Home

EDC User Manual 29-Jul-08

1. Hepatic failure IES Respiratory Gastrointestinal ka Neurologic ka Sepsis a Trauma a Metabolic E Hematologic Renal E Other Comorbid Diseases Select all appropriate Comorbidites ES S Myocardial NONE Vascular ka Pulmonary E Neurologic H Endocrine H Renal H gastrointestinal l i Cancer immune ia Psychological a Muskoskeletal ltl na Miscellaneous WOME Comments Please enter any other details you would like to specify Save Patient 1 Reset Form Sex Indicate patient s sex by ticking appropriate box Age Enter the patient s age Height Enter the patient s admission height in centimetres If a height is not documented check the N A box Height in inches multiplied by 2 54 height in centimetres Weight Enter the patient s admission weight in kilograms If a weight is not documented check the N A box Weight in pounds divided by 2 2 weight in kilograms Hospital Admission Date Time Enter the date and time the patient was admitted to the hospital For the patient that is admitted to the hospital through the emergency department this is same as the date and time of admission to emergency For patients transferred from another institution this is the date of transfer The system will not permit the hospital admission date time fields to be left blank The electronic form can not be saved with this information missing Version 29 July 2008 Page 18 of 63
2. Indicate where the patient was when they were intubated select from the following options ICU Hospital outside of ICU ER OR ER OR elective OR emergency EMS in field Transferred from other institution Is the patient immunocompromised Indicate whether the patient was iImmunocompromised at the time of ICU admission Immunocompromised is defined as the patient has received therapy that suppresses resistance to infection i e immuno suppressive treatment chemotherapy radiation long term or recent thigh dose steroids or has a disease that is sufficiently advanced to suppress resistance to infection i e leukemia lymphoma AIDS tHigh dose steroids are defined as 1 A patient receiving corticosteroids for a reason other than renal replacement for at least 3 weeks Prednisone gt 5 10 mg Medrol gt 4 8 mg PLUS 2 More than adrenal doses for more than 3 weeks Version 29 July 2008 Page 19 of 63 Replaces version 8 January 2008 Type of Admission For admission categories choose either medical or surgical If surgery is chosen indicate if this is elective or emergency surgery Admission Diagnosis Using the Primary Diagnosis Taxonomy see Appendix B provided on the web enter the most responsible reason for the patient s admission to the ICU Example A patient is admitted with sepsis secondary to an UTI with elevated cardiac enzymes and renal failure The ICU admitting diagnosis is sepsis Select the adm
3. Day 1 12 May 07 Help VYasopressor Day Date Dopamine Norepinephrine Epinephrine ali 12 Mayf 2007 0 0 14 0 0 0 z ia May 200 7 o 0 10 0 0 0 E 14 May 2007 0 0 2 0 0 0 4 15 May 2007 J 16 May 2007 17 May 2007 Dopamine 44 Norepinephrine 14 0 meg karin Epinephrine oo Dobutamine qq mcgi k gi mini Phenylephrine no Vasopressin qq units minute Milrinone oo Comments Did patient receive any pressors inotropes during the study If you respond by clicking NO this form will default to complete i e status dot green for all study days Did patient receive any pressors inotropes today Did patient receive any pressors inotropes during the study yves Ono Did patient receive any pressors inotropes today Oves no Version 29 July 2008 Page 32 of 63 Replaces version 8 January 2008 lf you respond by clicking NO no further questions need to be answered Click 2575 P a you will be directed to the PATIENT STATUS page If you respond YES the patient received pressors inotropes Record the highest hourly dose infused of all that apply dopamine mcg kg min norepinephrine mcg kg min or mcg min epinephrine mcg kg min or mcg min dobutamine mcg kg min phenylephrine mcg kg min or mcg min milrinone mcg kg min or mcg min vasopressin units min Do NOT record single injections i e One time doses Click on 2a 2 Data you will be directed to the PAT
4. Patient on vasopressors or undergoing resuscitation time of HOB assessment H 2 g spine unstable or not cleared Pelvic instability or fractures Frone position EF at time of HOB assessment Systolic mmHg Diastolic mmHg all No pressors at time of HOB Patient did not receive any pressors inotropes today Pressors inotropes at time of HOB assessment Dopamine PEZ GE Norepinephrine Epinephrine Dobutamine micas ear aini Phenylephrine vasopressin units minute Milrinane Did the patient receive a fluid bolus gt 500 ml within 1 hour of HOB assessment Oves Ono specify whether any of the listed conditions were present at the time of HOB assessment You options are Patient on vasopressors or undergoing resuscitation Spine unstable or not cleared Pelvic instability or fractures Prone position Intra aortic balloon pump in femoral vessels Unable to raise HOB because of obesity Procedures including bathing None of the above means none of the listed exclusions were present Patient on vasopressors or undergoing resuscitation is defined as any of the following gt 5 dopamine mcg kg min Any dose of epinephrine norepinephrine phenylephrine vasopressin 500 cc fluid within 1 hour of HOB assessment Note You are able to select more than one of conditions present at the time of the HOB assessment by holding down the Ctrl button and highlighting the applicable options
5. White Blood Count total mm3 in 1000s S 1l Z Glasgow Coma Scale aiai Inappropriate words 3 Best Motor Response Localizes to pain T Glasgow Coma Score E Chronic Health Points Explain lt Elective postoperative patient a Total Apache II Score 37 Comments Save Apache II Form Reset Form APACHE II Score Variables Age Automatically entered by EDC system based on demographic data entered on previous electronic form Version 29 July 2008 Page 22 of 63 Replaces version 8 January 2008 Physiological Variables lf a patient has been transferred from another institution ICU or ER refer to data collected at the other institution to ensure assessment is made within the first 24 hours prior to any treatments being administered Record the highest and lowest value during the 24 hour assessment period The APACHE II score will be automatically calculated by the EDC System Do not include values from the OR Do not include values you assess as being transient e g a 1 time spike or drop in BP Temperature Enter the value and indicate rectal core oral axilla or tympanic listed in the second drop box The program will re calculate to the appropriate core temperature Note esophageal temperature is considered core temperature Temperature strips applied to the skin are considered oral temperature e e e ee ee ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB eB eB eB eB eB eB eB eB eB
6. as best they can then confirm the information with the attending physician Residents should not complete these forms Chest X Ray Indicate whether the patient has had a chest x ray Chest X Ray Findings Refer to the attending physician or site Investigator to clarify the appropriate response for chest x ray findings within the past 24 hours The response options are No infiltrate New infiltrate Persistent infiltrate unchanged from previous study Persistent infiltrate with progression from previous study Persistent infiltrate improved from previous study lf there is an x ray finding of new infiltrate or persistent infiltrate the following question will reveal itself Indicate the cause to the new or persistent infiltrates Infectious or Non infectious Refer to the MD Consultation Worksheet for the documented response to this question If non infectious the system will reveal the following question Please specify the cause to the non infectious cause to these infiltrates This question replaces the specify a new pulmonary diagnosis question from the baseline data collection period If infectious the system will reveal the following question Does the patient have a new suspicion of VAP in the past 24 hours In consultation with the attending physician or site investigator indicate whether pneumonia has been suspected in the past 24 hours The suspicion must be associated Version
7. available the site investigator Did the patient have a sedation vacation Sedation vacation is defined as the interruption of the administration of sedative agents midazolam propofol lorazepam and or narcotic agents until the patients are awake and could follow instructions or until they become uncomfortable or agitated and are deemed to require the resumption of sedation If a patient is receiving a paralytic drug sedation vacation is not applicable For further clarification first refer to the ICU attending physician for the week or if not available the site investigator Click on 238 Pata you will be directed to the PATIENT STATUS page Version 29 July 2008 Page 28 of 63 Replaces version 8 January 2008 VAP DIAGNOSIS SS Enrolment 02201 WAP Diagnosis Site name a kingston General Hospital Day 3 04 Nov 07 Chest Ray Chest X ray ves Ono X Ray Findings Persistent infiltrate unchanged from previous study D Indicate the cause to the new or persistent infiltrates Non Infectious infectious VAP Diagnosis 7 Does the patient have a new suspicion of YAP in the past 24 hours Oves no Sputum Yolume Large Amount w Ll na Secretions hucopurulent Cl na Hemoptysis Oves no Lina MD Consultation Forms Appendix E are used to document the collection of the following data points on a prospective basis Ideally the site research coordinator will complete the form
8. case the site investigator should choose Category 11 ICU Acquired Pneumonia this is a I default in the EDC system and then choose either definite probable or possible yes o If there was no VAP the site investigator should clarify if it is probably or possible NO Version 29 July 2008 Page 49 of 63 Replaces version 8 January 2008 o Following the site investigator s adjudication the RC returns to the online ADJUDICATION FORM for the corresponding patient and enters the results of the adjudication A Comments box has been added for the site investigator or RC or to record any issues or concerns regarding the adjudication All adjudicated suspicions of VAP will be reviewed by the study Principal Investigators All worksheets should be filed with the other patient study source documents in the regulatory binder INVESTIGATOR CONFIRMATION AND PATIENT FINALIZATION The Investigator s Confirmation form must be completed for each patient after all electronic forms are completed and outstanding issues are resolved Click on BUTTON under Outcomes and Follow up on the Patient Status Page A box will appear asking the user if they are sure they would like to finalize the patient Finalizing a patient means that all data has been entered and the site is ready to sign off on the electronic forms When a patient is finalized the site can no longer make any changes to data The Methods Centre can unfinalize a pa
