Agenda

1. Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (PAIN Study) Research Coordinator Training PIs: Renan Castillo, PhD Srinivasa N. Raja , MD J. Lawrence Marsh, MD

2. Agenda • Screening Patients • Enrollment Scenarios • Initiating Drugs for Study • Definitive fixation considerations • Completing CRFs • PTOA study/image transfers

3. Screening patients

4. Who to Screen? • Screen (CRF00) all of the following patients, regardless of whether or not you could enroll them: • 18-80 years of age (inclusive) with • (A) isolated, unilateral grade I & II open or closed pilon (distal tibial plafond), calcaneus, talus fractures and Lisfranc dislocations; • (B) isolated, unilateral open (type I, II, or IIIA) ankle fractures with associated dislocation on presentation (OTA 44B3 or 44C); or • (C) any combination of the above injuries which are surgically treated as a whole. [NOTE: Patients with other midfoot fractures not listed in the inclusion criteria above may be included in this study provided these fractures are surgically treated as a whole.]

5. Important Exclusion Criteria • NEED TO GET CREATININE AND PREGANANCY TEST RESULTS TO ENROLL • Need to assess for current medications prior to enrollment • NO patients with chronic NSAID (including aspirin >81mg), gabapentinoid or opioid use • NO patients with ace inhibitors (cardiac patients) • NO patients on glucocorticoids • NO chronic pain pts or IV drug abusers • Transfer issues • Do NOT want patients who spent more than 24 hours at another facility b/c they may have received pain meds there

6. ENROLLMENT SCENARIOS

7. Enrollment scenarios • Patient has come in and will be fixed today! • Can still enroll, only gets perioperative (pre and post op) meds. • Patient is going to the OR for a temporary ex-fix or debridement right away. Can I enroll him, and what does this mean for meds? • Yes! If you consent before surgery, pt will receive perioperative meds, start blister pack after 48 hrs (you may miss the pre op dose). If you consent after surgery, start immediately on the blister pack meds. • Someone was in the ER over the weekend who would be perfect for this study. She’s coming back this week for a clinic visit. • You can enroll this patient, however, you need to have pre-op labs.

8. INITIATING MEDICATIONS

9. When should meds be initiated? • Blister pack • Procedures must be in place to rapidly send pharmacy blister pack identification number. If patient is admitted, first dose will be at the next regularly scheduled 12 hour mark. If patient is going home, you can give the patient the blister pack (and educate on use!) before they leave. • Timing of every 12 hours – some hospitals have a BID schedule, others allow you to set the time. Ideally, want pt to receive medication morning and evening, so that they can maintain the schedule at home • Once the patient goes home, a follow-up call the next day is a good idea.

10. When should meds be initiated? • OR kits • Is patient going directly back to OR, or to OR day of enrollment? If yes, start OR kit, not blister pack. • If patient has started blister pack, stop blister pack day of surgery (if am procedure) and start OR kit according to instructions. If it is a pm procedure, pt can receive am blister pack dose and then be NPO after noon. • Post op meds begin at the next regularly scheduled 6 hour dose. If your site does not have scheduled timing, then aim for 6 hour or more after pre op dose. • If you use the first kit ID on intermediate procedure, query REDCap for a new kit ID • 48 hours after intermediate procedures, patients will return to blister pack medication (pharmacy should have wasted meds that would have been taken during these days).

11. Challenges working with pharmacies • Need to enroll patient over weekend, have medications ready for first OR case, or available first thing in the morning • On-call pay system can be covered by the study. • Pharmacist carries pager, if needed, can come in to prepare medications over the weekend • Explore this option with your pharmacy to start 1/1/15. We are available to help.

12. Definitive Fixation

13. Challenges with Definitive Fixation • Finding the form – CRF06 vs CRF07 • If it occurs during index hospitalization, enter number of surgeries in CRF06 and CRF08 will appear on menu • If it occurs during a rehospitalization, need to add hospitalization form (CRF07) using REDCap’s hospitalization lookup/add form (NOTE – THIS FORM ALLOWS MANY REHOSPS TO BE RECORDED AND WILL THEREFORE NEVER BE “COMPLETE.”) Enter number of surgeries in CRF07 and CRF08 will appear on menu • “Staged” fixation – VERY SPECIFIC procedure, does NOT apply to temporary fixation followed by definitive fixation. Consult with your surgeon.

14. Guidance on completing these CRFs • https://metrc.org/images/documents/PAIN/Pain_Study-Filling_Out_CRF06_07_and_08_in_REDCap.pdf

15. Changes to Definitive Fixation Form • Adding pain medication use to CRF08 – OR Trip form – when trip is for definitive fixation. • Rationale – our primary outcome is driven by calculating the morphine equivalent opioid utilization in the 48 hours following definitive fixation. • Reduces burden regarding collection of medications administered during index and other hospitalizations • Provides specific details on pain medication use, including date and time of dosing, during specific period of time • Follows way data is displayed in EMR – as a series of medication • Will need you to go back and abstract this for previously enrolled patients

16. CRF08 – new pain med table

17. CRF06/07 – ONLY med table

18. CRF Issues

19. Other Forms • Lab forms – complete a new form for each set of labs drawn. Record all requested labs, and any labs that are out of range but not on our list • Recording study drugs – make sure this is as complete as possible. If a dose is missed, it needs to be recorded as such. • MPOPS & BPI – need to be collected before pt leaves hospital following definitive fixation. If you miss this, you need to complete an AF03 and call the patient.

20. PTOA Consent and procedures

21. Pilon Fractures • As part of the pain study, we are sending all SOC images for ALL patients with pilon fractures to UIA • PTOA substudy consent (and payment) is ONLY for additional CT scan and follow-up • You should send images for all pilon fractures to UIA via secure FTP site or on a CD • We will provide you with a list of pilon fracture patients to help you track cases you still need to send.

22. NEXT STEPS

23. Timeline and Activities • Early December – expect to receive new CRFs 06/07/08 and retrospectively complete pain medication data entry for 48 hours post definitive fixation • Mid December – potential protocol amendment. PC met two weeks ago and discussed opening up inclusion criteria even further to include other long bones (femur, tibia, humerus). Still under review, but a change is likely. With this amendment, we would remove the transfer exclusion (interested in post-definitive fixation pain meds, so rationale no longer critical) and add a line to the consent form allowing a lab draw, if patient not consented in hospital • Mid January – release of new medications, study will start enrolling again.