Patients enrolled in the study need to be able to begin their assigned treatment within 2 months (8 weeks). Since treatment assignment is randomized, there is no way to know in advance which treatment arm a patient will be assigned to for the trial. If a patient’s insurance company will not pay for surgery, they [...]
No. If the patient declines to watch the videos and would prefer to have you present the information to them verbally, that is their choice. However, for informed consent purposes, all the relevant information about the trial and participation in it must be presented to the patient. You can use the printed versions of the [...]
Be flexible when approaching a patient about participating in the study. Use the RA script as a guide, but do not feel like you have to adhere to it rigidly. Some patients may want to ask you questions first or hear you give a brief overview of the study before proceeding. To be prepared for [...]
The RA should note this ahead of time while pre-screening and arrange for a second, back-up recruiter to help with recruitment at that time. If a second recruiter is not available, approach one patient and record that the other was missed as discussed in the previous question.
If the physician completed a Clinic Screening Form (CSF) but the RA did not approach the patient about the study in clinic, record this in the Study Recruitment section (F) of the screening log. Then select “missed/skipped - RA unavailable” as the reason the patient was not approached, or “Other,” as appropriate. If other, please [...]
This scenario might occur at clinics that serve rural populations but is likely to be rare otherwise. Like the pending MRI cases discussed in C3, these patients can be consented and provisionally enrolled if they meet all eligibility criteria. Perform all of the usual enrollment procedures with the patient except for randomization. Follow up with [...]
A patient can take as much time as they need to consider and/or discuss with other family members before deciding to participate. If they need more time, give them a Patient Study Fact Sheet to take home, as well as your business card with your contact information. Ask the patient to contact you if they [...]
Yes, but ONLY IF: (1) the patient meets ALL other pre-MRI eligibility requirements, (2) an MRI has been ordered, and (3) the patient will not return to clinic to receive their MRI results (due to provider standard practice); OR the patient will receive a research MRI. (NOTE: A patient must be consented prior to receiving [...]
If this is the patient’s only hesitation about participating in the study, remind them that they are permitted to withdraw from the study at any point in time. The data for the first 12 months (i.e., the primary study) is the most important, so we would like for them to participate for at least that [...]
The ARC Recruitment & Consent videos can be found in the Research Personnel section of the www.shoulderstudy.org website. Both that section of the website and the videos themselves are password protected. The password to access the Research Personnel section is: arcshoulder123 (all lowercase). The password for the videos is: ARCtrial (ARC in caps, trial lowercase)