Co-enrolment TTM-TBI, PREVENT, REACTOR General TARGET information http://www.anzicrc.monash.org/target.html Screening & randomisation of potential patients Readmitted patients: If did not meet Inclusion criteria 1 st admission, can be considered in 2 nd admission If did meet IC in first admission & missed, don t include 2 nd admission 2 INCLUSION CRITERIA explained: 2. Intubated and receiving INVASIVE mechanical ventilation (not Bipap, not long term trachy on Bipap) 3. EN commenced within the previous 12 hours includes feeds not given from the 12 hour start (ie not a total of 12 hours of feed delivery: THIS INCLUDES spent in another ICU) Screening: Directly into website All who met inclusion with an exclusion criteria Don t add patients who received feeds beyond 12 hours over a weekend when we are not here Randomisation: 1. Follow steps on How to randomise a patient to TARGET 2. https://target.spinnakersoftware.com Desktop / favourites link on computers connected to a printer 3. Windows Security will pop up keep closing this, the URL will still work (can t be removed according to IM&T) 4. Generic Username: xxxxxx Password: xxxxx 5. If incorrect height or gender entered, these can be altered on the website for a more accurate goal rate 6. MEASURE height at some stage (pre post rando) & document somewhere to confirm accuracy of estimate TARGET RC Run sheet developed by, RNSH, 2017 Page 1 of 5
NUTRITION TARGET Nutrition Study Research Coordinator run sheet Commence Study intervention: 1. Print confirmation of enrolment 2. Collect study feed box & bedside plastic sleeve from 6F storeroom 3. Flowchart feed order for the Dr to prescribe: Oral Diet Enteral Feed Type TARGET study feed Patient No: 008-xxx Enteral Nutrition & TPN Orders Starting Rate L/hr Target Rate ml/hr Strictly Nil-by-mouth Break from to Stop feeds @ hrs hrs MO Sign AD Parental Nutrition (IV) order TPN Starting Rate TPN Target Rate MO Sign RN RN ml/hr ml/hr 4. Diet needs to be ordered on PowerChart Orders - Nutrition: NBM & Enteral feed 5. Add TARGET sticker to: Admission sheet & flowchart both sides 6. In emr add Alert & entry regarding inclusion / feed management 7. Add name to enrolment log & ials to consent log 8. Email 3 Dietitians that the patient has been added to TARGET: xxxxxxxx@health.nsw.gov.au xxxxxxx@health.nsw.gov.au, xxxxxxx@health.nsw.gov.au & the Speech Therapist Rebekah xxxxxxxx@health.nsw.gov.au 9. Dietitian will review & suggest a feed should the patient come off study feed / go onto open label feeds 10. Keep box outside room 11. Keep used bags inside the room & we will check accountability log 12. The TARGET study feed bag Accountability Worksheet is source data for bag administration 13. Will collect feeds in ml/hr, no extra documentation required beyond usual practice 14. If fasting for OT, don t increase rate beyond goal rate to catch up 15. If can t reach goal rate due to aspirates, NOT a protocol deviation 16. Bags need to be changed after 24 hours NB if rate is 50ml/hr it may run over 24 hours 17. A copy of the Guideline for delivery of enteral nutrition therapy to intensive care patients is in the TARGET study folder behind the Dr desk or ICU Wiki DAILY checks of on study patients: TARGET bed sign is up TARGET feed order + goal rate are accurate Feed being given at goal rate Bags are not hung for > 24 hr..if a bag is hung >24 we need to IIMS this TARGET RC Run sheet developed by, RNSH, 2017 Page 2 of 5
Patients for ward discharge still being fed: Swap to open label feeds JUST PRIOR to transfer to ward TARGET study box is not to leave the ICU Discontinuation of feeds: 1. When any calories are given orally (including test swallowing), or supplemental to NG feeds or considered not safe for patient to have study feeds going: swap to open label feeds (NOT a protocol deviation) 2. If NG feeding required overnight only, swap to open label feeds 3. TARGET study feeds are considered stopped after 24 hours of no feeds can recommence TARGET study feed if less than 24 hours 4. Email 3 Dietitians that the patient has been ceased study feed: xxxxxxx@health.nsw.gov.au xxxxxx@health.nsw.gov.au, xxxxxxxx@health.nsw.gov.au & the Speech Therapist Rebekah xxxxxxxx@health.nsw.gov.au 5. Diet needs to be ordered changed as required on PowerChart Orders - Nutrition: thickened fluids Recommencement of feeds: If the problem has been resolved causing study feeds to stop & feeds are continuing & no reason not to continue in TARGET, then recommence feeds & aim for goal rate If readmitted to ICU & needing NG feeds, within day 28 of randomisation & no reason not to give TARGET study feed, then use Resupply info to obtain a new box or else this is a PD. Does not need to be tubed (this is only for meeting study inclusion) Resupply of TARGET study feeds (ie 2 nd & 3 rd boxes): 1. If resupplying a 3 rd box to a patient, make sure the first has been completed online can t have more than 2 with a patient at any one 2. Can resupply Fri & return to stock Monday if unopened 3. Follow Resupply instructions (2 page) RC reconciliation of bags & boxes: Check used bags against accountability log, discard bags in patient room If more than 3 bags left & want to reassign, do data collection FIRST, enter into website. Under Bag inventory for patient 00800x edit each used & checked bag to FINISHED & leave unused bags as ASSIGNED To return unused bags to the ready to assign shelf (ie > 3 bags), go to Inventory & edit box to ready to assign. Will then be asked to select whether box is open or closed & will give you the option to select the bags still Assigned ready to go into Ready to assign TARGET RC Run sheet developed by, RNSH, 2017 Page 3 of 5
