Module 6: Module 6: Case Report Case Report Form (Chart Form (Chart Abstraction)Abstraction)

This training session This training session contains information contains information

regarding:regarding: Overview the CRFOverview the CRF Highlights of certain points of data

collection from the medical record

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)

At this point you have done the At this point you have done the following:following:

Identifying RespondentsIdentifying Respondents In order for the site to be able to access In order for the site to be able to access

the relevant medical record, they will the relevant medical record, they will need to know the unique, hospital need to know the unique, hospital assigned, medical record number. We assigned, medical record number. We recommend keeping an identification list. recommend keeping an identification list. You can find a template on the study You can find a template on the study website.website.

What is a CRF?What is a CRF?

Official clinical data collection Official clinical data collection documentdocument

Data abstracted from medical chartsData abstracted from medical charts Allows for efficient and complete data Allows for efficient and complete data

processing, analysis and reportingprocessing, analysis and reporting Study questions determine what data Study questions determine what data shouldshould be collected on the CRF be collected on the CRF

CRF WorksheetsCRF Worksheets A tool to facilitate chart abstractionA tool to facilitate chart abstraction

Instructions

Worksheet

Tips for Completing Chart Tips for Completing Chart AbstractionAbstraction

Understand what kinds of data you Understand what kinds of data you are looking forare looking for

Orient yourself to the various sections Orient yourself to the various sections of your local medical chartsof your local medical charts PaperPaper ElectronicElectronic

Determine any local standards used Determine any local standards used to document ACP/ADto document ACP/AD

Be clear on how information is Be clear on how information is recorded (e.g. abbreviations, dose recorded (e.g. abbreviations, dose units, etc…)units, etc…)

Tips for Completing Chart Tips for Completing Chart Abstraction con’tAbstraction con’t

Sometimes there are several sources Sometimes there are several sources for the same information. for the same information.

The best thing to do is The best thing to do is be be consistentconsistent..

Example:Example:Hospital Admission Date/TimeHospital Admission Date/Time Arrival note listed on ambulance recordArrival note listed on ambulance record The first entry in the ED notesThe first entry in the ED notes Date/time logged in the hospital Date/time logged in the hospital

computer systemcomputer system

Types of CRF Types of CRF DataData

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

ComorbiditiesComorbidities Patient characteristics that affect Patient characteristics that affect

outcomesoutcomes Medical Chart sources of info:Medical Chart sources of info:

Admission notes, ED assessments, previous Admission notes, ED assessments, previous admission notesadmission notes

Progress notesProgress notes Discharge SummaryDischarge Summary

Collect only those that appear on the Collect only those that appear on the CRF, record them by:CRF, record them by: Body systemBody system Illness/conditionIllness/condition

CRF pg. 4-5

Vasopressors/InotropesVasopressors/Inotropes

From the current hospitalizationFrom the current hospitalization Usually only administered in the ICU Usually only administered in the ICU

or step-down units.or step-down units. Record any instance where an Record any instance where an

infusion is given for > 30 minsinfusion is given for > 30 mins Don’t count bolusesDon’t count boluses

Record start and stop datesRecord start and stop dates

CRF pg. 6-7

ConsultationsConsultations List all consultations that were List all consultations that were orderedordered

during this hospital stayduring 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

DialysisDialysis

Current hospitalization, Current hospitalization, newnew onset of onset of acuteacute renal failure renal failure requiring any form of requiring any form of dialysisdialysis Start and stop date for dialysisStart and stop date for dialysis

CRF pg. 10-11

Percutaneous Feeding Percutaneous Feeding TubeTube

Percutaneous feeding tubes are those Percutaneous feeding tubes are those inserted through the skin and into the inserted through the skin and into the stomach or intestine.stomach or intestine. If nasoenteric or nasogastric do If nasoenteric or nasogastric do notnot record here record here

Indicate whether the patient arrived at the Indicate whether the patient arrived at the institution with a percutaneous feeding tube institution with a percutaneous feeding tube already in place (removal date)already in place (removal date)

Indicate if the patient ever had a Indicate if the patient ever had a percutaneous feeding tube inserted during percutaneous feeding tube inserted during the current hospitalization (insertion & the current hospitalization (insertion & removal dates)removal dates)

CRF pg. 10-11

Mechanical VentilationMechanical 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

