The study does not cover the cost of treatment, so the surgery would likely not be performed and this patient would become a “crossover.” While every effort should be made to avoid randomizing a patient whose insurance will not pay for treatment, once randomized – regardless of whether the assigned treatment is completed – a [...]
There is a lot of flexibility in the physical therapy treatment protocols (for both postop & non-op) regarding how often a patient attends physical therapy. In consultation with their treating physical therapist, patients can customize the ratio of in-clinic physical therapy visits to home exercise days to fit their individual needs, schedule, and insurance coverage.
That patient would continue in the study as normal and complete all follow-up questionnaires as usual. However, the late start of treatment would be recorded as a protocol deviation.
Ideally, patients should begin treatment as soon as possible, but – at most – they should begin their assigned treatment within 2 months (8 weeks) after randomization. If a patient cannot begin treatment within 2 months, they could wait to enroll in the trial until they can begin treatment. Otherwise, it would be a protocol [...]
Yes. Any other non-surgical treatments, such as cortisone injections, pain medications, acupuncture, etc., can be used while the patient undergoes the assigned treatment.
Yes. The patient can do physical therapy with the physical therapist of their choice. For patients who simply cannot or do not want to travel to the recruiting site, you can help refer them to a clinic near them that is part of our study physical therapy network (found on study website). The advantage here [...]
The Physical Exam Form (CRF-02) has two parts: Part A – Range of Motion Measurements (completed by the physician or designee), and Part B – Strength Measurements (completed by research personnel). The physician (or designee) can complete Part A in one of three ways: on paper, electronically in clinic, or as a REDCap email survey [...]
Yes, an individual such as a Physician’s Assistant (PA) or Medical Assistant (MA) designated and trained by the physician may perform the range of motion measurements. However, these individuals must complete the necessary research training and be added to the study roster before performing any research activities. Please notify the study coordinator immediately if your [...]
Call the coordinating center immediately for assistance. If the problem is local to your site, coordinating center staff may be able to randomize the patient for you. Otherwise, you would need to either wait until the system is working again to randomize the patient & inform them by phone or withdraw the patient from the [...]
The patient should be informed of this when they receive their MRI results (either in person or via phone). The Patient Study Info Overview in REDCap should be updated to reflect that the patient was “not randomized” and the patient should be withdrawn from the study. This would then be counted as a screen fail.