The lead PEPPER team can tell you your NetID. In order to have your password manually reset, you must contact the MUSC help desk at 843-792-9700 and tell them you are an external affiliate and need a password reset.

Please contact the Clinical Site Liaison who will give you access to all relevant PEPPER systems. You will be placed in the “playground” sites while you get acclimated to PEPPER

All patients scheduled for a hip or knee replacement surgery by a PEPPER surgeon at your site must be pre-screened in Statix to receive an ID number. Patients are pre-screened regardless of eligibility and are screen-passed/screen-failed based on the inclusion/exclusion criteria.

​​​Yes. Despite the fact that this patient is clearly ineligible, we are capturing all patients who present for surgery. This patient will get a PEPPER ID and be Screenfailed based on age.

No, Plavix is an antiplatelet medication and does not exclude a patient from the trial. However, it is best to confirm the post-surgery medication plan with the patient’s surgeon.

If this was discovered after the patient was screen-passed in Statix, the patient will need to be withdrawn. If the patient had not already been screen-passed, you will screenfail the patient as normal. **Important**--because the patient signed the consent form but was determined to be ineligible, this will be seen as a “true screen fail” that needs to be reported to the IRB. Please keep track of all “true screen fails” and report them each year at the time of the continuing review

If the patient is returning for the same surgery, they will keep their original ID number and randomization assignment. The patient will need a new baseline survey if the previous one was filled out over 3 months before the newly scheduled surgery date. Please also confirm that the patient is still eligible and there have been no changes in terms of medication contraindications. The patient does not need to be re-consented, as the PEPPER consents do not expire.

This ID number will remain in Statix in the “Pre-Screened” state. The ID number will not be reassigned.

No, this patient will remain in the “randomized” state in Statix until the surgery is scheduled, or the study has ended, whichever comes first. If the patient does return for the same surgery, the patient will keep their original ID and randomization. If the patient returns for a different joint surgery (i.e. originally consented for a knee surgery and is now returning for a hip surgery), they will be given a new ID and all screening/enrollment procedures will be followed.

Unfortunately, you cannot randomize a patient after surgery. Randomization can only occur after the surgeon has confirmed the patient and up to one day prior to surgery. This patient must be withdrawn from the study.

No, randomization can only occur once. If a randomization error occurred, or a medication switch is required, the treating physician will decide which of the other two PEPPER medications should be assigned.

No, the protocol allows for medication switches for a variety of reasons—inability to have the INR monitored, cost, AEs, etc. This patient must be switched to one of the other 2 PEPPER medications.

No, the protocol allows for medication switches for a variety of reasons—inability to have the INR monitored, cost, AEs, etc. This patient must be switched to one of the other 2 PEPPER medications.

The patient should remain on the randomized medication for as long as possible. Normally, this would be during the inpatient hospital stay. The patient will take the randomized medication while in the hospital and then be switched to another PEPPER medication at discharge. This switch must be recorded on the Surgery Data Form.

Any medication switch or error not covered in the protocol requires a Protocol Deviation to be submitted to the IRB of record (either the MUSC central IRB, or your local IRB). These include medication switches due to provider error, extra doses of medications given outside the PEPPER protocol, and missed doses of medications while the patient is in the hospital. These do not include patient refusal to take the randomized medication, switches resulting from high copays or inability to obtain INR monitoring, or switches/discontinuation of medication due to adverse events.

A protocol deviation is not required for any medication switch or discontinuation following an AE. This patient should remain in the PEPPER trial regardless of the course of treatment prescribed by the physician.

Participants should only be withdrawn from PEPPER if they are not randomized prior to surgery, never receive any of the 3 PEPPER medications, or if they specifically ask to be withdrawn from PEPPER.

The submission of this form triggers two things: 1. Follow-Ups: the follow up windows are set based on the submission of the form, not the date of surgery. Submitting this form late will cause the 1-, 3-, and 6-month follow up surveys to be administered late by Statix. 2. Payment to sites: Payment to sites is based on the number of Surgical Adherence forms submitted. If you do not submit these, your site will not be paid for that patient.

You will always record the first dose of anticoagulant the patient received. In this case, you will complete the following steps: 1. Record Aspirin 325 mg on the evening of surgery on the Surgical Adherence Form. You will also record that it was different than what was assigned at randomization. 2. Complete a protocol deviation form for the extra dose of Aspirin the patient received. 3. Record a medication switch to rivaroxaban on the Surgery Data Form.

Complete both forms in Statix. Contact Brook Martin at Statix or the lead PEPPER team and inform them of the error. The date will be manually changed and the patient will be set up on the correct follow-up timeline. Based on the amount of time that has passed, the patient may have missed 1 or all of their follow-up surveys and may end up in the REDCap LTFU database.