Module 6: Case Report Form (Chart Abstraction)

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Module 6 Case Report Form (Chart Abstraction)
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This training session contains information
regarding

• Overview the CRF
• Highlights of certain points of data collection
  from the medical record

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At this point you have done the following
Identified Eligible Respondents Obtained
Consent Enrolled Respondents Administered the ACP
Questionnaire
Next you will need to collect data from the
medical record into the Case Report Form
Completion (i.e. Chart Abstraction)
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Identifying Respondents

• In order for the site to be able to access the
  relevant medical record, they will need to know
  the unique, hospital assigned, medical record
  number. We recommend keeping an identification
  list. You can find a template on the study
  website.

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What is a CRF?

• Official clinical data collection document
• Data abstracted from medical charts
• Allows for efficient and complete data
  processing, analysis and reporting
• Study questions determine what data should be
  collected on the CRF

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CRF Worksheets

• A tool to facilitate chart abstraction

Instructions
Worksheet
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Tips for Completing Chart Abstraction

• Understand what kinds of data you are looking for
• Orient yourself to the various sections of your
  local medical charts
• Paper
• Electronic
• Determine any local standards used to document
  ACP/AD
• Be clear on how information is recorded (e.g.
  abbreviations, dose units, etc)

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Tips for Completing Chart Abstraction cont

• Sometimes there are several sources for the same
  information.
• The best thing to do is be consistent.
• Example

• Hospital Admission Date/Time
• Arrival note listed on ambulance record
• The first entry in the ED notes
• Date/time logged in the hospital computer system

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Types of CRF Data
Comprehensive instructions are available in the
CRF Worksheets. The following slides are meant
to highlight the types of data collection
required.
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Comorbidities

• Patient characteristics that affect outcomes
• Medical Chart sources of info
• Admission notes, ED assessments, previous
  admission notes
• Progress notes
• Discharge Summary
• Collect only those that appear on the CRF, record
  them by
• Body system
• Illness/condition

CRF pg. 4-5
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Vasopressors/Inotropes

• From the current hospitalization
• Usually only administered in the ICU or step-down
  units.
• Record any instance where an infusion is given
  for gt 30 mins
• Dont count boluses
• Record start and stop dates

CRF pg. 6-7
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Consultations

• List all consultations that were ordered during
  this hospital stay
• RACE (Rapid Assessment of Critical Event) Team or
  Code 66 or Code Blue
• Critical Care or Critical Care Outreach
• Home Care/Transition Services
• Social Work
• Spiritual Care
• Palliative Team
• Palliative Home Care
• Geriatrics Team

CRF pg. 8-9
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Dialysis

• Current hospitalization, new onset of acute renal
  failure requiring any form of dialysis
• Start and stop date for dialysis

CRF pg. 10-11
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Percutaneous Feeding Tube

• Percutaneous feeding tubes are those inserted
  through the skin and into the stomach or
  intestine.
• If nasoenteric or nasogastric do not record here
• Indicate whether the patient arrived at the
  institution with a percutaneous feeding tube
  already in place (removal date)
• Indicate if the patient ever had a percutaneous
  feeding tube inserted during the current
  hospitalization (insertion removal dates)

CRF pg. 10-11
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Mechanical Ventilation

• Record if the patient received any ventilation
  (non-invasive and/or invasive support) throughout
  the entire hospital admission
• Non-Invasive ventilation refers to all modalities
  of ventilation that assist with breathing without
  the use of an endotracheal tube. (BI-PAP, nasal
  or mask ventilation, mask CPAP)
• Invasive mechanical ventilation refers to any
  mode of intermittent positive pressure delivered
  via an oral/nasal tracheal tube or tracheostomy
  with or without positive end expiratory pressure
  and high frequency jet ventilation or
  oscillation.
• Nasal prongs, facemask or supplementation O2 are
  NOT considered ventilation since the patient
  still breathes spontaneously.

CRF pg. 12-13
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Mechanical Ventilation cont

• Record start and stop date/time for each episode
• If stopped for gt 48 hrs, then restarted,
  considered it a new episode
• Use actual start date (ED, OR, etc), if
  initiated externally (i.e. referring hospital)
  then enter the start date/time as hospital
  admission

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Mechanical Ventilation cont

• MV stop is when patient is off gt 48 continuous
  hrs
• intubated or breathing through a t-tube OR
• tracheostomy mask breathing OR
• CPAP 5cmH2O without pressure support or
  intermittent mandatory ventilation assistance
• If transferred out of hospital while vented, stop
  date is hospital discharge date/time

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CPR Use in Hospital

• CPR is defined as at least any one of the
  following occurs
• Chest compressions
• Defibrillation
• Intubation (if not already intubated).
• Enter each episode separately
• If CPR was used multiple times in a day, please
  document it only once.

