SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY Notes: Green used for Notes/Reminders that will help you fully complete the orders for your protocol. Blue: Options you can choose from for your protocol’s orders. NOTE: Specify what tasks CRU nursing vs study staff are responsible for doing. Protocol #1040: Circadian clocks and nocturnal asthma. STU #: PI: Dr. Ravi Allada phone: 847-491-2809 pager: Study coordinator: Brandon Lu, MD phone: pager: 5-1876 NOTE: List PI, coordinator(s) and others who should be contacted during study visits along with phone/pager numbers. Day 1: Date: ___________ Pt. Study #: ___________ NOTE: Need a set of orders for each day the subject is at CRU. 1. Admit to CRU as Inpatient between 17:00-20:00. Consent will have been previously obtained by study team and supplied to CRU staff./Consent obtained upon subject arrival/Page at to have subject consented. NOTE: The CRU must have a signed subject consent before any treatment can begin. 2. Page Dr. Brandon Lu (5-1876) upon subject arrival to provide signed orders, perform H/P, pain score and AE assessment. NOTE: list tasks that MD completes (e.g. sign orders, h/p, AE assessment, GI/liver exam, pain score, ECOGPS, etc.) NOTE: the timing of when physician should be contacted/conduct H/P should be determined for each protocol & visit. e.g., upon admission or after STAT labs results arrive? 3. Diet: General diet. Dinner tray if patient arrives by 19:00. Only water and 3 decaffeinated diet sodas /24hrs will be permitted. (Eg: General Diet; prohibited foods: Grapefruit Juice and Star Fruit) NOTE: List any RESTRICTIONS (with clear definition), TIME frame for restriction, and ACTION to take if restriction not followed. e.g., : Fast for 8 hour prior to study medication defined as: no food or liquid after midnight night before. Notify coordinator if has not fasted so that PK’s are not taken OR e.g., (approximately 30% of calories from Fat and about 50% from carbohydrates). E.g., Only three scheduled meals per day and one evening snack (around 8pm) permitted and water to quench thirst. Allow 30 mins for consumption of meal. All other food and beverage not permitted. 4. Activity: (Bedrest, up with assistance, bathroom assistance, up ad lib as tolerated) NOTE: If subject will be in clinic a few hours then activity orders are needed. 5. CRU Staff to obtain vital signs upon admission (sitting blood pressure, heart rate (bpm), respiration rate and oral temperature): NOTE: What specific vitals do you want taken and recorded? NOTE: Sitting or standing blood pressure and if sitting, 5, 10 , 15 min sitting? Contact MD if: Standard criteria: Temp greater than 100.4 HR greater than 120 or less than 50 BP greater than 160/90 or less than 85/45 RR greater than 30 or less than 12 #1040 10.18.10 AT 1 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY NOTE: List CRITERIA to use to determine if there is a problem and ACTION to take if criteria met. (see example of standard criteria above) 6. CRU staff obtain height (inches) and weight (pounds/kg) w/out shoes & jacket/coat and record on flow sheet. NOTE: clarify if want measured in cm/inches or kg/lbs. 7. CRU RN to insert PIL for venous blood draws. 8. CRU staff to collect the following labs, enter draw time, and send to NMH lab/ CRU lab STAT: NOTE: list WHERE samples to be sent, TIME frame for samples. 1 (2 ml) lavender top for Hematocrit (Immediately place on wet ice / Immediately protect from light with aluminum foil / Process within 30 minutes / Handle at room temperature / Send STAT to ) 1 (2ml) purple top for platelet levels (Immediately place on wet ice / Immediately protect from light with aluminum foil / Process within 30 minutes / Handle at room temperature / Send STAT to ) URINE: Urine pregnancy test Urine drug/alcohol screen NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample) NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 9. Notify MD if: Hematocrit less than 34 Pregnancy test is positive or inconclusive NOTE: remove this line if MD does not need to review labs. 10. Subject may take own meds from home while in the CRU as listed below: (Coordinator will notify subject to bring subject’s medication in original bottles) NOTE: MD must list meds to be taken from home, dosage, and then sign for each subject visit. NOTE: Do not list standard con meds since the list of meds taken from home should be checked by PI/MD prior to being listed in the orders) NOTE: Subject must bring meds from home in original bottles. 11. Study Coordinator to: CHECK OUT and setup sleep recording equipment set subject up with full PSG [2-3 hours prior to scheduled bed time] place WP100 on subjects non-dominant hand. 12. Subject is allowed to sleep. Light level will be at less than 3 lux. __________ Scheduled light out time 13. Subject to push call button if awake during the night to urinate. Light level will be less than 10 lux for restroom visits. Record time Day 2: 14. Subject to press call button at final awakening OR awaken at scheduled wake time if asleep. 15. Study Coordinator to: record exact waking time. Click event recorder “lights on” on the sleep recording #1040 10.18.10 AT 2 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY computer at wake time and turn lights on. _____________ wake time after turning lights on (less than 10 lux), click the red stop sign icon twice on the sleep recording computer to stop the recording. The system will ask you to verify stoppage—click “yes.” 16. Lights on at less than 10 lux until scheduled bedtime. 17. CRU Staff to remove all sleep electrodes except for EKG leads and place on counter for sleep tech to clean and put away. 18. Activity: (Bedrest, up with assistance, Bathroom assistance, up ad lib as tolerated) 19. Diet: Only water and 3 decaffeinated diet sodas will be permitted. Snacks given at 2 hourly intervals. 20. CRU RN to insert 2nd PIL in opposite arm for drug administration using 16/18/20 or standard gauge line. NOTE: If using a PIL for blood draws, and not employing blood sparing technique, you must add 1.5mL to each blood sampling time point to account for clearing the line prior to blood draw. 21. Administer 1L 0.9NS with 7500 units heparin at 10ml/hr NOTE: Administration of drug orders should always follow this format: Administer ___ (drug name), ___(dose) __ (route: PO/IV) _over time period) NOTE: note if time is relevant, e.g., 30-60 minute prior to….) 22. Record exact time IV was administered/completed. 