Research Research Coordinator Coordinator

TrainingTrainingPart 1Part 1

OverviewOverview

Study designStudy design ScreeningScreening Obtaining Obtaining

ConsentConsent EnrollmentEnrollment ToolsTools

CERU ContactsCERU Contacts

SponsorSponsor Dr. Daren Heyland

Cell: 403-915-5573Cell: 403-915-5573

dkh2@queensu.cadkh2@queensu.ca

Project Project LeaderLeader

Janet Overvelde

Office: 613.549.6666 x6241Office: 613.549.6666 x6241

Cell: 613-331-1270Cell: 613-331-1270

overvelj@kgh.kari.netovervelj@kgh.kari.net

Site PackagesSite Packages

Study Procedures Study Procedures ManualManual REB documentsREB documents Site AgreementSite Agreement InstructionsInstructions TemplatesTemplates

Patient BindersPatient Binders Tabs for 60 Tabs for 60

respondentsrespondents Tab labelsTab labels File are respondent File are respondent

documentationdocumentation

AAdvandvancce e CCare Planning are Planning EEvaluation valuation in Hospitalized Elderly in Hospitalized Elderly PPatienatientts: s: A multicenter, prospective studyA multicenter, prospective study

The ACCEPT StudyThe ACCEPT Study

Overall goal of this study is to inform decision-makers as the best strategies to implement advance care planning (ACP).

Primary objective of this study is to determine, from the patient and families’ perspectives, the prevalence of ACP and its various components, satisfaction with end of life communication and decision-making, and what barriers to improving the quantity and quality of ACP exist.

Advance Care Planning Advance Care Planning (ACP)(ACP)

ACP is a process by which a person ACP is a process by which a person considers options about ‘future’ health considers options about ‘future’ health care decisions and identifies what his/her care decisions and identifies what his/her wishes are. wishes are.

1) Patient’s personal values & wishes related to EOL care

2) Prognosis

3) Treatment options (risks, benefits, expected outcomes)

4) Deciding on future care or goals of care

5) Documenting decisions and discussions

Study DesignStudy Design

Multicenter, prospective, observational Multicenter, prospective, observational studystudy

Conducted annually x 3Conducted annually x 3 Acute care institutions in Ontario, Alberta, Acute care institutions in Ontario, Alberta,

BC and QuebecBC and Quebec Patients who are at high risk of dying Patients who are at high risk of dying

and/or their families (where available)and/or their families (where available) Administer ACP questionnaire, chart Administer ACP questionnaire, chart

abstractionabstraction Benchmark reports to institutionsBenchmark reports to institutions

Audit Cycle #1 (Year 1)

Data Collection for 60 respondents

Audit Cycle #2 (Year 2)

Data Collection for 60 respondents

Study Start-up

Obtain ethics approvals at participating sites

Obtain fully executed site agreements for participating sites

Audit Cycle #3 (Year 3)

Data Collection for 60 respondents

Benchmark Reports

Develop local action plans

Generate knowledge translation and communication strategies

Implementation of action plans to improve ACP

CERU

Coordinating CentreResearch Site

Procedures

Training

REDCap (data)

Benchmark reports

RecruitmentData

CollectionData Entry

Implementing Action Plans

ACCEPT TeamACCEPT Team

Setting the StageSetting the Stage

Finding the Correct Patient Finding the Correct Patient PopulationPopulation

Target patient units:Target patient units: General medicalGeneral medical OncologyOncology

We are We are NOTNOT recruiting ICU recruiting ICU patients/family patients/family membersmembers

Creating Study Creating Study AwarenessAwareness

Education of unit staff is an Education of unit staff is an important aspect to initiating the important aspect to initiating the study at your site.study at your site. In-servicesIn-services Letter of informationLetter of information Ongoing promotion to house staff Ongoing promotion to house staff

residents and nurses (poster)residents and nurses (poster) Identify research team to unit staffIdentify research team to unit staff

