ARC Trial Study Personnel FAQs

What happens if a patient’s insurance company refuses to pay for surgery AFTER they have been randomized to the operative arm?

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 [...]

What if a patient’s insurance company limits the number of physical therapy visits it will cover?

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.

How soon does the patient need to start their assigned treatment?

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 [...]

Is it okay if the patient does not want to do physical therapy at the recruiting site?

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 [...]

How and when should the Physical Exam Form be completed?

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 [...]

Can anyone besides the recruiting MD complete part A of the Physical Exam Form? (range of motion measurements)

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 [...]

What if I can’t access REDCap to randomize?

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 [...]

What if a patient with a pending MRI who was provisionally enrolled in the study turns out to not be eligible?

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.

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