Mechanical Ventilation Mechanical Ventilation con’tcon’t

Record start and stop date/time for each Record start and stop date/time for each episodeepisode If stopped for > 48 hrs, then restarted, If stopped for > 48 hrs, then restarted,

considered it a new episodeconsidered it a new episode Use ‘actual’ start date (ED, OR, etc), if Use ‘actual’ start date (ED, OR, etc), if

initiated externally (i.e. referring hospital) initiated externally (i.e. referring hospital) then enter the start date/time as hospital then enter the start date/time as hospital admissionadmission

Mechanical Ventilation Mechanical Ventilation con’tcon’t

MV stop is when patient is off > 48 MV stop is when patient is off > 48 continuous hrscontinuous 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 If transferred out of hospital while vented, stop date is hospital discharge vented, stop date is hospital discharge date/timedate/time

CPR Use in HospitalCPR 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

Goals of Care DiscussionsGoals of Care Discussions

Document any goals of care Document any goals of care discussions from the discussions from the currentcurrent hospitalizationhospitalization

CRF pg. 16-19

Goals of Care Goals of Care DiscussionsDiscussions

Each instance in chronological orderEach instance in chronological order Did the patient have an existing GoC in the Did the patient have an existing GoC in the

medical chart upon admission to hospital?medical chart upon admission to hospital? Yes → Record the GoC designationYes → Record the GoC designation

Record all instances of GoC discussions Record all instances of GoC discussions from the current hospitalizationfrom the current hospitalization

Date of GoC discussionDate of GoC discussion Where did it occur (e.g. ER)Where did it occur (e.g. ER)

Date of GoC order writtenDate of GoC order written GoC decision madeGoC decision made

Goals of Care Decision Goals of Care Decision MadeMade

Use the most appropriate GoC Use the most appropriate GoC designation system presented:designation system presented: No decision madeNo decision made Decision madeDecision made

No change from previousNo change from previous Change from previous:Change from previous:

AlbertaAlberta BC DNARBC DNAR BC MOSTBC MOST All other regionsAll other regions

GoC – All other regions GoC – All other regions optionsoptions

Goals of care designation – Goals of care designation – All other All other regionsregions The coordinator should use their own The coordinator should use their own

judgment when determining how locally judgment when determining how locally documented designations translate into documented designations translate into the options available on the CRFthe options available on the CRF 1 – Aggressive use of heroic measures….1 – Aggressive use of heroic measures…. 2 – Full medical care but in the event…2 – Full medical care but in the event… 3 – Doctors will be focused on my comfort…3 – Doctors will be focused on my comfort… 4 – A mix of the above…4 – A mix of the above… 5 – Unsure, documentation unclear5 – Unsure, documentation unclear 6 – no documentation6 – no documentation 7 - Other7 - Other

Processes of CareProcesses of CareUpon Hospital AdmissionUpon Hospital Admission

Upon hospital admission Upon hospital admission ++ 1 day 1 day Orders written to Orders written to WITHHOLDWITHHOLD LSTs LSTs

VentilationVentilation VasopressorsVasopressors DialysisDialysis CPRCPR

WITHHOLDING LSTsWITHHOLDING 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

Upon Hospital Admission Upon Hospital Admission con’tcon’t

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 doctor’s orders, it might be captured in the progress notes. If this is the case then please use the date the note was written.

Upon Hospital Admission Upon Hospital Admission con’tcon’t

Upon hospital admission Upon hospital admission ++ 1 day 1 day Orders written to Orders written to WITHDRAWWITHDRAW LSTs LSTs

VentilationVentilation VasopressorsVasopressors DialysisDialysis

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

Upon Hospital Admission Upon Hospital Admission con’tcon’t

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 ordersNO escalation of care orders Receiving LSTs Receiving LSTs no escalation = Withholding no escalation = Withholding Receiving LSTs Receiving LSTs comfort measures = comfort measures =

WithdrawingWithdrawing Not receiving LSTs Not receiving LSTs no escalation = no escalation =

WithholdingWithholding

Process of CareProcess of CareDuring HospitalizationDuring Hospitalization

After Admission orders – After Admission orders – Discharge/DeathDischarge/Death

Orders written to Orders written to WITHHOLDWITHHOLD LSTs LSTs Orders written to Orders written to WITHDRAWWITHDRAW LSTs LSTs

CRF pg. 22-23

Index Hospital OverviewIndex Hospital Overview Index hospitalizationIndex 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

Hospital DischargeHospital 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.