9. eB eB eB ee eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB e Lhe ld Manual temperature adjustments if oral temperature is reported add 0 5 C if axilla temperature is reported add 1 0 C Systolic and Diastolic blood pressures Enter the lowest and highest documented blood pressures Once these values have been entered the Mean Arterial Pressure MAP value will be automatically calculated and entered in the right hand column Manual calculation of MAP SBP DBP x 2 3 Heart Rate Record the documented ventricular rate Respiratory rate either ventilated or non ventilated Oxygenation Choose a if EIO is gt 0 5 Enter the FiOz PaCQz2 and the PaO into the appropriate boxes Again the program will calculate the A aDQ2 and enter the value in the right hand column For the purposes of this trial the barometric pressure value will be standardized at 713 O Choose b if the FiQ2 is lt 0 5 only the Pa box will appear Enter the value o Ifno ABGs available tick the appropriate box and enter the HCO in place of arterial pH Serum HCO3 should only be used if there are no ABGs available in the previous 24 hours Arterial pH Serum Sodium the unit of measure is mmol L Serum Potassium the unit of measure is mmol L Version 29 July 2008 Page 23 of 63 Replaces version 8 January 2008 Serum Creatinine the unit of measure is umol L Double points are assigned if the patient is experiencing acute
10. page when the user first logs into the EDC system You will see a listing of all of the data collection periods i e Baseline 6 Month 12 Month 18 Month and 24 Month Enter edit or view data for enrolled patients Click on the button to expand the view for a particular data collection period Each enrolled patient is listed under the corresponding data collection period Version 29 July 2008 Page 6 of 63 Replaces version 8 January 2008 ABATE VAP Study Translating VAP CPGs into Clinical Practice Enroled Patients aaa Kingston General Hospital Baseline Data Collection Period 6 Month Collection Period 15 Month Collection Period 24 Month Collection Period 33 Month Collection Period a UNIT SPECIFIC DATA Unit Specific Data Click on the UNIT SPECIFIC DATA option on the left menu You will be directed to the Unit Specific Data Status page C____ Unit Specific Data Kingston General Hospital Bottom Unit Baseline Data Edit ICU Information Unit Specific Daily Data appropriate day Baseline Data Collection Period 6 Month Collection Period 15 Month Collection Period 24 Month Collection Period 33 Month Collection Period tl El E EDIT USER PROFILE Record unit specific daily data for everyday that patient clinical and concordance data are collecte data at the same time every day To review or edit a day s data click on the row corresponding 1 Version 29 Jul
11. record this date You do not complete Hospital Outcomes Form e e ee ew eee eB eB ee eB ee ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB ee eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB e Le lL You will be prompted to provide date and time of actual death Is the date and time of final ventilation discontinuation the same as death date amp time Yes or No lf Yes Note Date and time of actual death will be final ventilation discontinuation date and time lf No provide date and time of final ventilation discontinuation If patient is discharged from ICU while still ventilated for example transfer to step down unit you must follow the patient to obtain the actual discontinuation date and time of ventilation In addition please make a comment in the Comment Box describing the situation If patient is transferred to another hospital ventilated the actual discharge date and time will become the ventilation discontinuation date and time please use the appropriate checkbox memes i m m mm ee Did patient die in ICU If No Provide date and time of actual ICU discharge Click 22 2 5 to save the form and be directed back to the PATIENT STATUS PAGE HOSPITAL OUTCOMES This form must be completed when patient is discharged from hospital or dies in the hospital On the Patient Status Page under Outcomes and Follow up select BU
12. study Start up meeting for further details concerning the types of documentation which should be filed and maintained by the research site A new patient binder will be forwarded for each data collection period 6 12 18 24 months to house all of the source documentation specific to the patients enrolled in each of the data collection periods GENERAL GUIDELINES FOR ELECTRONIC DATA CAPTURE Accessing the Web The Methods Centre MC will provide a username and password ONLY to authorized personnel involved with data entry for the ABATE VAP Study Version 29 July 2008 Page 3 of 63 Replaces version 8 January 2008 All authorized personnel accessing the web site must sign an Electronic Data Capture System Access Signature Sheet Appendix A provided by the MC The site Research Coordinator RC will be responsible for notifying the PL with any changes in study personnel requiring the revocation and or issuance of user IDs and passwords The EDC System for the ABATE VAP Study is accessible at the following web address https ceru hpcvl queensu ca ABATE_VAP All authorized study personnel must log onto the web site using their own username and password prior to data entry User profiles and passwords can be changed at any time by clicking the appropriate links on the ABATE VAP Study home page General Guidelines for Electronic Data Entry ONLY patients meeting inclusion criteria should be entered on the web The site number will be prog
13. they have not been previously included in the study Enrolment Date This field will be automatically filled in by the system once the Demographic Data form is complete Enrolment Number This will be automatically assigned by the EDC system once the form is saved Click on Enroll Patient to save this patient in the EDC system NOTE Once a patient has been saved the data cannot be removed PATIENT DEMOGRAPHICS Enrolment 02102 Patient Demographics Site name Help Demographic Information Sex O Male O Female Age years 60 Height cm 165 0 Clua Weight ikg 68 0 ie BMI 14 Admission Information Hospital Admission Date 0 B Apr v 5007 v Time 47 37 24 hrs ICU Admission Date a Time 17 Apr M UD m 24 hrs SL Mechanical entilation Start Date 17 Apr v a0 Time 29 24 24 hrs Where was the patient intubated ha Is the patient immunocompromised Oves no The patient has received therapy that suppresses resistance to infection i e immmuna suppressive treatment chemotherapy radation long term or recent high dose steriads or has a disease that is sufficiently advanced to suppress resistance to infection i e leukemia lymphoma AIDS Version 29 July 2008 Page 17 of 63 Replaces version 8 January 2008 Type of Admission Medical O Surgical Elective O Surgical Emergency Admission Diagnosis Select Only One tl cardiovascular vascular prnmary Ieu diagnosis i
14. to save the form ABATE VAP Study SS Enrolment 11108 Concordance Data Physical Site name Surgical Day 1 05 Apr 07 Help Comments Please enter any other details you would like to specify Reset Form Indicate the route of endotracheal intubation Orotracheal Nasotracheal Tracheostomy lf Orotracheal route of intubation Does the patient have endotracheal intubation ETT with subglottic secretion drainage SSD If Yes Enrolment 11108 Concordance Data Physical Site name Surgical Day 1 05 Apr 07 Help Not ventilated E Indicate the route of endotracheal intubation B srotracheal O Masotracheal Tracheostomy Does the patient have endotracheal intubation ETT yes One with subglottic secretion drainage SSD suction port blocked Is the SSD port on the ETT functional Oves no eekeatouchian quiets Indicate Reasons hes i g Date and time endotracheal tube with 55D placed B l a Time Ie L 24 hrs Version 29 July 2008 Page 36 of 63 Replaces version 8 January 2008 If NO Indicate the route of endotracheal intubation ee sa Nasotracheal O Tracheostomy Does the patient have endotracheal intubation ETT Oves no with subglottic secretion drainage SSD Indicate Reason If nasotracheal route of intubation Indicate the route of endotracheal intubation orctrachesl Masotracheal O Tracheostomy Were any
15. with your 1 mouse Version 29 July 2008 Page 41 of 63 Replaces version 8 January 2008 BP at time of HOB Assessment Record the blood pressure at the time of HOB assessment in millimetres of mercury mmHg There are separate fields for systolic and diastolic blood pressure Pressors inotropes at time of HOB Assessment Record the dose of pressors inotropes at the time the HOB measurement is taken This value may differ from the pressor inotrope daily data Did the patient receive a fluid bolus within 1 hour of HOB assessment Indicate whether the patient received a fluid bolus gt 500 mL within 1 hour of the HOB measurement Fluid boluses lt 500 mL should not be recorded Click on 228 Pta you will be directed to the PATIENT STATUS page DIAGNOSTIC STRATEGY DATA i Enrolment 02201 Concordance Data Diagnosis Site name Kingston General Hospital Day 3 04 Nov 07 Has a bronchoscopy been performed in the past 74 hours for diagnosis of YAP S res Ono Time Indicate the date and time of the bronchoscopy W of Ha v L l Fe Has the Patient had an endotracheal aspirate ETA in the past 274 hours n res Ono Indicate the date and time of the endotracheal aspirate a007 Pdi 04 30 Comments Please enter any other details you would like to specify Save Reset Form Has a bronchoscopy been performed in the past 24 hours for diagnosis of VAP A therapeutic bronchoscopy is performed when the physician need