Opt-out information brochure: If clinical staff are giving this out use blue sheet to document this Print from S-drive double sided & flip on the short side Consent Log S-drive folder needs date brochure given to NOK or patient & signature (or name of RN / Dr) & whether consent was withdrawn or not. If there was an opt-out: date, method of withdrawal & who (patient/ NOK) withdrew & reason if volunteered IMPORTANT when discussing follow up: main priority is Day 90 follow up (alive / location), Day 180 questionnaires are not as important PowerChart notation: discussion, declined opt-out, document employment & highest educational level (source may not be documented elsewhere) Transfers from / to xxxxx & xxxxx ICUs: The boxes of TARGET study feed do NOT get transferred between ICUs The patient details will be removed from the enrolling ICU database and transferred to the receiving ICU database Check if it is still appropriate and study day 28 is not reached Patients transferred in: Use the patient study number (check PowerChart Alert / call sending RC) to Resupply a new box via the study website when the patient gets here If returns and could have had TARGET study feed and didn t get a resupply Protocol Deviation If couldn t due to fluid / nutritional requirements then not a PD Patients transferred out: Contact the receiving RC or Nursing Team Leader of the receiving ICU to determine if the ICU is a participating in TARGET pass on the patient study number RC Info Reallocation of bags in an opened box: Follow How to reassign opened boxes instructions Only if there is 4 or more bags left in a box (ie >3) Data Collection: For System & procedure (section 2.3.4a & b) try not to use other APACHE serum creatinine if the patient has chronic renal failure & creatinine is elevated, DON T double the creatinine score. DO double the score if the patient has acute renal failure / new creatinine elevation Day 1 is of randomisation to 07:59hr website knows this about our site Death: copy of death certificate & cause of death is to be reviewed by the Intensivist & can sign & date the CRF page to validate cause selected TARGET RC Run sheet developed by, RNSH, 2017 Page 4 of 5
Adverse Events anything the PI feels should be reported: Report up to 48hr from cessation of TARGET study feeds: 1. Hypoglycaemia 2.2 mmol/l via ANY method 2. Respiratory eg aspiration pneumonia 3. Metabolic eg severe hypophosphataemia 4. Gastrointestinal eg severe diarrhoea 5. Other Follow up: 1. Main priority is Day 90 follow up (alive / location), Day 180 questionnaires are not as important 2. Day 28 & Day 90 use of hospital visits is ok, document on CRF cover sheet or on the paper CRF where information was found - sign & date (ok GCP for this to be source data see MofOp) End of Study Ask xxxxxxx for the APD numbers of included patients for entry into the ecrf Delivery & set up of study feeds 1. I need to know of delivery a week prior & contact Rebecca (ISS loading dock ext 9926 xxxxx) that a delivery is coming Call Xxxxxxx on the morning of delivery Xxxxxx (logistics manager) & Xxxxxx (dock manager) may not have staff available when delivered, but will get to the pallet within an hour of it being in loading dock. Loading dock is the same temperature as outside (not cooled, doesn t get hotter). 2. Address: Loading Dock Xxxxxxxxx Royal North Shore Hospital St Leonards 2065 Delivery Information: Attention to Elizabeth Yarad or Anne O Connor Department of Intensive Care Research 9463 2771 or 9463 2772 Deliver to 6F Storeroom 3. The courier will come up & find us before unloading Will assist with pallet being brought up & move up to outside 6F storeroom Decant into metal first (storage) & white (16 ready to assign) shelving First boxes to come off will have the highest numbers, therefore first to come off will be in storage, the last 14 boxes can go in the ready to assign shelving 4. May or may not have a Consignment note with the shipment 5. Will be emailed a Warehouse to Site Shipping Form from LL Fill in & email to LL with the temp log press VERY hard & log on the temp monitor to turn it off Photograph any box / bag damage & send to LL Need sign off of form or written instruction before assigning boxes online On website - https://target.spinnakersoftware.com move all boxes to Stock storage area THEN select 14 or less boxes to Assign Ready to assign study EN / topping up the shelves: 1. Attach to the top in plastic sleeve: study sign, PR/patient brochure, product information, Accountability log, bedside information 2. Add numbering large labels to the box sides & tops = box number & do not throw out label 3. IP Inventory = Box numbers 4. IP Accountability = Bag numbers TARGET RC Run sheet developed by, RNSH, 2017 Page 5 of 5