CRF pg. 14-15
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Goals of Care Discussions

• Document any goals of care discussions from the
  current hospitalization

CRF pg. 16-19
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Goals of Care Discussions

• Each instance in chronological order
• Did the patient have an existing GoC in the
  medical chart upon admission to hospital?
• Yes ? Record the GoC designation
• Record all instances of GoC discussions from the
  current hospitalization
• Date of GoC discussion
• Where did it occur (e.g. ER)
• Date of GoC order written
• GoC decision made

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Goals of Care Decision Made

• Use the most appropriate GoC designation system
  presented
• No decision made
• Decision made
• No change from previous
• Change from previous
• Alberta
• BC DNAR
• BC MOST
• All other regions

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GoC All other regions options

• Goals of care designation All other regions
• The coordinator should use their own judgment
  when determining how locally documented
  designations translate into the options available
  on the CRF
• 1 Aggressive use of heroic measures.
• 2 Full medical care but in the event
• 3 Doctors will be focused on my comfort
• 4 A mix of the above
• 5 Unsure, documentation unclear
• 6 no documentation
• 7 - Other

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Processes of CareUpon Hospital Admission

• Upon hospital admission 1 day
• Orders written to WITHHOLD LSTs
• Ventilation
• Vasopressors
• Dialysis
• CPR
• WITHHOLDING LSTs the patient is NOT currently
  receiving the applicable life sustaining
  therapy(ies) and then an order is written to
  never start the therapy or re-start it.

CRF pg. 20-21
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Upon Hospital Admission cont

• Enter the date the order was written.
• If there are instances where multiple changes of
  process of care orders are documented regarding
  withholding care please collect the first order
  date written to withhold therapy.
• Withholding dialysis may not be written in the
  doctors orders, it might be captured in the
  progress notes. If this is the case then please
  use the date the note was written.

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Upon Hospital Admission cont

• Upon hospital admission 1 day
• Orders written to WITHDRAW LSTs
• Ventilation
• Vasopressors
• Dialysis
• WITHDRAWING LSTs is defined as currently
  receiving any life sustaining therapy(ies) and
  then an order is written to stop it for patients
  whose outcome is not favourable.
• Enter the date the order was written

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Upon Hospital Admission cont

• End of life scenario, this does not apply for
  orders written for stopping normal every day
  treatment when no longer needed.
• NO escalation of care orders
• Receiving LSTs ? no escalation Withholding
• Receiving LSTs ? comfort measures Withdrawing
• Not receiving LSTs ? no escalation Withholding

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Process of CareDuring Hospitalization

• After Admission orders Discharge/Death
• Orders written to WITHHOLD LSTs
• Orders written to WITHDRAW LSTs

CRF pg. 22-23
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Index Hospital Overview

• Index hospitalization Enter the date and time
  the patient was admitted to hospital
• initial presentation to ED or hospital ward
  (earliest)
• Document all ICU and Step Down admission and
  discharge dates/times chronologically for the
  entire hospital stay
• If patient dies in hospital, date/time of death
  discharge

CRF pg. 24-25
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Hospital Discharge

• For patients who are discharged to a
  Rehabilitation ward within the institution, the
  date/time patient is discharged from the hospital
  to the Rehabilitation ward hospital discharge
• Indicate where the patient was discharged
• Home
• Retirement Residence
• Long Term Care or Nursing Home
• Rehabilitation Facility
• Ward in another hospital
• If still in hospital at Day 90, check the
  appropriate box.

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Entering Data into REDCap

• Once you have
• Administered the ACP questionnaire(s)
• Collected the CRF data
• Degree of system implementation
• Proceed to enter the data into REDCap.
• See Module 7 for instructions.

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Training Module 6 Complete
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Live Demo of REDCap

• Navigation
• Institutional Data
• Patient and Family Members
• ACP Questionnaires
• Case Report Form

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ReCap of REDCap
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Institutional Data
Enter once per audit cycle
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Patient/Family Member Data
Patients are enrolled on the eScreening/Ernollmen
t Log
Enrollment numbers are automatically inserted
into REDCap
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The Grid
Enrollment
ACP Questionnaire Patient version
ACP Questionnaire FM version
ACP Questionnaire
Case Report Form
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Data Conventions in REDCap

• Dates YYYY - MM - DD
• A date picker calendar is available to enter
  dates.
• Times HHMM
• 24-hour period format i.e. 2237. The semicolon
  must be entered. Use leading zeros where
  applicable i.e. 0128.
• Midnight should be entered as 0000
• If data is NOT available use the NA options.

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Lock your Data

• Once you have entered all of your data select the
  Lock button.
• This tells us you have finished your data entry.

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Error Messages
All errors must be addressed before you can LOCK
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Technical Support

• HELPDESK http//www.ceru.ca/helpdesk/open.php
• Important to provide a description of the error
  message you are receiving
• Copy and paste to the Helpdesk
• Screen Shots (print screen, paste into a
  document, send)

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ACP Questionnaire Section 4
Patients who arrive in hospital with AD in place.
Patients who arrive in hospital with AD in place,
but there is a change in hospital
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ACP Questionnaire Section 6

• Documentation of ACP/AD in Hospital Chart at end
  of interview
• Modification to response options for questions
  1ci, 1cii, 2bi and 2bii
• If yes, in addition to recording the date, also
  indicate the option chosen.

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Example, 1ci

• Goals of Care designation or MOST form
• Yes/No

• Aggressive use of heroic measures and artificial
  life sustaining treatments including CPR to keep
  me alive at all.  
• Full medical care but in the event my heart
  stops, or my breathing stops, No CPR
• Doctors will be focused on my comfort and
  alleviate suffering and not on being kept alive
  by artificial means or heroic measures
• A mix of the above options (e.g. try to fix
  problems but if not getting better switch to
  focusing only on my comfort even if it hastens
  death)
• Unsure
• Other ____________

Date of Document
Option
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Training Module 6 Complete