POINT enrollment instructions

Enrollment:

  1. Review inclusion/exclusion criteria to ensure eligibility
  2. Get consent from patient
  3. Log into the WebDCU https://webdcu.musc.edu/login.asp  to enroll patient and get randomization number.  Call 24-hour hotline if you need assistance with randomization:  1-866-94POINT

 

    • Enter user name (your email) and your password
    • Select box with POINT icon
    • Where it says Select Hub-Spoke, use drop down menu to select UPenn- HUP
    • Enter the date of enrollment (today) where it says “Baseline/Randomization on:”
    • Click “ADD SUBJECT.” The subject ID will be assigned and baseline/randomization forms will be posted, you will be directed to the subjects CRF collection schedule.
    • Click on the ICON for (00 Eligibilty Form) – enter eligibility CRF data.  You will need labs including RBC count.   We are using Version 4 of the protocol.  Click No for the Mytrus video question.  Then click (Save Record) button at the bottom then Click (Submit CRF) button in upper right of screen.
    • Click on the “Subject CRF” button at the top left of the screen and click the icon for (10 Randomization Form). Enter the Randomization data and click (Save Record) at the bottom of the screen and then click (Submit CRF) at the top right.
    • It will then show you the randomization form
    • Click green curved arrow to PRINT COMPLETED Randomization Verification Form. After you have done below steps and given study drug, complete this form and file in study binder.
    • In the binder there is a paper “Study Enrollment & Prescription Fax Form.”  Complete this form–where it asks for “Bottle Number assigned by IVRS” insert the Study DRUG ID# , where it asks for “Patient ID#” insert the Subject# generated on the POINT website randomization form.  Sign and data and fax this form to inpatient pharmacy –  fax 215-349-5841 and call to make sure they receive it 215-662-2907 and to let them know you will be needing the drug.  Fax machine in ED is behind main secretary desk – ask them and they will help you.  You do not have to enter an order in EPIC.
    • Inpatient pharmacy is in ground Rhodes – they may offer to bring you drug which is a pill bottle, or you can go pick it up.  Often faster to just pick it up.  Once you have it make sure randomization # on study drug bottle matches randomization # from WebDCU.
    • Give patients study drug as per instructions on pill bottle.
    • For biomarker substudy (assuming patient consents for that), there is a box labeled POINT with several collection tubes in it in ED study box or in fellows office above desk.  Fill these tubes and process as per instructions in box.  Patient does not have to consent for biomarker substudy to be in main POINT trial.

 

Baseline:

  • Enrollment/demographics
  • Inclusion/exclusion criteria
    • ABCD2 score
    • NIHSS
  • Prior medications
  • TIA or Minor Stroke Symptoms
  • Medical history
  • Vital signs
  • CT/MRI scan
  • Labs:
    • CBC w/diff (WBC, RBC, Hgb, Hct, platelets, absolute neutrophil/granulocyte count)
    • INR
    • Serum creatinine
    • Glucose
    • Pregnancy test, if applicable
  • ECG
  • Consent

 

Day 7 (+/- 2 days) Telephone call f/u

  • Serious Adverse Events form
  • Concomitant Medications form
  • Stroke-Free questionnaire (QVSFS)
  • Morisky Questionnaire

 

Day 90 (+/- 14 Days) In person f/u

  • NIHSS
  • mRS
  • Serious Adverse Events form
  • Stroke-Free questionnaire (QVSFS)
  • Study Drug Compliance form
  • Morisky Compliance form
  • End of Study form