16. 29 July 2008 Page 29 of 63 Replaces version 8 January 2008 with new progressive or persistent infiltrates on CXR noted to be of infectious origin and be associated with signs and symptoms of infection fever leukocyotosis worsening oxygenation purulent secretions etc If yes then specify date time of suspicion If no no further questions Sputum volume Select the worst sputum volume in the past 24 hours Copious Large amount Moderate amount Small amount None Purulence Secretions Select the worst secretions description in the past 24 hours Clear Mucoid Mucopurulent Purulent None Hemoptysis Defined as visibly soiled by bloody secretions This does not include streaking Note If there is no suction data at the time of data collection enter none for sputum volume and secretions and make a comment at the bottom of the form In the same circumstance enter no for hemoptysis Click on 22 Pta you will be directed to the PATIENT STATUS page LABORATORY Version 29 July 2008 Page 30 of 63 Replaces version 8 January 2008 Enrolment 11106 Daily Data Form A Site name Surgical f Dav 1 Help Blood Gas Click here if ABG not done pH 7 43 PaO mmHg 70 0 PaCO mmHg 38 0 Hematology Click here if Hematology not done 3 WBC 10 mm 21 2 Hemoglobin mmol L 107 0 Platelets 10 mm 218 0 Biochemistry Bilirubin pmol L Het bere Creatinine umol L
17. 47 p Not Done Blood Gases If blood gas data is not available check the NOT DONE box all of the blood gas fields will be hidden from view NOTE Blood gas data should be collected at the same time or as close as possible 6 hours to the respiratory data i e ventilator settings If there is no data available within 6 hours of the ventilator check then check Not Done SS i a i i i i i i a a pH Record the pH value Pa0O2 Record the PaO2 value mmHg PaCOz Record the PaCO2 value mmHg Hematology If hematology results are not available check the NOT DONE box The hematology fields will be hidden from view WBC Record the white blood count 102 mm Hemoglobin Record the hemoglobin g L result Conversion g dL x 10 g L Platelets Record the platelet count 10 mm for the day Biochemistry Version 29 July 2008 Page 31 of 63 Replaces version 8 January 2008 Bilirubin Record the bilirubin umol L result If the result is not available check the NOT DONE box Conversion mg dL x 17 1 umol L Creatinine Record the creatinine umol L result If the result is not available check the NOT DONE box Conversion mg dL x 88 4 umol L Click on 238 Pata you will be directed to the PATIENT STATUS page VASOPRESSORS AINOTROPES Did patient receive any pressors inotropes today yes One Record highest hourly dose i Enrolment 02127 Vasopressors I notropes Site name
18. Electronic Data Capture System User Manual Active OBservational Study of the Adoption and Transfer of Clinical Practice Guidelines through Education for Ventilator Associated Pneumonia C a yor A p lt d as z E a Study This study is registered at Clinicaltrials gov Identification number NCT00434460 Version 29 July 2008 Page 1 of 63 Replaces version 8 January 2008 CONTACTS Principal Investigators Dr John Muscedere Dr Taz Sinuff Co Principal Investigator Co Principal Investigator Kingston General Hospital Sunnybrook Health Sciences Centre Angada 4 Rm 5 411 Department of Critical Care Medicine 76 Stuart Street Rm D131 Kingston ON K L 2V7 2075 Bayview Avenue Tel 613 549 6666 ext 4642 Toronto ON M4N 3M5 Fax 613 548 2428 Tel 416 480 6100 ext 7694 Email muscede kgh kari net email taz sinuff sunnybrook ca Project Leader Janet Overvelde Project Leader Clinical Evaluation Research Unit Kingston General Hospital Angada 4 Rm 4 518 76 Stuart Street Kingston ON Tel 613 549 6666 ext 6241 Fax 613 548 2428 Email overveli kgh kari net ROLES amp RESPONSIBILITIES METHODS CENTRE The Methods Centre MC is responsible for the following tasks Providing training on the EDC System Supplying a user name and password to site personnel that is responsible for data entry Providing technical support for the EDC system and associated functions Notifying research sites of any
19. IENT STATUS page DATA EDIT AND LOGIC CHECKS The EDC system has a built in process for dealing with queries related to Variable ranges Date time logic Concordance data logic These queries are grouped into 2 categories INPUT RESTRICTIONS and INPUT WARNINGS Both are logged into the system in real time Input Restrictions Input restrictions appear as warning messages on the form the user is actively entering data on The user will not be able to save the form without first addressing the input restrictions As shown below the input restriction appears as red text at the top of the form Version 29 July 2008 Page 33 of 63 Replaces version 8 January 2008 Enrolment 11510 Patient Demographics Site name Surgical Help Patient s sex is required Patient s age is required Date of Admissian to ICU is required Date of Admission to hospital is required Demographic Information Sex O Male O Female Age years Height cm CI a Weight kg Olma BMI U Admission Information Hospital Admission Date Ti ICU Admission Date lel 1 Ti Mechanical ventilation Start Date sal axl Ti Input Warnings Input warning will not restrict the user form saving the active data entry form but will be displayed on the PATIENT STATUS PAGE Input warnings can be addressed at the time they appear on the PATIENT STATUS PAGE or the user can save their work and come back to resolve the input warnings at another time Below is a scre
20. July 2008 Page 52 of 63 Replaces version 8 January 2008 APPENDIX B PRIMARY ADMISSION DIAGNOSIS TAXONOMY Version 29 July 2008 Page 53 of 63 Replaces version 8 January 2008 APPENDIX C COMORBID DISEASES TAXONOMY Version 29 July 2008 Page 54 of 63 Replaces version 8 January 2008 APPENDIX D APACHE II WORKSHEET Version 29 July 2008 Page 55 of 63 Replaces version 8 January 2008 APPENDIX E MD CONSULTATION SHEET Version 29 July 2008 Page 56 of 63 Replaces version 8 January 2008 APPENDIX F HEAD OF BED ELEVATION ASSESSMENTS Version 29 July 2008 Page 57 of 63 Replaces version 8 January 2008 APPENDIX G ANTIBIOTIC TAXONOMY Version 29 July 2008 Page 58 of 63 Replaces version 8 January 2008 APPENDIX H MICRO ORGANISM TAXONOMY Version 29 July 2008 Page 59 of 63 Replaces version 8 January 2008 APPENDIX AD UDICATION OF SUSPECTED VAP Version 29 July 2008 Page 60 of 63 Replaces version 8 January 2008 APPENDIX J ALGORITHM FOR MAKING DETERMINATIONS REGARDING SUSPECTED VAP Version 29 July 2008 Page 61 of 63 Replaces version 8 January 2008 APPENDIX K DEFINITIONS FOR VAP DETERMINATIONS Version 29 July 2008 Page 62 of 63 Replaces version 8 January 2008 APPENDIX L INVESTIGATOR S CONFIRMATION FORM Version 29 July 2008 Page 63 of 63 Replaces version 8 January 2008
21. Replaces version 8 January 2008 ICU Admission Date Time Enter the date and time the patient was admitted to the ICU Ifthe patient has been in the ICU for a period of time before this current admission only record the date and time the patient was admitted for this current period of care The user will not be permitted to proceed with data entry without this information Bic The system will not permit the ICU admission date time fields to be left blank The electronic form can not be saved with this information missing Mechanical Ventilation Start Date Time Enter the date amp time when invasive mechanical ventilation began For a patient transferred from another institution the actual date and time of initiation of mechanical ventilation from the original institution should be captured If the patient was intubated in the field by EMS and the time was not documented use the hospital admission date time Invasive mechanical ventilation means the presence of an endotracheal tube intubation with mechanical ventilation or tracheostomy with mechanical ventilation This includes any positive pressure delivered via endotracheal tube or tracheostomy This does not refer to non invasive methods of ventilation such as BI PAP or mask CPAP The system will not permit the mechanical ventilation start date time fields to be left blank The electronic form can not be saved with this information missing Where was the patient intubated
22. TTON You will be directed to the Hospital Outcomes Form Did patient die If Yes you will be prompted to provide date and time of actual death Note Death date amp time will be same as Hospital discharge date and time therefore you will not be required to record this date e m es ee ee ee ee ee ee ee ee eB ee eB eB ee eB eB eB eB eB eB eB eB ee ee eB ee eB eB ee ee ee eB eB ee ee eB eB ee ee ee eB eB eB eB eB eB eB eB eB eB ee eB eB eB eB eH el e e 0 If No provide date and time of actual Hospital discharge Version 29 July 2008 Page 48 of 63 Replaces version 8 January 2008 For patients whose hospitalization lasts several months the ALC Alternate Level of Care date time should be used for the hospital discharge date time This is the date when the patient s acute hospitalization is complete e g awaiting placement in a long term care bed Click Save to save the form and be directed back to the patient status page AD UDICATON OF SUSPECTED VAP The EDC system has been programmed to automatically generate a listing of relevant clinical data that will enable the site investigator to adjudicate suspected cases of VAP 1 Before the adjudication can be performed by the site investigator the RC must enter ALL clinical and concordance daily data ICU outcome data and resolve all outstanding items on these forms i e queries 2 If VAP was never suspected for a particular patient or the RC has not entered clinical and
23. The user will be prompted to enter an explanation why the data was out of the specified system edit checks Research sites will be queried if the explanation section of an accepted input warning is left blank Input Warnings Height 255 0 is not in the range 100 0 to 250 0 View Edit Accept Explanation Submit Acceptance Once input warnings have been addressed they will disappear from the listing NOTE Patients can not be finalized until all input warnings have been resolved DAILY CONCORDANCE DATA Concordance data will be collected everyday following patient enrolment into the study i e MV gt 48 hours until daily data collection is discontinued There are 4 separate forms with concordance data grouping the data into VAP CPG recommendation categories Physical Strategy Positional Strategy Pharmacological Strategy Diagnostic Strategy Logic has been built into the electronic forms such that how you answer one question affects which subsequent questions apply e g For a question with a YES NO answer answering YES will have different follow up questions from answering NO Version 29 July 2008 Page 35 of 63 Replaces version 8 January 2008 PHYSICAL STRATEGY DATA The selected response to the first question determines the subsequent questions on this page If there is no ventilation data for a particular day check the Not Ventilated box All other data entry fields will be hidden from view Proceed
