STUDY DRUG: List the study drugs that will be used at your site based on your hospital formulary 1. Insulin Humulin R 2. Insulin Humalog 3. Insulin Lantus DRUG SUPPLY & STORAGE: Since study drugs are not being supplied they will be pulled from the hospital pharmacy stock. We do not keep accountability logs on hospital supplied meds. RANDOMIZATION: Once a patient has been randomized DRUG ORDERING & DISPENSING: When a patient is enrolled the study coordinator will call pharmacy to let them know a patient has been enrolled. Once the orders are placed, it automatically sends labels to the pharmacy to dispense study drug. A binder is prepared by the investigational dug pharmacist for each study. In this binder is a summary of the protocol and preparation guidelines. Also, this binder will have the patient s drug assignment arm documented. If anyone dispenses a drip or a drug vial for a study, they must first sign and date the binder. When the pharmacist sign and date this, it is stating that they fully understand the protocol and the treatment they are dispensing. The Investigational Drug Pharmacist will also prepare a patient specific dosing card for the IV room. This card will have specifics about arm assignment, what should be prepared, and what time it should be sent to the floor. These cards will be signed off by the dispensing pharmacist when dose has been checked and crossed checked with the dosing card. The Investigational drug pharmacist also prepares a study specific binder to be kept in the IV room. The binder contains essential information for pharmacy to safely and accurately dispense study medications. All study drips will have a WVUH electronically generated label which contains pertinent patient and drug information for both the pharmacy and nursing. All investigational agents are labeled with a HIGH ALERT sticker in addition to the sticker that is provided by the study. A vial of D50 will be sent to be kept in the patient medication bin as well as a bottle of lispro, Regular insulin and NS depending upon arm assignment. A copy of the order-set will be included for your viewing. STUDY DRUG LABELS: Describe how the study drug will be labeled. According to institution, state and federal mandates. PHARMACY CONTACT INFORMATION: Lisa Giblin Sutton, PharmD West Virginia University Healthcare 1 Medical Center Drive Morgantown, WV 26506 giblinl@wvuhealthcare.com 304-598-4000 ext 73760 304-598-4073 fax
INV SHINE - NORMAL SALINE INFUSION (CONTROL ARM) [3375] This research order set to be used in conjunction with any of the Stroke Admit ordersets. Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). Do not order the home medications of insulin or oral diabetic medications during medication reconciliation. Discontinue any current orders for insulin or oral diabetic medications. PATIENT PARTICIPATING IN CLINICAL TRIAL Routine, CONTINUOUS, Starting today For Until specified Trial: SHINE STUDY STUDY ORDERS INITIAL STUDY LAPTOP PROGRAM ORDERS PARTICIPANT/INITIAL STUDY LAPTOP PROGRAM ORDER: PATIENT IS NOT TO RECEIVE ANY PREVIOUS INSULIN ORDERS OR ORAL DIABETIC MEDICATION ORDERS AT START OF STUDY THROUGH THE DURATION OF 72 HOUR STUDY PARTICIPANT/STUDY LAPTOP PROGRAM ORDER: OBTAIN INITIAL FINGERSTICK GLUCOSE AND DOCUMENT IN STUDY LAPTOP PROGRAM. DOCUMENT EACH SUBSEQUENT FINGERSTICK VALUE IN THE STUDY LAPTOP PROGRAM. PARTICIPANT/STUDY LAPTOP PROGRAM ORDER: INITIALIZE & MAINTAIN IV STUDY LAPTOP PROGRAM SHINE STUDY STROKE PARTICIPANT:ENTER BLOOD GLUCOSE VALUES (FINGERSTICK). HUMAN REGULAR INSULIN (HUMULIN R OR NOVOLIN R) WILL BE USED FOR SUBCUTANEOUS INJECTIONS AT 06:00, 12:00, 18:00, AND 24:00 WHEN APPROPRIATE BASED ON SLIDING SCALE For 72 Hours, Page physician or Study Coordinator at 103-2193 with any needs to have medication orders discontinued or concerns For 72 Hours, Enter glucose result into program. Adjust SHINE Study IV drip per Study Laptop instructions. For 72 Hours For Until specified
NURSING ORDERS PARTICIPANT: PT IS PARTICIPATING IN A 72 HOUR RESEARCH STUDY PARTICIPANT: BLOOD GLUCOSE WILL BE MONITORED USING POINT OF CARE FINGER STICK GLUCOSE CHECKS PARTICIPANT:NURSING- ENTER A SECONDARY ORDER FOR STAT SERUM NON-FASTING GLUCOSE IF FINGERSTICK IS LESS THAN OR EQUAL TO 70 : NIH STROKE SCALE AT 10AM & 10PM AND WHEN DRUG STUDY IS DISCONTINUED For 72 Hours, Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). For 72 Hours, Do not use blood from an intravenous line for fingersticks. The decision support tool requires fingerstick glucose checks every 1 hour for the first 4 hours and then every 3 hours for the remainder of the study treatment period. The schedule for these checks is 03:00, 06:00, 09:00, 12:00, 15:00, 18:00, 21:00, and 00:00. If the blood glucose drops <80 mg/dl, the study laptop tool will initiate the hypoglycemia prevention and management protocol. The study laptop will recommend stopping all SHINE study IV and insulin & administering a dose of 25ml of D50 IV over 1-2 minutes and more frequent blood glucose monitoring (every 15 minutes) until the fingerstick glucose is greater than 80mg/dL. Perform the Hypoglycemia Symptomatic Questionnaire with each 15 minute fingerstick until fingerstick is greater than or equal to 70 mg/dl. Resume the previous fingerstick schedule once the patient has one fingerstick glucose reading above 70mg/dL. For 72 Hours, Do not enter the serum glucose value into the study laptop program. Do not delay treatment with D50 by waiting for this serum blood draw result. Only the results from fingerstick point of care glucose checks should be used for insulin dosing. Routine, EVERY 12 HOURS, Starting today DIET ORDERS DIET SHINE STUDY 60GM CARB PARTICIPANT: BREAKFAST NEEDS TO BE EATEN AT 0600, LUNCH NEEDS TO BE EATEN AT 1200 & DINNER AT 1800. PATIENT WILL NOT BE UTILIZING ROOM SERVICE FOR Consistency/thickening: Instructional/informational: ALL MEALS, Starting today
DURATION OF 72 HR STUDY PARTICIPANT: LIMIT SNACKS BETWEEN MEALS PATIENT UNABLE TO UTILIZE ROOM SERVICE MNT PROTOCOL FOR DIETITIAN Choose One: SEND AUTOMATIC HOUSE TRAY CONSULT ORDERS IP CONSULT TO NUTRITION SERVICES Routine, ONE TIME, Starting today For 1 Occurrences Reason for Consult: z-other (specify in comments) Is Discharge Pending This Consult: No Do you want to initiate MNT Protocol?: Yes LAB ORDERS HGA1C (HEMOGLOBIN A1C WITH EST AVG GLUCOSE) Routine, ONE TIME, Starting today For 1 Occurrences, System Default MEDICATIONS MEDICATIONS (CONTROL ARM) INV insulin regular human (HUMULIN R) 250 units OR placebo in NS 250mL infusion insulin R human (HUMULIN R) 100 units/ml injection dextrose 50% (0.5 g/ml) injection at 5 ml/hr, Intravenous, CONTINUOUS, For 72 Hours 1-16 Units, Intravenous, EVERY 6 HOURS (SCHEDULED), For 72 Hours 25 ml, Intravenous, EVERY 15 MIN PRN, Blood sugar below, 80 mg/dl, For 72 Hours