Audit Cycle Audit Cycle BeginsBegins

Institution Level Institution Level DataData

Degree of System of Degree of System of ImplementationImplementation

Catalogue the nature of the Catalogue the nature of the hospital and larger system level hospital and larger system level

integration of ACP integration of ACP implementationimplementation

To be filled out by each site once at To be filled out by each site once at the beginning of the audit periodthe beginning of the audit period

Two versions: Two versions: Acute Care SiteAcute Care Site Health Care Organization LevelHealth Care Organization Level

Individual most Individual most responsible for responsible for ACP at your ACP at your hospitalhospital

Individual(s) who is Individual(s) who is responsible for ACP responsible for ACP across the health across the health care system.care system. Palliative care teamPalliative care team Smaller institutions Smaller institutions

may not have a may not have a respondent for this respondent for this version of the version of the questionnairequestionnaire

Patient/Family Patient/Family Member Member

RecruitmentRecruitment

Screening for Patients/Family Screening for Patients/Family MembersMembers

Time initial approach 48-96 hrs after Time initial approach 48-96 hrs after admission to hospital.admission to hospital.

Check for new admissions to the unitCheck for new admissions to the unit Assess eligibilityAssess eligibility

Screen ward again tomorrow

Inclusion CriteriaInclusion Criteria

55 years or older 55 years or older with one or more with one or more of the following of the following diagnoses: diagnoses:

Chronic obstructive lung disease

Congestive heart failure

Cirrhosis Cancer End-stage dementia

Any patient 80 Any patient 80 years of age or years of age or older admitted older admitted to hospital from to hospital from the community the community because of an because of an acute medical acute medical or surgical or surgical condition.condition.

OORR

Patients who are:

Exclusion CriteriaExclusion Criteria

Non English/French speaking Non English/French speaking (patient and/or family member)(patient and/or family member)

Cognitive impairment (patient)Cognitive impairment (patient)

Types of RespondentsTypes of Respondents

Patient onlyPatient only

Family Member onlyFamily Member only

Patient & Family Member (both)Patient & Family Member (both)

Family Member can be included if:Family Member can be included if:>18 yrs old>18 yrs old

Visited the patient in hospital at least onceVisited the patient in hospital at least once

Provides the most care to the patient and is not Provides the most care to the patient and is not paid to do sopaid to do so

Informed Informed ConsentConsent

Free and informed consent refers Free and informed consent refers to the dialogue, information to the dialogue, information sharing and general process sharing and general process through which prospective through which prospective subjects choose to participate in subjects choose to participate in research involving themselves.research involving themselves.

Informed Consent Form Informed Consent Form (ICF)(ICF)

Patient version & Family Member Patient version & Family Member versionversion

Only use REB approved versionOnly use REB approved version

Consent ProceduresConsent Procedures The research site should always adhere The research site should always adhere

to local REB procedures when to local REB procedures when obtaining informed consent.obtaining informed consent.

Assess the patient/family members Assess the patient/family members competence to consent to researchcompetence to consent to research

Review the study details with the Review the study details with the patient/family member in a quiet and patient/family member in a quiet and private locationprivate location

Fully inform the Patient/Family Member of Fully inform the Patient/Family Member of all pertinent aspects of research, in non-all pertinent aspects of research, in non-technical language that is easy to technical language that is easy to understand.understand.

Explain the Study Explain the Study ProceduresProcedures

Collection information from the Collection information from the patient’s medical recordpatient’s medical record

Ask some questions:Ask some questions: Demographics (might affect your Demographics (might affect your

perspectives and responses to subsequent perspectives and responses to subsequent questionsquestions))

ACPACP Satisfaction with communication and Satisfaction with communication and

decision making regarding current and decision making regarding current and future medical carefuture medical care

Consent Procedures Consent Procedures Con’tCon’t

Ensure the patient/family member fully Ensure the patient/family member fully understands the informationunderstands the information

If the Patient/Family Member is showing If the Patient/Family Member is showing signs of stress, ask if they would like you signs of stress, ask if they would like you to come back at another time.to come back at another time.

Ascertain the Patient/Family Member’s Ascertain the Patient/Family Member’s willingness to participate. willingness to participate.