24. U physician meetings per year Number of ICU nurses Enter the number of ICU nurses This is the total of full time part time and casual nurses who work in the ICU Number of ICU nurse meetings per year Indicate the number of nurse meetings per year Number of ICU respiratory therapists Enter the number of ICU specific respiratory therapists Number of respiratory therapist meetings per year Indicate the number of respiratory therapist meetings Number of dietician full time equivalents Enter the number of ICU dietician FTEs Full time equivalents FTE are a way to measure an employee s productivity and or involvement in a project A FTE of 1 0 means that the individual is equivalent to a full time employee a FTE of 0 5 indicates that the individual is equivalent to a part time employee Number of pharmacist full time equivalents Enter the number of ICU pharmacist FTEs Number of infection control practitioner full time equivalents Enter the number of ICU infection control practitioner FTEs ICU Education Number of ICU nurse educator full time equivalents Enter the number of ICU nurse educator FTEs Number of ICU respiratory therapist educator full time equivalents Enter the number of ICU respiratory therapist FTEs Number of quality improvement full time equivalents Enter the number of ICU quality improvement FTEs Version 29 July 2008 Page 12 of 63 Replaces version 8 January 2008 Click on 5515 Pata you will b
25. amendments or changes to the EDC A periodic newsletter email will inform the research sites of current enrolment status and share frequently asked questions Performing data verification Version 29 July 2008 Page 2 of 63 Replaces version 8 January 2008 RESEARCH SITES The Research Sites are responsible for the following Supplying a computer with internet access Maintenance of local computer equipment Notifying the MC of any technical difficulties or malfunctions related to the EDC system Allowing only authorized study personnel with assigned password access to the EDC system for completion of electronic data capture Entering enrolled patient data SITE INVESTIGATOR Site Investigators should Review and adjudicate all suspected cases of VAP Confirm all entered data by signing the Investigator s Confirmation Form SOURCE DATA amp DOCUMENTATION sites should maintain all original documentation that substantiates the integrity and reproducibility of the data entered into the EDC system This includes the patient s medical chart maintained as per institutional policies and any study specific documentation Study specific documentation includes but is not limited to Patient worksheets ICU specific data worksheets MD Consultation Form Adjudication of Suspected VAP table generated from EDC System Investigator s Confirmation Form generated from EDC System Refer to the Regulatory Binder provided at the
26. antadine mr Amikacin Aminosalicylic acid Mo Susceptibilities reported Amoxicillin Amoxicilliniclavulinic Amphotericin E Ampicillin N add Organism Organism Species sub species To add an additional organism to the same culture sample click on next to Add Organism and the taxonomy will appear Click on L_Sae ticrobisleay to save the form and return to the PATIENT STATUS PAGE or Click ON New microbiology to Save the form and continue entering cultures for this patient PATIENT OUTCOMES Collect the outcome data until the first of the following has occurred 1 Patient has died 2 Patient discharged from ICU 3 28 days from the time of enrolment into the study There are 2 outcome forms ICU Outcomes Hospital Outcomes On the PATIENT STATUS PAGE under FINAL OUTCOMES category select ICU Outcomes You will be directed to the ICU Outcomes Form Final Gutcomes Record the outcome data when the first of the follawing has occurred 6 1 Patient has died 6 2 Patient discharged from ICU 6 3 Patient has been in the ICU for 30 days from the time of mechanical ventilation initiation ICU Outcomes Hospital Qutcomes Investigators Confirmation Form Version 29 July 2008 Page 47 of 63 Replaces version 8 January 2008 ICU OUTCOMES Did patient die in ICU If Yes Note Death date amp time will be same as Hospital amp ICU discharge date and time therefore you will not be required to
27. aseline category to enter your site Baseline data This form is to be completed once at the commencement of the Baseline data collection period Information requested on this form relates to the last calendar year i e 2006 Version 29 July 2008 Page 10 of 63 Replaces version 8 January 2008 Unit Baseline Data KGH Surgical Help This form is to be completed once at the commencement of the Baseline data collection period Information requested on this form relates to the last calendar year i e 2006 Institution Type of Institution academic community Number of Hospital Beds Number of available ICU beds Number of ICU patien ts per year Number of ICU beds capable of mechanical ventilation Number of patient ICU days per year Number of days of mechanical ventilation per year ICU Organization Does the ICU have a Medical Director res One Staff size Number of attending physicians Number of physician meetings per year Number of nurses Number of nurse staff meetings per year Number of respiratory therapists Number of respiratory therapist meetings per year Number of dietitian full time equivalents Number of pharmacist full time equivalents Number of infection control practitioner full time equivalents ICU Education Number of ICU nurse educator full time equivalents Number of respiratory therapist educator full time equivalents Number of ICU quality improvement full time equ
28. concordance daily data or ICU outcomes data an ADJUDICATION FORM will NOT appear on the web 3 lf there was a suspicion of VAP and the RC has entered all the clinical and concordance daily data and ICU outcome data an ADJUDICATION FORM will appear see Appendix 4 The site investigator can use a print out of the adjudication form as a worksheet for their determinations of the suspicions of VAP RCs should print off these forms prior to entering any data NOTE Ifa paper worksheet is used the adjudication result must be entered on the electronic form 5 The site investigator should adjudicate suspected cases of VAP The following documentation will be provided to assist the site investigator in making the determination o Complete ADJUDICATION OF SUSPECTED VAP FORM printed from the web o Algorithm for Making Determinations Regarding Suspected VAP Appendix J o Definitions for VAP Determinations Appendix K The adjudication process involves consideration of the clinical and microbiological events surrounding the suspicion of VAP The clinical features of VAP need to be present since without the clinical features a positive culture likely represents colonization rather than VAP The probability of pneumonia is then based on the microbiological evidence 6 The site investigator will make the determination based on the algorithm and if needed a review of the patient s chart o If there the suspicion of VAP is determined to be a confirmed
29. e If the sub species are not listed select OTHER and record the other sub species See appendix H for the organism taxonomy Quantitative Results Record results using the same units as reported on the microbiology reports When appropriate use the drop down menu to specify units for the culture measurements If quantitative results are not reported use the appropriate checkbox susceptibilities Record all susceptibilities for each individual organism by selecting the appropriate antibiotic from the taxonomy The selected antibiotic will be highlighted in blue Click on the SENSITIVE INTERMEDIATE or RESISTANT tab and the susceptibilities will be listed automatically in the box on the right hand side of the screen Repeat for each antibiotic meee i i ee dwe eB eB BB eB eB eB eB a d eB eB BP d a BB BM BEB MB BM MB BP SB BM BM BM BP BM BEB BE BSB BP BM BP m m BB BB BP MB BP BM BM BP BSB BM BEB BP BP BP SB BP SB SB BM SB BSB SB SB SB SB SE EK EK m a For BAL or bronchial washings with no quantitative results choose sample type OTHER and write in comments bronchial washings no quantitative growth If toxin for C difficile present consider this as a positive culture and choose C difficile from the taxonomy Version 29 July 2008 Page 46 of 63 Replaces version 8 January 2008 Organisms staph sp S Coaqulase Negative epidermatitis ka Quantitative Results F No results reported Susceptibilites Acyclovir Am
30. e directed to the UNIT SPECIFIC DATA STATUS page Unit Specific Daily Data Record unit specific daily data for everyday that patient daily data is collected Sites are instructed to collect this data for a maximum of 60 days It is recognized that the data for these variables will change throughout the day The site should collect data at the same time every day Select the appropriate data collection period and expand the view by clicking on the Y beside the applicable data collection period Click on Enter new Daily tata to Open the data entry form Unit Specific Data Kingston General Hospital Unit Baseline Data Edit ICU Information Unit Specific Daily Data Record unit specific daily data for everyday that patient clinical and concordance data are collected Collect data atthe same time every day To review or edit a day s data click on the raw corresponding ta the appropriate day Baseline Data Collection Period Date Patients Available ICU Beds MY Patients Charge Nurse RTs 2007 04 16 13 2 z007 04 16 ZU D 14 Yes 70 2OOY O4 17 z1 U 14 Yes 7 0 2007 04 12 Z1 U 14 Yes 7 0 2007 04 12 z0 1 14 Yes 20 2007 04 20 13 Z 13 Yes 2 0 2007 04 20 20 all 13 Yes 2 0 2007 04 21 20 1 Yes 2 0 2007 04 22 13 z 16 Yes 7 0 2007 04 22 z0 1 Yes 7 0 U 7 0 2007 04 23 23 18 Yes Double click on the date within a particular row in the above table to edit previously entered data Unit Specific Daily Data Kingston General H