INV SHINE - INTRAVENOUS INSULIN GROUP (ACTIVE ARM) [3374] This research order set to be used in conjunction with any of the Stroke Admit ordersets. Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). Do not order the home medications of insulin or oral diabetic medications during medication reconciliation. Discontinue any current orders for insulin or oral diabetic medications. PATIENT PARTICIPATING IN CLINICAL TRIAL Routine, CONTINUOUS, Starting today For Until specified Trial: SHINE STUDY STUDY ORDERS INITIAL GLUCOSTABILIZER PROGRAM ORDERS PARTICIPANT/INITIAL GLUCOSTABILIZER PROGRAM ORDER: PATIENT IS NOT TO RECEIVE ANY PREVIOUS INSULIN ORDERS OR ORAL DIABETIC MEDICATION ORDERS AT START OF STUDY THROUGH THE DURATION OF 72 HOUR STUDY PARTICIPANT/GLUCOSTABILIZER PROGRAM ORDER: OBTAIN INITIAL FINGERSTICK GLUCOSE AND REPEAT AS DIRECTED BY THE IV GLUCOSTABILIZER PROGRAM PARTICIPANT/GLUCOSTABILIZER PROGRAM ORDER: INITIALIZE & MAINTAIN IV GLUCOSTABILIZER PROGRAM PARTICIPANT/GLUCOSTABILIZER PROGRAM ORDER: ENTER BLOOD GLUCOSE VALUES (FINGERSTICK) AND CARBOHYDRATE GRAMS AS NEEDED INTO IV GLUCOSTABILIZER PROGRAM For 72 Hours, Page physician or Study Coordinator at 103-2193 with any needs to have medication orders discontinued or concerns. For 72 Hours, Enter glucose result into program. Adjust Insulin drip per Glucostabilizer instructions. For 72 Hours For Until specified NURSING ORDERS
PARTICIPANT: PT IS PARTICIPATING IN A 72 HOUR RESEARCH STUDY PARTICIPANT: BLOOD GLUCOSE WILL BE MONITORED USING POINT OF CARE FINGER STICK GLUCOSE CHECKS PARTICIPANT ENTER A SECONDARY ORDER FOR STAT SERUM NON-FASTING GLUCOSE IF FINGERSTICK IS LESS THAN 70 : NIH STROKE SCALE AT 10AM & 10PM AND WHEN DRUG STUDY IS DISCONTINUED PARTICIPANT: IF PATIENT IS NPO OR ON CONTINUOUS TUBE FEEDINGS GIVE 0.05ML(5 UNITS) NORMAL SALINE USING A U100 INSULIN 1ML SYRINGE AT 0900 AND AT 2100. For 72 Hours, Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). For 72 Hours, Do not use blood from an intravenous line for fingersticks. The decision support tool requires fingerstick glucose checks at least every 1-2 hours. The testing frequency is determined by the GlucoStabilizer tool. If the blood glucose drops <80 mg/dl, the GlucoStabilizer tool will initiate the hypoglycemia prevention and management protocol. GlucoStabilizer will recommend stopping all insulin, administering an individualized corrective dose of D50 over 1-2 minutes and more frequent blood glucose monitoring (every 15 minutes). Continue until the blood glucose is greater than 80mg/dL. Perform the Hypoglycemia Symptomatic Questionnaire with each 15 minute fingerstick until fingerstick is greater than or equal to >70 mg/dl or the symptoms have resolved, whichever comes first, one final assessment with the questionnaire is required. For 72 Hours, Do not enter the serum glucose value in the GlucoStabilizer program. Do not delay treatment with D50 by waiting for this serum blood draw result. Only the results from finger stick point of care glucose checks should be used for insulin dosing. Routine, EVERY 12 HOURS, Starting today, This is to keep study blinded to patient/family. DIET ORDERS DIET SHINE STUDY 60GM CARB PARTICIPANT: BREAKFAST NEEDS TO BE EATEN AT 0600, LUNCH NEEDS TO BE EATEN AT 1200 & DINNER AT 1800. PATIENT WILL NOT BE UTILIZING ROOM SERVICE FOR Consistency/thickening: Instructional/informational: ALL MEALS, Starting today
DURATION OF 72 HR STUDY PARTICIPANT: LIMIT SNACKS BETWEEN MEALS SHINE STUDY STROKE PARTICIPANT: 20 MINUTES AFTER INITIATION OF MEAL, NURSE WILL ESTIMATE PROPORTION OF MEAL CONSUMED PATIENT UNABLE TO UTILIZE ROOM SERVICE MNT PROTOCOL FOR DIETITIAN Choose One: SEND AUTOMATIC HOUSE TRAY CONSULT ORDERS IP CONSULT TO NUTRITION SERVICES Routine, ONE TIME, Starting today For 1 Occurrences Reason for Consult: z-other (specify in comments) Is Discharge Pending This Consult: No Do you want to initiate MNT Protocol?: Yes LAB ORDERS HGA1C (HEMOGLOBIN A1C WITH EST AVG GLUCOSE) Routine, ONE TIME, Starting today For 1 Occurrences, System Default MEDICATIONS INV SHINE INSULIN INF GROUP (ACTIVE ARM) INV insulin regular human (HUMULIN R) 250 units OR placebo in NS 250mL infusion insulin lispro human (HUMALOG) 100 units/ml subq injection Intravenous, CONTINUOUS, For 72 Hours 1-8 Units, Subcutaneous, CUSTOM FREQUENCY, For 72 Hours saline 0.9% (NS) subq injection 0.05 ml, Subcutaneous, 2 TIMES DAILY, For 72 Hours dextrose 50% (0.5 g/ml) injection 1-25 ml, Intravenous, EVERY 15 MIN PRN, Blood sugar below, 80 mg/dl, For 72 Hours
INV SHINE - INTRAVENOUS INSULIN GROUP (ACTIVE ARM) [3374] This research order set to be used in conjunction with any of the Stroke Admit ordersets. Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). Do not order the home medications of insulin or oral diabetic medications during medication reconciliation. Discontinue any current orders for insulin or oral diabetic medications. PATIENT PARTICIPATING IN CLINICAL TRIAL Routine, CONTINUOUS, Starting today For Until specified Trial: SHINE STUDY STUDY ORDERS INITIAL GLUCOSTABILIZER PROGRAM ORDERS PARTICIPANT/INITIAL GLUCOSTABILIZER PROGRAM ORDER: PATIENT IS NOT TO RECEIVE ANY PREVIOUS INSULIN ORDERS OR ORAL DIABETIC MEDICATION ORDERS AT START OF STUDY THROUGH THE DURATION OF 72 HOUR STUDY PARTICIPANT/GLUCOSTABILIZER PROGRAM ORDER: OBTAIN INITIAL FINGERSTICK GLUCOSE AND REPEAT AS DIRECTED BY THE IV GLUCOSTABILIZER PROGRAM PARTICIPANT/GLUCOSTABILIZER PROGRAM ORDER: INITIALIZE & MAINTAIN IV GLUCOSTABILIZER PROGRAM PARTICIPANT/GLUCOSTABILIZER PROGRAM ORDER: ENTER BLOOD GLUCOSE VALUES (FINGERSTICK) AND CARBOHYDRATE GRAMS AS NEEDED INTO IV GLUCOSTABILIZER PROGRAM For 72 Hours, Page physician or Study Coordinator at 103-2193 with any needs to have medication orders discontinued or concerns. For 72 Hours, Enter glucose result into program. Adjust Insulin drip per Glucostabilizer instructions. For 72 Hours For Until specified NURSING ORDERS
PARTICIPANT: PT IS PARTICIPATING IN A 72 HOUR RESEARCH STUDY PARTICIPANT: BLOOD GLUCOSE WILL BE MONITORED USING POINT OF CARE FINGER STICK GLUCOSE CHECKS PARTICIPANT ENTER A SECONDARY ORDER FOR STAT SERUM NON-FASTING GLUCOSE IF FINGERSTICK IS LESS THAN 70 : NIH STROKE SCALE AT 10AM & 10PM AND WHEN DRUG STUDY IS DISCONTINUED PARTICIPANT: IF PATIENT IS NPO OR ON CONTINUOUS TUBE FEEDINGS GIVE 0.05ML(5 UNITS) NORMAL SALINE USING A U100 INSULIN 1ML SYRINGE AT 0900 AND AT 2100. For 72 Hours, Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). For 72 Hours, Do not use blood from an intravenous line for fingersticks. The decision support tool requires fingerstick glucose checks at least every 1-2 hours. The testing frequency is determined by the GlucoStabilizer tool. If the blood glucose drops <80 mg/dl, the