, Vanderbilt University; Brittany M Gibbons, University of Southern California; Huong Q Nguyen, Kaiser Permanente Southern Calif; Daisy R Singla, Ctr Addict & Mental Hlth; Eva Szigethy, University of Pittsburgh; Elizabeth Krupinski, Emory University
• Language: English
• Date: 2021-09-20
• Publisher: JMIR PUBLICATIONS, INC
• Publication Version: Final Published Version
• Copyright Statement: ©Patricia Commiskey, April W Armstrong, Tumaini R Coker, Earl Ray Dorsey, John C Fortney, Kenneth J Gaines, Brittany M Gibbons, Huong Q Nguyen, Daisy R Singla, Eva Szigethy, Elizabeth A Krupinski. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 20.09.2021.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.2196/29511
• Title of Journal or Parent Work: JOURNAL OF MEDICAL INTERNET RESEARCH
• Volume: 23
• Issue: 9
• Start Page: e29511
• End Page: e29511
• Grant/Funding Information: KJG is supported by a grant from PCORI (grant PCS-2017C3-9081). BG is supported by a grant from PCORI (grant IHS-071502-IC). HQN is supported by a grant from PCORI (grant PLC-1609-36108). DRS is supported by a grant from PCORI (grant PCS-2018C1-10621) and by an Academic Scholars Award from the Department of Psychiatry at the University of Toronto. ES is supported by a grant from PCORI (grant IHS-2017C3-8930).; PC is supported by a grant from PCORI (grant PCS-2017C3-9081) and partially supported by a grant from the United States Department of Agriculture Distance Learning and Telemedicine program (grant TN 754-A17). AWA is supported by a grant from PCORI (grant IHS-071502-IC). TRC is supported by a grant from PCORI (grant IH-12-11-4168-IC). ERD is supported by a grant from PCORI (grant AD-12-11-4701). JF was supported by a grant from the PCORI (grant PCS-1406-19295) and by a Research Career Scientist award from the Department of Veterans Affairs.; The research reported in this publication was partially funded by the PCORI Awards (HIS-071502-IC, IH-12-11-4168-IC, AD-12-11-4701, PCS-2017C3-9081, HSRP-2018-1686, PCS-2018C1-10621, HIS-2017C3-8930). The views, statements, and opinions in this publication are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors, or Methodology Committee.
• Keywords: TELEHEALTH; telemedicine trials; Health Care Sciences & Services; Life Sciences & Biomedicine; multisite; IMPACT; PROTOCOL; HEALTH-CARE; CHALLENGES; randomized trials; Medical Informatics; challenges; mobile phone; Science & Technology; ACCESS
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Mental Health; Health Sciences, Radiology; Health Sciences, Rehabilitation and Therapy

Abstract

Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials.