Strategies for PROSPECT Trial Consent Encounter

1. Tips From the Experts Deborah Cook

2. The Consent Encounter

3. Smith et al, for the PROTECT RCs, Intensive Crit Care Nursing 2013

4. Strategies & Suggestions • Ask the MD about predicted duration of ventilation, asking if the patient is likely to be extubated tomorrow….if not likely, approach for consent encounter • Prioritize Monday morning screening to consider patients admitted on the weekend • Capitalize on telephone consent when needed • Call forth the vitality culture & health literacy in your community

5. 10 Reasons Why PROSPECT Consent is Easy 1) Public is familiar with probiotics 2) Probiotics are a natural health food product 3) Probiotics appear to be safe 4) Probiotics may regulate the bowels 5) Probiotics may introduce `good bacteria` 6) Probiotics may prevent infection 7) Care is otherwise `as usual` 8) PROSPECT occurs only in the ICU 9) Canadian $$ are funding PROSPECT 10) CCCTG is committed to this trial

6. Tracking Study Product

7. Strategies & Suggestions • All of you worked closely with your pharmacy & bedside nurses • Reminders for staggered dosing with some oral antibiotics • PROSPECT orders:electronic medical record • A collaboration of research team and IT • Alerts for staggered timing re: some oral antibiotics • Easier • for RNs to administer per protocol • for pharmacy to track doses

9. Tracking Patients

10. Clinical Outcomes VAP All nosocomial infections Diarrhea (total, antibiotic-associated, C. difficile) Antimicrobial use (DDD, DOT, antibiotic-free days) Adverse events: Lactobacillus spp. infection Duration of Mechanical ventilation, ICU & hospital stay Mortality ICU & hospital

11. Post-It note reminders on Research Coordinator’s computer

13. Checklist on the front of every patient’s research file folder

14. Bedside Aids

15. Reminders to bedside nurses about documenting each bowel movement, if not reliably recorded

16. "aide-mémoire infirmière"

17. "aide-mémoire infirmière"

18. SOP: aseptic techniquehand hygiene before & after preparation +wear gloves, +prepare >4 feet from the patient

19. and Resources such as: Duotang of info at each bedside Binder of info at nursing station

20. Engage with Everyone Around You

21. Teach Others • Attend rounds when you can • especially the first few days on protocol • when intensivists or residents change • Give verbal summaries of the trial • Indicate ‘what it means for each ICU staff’ • business as usual • “I will be asking you about infections when you prescribe antibiotics”

22. It Takes a Village • “Include & invite anyone and everyone whom you might think will be exposed to the study to be part of the process – particularly the nursing team.” • “You might find your best ally for the study in the most unexpected places.”

23. With Input From • Families • Nurses • Nurse Educators • Pharmacists • Study Pharmacists • IT staff • Residents • Intensivists

24. Lori Hand Tina Millen Eileen Campbell Andrea Matte Irene Watpool Brigette Gomes Orla Smith Josie Campisi Marie-Claude Tremblay Erik Tamberg Virginie Williams Marie-Hélène Masse Victoria Alcuaz Barbara Kosky Nicole Marten France Clarke Lisa Julien With Thanks To