GlucoStabilizer tool will initiate the hypoglycemia prevention and management protocol. GlucoStabilizer will recommend stopping all insulin, administering an individualized corrective dose of D50 over 1-2 minutes and more frequent blood glucose monitoring (every 15 minutes). Continue until the blood glucose is greater than 80mg/dL. Perform the Hypoglycemia Symptomatic Questionnaire with each 15 minute fingerstick until fingerstick is greater than or equal to >70 mg/dl or the symptoms have resolved, whichever comes first, one final assessment with the questionnaire is required. For 72 Hours, Do not enter the serum glucose value in the GlucoStabilizer program. Do not delay treatment with D50 by waiting for this serum blood draw result. Only the results from finger stick point of care glucose checks should be used for insulin dosing. Routine, EVERY 12 HOURS, Starting today, This is to keep study blinded to patient/family. DIET ORDERS DIET SHINE STUDY 60GM CARB PARTICIPANT: BREAKFAST NEEDS TO BE EATEN AT 0600, LUNCH NEEDS TO BE EATEN AT 1200 & DINNER AT 1800. PATIENT WILL NOT BE UTILIZING ROOM SERVICE FOR Consistency/thickening: Instructional/informational: ALL MEALS, Starting today
DURATION OF 72 HR STUDY PARTICIPANT: LIMIT SNACKS BETWEEN MEALS SHINE STUDY STROKE PARTICIPANT: 20 MINUTES AFTER INITIATION OF MEAL, NURSE WILL ESTIMATE PROPORTION OF MEAL CONSUMED PATIENT UNABLE TO UTILIZE ROOM SERVICE MNT PROTOCOL FOR DIETITIAN Choose One: SEND AUTOMATIC HOUSE TRAY CONSULT ORDERS IP CONSULT TO NUTRITION SERVICES Routine, ONE TIME, Starting today For 1 Occurrences Reason for Consult: z-other (specify in comments) Is Discharge Pending This Consult: No Do you want to initiate MNT Protocol?: Yes LAB ORDERS HGA1C (HEMOGLOBIN A1C WITH EST AVG GLUCOSE) Routine, ONE TIME, Starting today For 1 Occurrences, System Default MEDICATIONS INV SHINE INSULIN INF GROUP (ACTIVE ARM) INV insulin regular human (HUMULIN R) 250 units OR placebo in NS 250mL infusion insulin lispro human (HUMALOG) 100 units/ml subq injection Intravenous, CONTINUOUS, For 72 Hours 1-8 Units, Subcutaneous, CUSTOM FREQUENCY, For 72 Hours saline 0.9% (NS) subq injection 0.05 ml, Subcutaneous, 2 TIMES DAILY, For 72 Hours dextrose 50% (0.5 g/ml) injection 1-25 ml, Intravenous, EVERY 15 MIN PRN, Blood sugar below, 80 mg/dl, For 72 Hours
INV SHINE - NORMAL SALINE INFUSION (CONTROL ARM) [3375] This research order set to be used in conjunction with any of the Stroke Admit ordersets. Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). Do not order the home medications of insulin or oral diabetic medications during medication reconciliation. Discontinue any current orders for insulin or oral diabetic medications. PATIENT PARTICIPATING IN CLINICAL TRIAL Routine, CONTINUOUS, Starting today For Until specified Trial: SHINE STUDY STUDY ORDERS INITIAL STUDY LAPTOP PROGRAM ORDERS PARTICIPANT/INITIAL STUDY LAPTOP PROGRAM ORDER: PATIENT IS NOT TO RECEIVE ANY PREVIOUS INSULIN ORDERS OR ORAL DIABETIC MEDICATION ORDERS AT START OF STUDY THROUGH THE DURATION OF 72 HOUR STUDY PARTICIPANT/STUDY LAPTOP PROGRAM ORDER: OBTAIN INITIAL FINGERSTICK GLUCOSE AND DOCUMENT IN STUDY LAPTOP PROGRAM. DOCUMENT EACH SUBSEQUENT FINGERSTICK VALUE IN THE STUDY LAPTOP PROGRAM. PARTICIPANT/STUDY LAPTOP PROGRAM ORDER: INITIALIZE & MAINTAIN IV STUDY LAPTOP PROGRAM SHINE STUDY STROKE PARTICIPANT:ENTER BLOOD GLUCOSE VALUES (FINGERSTICK). HUMAN REGULAR INSULIN (HUMULIN R OR NOVOLIN R) WILL BE USED FOR SUBCUTANEOUS INJECTIONS AT 06:00, 12:00, 18:00, AND 24:00 WHEN APPROPRIATE BASED ON SLIDING SCALE For 72 Hours, Page physician or Study Coordinator at 103-2193 with any needs to have medication orders discontinued or concerns For 72 Hours, Enter glucose result into program. Adjust Insulin (SHINE Study IV) drip per Study Laptop instructions. For 72 Hours For Until specified