31. ed to the Microbiology Form You will be asked Did the patient have any positive cultures from 7 days prior to ICU admission until ICU discharge Enrolment nullio1 Mi Site name Janet a icrobiology Li Help Is patient has any positive cultures from 7 days prior YES HO to ICU admission until ICU discharge O O If NO click 52e Misrobiclegy and you will be directed back to the PATIENT STATUS page If YES you will be prompted to record positive culture data Microbiological findings of normal flora or commensurate flora do NOT need to be recorded Accession Number Provide the Accession Number also known as the laboratory requisition number Date time Culture Taken Enter the date and time the culture was taken Sample Type Select the sample type from the drop down menu The options are Blood Endotracheal Aspirate Version 29 July 2008 Page 45 of 63 Replaces version 8 January 2008 Bronchoalveolar Lavage BAL or Protected Brush Catheter PBC sample Wound Cath tip line Urinary Stool Other please specify To add organism specific data click on under the Organisms heading Organisms T Add Organism Organism Category Select the type of microorganism from the drop down list bacteria fungi yeast virus mycobacteria Species Select the species from the drop down menu See Appendix H for the organism taxonomy Subspecies Select the micro organism sub species from the drop down menu Not
32. edical history should be reviewed for assessment of this category No history of severe organ system insufficiency AND not immunocompromised Elective post operative patient Non operative OR emergency post operative patient Version 29 July 2008 Page 24 of 63 Replaces version 8 January 2008 An emergency post operative patient is defined as a patient who has received surgery required immediately to correct a life threatening condition Organ insufficiency or immunocompromised state must have been evident prior to the present hospital admission and conform to the definitions listed below Chronic Health Definitions Organ insufficiency or immunocompromised state evident prior to this hospital admission and are consistent with the following criteria Liver Biospy proven cirrhosis and documented portal hypertension prior episodes of upper GI bleeding attributed to portal hypertension or prior episodes of hepatic failure encephalopathy coma Cardiovascular New York Heart Association Class IV Respiratory Chronic restrictive obstructive or vascular disease resulting in severe exercise restriction i e unable to climb stairs or perform activities of daily living or household duties or documented chronic hypoxia hypercapnia secondary polycythemia severe pulmonary hypertension gt 40 mmHg or ventilator dependency Renal Receiving chronic dialysis Immunocompromised The patient has received therapy that suppresses resistance to in
33. en shot of a PATIENT STATUS PAGE If there are any input warnings for a particular patient the Input Warnings category will appear at the top of the page Patient Status Page Patient 11104 status In Progress Baseline Forms Enrolment g Demographics Apache II a Daily Data T Concordance Data T Antibiotics T Microbiology Final Outcomes To address the noted Input Warnings select the to reveal the list of flagged input warnings For each warning the user has 2 options 1 to review and edit data and 2 to accept the data as it was entered Version 29 July 2008 Page 34 of 63 Replaces version 8 January 2008 Patient Status Page Patient 11107 Status In Progress Input Warnings 6 Height 255 0 is not in the range 100 0 to 250 0 ViewfEdit Accept 6 Weight 250 0 is not in the range 50 0 to 200 0 ViewfEdit Accept ICU admission date time cannot precede Hospital admission datetime View Edit Resniratnru rate 51 00 is nnt in the ranne 7 0 ta 50 0 Wiew Fdit amp rrent Clicking on he ie w Edit outton will link the user directly to the page where the input warning was generated e g for an input warning regarding the patient s height the user will be linked directly into the Demographic Data page If the user wishes to update the information the correction can be made directly on the page and saved Clicking on the szept button acknowledges the data was correct at the time of entry
34. ent receives If the antibiotic is ongoing at ICU discharge check the appropriate box Do not record any changes in dose route frequency as a separate entry If antibiotics are held for gt 48 hours and then restarted then enter as a separate entry except if drug levels are high Do not record 1 time single doses of antibiotics e g erythromycin for gut prophylaxis Version 29 July 2008 Page 44 of 63 Replaces version 8 January 2008 The form gives the user the option to enter one antibiotic save their work and return to the PATIENT STATUS PAGE or to continue entering all of the antibiotics at once MICROBIOLOGY DATA Record all positive cultures from 7 days prior to ICU admission until the first of the following occurs Mechanical ventilation has been discontinued for at least 24 hours AND All antibiotics for VAP have been discontinued Patient is discharged from the ICU 30 days from the start of mechanical ventilation Note Do not record cultures if they are reported as No Growth or Common Mixed Flora Do not record cultures that are considered to be a contaminant m ee ee ee ee ee eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB eB Be He el e eld On the PATIENT STATUS PAGE click on next to Microbiology A blue NEW MICROBIOLOGY Tab will appear click here to be direct
35. ew TCU Outcome New Hospital Outcome Infection Adjudications View Adjudicatians PATIENT ENROLMENT BASELINE DATA Only enter enrolled patients into the EDC system i 7 Enrolment nullLaz Patient Enrolment Site S iiag Help Inclusion Criteria Age gt 17 years Oi yes Ome Mechanically ventilated gt 46 hours lt 96 hours Oves Ono Exclusion Criteria Previous enrolment in the ABATE YAP study Oves Ono Enrolment Enrolment Date 777 Enroll Patient Reset Form Inclusion Criteria Patients must be gt 17 years of age to be eligible for entry into the ABATE VAP study Patients must be invasively mechanically ventilated for gt 48 hours not more than 96 hours to be included in the study Version 29 July 2008 Page 16 of 63 Replaces version 8 January 2008 Invasive mechanical ventilation means the presence of an endotracheal tube intubation with mechanical ventilation or tracheostomy with mechanical ventilation This includes any positive pressure delivered via endotracheal tube or tracheostomy This does not refer to non invasive methods of ventilation such as BI PAP or mask CPAP For patients that have been transferred from another ICU the time invasive mechanical ventilation was started in another ICU is used to determine the window of eligibility Exclusion Criteria Previously enrolled patients are not eligible to be enrolled in the study a second time Review all re admitted patients to ensure
36. fection i e Immuno suppressive treatment chemotherapy radiation long term or recent high dose steroids or has a disease that is sufficiently advanced to suppress resistance to infection i e leukemia lymphoma AIDS Total APACHE II Score Once data has been entered for all of the above variables the EDC system will automatically calculate the total APACHE II score Click on the box labelled Save Apache II Farm to save all entered APACHE II data DAILY CLINICAL DATA Record patient data daily until the first of the following occurs Mechanical ventilation has been discontinued for at least 24 hours AND all antibiotics for VAP have been discontinued Patient is discharged from the ICU 30 days from the start of mechanical ventilation Study days will follow the ICU flow sheets at your institution i e 7 7 or 12 12 The study day and date will automatically appear on the screen Ti Version 29 July 2008 Page 25 of 63 Replaces version 8 January 2008 Study Day 1 Mechanical Ventilation Start Date Study Day 2 and subsequent days follow the ICU flowsheet clock Daily Clinical Data Forms The Daily Clinical Data is separated into 5 electronic forms Below is a table from the PATIENT STATUS PAGE with the forms Click on the s silv tata ink to add a data collection day Click on the status dot under a form to open the form and enter or edit data Daily Data f Study Day vital Signs Respiratory VAP Diagnosis Lab
37. field at the bottom of the form if the patient remains on antibiotics beyond the data collection period On the PATIENT STATUS PAGE click on next to Antibiotics A blue NEW ABTIBIOTIC tab will appear click here to be directed to the Antibiotic Form You will first be asked Did the patient receive antibiotics started from 7 days prior to ICU admission until ICU discharge A Enrolment nullLo1 Antibiotics Site name lanet Test Help Is patient takes any antibiotics started 7 days prior YES HO to ICU admission until ICU discharge Q Save Antibiotic Reset Form If NO click 2 2 Ethie and you will be directed back to the PATIENT STATUS page If YES you will be prompted to record all antibiotics Need new screen shot Version 29 July 2008 Page 43 of 63 Replaces version 8 January 2008 R Enrolment 8 02 201 Antibiotics Site name E Kingstan General Hospital Antibiotics Antibiotic Date First dose received Date last dose received Metronidazole O3 Mow 2007 O6 Mow 2007 Cefuroxime O3 Mow 2007 O6 Mow 2007 Antibiotics J Record all antibiotics started 7 days prior to ICU admission and those during ICU stay Antibiotic Metronidazole 500 0 Route qy porna Frequency g hrs g Date antibiotics T T Time l O3 Nov 2007 IZ Mo Time ordered l l I 201 I G oS Date first dose f alt Time received 03 pe Nov wp 2007 i 24 hrs 10 00 Date last dose 06 Ia slew m gt 007 a Ti
38. ission diagnosis by clicking on the beside the diagnosis category then select the most applicable option If a Primary ICU Diagnosis is not present in the taxonomy look for the appropriate category based on systems i e Cardiovascular Vascular use Other CV disease option and type in the diagnosis in the text box provided The following should NOT be entered as Primary diagnoses as these are conditions caused by the primary diagnoses Hypotension Respiratory Failure Hemoptysis Renal Disease Coronary angiogram stenting Coronary Artery Disease Comorbid Diseases Using the Comorbid Diseases taxonomy Apendix C provided enter all cormorbidities that apply to the patient Comorbidities that do NOT appear in the taxonomy do not need to be documented If there are NO comorbidities or a comorbidity that does not appear on the form then select NONE For etiology of shock select only one that applies from the taxonomy provided i e cardiogenic septic neurogenic anaphylactic If the shock is of uncertain origin please check the appropriate box and provide an explanation in the Comment box at the bottom of the page Save Patient Click on you will be directed to the PATIENT STATUS page APACHE II SEVERITY OF ILLNESS There are 2 methods for entering the APACHE II score 1 If your site already captures this information as part of the clinical database then you can enter the APACHE II score and GCS from
39. ivalents Comments Please enter any other details you would like to specify Save Data Reset Form Institution Type of Institution Indicate whether your Institution is an academic or community facility Academic refers to teaching hospitals Total number of hospital beds Enter the total number of hospital beds at your Institution Number of available ICU beds Indicate the number of ICU beds available for admission during the year Number of ICU patients per year Indicate the total number of admitted ICU patients Number of ICU beds capable of mechanical ventilation Enter the total number of ICU beds capable of invasive mechanical ventilation At many institutions this will be the same as Number of available ICU beds Version 29 July 2008 Page 11 of 63 Replaces version 8 January 2008 Number of patient ICU days per year This is the number of days the ICU bed is occupied For example For a 21 bed unit with 100 bed occupancy over the whole year the number of patient ICU days would be 365 days yr x 21 beds 7665 patient ICU days Number of days of mechanical ventilation per year This is the sum of the number of days each patient is mechanically ventilated ICU Organization Does the ICU have a medical director Indicate whether your ICU has a medical director Number of ICU attending physicians Enter the number of attending physicians in the ICU Number of ICU physician meetings per year Indicate the number of IC
40. mask liberated and extubated are the same thing Once the patient has been liberated extubated from mechanical ventilation the following questions will appear In the past 24 hours has the patient received inhaled epinephrine for upper airway obstruction This is simply a Yes or NO answer No further questions will reveal themselves In the past 24 hours has the patient received systemic corticosteroids for upper airway obstruction NOTE collect only for patients who have been extubated and within 24 hours of extubation No further questions are applicable if the answer is NO If the patient has received systemic corticosteroids for upper airway obstruction then enter the corticosteroid and total dose for the 24 hour period Enter data for all corticosteroids received Corticosteroid Dose mg The next questions also apply to all patients regardless of route of endotracheal intubation Version 29 July 2008 Page 38 of 63 Replaces version 8 January 2008 Has the ventilator circuit been changed in the past 24 S ves One hours If yes indicate the reason WD TT per erence eae O Circuit soiled or Damaged PRN None of the above Type of airway humidification HME Heated Humidifier Frequency of HME changes Was the HME changed in the past 74 hours Oves Na What type of endotracheal suctioning system was O open closed used in the past 274 hours Was the endotracheal suctioning system changed in ves Ono the
41. me iopo Cl ongoing at ICU received 24 hrs discharge w Dose F T nm Antibiotic Enter the generic name of the antibiotic using the taxonomy Appendix G drop down options If the antibiotic is a combination drug e g Septra then enter the first ingredient listed in the formulation information and make a note in the comments field that this is a combination product For example Septra 80 mg trimethoprim and 400 mg sulfamethoxazole therefore trimethoprim would be recorded Consult with the formulation information to determine the dosage Dose Enter the initial dose Use the drop down option to indicate specify the units Route Select the appropriate route of administration IV intravenous PO NG oral naso gastric tube Frequency Enter the initial frequency of administration of the antibiotic per 24 hour period e g BID TID QID q4h Date and time antibiotics ordered Enter the date and time the physician order for the antibiotic is made If the physician order date and time is not documented record the date and time when the nurse processes the order If this information is not available check the appropriate checkbox Date first dose received Enter the date and time of the first dose of the antibiotic Date last dose received Enter the date and time of the last dose of antibiotic the pati
42. n is selected the system will default the following fields as N A tidal volume PEEP CPAP RR set on ventilator minute volume and pressure support i level FiO2 Record the inhaled oxygen concentration as a decimal Tidal Volume Record the tidal volume in millilitres PEEP CPAP Record the positive end expiratory pressure PEEP or continuous positive airway pressure CPAP PAW Record the peak airway pressure Paw Some sites may capture this as peak inspiratory pressure PIP If the patient s ventilator mode is CPAP pressure support this field is considered not applicable Patient s Respiratory Rate This refers to the total rate spontaneous breathing mechanical ventilation or both Respiratory Rate set on Ventilator Record the ventilator set rate If the patient is on CPAP Pressure Support or SIMV Pressure Support the rate set on the ventilator should be zero this will be automatically completed for you Minute Volume Record the minute volume L min Pressure Support Level Record the pressure support level cm H20 Did the patient have a trial of spontaneous breathing A trial of spontaneous breathing is defined as the patient breathes through a T tube circuit or a ventilatory circuit with a continuous positive airway pressure of 5 cm water or less and or pressure Support of maximum 5 8 cm water with an Fi020 5 or less For further clarification first refer to the ICU attending physician for the week or if not
43. n the left hand column the severity score associated with the worst value will be automatically calculated once the form is completed memes i i ss i Note You are not able to leave fields blank on this form If a result is not available go outside the 24 hour window and use the data closest to ICU admission Use Comments field to indicate _ that you used data outside the 24 hour window The following web shot illustrates the APACHE II Worksheet form applicable for the NO option Version 29 July 2008 Page 21 of 63 Replaces version 8 January 2008 ABATE VAP Study Translating YAP CPGs into Clinical Practice Enrolment null201 Apache II Worksheet aing Help Does this patient have an APACHE II score available from first 24 hrs admission to ICU Oves no Chart Information Enter the highest and lowest values for all variables within the first 24 hours from admission to ICU The worksheet will calculate and display the severity score based on these values Metric Low High Seventy Age n Temperature C 364 Route Axillary vi 35 9 Route Axillary vi Systolic BP ram Hg 120 145 Diastolic BP mm Ha 50 95 Mean Arterial BP Cram Ha 93 333 111 661 lt Heart Rate 145 166 3 Respiratory Rate 45 50 4 Oxygenaton Ho ABGs d Serum Sodium mmol l 35 40 A Serum Potassium mmol L 120 135 4 Serum Creatinine umol L 25 45 lt LT acute renal failure Explain Hematocrit 25 1 25 35 d
44. ntered on an electronic form it will be marked with N A on the Patient Status Page If no data has been entered and saved on an electronic form it will be marked with a red amp on the Patient Status Page f there is outstanding data or input warnings on an electronic form it will be marked with an amber 4 on the Patient Status Page fall data fields have been completed and all outstanding input warnings resolved on an electronic form it will be marked with a green amp on the Patient Status Page Patient status categories n Progress Data entry is ongoing Eligible for Finalization All data has been entered all input warnings have been addressed and the electronic forms are ready for finalization Finalized The Investigator Confirmation Form has been completed and forwarded to the PL Data can only be modified by contacting the PL Version 29 July 2008 Page 15 of 63 Replaces version 8 January 2008 II Patient Status Page Patient null101 Status In Progress Baseline Forms Enrolment g Demographics G Apache II G Daily Data Study Day vital Signs Respiratory YAP Diagnosis Labs Vasopressor 1 a E a a a New Daily Data Concordance Data Study Day Physical Pharmacological Positional Diagnostic 1 y y a a Antibiotics Antibiotic Type Order Date Hone Microbiology Accession Number Datetime Hone New Microbiology Final Outcomes M
45. of the following present Has the patient been liberated fron 4a yj ofacial trauma es mechanical ventilation Difficult oral airway Was the patient extubated in the pa None ofthe above es If tracheostomy E TAERE ER Concordance Data Physical Dav 1 Help Indicate the route of endotracheal intubation araba bazi Masotracheal LS Tracheostomy Indicate the date of tracheostomy BOO ay L J J rs Indicate the reason for tracheostomy Other Method of tracheostomy Site narne Surgical E The next questions apply to every patient regardless of the route of endotracheal intubation If NO is answered to the questions then follow up questions reveal themselves Below is the scenario revealing all hidden questions i e answering YES Version 29 July 2008 Replaces version 8 January 2008 Page 37 of 63 Has the patient been liberated from invasive yes One mechanical ventilation Was itin the past 24 hours ves Ono 24 hrs Was the patient extubated in the past 24 hours GG res Ono Was the patient reintubated ves Ono Indicate the reason for ma reintubation Has the patient been liberated from mechanical ventilation Defined as patient is off the mechanical ventilator but still has ETT or tracheostomy tube in place i e is on a t piece or trach mask Was the patient extubated in the past 24 hours Defined as patient no longer has ETT in place For patients with trach
46. ospital Observation Date and Time 18 Apr 2007 Time sl Apr leel 2007 s 08 00 24 hrs Number of patients 21 Number of available ICU beds n Number of mechanically ventilated patients 18 Number of nurses a4 Charge Nurse G res Ono Number of ICU specific RT FTEs 20 Comments Please enter any other details you would like to specify Version 29 July 2008 Page 13 of 63 Replaces version 8 January 2008 Observation Date and Time Indicate the date and time of day the following data was collected Number of patients Indicate the number of patients in the ICU at the time of data collection Number of available ICU beds Enter the total number of ICU beds available for admitting patients Number of mechanically ventilated patients Enter the number of patients receiving mechanical ventilation at the time of data collection Number of nurses Enter the number of nurses working at the time of data collection This includes the charge nurse Charge Nurse Indicate whether there is a charge nurse working at the time of data collection Number of ICU specific RT FTEs Enter the total number of ICU dedicated RTs as FTE or enter the proportion of time spent in the ICU relative to total hours worked Click on 3 2 Peta you will be directed to the UNIT SPECIFIC DATA STATUS page ENROLLED PATIENTS STATUS PAGE By selecting the ENROLLED PATIENTS button on the left menu bar you will be directed to the Enrolled Patients Statu
47. our email address and type the text as you see it in the verify human user field of the form Click on the _ReavestReminder___ button to submit the request An email should appear in your inbox momentarily with a new password to access your account You can change your password after loggin into the system ABATE VAP Study a Request Password Reminder User verification Please enter your e mail address Verify Human User Please type the text as it appears in the bax below Request Reminder Clear Form LOG OUT To log out of the web application and return to the login page click on LOG OUT on the bottom of the left hand side menu UNIT SPECIFIC DATA By selecting the UNIT SPECIFIC DATA button on the left menu bar you will be directed to the Unit Specific Data Status Page Version 29 July 2008 Page 9 of 63 Replaces version 8 January 2008 Unit Specific Data Kingston General Hospital Bottom Unit Baseline Data Edit ICU Information Unit Specific Daily Data Record unit specific daily data for everyday that patient clinical and concordance data are collecte data at the same time every day To review or edit a day s data click on the row corresponding 1 appropriate day Baseline Data Collection Period 6 Month Collection Period 15 Month Collection Period 24 Month Collection Period 33 Month Collection Period I Unit Specific Baseline Data Select the Ett ict Information under the B
48. past 74 hours If yes indicate the date of change w ma G j L F Indicate the reason for the change soiled circuit O Malfunction specify type O Mone of the above Click on 22 Pta you will be directed to the PATIENT STATUS page PHARMACOLOGICAL STRATEGY DATA Did the patient receive oral Povidone lodine in the past 24 hours lf YES Did the patient receive oral Povidone Iodine in the past 274 hours ves One If yes indicate the number of times in the past 24 hours If NO Did the patient receive oral Povidone Iodine in the past 24 hours Oves no f no indicate the reason C3 Not available O Unable to access patient s oral cavity allergy None of the above Has there been a chlorohexidine application in the past 24 hours If YES Has there been a chlorohexidine application in the past 24 hours ves Ons If yes indicate the number of applications in the past 24 hours If NO Version 29 July 2008 Page 39 of 63 Replaces version 8 January 2008 Indicate the reason it was not applied Not available Has there been a chlorohexidine application in the past 24 hours Oves Ne O unable to access patient s oral cavity O Allergy O None of the above Was nebulized or intratracheal tobramycin used If Yes Was nebulized or intratracheal tobramycin used ves Ona Indicate the route yobulized O Intratracheal instillation If intratracheal instillation or nebulized
49. rammed for each site by the MC Dates are entered using DD MMM YYYY format i e 24 Jul 2004 Single click on day and choose appropriate day from the drop down box Repeat again for month and year By using the drop down boxes provided you are assured proper date format is obtained Enter all times using the 24 hour 00 00 23 59 period format i e 22 37 There is no need to enter a colon as the web application will format the time for you selecting NONE or NOT AVAILABLE as an option instead of leaving a field blank indicates that you have acknowledged the field and not overlooked it Do not leave a data field blank You will not be able to finalize an electronic form with blank data fields Study Day 1 is mechanical ventilation start date time study Day 2 and subsequent days follow the clock observed by each institution i e ICU flow sheet clock To access electronic forms single click the appropriate link using the left side of your mouse To expand a menu or taxonomy click on next to the title of the menu taxonomy To collapse the menu or taxonomy click on To enter data directly into each field single click on the left side of the mouse pointer and type information or select from the available taxonomy In the event that the value you enter is outside of the EDC system parameters edit checks you will receive a warning Please address the system warnings as per the instructions found later in this manual Use
50. renal failure If you require a definition of acute renal failure click on Explain and definitions will be provided Acute Renal Failure is defined as Creatinine gt 124 mol L and lt 177 umol L and subsequent creatinines show a steady increase gt 177 mol L OR Creatinine gt 177 mol L and a Patient has documented pre admission creatinine lt 124 mol L OR b creatinine decreases to lt 124 umol L while patient is hospitalized Hematocrit enter this value as a percentage White Blood Count total L x10 Glasgow Coma Score GCS To determine the GCS choose the best response from each of the 3 categories eye opening motor response verbal response If the patient is sedated then go back to the period when the patient was not receiving sedation or approximate what the score would be if the sedation where to be removed Enter the values in the 3 separate categories and the GCS will automatically be calculated Verbal Response 1 No response Eye Opening 1 None 2 Incomprehensible words 2 To Pain 3 Inappropriate words 3 To speech 4 Confused 4 Spontanous 5 Oriented Best Motor Response 1 None 2 Extension 3 Abnormal flexion 4 Withdraws from pain 5 Localizes to pain 6 Obeys commands serum HCO3 should only be used if there are no arterial blood gases available in the previous 24 hours Chronic Health Points Assign chronic health points using the categories listed below The patient s complete m
51. riteria are satisfied Antibiotics start 7 days before ICU admission until one fo the above criteria aer satisfied A Study Day 1 is mechanical ventilation start date NAVIGATION AND FORM VIEWS LOGIN PAGE Connect to the ABATE VAP Study EDC system login page at the following web address https ceru hpcvl queensu ca ABATE_VAP Each user will be provided with a unique user ID and password 1 Enter your User Name and Password 2 Click the l tesin button to enter the EDC system If the login information is correct the user will be brought to the web application Menu Page If you forget your password click on Forgot your password tab Enter your e mail address and complete the human user verification You will be sent an e mail with your username and a temporary password Please change this password when you next login to the web application Version 29 July 2008 Page 5 of 63 Replaces version 8 January 2008 ABATE VAP Study Translating YAP CPGs into Clinical Practice Attention Users Please note the Electronic Data Capture EDC System will be closed every Friday fram 08 00 ta 09 00 hours CEST Login Existing User If you are an existing user please enter your username and password below User Name Password Forgot your password Please verify that your browser is properly configured ta accept queensu ca cookies Click here for directions PATIENT DATA The site will default to the ENROLLED PATIENTS
52. s Page Enrolled patients are grouped according to the corresponding data collection period Click on the beside the applicable data collection period to view corresponding patients Double click on the row of the table for a particular patient to modify existing data or enter new data for an already enrolled patient Click on Enroll New Patient to enter a new patient onto the EDC system Version 29 July 2008 Page 14 of 63 Replaces version 8 January 2008 E _ Enrolled Patients KGH Surgical Baseline Data Collection Period To review or edit patient status click on the row corresponding to the appropriate patient Patient Number Age Sex Admit Date Status 11101 67 M 15 Jan 2007 In Progress 11102 73 M 13 Jan 2007 In Progress 11103 FE M 1 6 Jan 2007 In Progress 11104 55 M 10 Aper 2007 In Progress 11105 60 M O1 fJan f2007 In Progress Enroll Hew Patient 6 Month Collection Period 15 Month Collection Period 24 Month Collection Period 33 Month Collection Period PATIENT STATUS PAGE The Patient Status Page allows the user to view all of the electronic forms for a particular patient i e the entire case report form The categories of forms are as follows Baseline Data Daily Data Daily Concordance Data Antibiotic Data Microbiology Data Outcome Data Adjudication of Infection if applicable Form status is noted with one of 3 colours fno data is required to be e
53. s Vasopressor m a a i Hew Daily Data VITAL SIGNS Enrolment 02102 Daily Data Form 1 Site name La f Day 1 17 Apr 07 Help Vital Signs Temperature 28 2 F Nr a Route Heart Rate bpm 95 0 C nia Systolic mmHg 115 nea Diastolic mmHg g4 C Nya MAP mmHg CYP mmHg 13 0 Ona Respiratory Rate 1 E N 6 Fluid Balance Urine Output in Past 24 hrs mL Comments Please enter any other details you would like to specify lf data is unavailable for any of the fields check the N A checkbox Temperature Record the temperature recorded trom midline 37 0 in degrees Celsius Note esophageal temperature is considered core temperature tympanic temperature is considered core temperature temperature strips applied to the skin are considered oral temperature Temperature Route Indicate the route of the entered temperature The EDC system will automatically make the calculation to core temperature Heart Rate Record the heart rate in beats per minute bpm Version 29 July 2008 Page 26 of 63 Replaces version 8 January 2008 Blood Pressure Record the blood pressure in millimeters of mercury mm Hg There are separate fields for systolic and diastolic blood pressure Mean Arterial Pressure MAP The MAP will automatically be calculated based on the entered blood pressure Central Venous Pressure CVP Record the CVP in millimeters of mercury mmHg Urine output in the past 24 hours mL Considering the pa