Consent = Yes = Sign/date ICFConsent = Yes = Sign/date ICF Place original ICF in study filesPlace original ICF in study files Copy of ICF in medical chart Copy of ICF in medical chart Copy of ICF to respondentCopy of ICF to respondent

Consent ScenariosConsent ScenariosPatient Consent Response

Family Member Consent Response

Procedures Considerations

A separate ICF should be signed by the patient and

the family member.

A consent should be

signed by the patient.

None

A consent should be A consent should be signed by the family signed by the family member.member.

ConfidentialityConfidentiality

Confidentiality refers to prevention Confidentiality refers to prevention of disclosure, to unauthorized of disclosure, to unauthorized individuals, of a Patient/Family individuals, of a Patient/Family Member’s identity and of records Member’s identity and of records that could identify a Patient/Family that could identify a Patient/Family Member. Member.

Follow your hospital policiesFollow your hospital policies All enrolled patients/family members All enrolled patients/family members

will be identified with a unique study will be identified with a unique study enrollment numberenrollment number

EnrollmentsEnrollments

60 respondents/hospital/audit period60 respondents/hospital/audit period At a minimum, 20 patient and 20 At a minimum, 20 patient and 20

family member respondentsfamily member respondents

Example: Example: 35 patients & 25 family 35 patients & 25 family membersmembers

20 patients & 40 family 20 patients & 40 family membersmembers

etc…etc…

Screening LogsScreening Logs

Live DemoLive Demo

Administration Administration the ACP the ACP

QuestionnaireQuestionnairePatient version 24-Aug-2011Patient version 24-Aug-2011

Family Member version 12-Family Member version 12-Sep-2011Sep-2011

Interview TipsInterview Tips

Have the appropriate version of the ACP Have the appropriate version of the ACP Questionnaire on-hand (i.e. Pt or FM)Questionnaire on-hand (i.e. Pt or FM)

Use the respondent’s nameUse the respondent’s name Introduce yourself and your roleIntroduce yourself and your role Ensure the respondent is ready and try Ensure the respondent is ready and try

to have a private location to conduct the to have a private location to conduct the interviewinterview

Ensure comfort and put the respondent Ensure comfort and put the respondent at easeat ease

~60 minutes~60 minutesMay be conducted over a few shorter May be conducted over a few shorter

sessionssessions

The questionnaires should be The questionnaires should be administered in-person with administered in-person with

the respondent. the respondent.

Do Do notnot give the questionnaires to give the questionnaires to the respondent to fill out at their the respondent to fill out at their

leisure.leisure.

Read each question to the Read each question to the respondent. If the respondent. If the

respondent does not understand, respondent does not understand, repeat the question. repeat the question.

The researcher administering The researcher administering the questionnaire should not the questionnaire should not

interpret the questions for the interpret the questions for the respondent.respondent.

When the question is open-ended, When the question is open-ended, do do notnot paraphrase or change the paraphrase or change the respondent’s answer. respondent’s answer. Record the answer verbatim.Record the answer verbatim.

If the respondent says “I don’t If the respondent says “I don’t know” provide them with the know” provide them with the applicable laminated reference applicable laminated reference card.card.

Ask the respondent to look at the Ask the respondent to look at the options presented on the card.options presented on the card.

Laminated CardsLaminated Cards

Use the correct Use the correct card set for the card set for the respondent:respondent:

BlueBlue = patient = patient

OrangeOrange = = family family membermember

Audit PeriodAudit Period

Enrollment Enrollment ##

Interview Interview DateDate

Inclusion Inclusion CriteriaCriteria

Section 1: Patient Section 1: Patient DemographicsDemographics

Enable us to adequately describe the Enable us to adequately describe the patients involved in this study patients involved in this study

Will help us explain if certain types Will help us explain if certain types of patients are or are not involved in of patients are or are not involved in ACPACP

ACP pg. 2

Health LiteracyHealth Literacy Health Literacy is a key determinant Health Literacy is a key determinant

to preferences for EOL treatment. We to preferences for EOL treatment. We are using a validated short item are using a validated short item questionnaire to measure health questionnaire to measure health literacy, the REALM tool. literacy, the REALM tool. Provide the respondent with the Provide the respondent with the

laminated card (CARD 1)laminated card (CARD 1) Ask them to read down the list, Ask them to read down the list,

pronouncing aloud as many words as pronouncing aloud as many words as they can.they can.