NURSING ORDERS PARTICIPANT: PT IS PARTICIPATING IN A 72 HOUR RESEARCH STUDY PARTICIPANT: BLOOD GLUCOSE WILL BE MONITORED USING POINT OF CARE FINGER STICK GLUCOSE CHECKS PARTICIPANT:NURSING- ENTER A SECONDARY ORDER FOR STAT SERUM NON-FASTING GLUCOSE IF FINGERSTICK IS LESS THAN OR EQUAL TO 70 : NIH STROKE SCALE AT 10AM & 10PM AND WHEN DRUG STUDY IS DISCONTINUED For 72 Hours, Single blinded study (no information given to patient or family as far as fingerstick/glucose results or the type of insulin being administered). For 72 Hours, Do not use blood from an intravenous line for fingersticks. The decision support tool requires fingerstick glucose checks every 1 hour for the first 4 hours and then every 3 hours for the remainder of the study treatment period. The schedule for these checks is 03:00, 06:00, 09:00, 12:00, 15:00, 18:00, 21:00, and 00:00. If the blood glucose drops <80 mg/dl, the study laptop tool will initiate the hypoglycemia prevention and management protocol. The study laptop will recommend stopping all insulin (SHINE Study IV) & administering a dose of 25ml of D50 IV over 1-2 minutes and more frequent blood glucose monitoring (every 15 minutes) until the fingerstick glucose is greater than 80mg/dL. Perform the Hypoglycemia Symptomatic Questionnaire with each 15 minute fingerstick until fingerstick is greater than or equal to 70 mg/dl. Resume the previous fingerstick schedule once the patient has one fingerstick glucose reading above 70mg/dL. For 72 Hours, Do not enter the serum glucose value into the study laptop program. Do not delay treatment with D50 by waiting for this serum blood draw result. Only the results from fingerstick point of care glucose checks should be used for insulin dosing. Routine, EVERY 12 HOURS, Starting today DIET ORDERS DIET SHINE STUDY 60GM CARB PARTICIPANT: BREAKFAST NEEDS TO BE EATEN AT 0600, LUNCH NEEDS TO BE EATEN AT 1200 & DINNER AT 1800. PATIENT WILL NOT BE UTILIZING ROOM SERVICE FOR Consistency/thickening: Instructional/informational: ALL MEALS, Starting today
DURATION OF 72 HR STUDY PARTICIPANT: LIMIT SNACKS BETWEEN MEALS PATIENT UNABLE TO UTILIZE ROOM SERVICE MNT PROTOCOL FOR DIETITIAN Choose One: SEND AUTOMATIC HOUSE TRAY CONSULT ORDERS IP CONSULT TO NUTRITION SERVICES Routine, ONE TIME, Starting today For 1 Occurrences Reason for Consult: z-other (specify in comments) Is Discharge Pending This Consult: No Do you want to initiate MNT Protocol?: Yes LAB ORDERS HGA1C (HEMOGLOBIN A1C WITH EST AVG GLUCOSE) Routine, ONE TIME, Starting today For 1 Occurrences, System Default MEDICATIONS MEDICATIONS (CONTROL ARM) INV insulin regular human (HUMULIN R) 250 units OR placebo in NS 250mL infusion insulin R human (HUMULIN R) 100 units/ml injection dextrose 50% (0.5 g/ml) injection at 5 ml/hr, Intravenous, CONTINUOUS, For 72 Hours 1-16 Units, Intravenous, EVERY 6 HOURS (SCHEDULED), For 72 Hours 25 ml, Intravenous, EVERY 15 MIN PRN, Blood sugar below, 80 mg/dl, For 72 Hours