23. Timing of Blood sampling is based on when drug taken (PO)/ start time of drug/end of infusion. 24. 5 Minutes POST Start of IV (First 18.5 mL blood draw) CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for Platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room temperature 1 (10 mL) purple top/EDTA for HCV-PCR Room Temperature. Take to Core Lab immediately. NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 25. 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature. 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 26. 60 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature. 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 27. 90 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature. #1040 10.18.10 AT 3 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 28. 2 HOURS POST START of IV CRU Staff serve a snack CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for Platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room temperature 1 (10 mL) purple top/EDTA for HCV-PCR Room Temperature. Take to Core Lab immediately. NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 29. 2 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 30. 3 HOURS POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 31. 3 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature. 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 32. 4 HOURS POST START of IV CRU Staff serve a snack CRU Staff to obtain vital signs (sitting blood pressure, heart rate (bpm), respiration rate and oral temperature): Contact MD if: #1040 10.18.10 AT 4 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY Standard criteria: Temp greater than 100.4 HR greater than 120 or less than 50 BP greater than 160/90 or less than 85/45 RR greater than 30 or less than 12 CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for Platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room temperature 1 (10 mL) purple top/EDTA for HCV-PCR Room Temperature. Take to Core Lab immediately. NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 33. 4 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature. 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 34. 5 HOURS POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 35. 5 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 36. 6 HOURS POST START of IV Snack given to subject CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for Platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature 1 (10 mL) purple top/EDTA for HCV-PCR Room Temperature. Take to Core Lab immediately. NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample) #1040 10.18.10 AT 5 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 37. 6 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 38. 7 HOURS POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 39. 7 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 40. 8 HOURS POST START of IV CRU Staff serve a snack CRU Staff to obtain vital signs (sitting blood pressure, heart rate (bpm), respiration rate and oral temperature): Contact MD if: Standard criteria: Temp greater than 100.4 HR greater than 120 or less than 50 BP greater than 160/90 or less than 85/45 RR greater than 30 or less than 12 CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for Platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room temperature 1 (10 mL) purple top/EDTA for HCV-PCR Room Temperature. Take to Core Lab immediately. NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) #1040 10.18.10 AT 6 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY 41. 8 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 42. 9 HOURS POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 43. 9 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 44. 10 HOURS POST START of IV Snack given to subject CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for Platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room temperature 1 (10 mL) purple top/EDTA for HCV-PCR Room Temperature. Take to Core Lab immediately. NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 45. 10 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 46. 11 HOURS POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT #1040 10.18.10 AT 7 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 47. 11 HOURS and 30 Minutes POST START of IV CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 48. 12 HOURS POST START of IV CRU Staff serve a snack CRU Staff to obtain vital signs (sitting blood pressure, heart rate (bpm), respiration rate and oral temperature): Contact MD if: Standard criteria: Temp greater than 100.4 HR greater than 120 or less than 50 BP greater than 160/90 or less than 85/45 RR greater than 30 or less than 12 CRU Staff collect the following, enter draw time and send to CRU lab/NMH lab STAT 1 (2 mL) lavender top for Platelet levels Room temperature 1 (1.5 mL) lavender top for Hematology Room Temperature 1 (10 mL) purple top/EDTA for HCV-PCR Room Temperature. Take to Core Lab immediately. NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place on ice/process within 30 minutes, etc) and where to send each sample NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance. NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins, creatinine clearance) 49. 50. 51. 52. 53. 54. D/C PIL Remove EKG leads Lights out to allow recovery sleep Shower and restriction on room lighting is lifted upon awakening. Normal meal served. Subject cannot be discharged until hematocrit and platelet count results are back and MD is notified. 55. Discharge Subject after at least 6 hours of sleep, if stable. OR Subject may be discharged prior to 6 hours if accompanied by adult friend/family member who is driving, if stable. Page Dr. Lu at 5-1876 for questions regarding study. NOTE: List PI or Attending physician who should be called for questions about study. Pharmacy to send: #1040 10.18.10 AT 8 SAMPLE TEMPLATE FOR EXTENDED IP/SLEEP STUDY 1 L 0.9 NS with 7500 units of heparin added to be infused at 10 mL/hr PRN Tylenol 650 mg PO Q4hrs: headache. Albuterol MDI 2 puffs Q6hrs: SOB. (Patient provided) NOTE: If your protocol needs CRU Staff to administer any medications, including heparin for IV lines, they should be listed by: Investigational Pharmacy Pre Medication PRN (as needed drugs on hand if side effects or problems occur) List Drug Name, Dose route (PO/IV) over what time period. #1040 10.18.10 AT 9