Data Collection Call #4 STOP CAUTI STOP CAUTI Data Collection Timeline (subject to change) April 22 Intro at NICHE meeting May 6: 1st data conference call: introduction and focus on demographic data elements May 25: 2nd data collection call: focus on urinary catheter elements and surgery elements June 15: 3rd data collection call: focus on laboratory data elements; validation of electronic data June 30: 4th call manual data collection; using REDCap for data collection and sending electronic files. Mid-July call: additional data issues; randomization; data collection waves August 1: Wave 1 data collection to begin What comes next for sites? Complete hospital worksheet Electronic data: prepare sample reports for study team review Get a data consultation July: Validate electronic documentation of catheter presence; pilot manual data collection; randomization August: Target data collection to begin – wave 1 sites When can we start data collection? 1. IRB approval obtained 2. Subcontract executed 3. Sample data files reviewed by STOP CAUTI team 4. Hospital worksheet completed 5. Electronic data validated/manual data piloted Source File Name* Column (Variable) Description Variable Type Allowed Values/Formats Supplied Values/Formats NOTE: the encounter number will come in all files Range from -21474836648 to 21474836648 - Y, we will assign a sequential Enum Encounter Number Numeric for dummy numbers assigned sequentially a number 4 digit number is preferred. Care Manager Study01012010.xls DateAdmit Date of Admission Date mm-dd-yyyy Y IDX Admin01012010.xls DateDischarge Date of Discharge Date mm-dd-yyyy Y IDX Admin01012010.xls DiagCode Principal Diagnosis Text ICD-9 code Y Care Manger Study01012010.xls Patient Age (In Age Numeric 18-100 Y Years) Care Manager Study01012010.xls Gender Gender Text 1 Character (Either "M" or "F") Y*, 1= female, 2 = male IDX Admin01012010.xls Maximum of 32 characters: “American Y*, native american, asian, Indian/Alaska Native”, “Asian”, “Black or African black, hawaiian/pacific Race 1 Race/Ethnicity Text American”, “Native Hawaiian or Other Pacific islander, caucasian, hispanic, Islander”, “White”,”Not Hispanic”, “More Than One Race”, “Unknown or Not Reported” multiracial, unknown. Race/Ethnicity 2nd Maximum of 32 characters: choices are N, we don’t have a 2nd Race 2 Text field same as above race/ethnicity question Data Consultations for Individual Sites What? 30 min calls for clinical IT, project coordinators, data collectors to discuss specifics of electronic data extraction, formatting issues. Who? The data team (Heidi, Brian, Patrick). When? Now through June 30. Why ? No two hospitals are alike. How: Contact email@example.com CORRECTION: Urinalysis Elements Encounter number Urinalysis Order number Result date/time Result name: Nitrite Urine Leuk Est U WBC U Bact U Result Value: “negative” or “positive” or other values as defined on next slide Data Flow Study Sites UCH Manual UCH REDCAP Secure Server Electronic Introduction to Research Electronic Data Capture and the REDCap Consortium: http://project-redcap.org/ REDCap site at University of Colorado Denver: https://redcap.ucdenver.edu/ Benefits of REDCap Web-based HIPAA compliant You can only access your own site’s data Designed for clinical research Data validation built in REDCap Access 3 logins per study site (more provided upon request): xxxxLead ex. ColoLead xxxxEntry1 ex. ColoEntry1 xxxxEntry2 ex. ColoEntry2 Passwords – will be emailed to the NICHE coordinator by Patrick Hosokawa https://redcap.ucdenver.edu REDCap Home Page https://redcap.ucdenver.edu Actions on REDCap 1. Sending data files to the STOP CAUTI team 2. Entering manually collected data 1. The STOP CAUTI database WILL NOT BE ACTIVE until August 1. 2. A test database will be active in July for practice. NO STUDY DATA SHOULD BE ENTERED IN THE TEST DATABASE. REDCap Main Page After User login 1. To enter data: 2. To send data My Databases files: Send-It Send Data Page (scroll down): 1. To: Brian.firstname.lastname@example.org 2. Subject: Data from [facility] 3. Message: Filenames (optional) 4. Select 14 days 5. Attach Data File 6. Hit Send! Main Page After User REDCap After User Login – Select My Login Databases Tab Main Page for Manual Data Entry Click on the table you would like to enter data into Manual Data Enter Study Encounter ID To add to an existing encounter, selct from the a list of IDs To start a new encounter you must enter the ID and hit TAB Manual Data Entry Form: EncounterTable Selected Table Will be assigned AFTER the discharge Select and go on to the next table (Location) for this encounter Manual Data Collection For sites with no or partial EMR implementation or limited reporting capability. Forms can be entered directly into REDCap at any computer with internet access. Forms can be printed out for data collection and later data entry. Manual Data Collection Procedures Needed: A data collector A set time of day (between 8 and 9 AM) REDCap Access or printed out forms Crosswalk file A daily census for study unit(s) Access to chart and clinical IT Daily Procedure – Identifying Patients Obtain daily census Identify eligible patients Catheterized – (EMR/chart review, charge nurse report, nursing query) Add each patient to crosswalk file Create a REDCap encounter Fill out encounter, location, catheter forms More information To be more efficient: get a report from your EMR, rather than hand query Use a charge nurse report however discrepancies will need to be resolved by patient’s nurse Stop data collection on discharge or on the 3rd hospital day after catheter removal. The Crosswalk File = The Key to Your Data 1. Add each Study Hospital Name MRN Admit Date eligible Encounter Encounter (optional) (optional) (optional) encounter Number Number 2. Use the Study 0001 987654321 John Doe 123456 1/1/10 Encounter 0002 987654322 Jane Doe 789123 1/2/10 Number as the 0003 unique identifier for the 0004 study 0005 3. Add more Study 0006 Encounter 0007 numbers as 0008 needed 4. Keep this up to Etc… date and securely stored Ongoing Data Collection: Daily Query Identify new patients (see prior slide) Catheter Query - fill out catheter form New patients – when was catheter placed? Existing patients – was catheter removed? Urine culture query – Was a urine culture sent? If yes: Was a urinalysis or blood culture sent? Did this patient have a temperature > 38C? Fill out culture, culture organism, urinalysis, and temp forms as needed. Piloting your manual data collection 1-2 weeks of piloting before anticipated start of data collection dry run of all collection procedures including data entry on REDCap Additional tools coming soon STOP CAUTI Study Data Collection Manual PDF document REDCap Forms A crosswalk file for manual data collection sites. Thank you! Questions?
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