During this unprecedented time, healthcare policy and procedures are rapidly changing in order to maintain patient safety and care. The Force Research Network is composed of some of the most innovative surgeons and research groups in the country who utilize Force to collect outcomes at higher rates, execute and track their own studies, and collaborate across their organization, and other members of the network across the country, to enhance the quality of care. Force’s Clinical Solutions and Research Team works with each partner organization to evaluate research protocols and, given the extraordinary circumstances, implement alternative measures to ensure patient safety and minimize workflow disruption for providers.
As this situation is rapidly evolving, it is important to ensure your organization is prepared. Here are a few areas we’ve seen impacted so far, and key insights and takeaways from the Force Research Network.
- Halt on Study Enrollment: For the safety of patients and their families, almost all elective surgeries have been postponed. As a result, enrollment has slowed significantly for almost all non-urgent research trials, with some enrollment having paused completely. The University of Kentucky has created a helpful decision tree to determine if your study needs modifications.
Amended Institutional Review Board: FDA regulations require that all research is followed according to written procedures.
Changes may not be initiated without IRB review and approval, except when necessary to protect human subjects (21 CFR 56.108(a)(4).
Work with your institutional review board to best determine the changes that need to be implemented at your institution. Force’s Research Team has been working with hospitals to add amendments to various study protocols to ensure patient safety and the ability to continue collecting study outcomes through recently approved methods such as phone calls and telehealth.
- Alternative Study Visits: As the primary focus remains of patient safety, researchers are changing the way they’re conducting study visits. Prior to the pandemic, most were conducted in person at clinics. Our work with partner organizations shows that the shift to telemedicine, saving patients a trip to the clinic, can yield continuation of obtaining research specific data while maintaining patient safety.
- Modified Assessments: Many of our research trials involve functional testing, such as range of motion or lab testing generally done in a clinical setting. Institutional review boards and research providers have approved modifications to some of these assessments to ensure patient safety. For example, many of these assessments can be conducted through telemedicine study visits or secure HIPPA supported messaging systems, both of which the Force platform supports.
- Variation in Outcomes Data: Understandably, outcomes will be impacted during this time. Force-enabled providers that generally prescribe some form of outpatient physical therapy may now be completely relying on the Force platform’s virtual physical therapy. Patients who were set to see their physician in the clinic, are now utilizing telemedicine. This may create a difference in both patient and provider engagement and PROMs, but the Force team is set to continue monitoring trends closely during the entirety of this unprecedented time.
- Increased Transparency for Safety Reporting: Reporting adverse events such as decreased clinical markers, readmissions, and study specific outcomes is imperative to comprehensive research. Force’s platform allows providers to closely monitor patients via the Force platform and determine any adverse events that would generally be determined in the clinic.
For research workflow guidance, submission assistance, and solutions for remote patient monitoring, reach out to Force’s Research Team: email@example.com or visit us here.