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

Module 6: Case Report Form (Chart Abstraction)

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Module 6: Case Report Form (Chart Abstraction). This training session contains information regarding:. Overview the CRF Highlights of certain points of data collection from the medical record. At this point you have done the following:. Identified Eligible Respondents Obtained Consent - PowerPoint PPT Presentation

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Page 1: Module 6: Case Report Form (Chart Abstraction)

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

Page 2: Module 6: Case Report Form (Chart 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

Page 3: Module 6: Case Report Form (Chart Abstraction)

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:

Page 4: Module 6: Case Report Form (Chart Abstraction)

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.

Page 5: Module 6: Case Report Form (Chart Abstraction)

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

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

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

Instructions

Worksheet

Page 7: Module 6: Case Report Form (Chart Abstraction)

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…)

Page 8: Module 6: Case Report Form (Chart Abstraction)

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

Page 9: Module 6: Case Report Form (Chart Abstraction)

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.

Page 10: Module 6: Case Report Form (Chart Abstraction)

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

Page 11: Module 6: Case Report Form (Chart Abstraction)

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

Page 12: Module 6: Case Report Form (Chart Abstraction)

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

Page 13: Module 6: Case Report Form (Chart Abstraction)

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

Page 14: Module 6: Case Report Form (Chart Abstraction)

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

Page 15: Module 6: Case Report Form (Chart Abstraction)

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

Page 16: Module 6: Case Report Form (Chart Abstraction)

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

Page 17: Module 6: Case Report Form (Chart Abstraction)

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

Page 18: Module 6: Case Report Form (Chart Abstraction)

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

Page 19: Module 6: Case Report Form (Chart Abstraction)

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

Page 20: Module 6: Case Report Form (Chart Abstraction)

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

Page 21: Module 6: Case Report Form (Chart Abstraction)

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

Page 22: Module 6: Case Report Form (Chart Abstraction)

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 judgment when The coordinator should use their own judgment when

determining how locally documented designations determining how locally documented designations translate into the options available on the CRFtranslate into the options available on the CRF

1 – Use machines …keeping me alive at all costs.1 – Use machines …keeping me alive at all costs. 2 – Use machines …keeping me alive …no 2 – Use machines …keeping me alive …no

resuscitation.resuscitation. 3 – Use machines only in the short term …3 – Use machines only in the short term … 4 – Use full medical care …4 – Use full medical care … 5 5 –– Use comfort measures only …Use comfort measures only … 6 – Unsure, documentation unclear6 – Unsure, documentation unclear 7 – no documentation7 – no documentation 8 – Other8 – Other

Page 23: Module 6: Case Report Form (Chart Abstraction)

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

Page 24: Module 6: Case Report Form (Chart Abstraction)

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.

Page 25: Module 6: Case Report Form (Chart Abstraction)

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

Page 26: Module 6: Case Report Form (Chart Abstraction)

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

Page 27: Module 6: Case Report Form (Chart Abstraction)

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

Page 28: Module 6: Case Report Form (Chart Abstraction)

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

Page 29: Module 6: Case Report Form (Chart Abstraction)

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.

Page 30: Module 6: Case Report Form (Chart Abstraction)

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.

Page 31: Module 6: Case Report Form (Chart Abstraction)

Training Module 6 Training Module 6 CompleteComplete