Interviewer scores the number of Interviewer scores the number of correctly pronounced wordscorrectly pronounced words ACP pg. 2

Ethnicity & LanguageEthnicity & Language Impact of ethnicity on access to Impact of ethnicity on access to

healthcare resourceshealthcare resources Disparities are most related to whether Disparities are most related to whether

you appear as a visible minority and you appear as a visible minority and speak another language, other than the speak another language, other than the 2 official languages of Canada. 2 official languages of Canada.

Categorize patients/family members as Categorize patients/family members as to whether they appear to be Caucasian to whether they appear to be Caucasian (by appearance) and by asking the (by appearance) and by asking the patient/family member if the are patient/family member if the are proficient in another language other proficient in another language other than English (or French if in Quebec).than English (or French if in Quebec).

We will want to be able to categorize We will want to be able to categorize patients/family members into one of patients/family members into one of the 4 quadrants:the 4 quadrants:

Frailty IndexFrailty Index

Consider the patient’s overall Consider the patient’s overall condition two weeks prior to condition two weeks prior to admission to the hospitaladmission to the hospital

Section 2: Determinants of Section 2: Determinants of Decision MakingDecision Making

Questions that may relate to the Questions that may relate to the respondent’s preferences for EOL respondent’s preferences for EOL carecare

We will analyze and to see if we can We will analyze and to see if we can better understand the key better understand the key determinants to preferred care at determinants to preferred care at EOL.EOL.

ACP pg. 4-5

Lifetime Line - Question 6Lifetime Line - Question 6

Patient indicates where they see Patient indicates where they see themselves between life and death.themselves between life and death.

Measure the distance from the Birth Measure the distance from the Birth anchor to the patient’s mark. Round anchor to the patient’s mark. Round to the nearest millimeter.to the nearest millimeter. ACP pg. 5

6.8

Life Sustaining Treatments, Life Sustaining Treatments, question 7question 7

Provide the patient with the Provide the patient with the laminated card (CARD 2)laminated card (CARD 2)

Before reading the options to them, Before reading the options to them, ask them to consider which of these ask them to consider which of these options they would prefer options they would prefer at this at this point in timepoint in time..

ACP pg. 5

Section 3: Decisions About Section 3: Decisions About Your Health Care Your Health Care Prior toPrior to

HospitalizationHospitalization

Whether the respondent has Whether the respondent has engaged in ACP engaged in ACP PRIOR toPRIOR to hospitalizationhospitalization Someone assigned to make decisions Someone assigned to make decisions

for themfor them Patient’s preferred care at EOLPatient’s preferred care at EOL Types of desired life-sustaining Types of desired life-sustaining

treatments (CARD 2)treatments (CARD 2)

ACP pg. 6-10

Section 3: Decisions About Section 3: Decisions About Your Health Care Your Health Care Prior toPrior to

HospitalizationHospitalization Laminated cards can be provided to Laminated cards can be provided to

the patient if they answer “I don’t the patient if they answer “I don’t know” to the following questions:know” to the following questions: Question 2, CARD 3Question 2, CARD 3 Question 3A, CARD 4Question 3A, CARD 4 Question 3B, CARD 5Question 3B, CARD 5 Question 3C, CARD 6Question 3C, CARD 6 Question 4, CARD 7Question 4, CARD 7 Question 5, CARD 8Question 5, CARD 8

ACP pg. 6-10

3) Have you ever thought about what 3) Have you ever thought about what kinds of life sustaining treatments you kinds of life sustaining treatments you would want in the event your physical would want in the event your physical

health deteriorated?health deteriorated? NO NO Reasons (CARD 4) Reasons (CARD 4) YES YES Complete table on pg. 8 Complete table on pg. 8

ACP pg. 7

YES YES Did you discuss these wishes Did you discuss these wishes with anyone? with anyone?