54. s to perform the procedure for ANY reason other than to make a diagnosis for an infectious or noninfectious cause of the lung problem In this situation the diagnosis is NOT in question but the patient needs treatment for some lung problem Examples include clearance of mucus plugs pulmonary toileting for copious secretions clearance of an obstruction causing lung collapse treat massive hemoptysis If YES indicate the date and time the bronchoscopy was performed Has an endotracheal aspirate ETA been performed in the past 24 hours If YES indicate the date and time the ETA was performed Version 29 July 2008 Page 42 of 63 Replaces version 8 January 2008 Click on 2575 CSS you will be directed to the PATIENT STATUS page ANTIBIOTIC DATA Record all antibiotics initiated within 7 days prior to ICU admission until the first of the following occurs Mechanical ventilation has been discontinued for at least 24 hours AND all antibiotics for VAP have been discontinued Patient is discharged from the ICU 30 days from the start of mechanical ventilation Only administered antibiotics will be recorded Example An antibiotic is ordered but the patient dies before the first dose of antibiotic is initiated In this case the antibiotic would NOT be recorded If an antibiotic continues longer than 30 days from initiation of mechanical ventilation enter the 30th day as the discontinuation date and time Make a note in the comment
55. the Comments field at the bottom of the pages to make any notes regarding aberrant or missing data Editing Previously Entered Data To ensure Good Clinical Practice is maintained all changes will be tracked and logged by the computer program Unfinalized Patients To edit previously saved information access the appropriate electronic form change the data entered and save the form You cannot delete a patient once it has been entered Finalized Patients Version 29 July 2008 Page 4 of 63 Replaces version 8 January 2008 Changes to be made to already finalized patients will usually originate from the PL The PL will unlock the patient changing the status to eligible for finalization The research site is then able to modify any previously entered data The research site will finalize the patient after the data has been modified Please contact the PL if you have any queries regarding editing or deleting data Duration of Data Collection All daily data needs to be collected from Study Day 1 and each day following until the first of the following occurs Mechanical ventilation has been discontinued for at least 24 hours AND all antibiotics for VAP have been discontinued ICU discharge actual or death 28 days from the time of enrolment into the study EXCEPTIONS include Concordance Data start collecting on Study Day 3 i e MV gt 48 hours Microbiology start 7 days before ICU admission until one of the above c
56. the first 24 hours of ICU admission only 2 Ifthe APACHE II score is not available then you will have to complete the APACHE II worksheet for the first 24 hours of ICU admission The answer to the following question will determine which of the 2 above data entry options will be applicable Does this patient have an APACHE II score available If YES the user will enter the APACHE II score already available and the Glasgow Coma Score GCS To determine the GCS choose the best response from each of the 3 categories for the first 24 hours of ICU admission If the patient is sedated then go back to the period when the patient was not receiving sedation or approximate what the score would be if the sedation where to be removed See below for further information on the GCS categories Version 29 July 2008 Page 20 of 63 Replaces version 8 January 2008 The following web shot illustrates the YES option ABATE VAP Study Translating YAP CPGs into Clinical Practice _ SS Enrolment null201 Apache II Worksheet c Help Does this patient have an APACHE II score available from first 24 hrs admission to ICU yes One Enter APACHE II score If Yes enter the GCS Comments Save amp pache II Form Reset Form If NO the APACHE II worksheet will reveal itself Enter the highest and lowest value recorded in the source documentation within the first 24 hours from admission to ICU When you enter the highest and lowest values i
57. tient therefore allowing a site to modify existing data The Methods Centre may unfinalize a patient if there are some clinical queries requiring updates to the data previously entered Baseline Forms Enrolment g Demographics G APACHE IT Worksheet g Daily Data Endl 5 Concordany Microsoft Internet Explorer T Antibiotics J Sre you ready to Finalize patient Microbiolo Final Gutco Record the outcome urred 1 Patient has died 2 Patient discharged fram ICU 6 3 Patient has been in the ICU for 28 days ICU Outcomes Hospital Outcomes Investigators Confirmation Form T Adjudication of Suspected VAP The RC must print this form see Appendix L The form will automatically be populated with the site number patient enrolment number and enrolment date The Site Investigator is then asked to sign and date the form to attest the following The electronic data collection was conducted under his her supervision according to the protocol during the entire study Version 29 July 2008 Page 50 of 63 Replaces version 8 January 2008 The data and statements including adjudication of all cases of suspected VAP are complete and accurate to the best of their knowledge Please fax the completed form to the PL as soon as possible after the signature is obtained Version 29 July 2008 Page 51 of 63 Replaces version 8 January 2008 APPENDIX A EDC SYSTEM ACCESS SIGNATURE SHEET Version 29
58. tient s total volume of urine output over the past 24 hours select the most appropriate option from the drop down menu e gt 9500 mL day e 200 499 mL day e 0 199 mL day Click on 22 8 Pta you will be directed to the PATIENT STATUS page RESPIRATORY Enrolment 02102 g Sit Daily Data Form 2 aii Day 1 17 Apr 07 Help Respiratory Yentilator Mode Full Volume Control ventilation Fio 0 35 L Mot available Tidal volume mL 600 0 L not available PEEP CPAP 10 0 L Net available Paw 35 0 C Not available Patient s Respiratory Rate 17 0 Mot available Respiratory Rate set on Yentilator 12 0 Pl Not PN E E Minute Yolume L min 5g not available Pressure Support Level cm H O Wl not available Did the patient have a trial of spontaneous Oves Nya O na breathing Did the patient have a sedation vacation Oves no O not Receiving Sedation lf data is unavailable for any of the fields check the Not available checkbox Ventilator Mode Indicate the type of ventilation the patient receiving Options include CPAP Pressure Support Version 29 July 2008 Page 27 of 63 Replaces version 8 January 2008 SIMV Pressure Support S MV Syncronized intermittent mandatory ventilation Full Volume Control Ventilation Full Pressure Control Ventilation Not Ventilated oxygen mask nasal prongs trach mask Other please specify meme i i i es Ce Note When the not ventilated optio
59. tobramycin used indicate the reason why Follow up questions do not apply if NO is selected Click on 22 8 Data you will be directed to the PATIENT STATUS page POSITIONAL STRATEGY DATA Has the patient been placed in a bed that rotates and or percusses If the patient is not ina rotating or percussing bed no further questions apply lf YES Has the patient been placed into a bed that rotates and or percusses G ves One If yes indicate the date of bed change How much time was the rotating and or percussing bed used in the past 24 hours Hours Minutes This is the form where head of bed HOB elevation is recorded The HOB assessment should be performed according to the procedure outlined in Appendix B using the supplied protractors If an HOB assessment was not performed i e weekends enter 9999 into the data field Enter the date and time corresponding to the specified assessment time on the schedule see Appendix F If it is not possible to adhere to the HOB assessment schedule every attempt should be made by the site to vary the time of assessment from day to day as much as possible Remember to document the actual time of HOB assessment Version 29 July 2008 Page 40 of 63 Replaces version 8 January 2008 Click here if HOB Not Done F What is the patient s Head of Bed HOB elevation Indicate the date of HOB assessment Time K KR a R lel isl hrs Were any of the following present at the
60. y 2008 Page 7 of 63 Replaces version 8 January 2008 To change your personal information click on EDIT USER PROFILE on the menu at the left side of the navigation pane Edit User Information Janet Help Personal Information First Name Janet Last Name overvelde Address 76 Stuart Street City Kingston Province State County oy Country CA Telephone Fax Save User Reset Form CONTACT US On the left hand side of the menu click on CONTACT US to view the contact details of the Project Leader and Technical Support ABATE VAP Study Translating YAP CPGs into Clinical Practice Contact Us For correspondence or questions related to the content of the survey Janet Gvuervelde Project Leader Clinical Evaluation Research Unit Angada 4 76 Stuart Street kingston General Hospital Kingston Of BFL ZW overveljakgh kari met phone 613 549 6666 ext 6241 CHANGE PASSWORD To change a password click on CHANGE PASSWORD on the left hand side menu You will be asked to enter your old password select and confirm a new password Change Password Janet Password Old password New Password Contirm New Password Save Version 29 July 2008 Page 8 of 63 Replaces version 8 January 2008 FORGOT YOUR PASSWORD You can retrieve your forgotten password by clicking on the Fstast yout password link located beside the password box on the login page You will be taken to the Request Password Reminder page Enter y

EDC User Manual 29-Jul-08

Contents

Download Pdf Manuals

Related Search

Related Contents