Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Apr 9, 2021
Open Peer Review Period: Apr 9, 2021 - Apr 15, 2021
Date Accepted: Jul 27, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A Blueprint for the Conduct of Large, Multi-Site Trials in Telemedicine
ABSTRACT
Background:
Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes, despite the wide variability in results.
Objective:
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.
Methods:
This viewpoint presents relevant challenges and solutions for conducting multi-site telemedicine trials using seven ongoing and completed studies funded by the Patient Centered Outcomes Research Institute (PCORI) portfolio of large multi-site trials to highlight the challenges in implementing telemedicine trials.
Results:
Implementation challenges related to clinical, informatics, regulatory, legal, quality and billing were identified and described.
Conclusions:
Lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multi-site telemedicine trials. Clinical Trial: NCT02358135: Improving Specialty-Care Delivery in Chronic Skin Diseases (PI: AWArmstrong) NCT02396576: Using Telehealth to Deliver Developmental, Behavioral, and Mental Health Services in Primary Care Settings for Children in Underserved Areas (PI: TRCoker) NCT02038959: Connect.Parkinson (PI: RDorsey) NCT04000971: C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care) Stroke Care Trial (PI: KGaines) NCT03694431: Noninferiority Comparative Effectiveness Trial of Home-Based Palliative Care (HomePal) Trial (PI: HNguyen, KMularski) NCT04153864: SUMMIT (Scaling Up Maternal Mental healthcare by Increasing access to Treatments) Trial (PI: DRSingla) NCT03985800: Specialty Medical Homes to Improve Outcomes for Patients with Inflammatory Bowel Disease (IBD) and Behavioral Health Conditions Trial (PI: ESzigethy)
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.