Entering Data into Entering Data into REDCapREDCap

Once you have:Once you have: Administered the ACP questionnaire(s)Administered the ACP questionnaire(s) Collected the CRF dataCollected the CRF data Degree of system implementationDegree of system implementation

Proceed to enter the data into Proceed to enter the data into REDCap.REDCap.

See Module 7 for instructions.See Module 7 for instructions.

Training Module 6 Training Module 6 CompleteComplete

Live Demo of Live Demo of REDCapREDCap

NavigationNavigation

Institutional DataInstitutional Data

Patient and Family MembersPatient and Family Members

ACP QuestionnairesACP Questionnaires

Case Report FormCase Report Form

ReCap of ReCap of REDCapREDCap

Institutional DataInstitutional Data

Enter once per audit Enter once per audit cyclecycle

Patients are enrolled Patients are enrolled on the on the eScreening/ErnollmeeScreening/Ernollment Lognt Log

Enrollment Enrollment numbers are numbers are automatically automatically inserted into inserted into REDCapREDCap

Patient/Family Member Patient/Family Member DataData

The The GridGrid

Enrollment #Enrollment #

ACP ACP QuestionnairQuestionnairee

Patient versionPatient versionACP ACP

QuestionnairQuestionnairee

FM versionFM version

Case Report Case Report FormForm

ACP ACP QuestionnairQuestionnairee

Data Conventions in Data Conventions in REDCapREDCap

Dates Dates YYYY - MM - DDYYYY - MM - DD A date picker calendar is available to A date picker calendar is available to

enter dates. enter dates. Times Times HH:MMHH:MM

24-hour period format i.e. 22:37. The 24-hour period format i.e. 22:37. The semicolon must be entered. Use leading semicolon must be entered. Use leading zeros where applicable i.e. 01:28. zeros where applicable i.e. 01:28.

Midnight should be entered as 00:00Midnight should be entered as 00:00 If data is NOT available use the If data is NOT available use the

“NA” options. “NA” options.

Lock your DataLock your Data

Once you have entered all of your Once you have entered all of your data select the “Lock” button.data select the “Lock” button.

This tells us you have finished your This tells us you have finished your data entry.data entry.

Error MessagesError Messages

All errors must be addressed before All errors must be addressed before you can LOCKyou can LOCK

Technical SupportTechnical Support

HELPDESK HELPDESK http://www.ceru.ca/helpdesk/open.php

Important to provide a description of Important to provide a description of the error message you are receiving:the error message you are receiving: Copy and paste to the HelpdeskCopy and paste to the Helpdesk Screen Shots (print screen, paste into a Screen Shots (print screen, paste into a

document, send)document, send)

ACP Questionnaire: ACP Questionnaire: Section 4Section 4

Patients Patients who who arrive in arrive in hospital hospital with AD with AD in place.in place.

Patients Patients who who arrive in arrive in hospital hospital with AD with AD in place, in place, but there but there is a is a change change in in hospitalhospital

ACP Questionnaire: ACP Questionnaire: Section 6Section 6

Documentation of ACP/AD in Documentation of ACP/AD in Hospital Chart at end of interviewHospital Chart at end of interview Modification to response options for Modification to response options for

questions 1ci, 1cii, 2bi and 2biiquestions 1ci, 1cii, 2bi and 2bii If “yes,” in addition to recording the If “yes,” in addition to recording the

date, also indicate the option chosen.date, also indicate the option chosen.

Example, 1ciExample, 1ci Goals of Care designation or MOST formGoals of Care designation or MOST form

Yes/NoYes/No

Date of Date of DocumentDocument

OptioOptionn

Aggressive use of heroic measures and Aggressive use of heroic measures and artificial life sustaining treatments artificial life sustaining treatments including CPR to keep me alive at all.  including CPR to keep me alive at all.  

Full medical care but in the event my Full medical care but in the event my heart stops, or my breathing stops, No heart stops, or my breathing stops, No CPR CPR

Doctors will be focused on my comfort Doctors will be focused on my comfort and alleviate suffering and not on being and alleviate suffering and not on being kept alive by artificial means or heroic kept alive by artificial means or heroic measuresmeasures

A mix of the above options (e.g. try to A mix of the above options (e.g. try to fix problems but if not getting better fix problems but if not getting better switch to focusing only on my comfort switch to focusing only on my comfort even if it hastens death) even if it hastens death)

Unsure Unsure Other ____________Other ____________

Training Module 6 Training Module 6 CompleteComplete