YES YES Complete table on pg. 8 Complete table on pg. 8

Section 4: Goals of Your Section 4: Goals of Your Health Care During the Health Care During the CurrentCurrent Hospitalization Hospitalization

Respondent’s perspective on Respondent’s perspective on communication and decision making communication and decision making about the use of life sustaining about the use of life sustaining treatments during the current treatments during the current hospitalization hospitalization

If respondents refer to previous If respondents refer to previous conversations outside the current conversations outside the current hospitalization, please keep directing hospitalization, please keep directing them back to conversations and events them back to conversations and events during the current hospitalization. during the current hospitalization.

Importance & Importance & SatisfactionSatisfaction

Prior to starting this section, show the card Prior to starting this section, show the card for response options and explain the for response options and explain the potential responses.potential responses.

For each question in this section, you are For each question in this section, you are asking the respondent ‘Did this happen, yes asking the respondent ‘Did this happen, yes or no?”or no?” Yes/No - we are interested in the perspective of Yes/No - we are interested in the perspective of

the respondent if that event is important to the respondent if that event is important to them and whether they are satisfied with care them and whether they are satisfied with care on that issue. on that issue.

Minimize the use of NA Minimize the use of NA

ACP pg. 11

YesYesAnswer questions 8-11Answer questions 8-11

9) What is your 9) What is your understanding of the understanding of the

Decision?Decision? Record the Record the decisiodecision that has been n that has been

reached regarding EOL treatments. reached regarding EOL treatments. Note: this is exactly the same Note: this is exactly the same

wording as in section #2. The wording as in section #2. The respondent was asked in section #2 respondent was asked in section #2 what their what their preferencepreference was for the was for the use of EOL treatments. use of EOL treatments. In most cases, the 2 should be the same, In most cases, the 2 should be the same,

but not always. Just check to see that but not always. Just check to see that the respondent answered the question the respondent answered the question the same way and if not, point that out the same way and if not, point that out to them and query them why different. to them and query them why different. ACP pg.

12

Here we are trying to measure the Here we are trying to measure the amount of uncertainty or decisional amount of uncertainty or decisional conflict the respondent feels in regards to conflict the respondent feels in regards to the decision expressed in Question #9. the decision expressed in Question #9.

This is a formal values scale and is used This is a formal values scale and is used to try and determine what values the to try and determine what values the respondent is appealing to in making respondent is appealing to in making their EOL treatment decisions.their EOL treatment decisions.

Section 5: CANHELPSection 5: CANHELP

The CANHELP questionnaire is a formal, The CANHELP questionnaire is a formal, validated satisfaction with EOL care validated satisfaction with EOL care measurement tool. measurement tool. We are using the validated subscales pertinent to We are using the validated subscales pertinent to

ACPACP Literally read the instructions at the Literally read the instructions at the

beginning of the questionnaire. beginning of the questionnaire. Also, explain that you are asking about their rating Also, explain that you are asking about their rating

of care over the past month, regardless as to where of care over the past month, regardless as to where the care occurred (at home, hospital or other the care occurred (at home, hospital or other location).location).

Before reading the question, show card (CARD Before reading the question, show card (CARD 11) and explain the response options.11) and explain the response options. ACP pg.

15-16

Section 6: Documentation Section 6: Documentation of ACP/AD in Medical Chartof ACP/AD in Medical Chart Must be completed Must be completed immediatelyimmediately

following the interview following the interview Go to the medical record and Go to the medical record and

abstract data on current use of ACP abstract data on current use of ACP tools or documented discussions tools or documented discussions regarding EOL treatments. regarding EOL treatments.

Timing is critical Timing is critical respondent respondent responses can be correlated to the responses can be correlated to the information obtained from the information obtained from the medical chartmedical chart

ACP Questionnaire: Family ACP Questionnaire: Family MemberMember

Section 1Section 1 Family Member DemographicsFamily Member Demographics Patient DemographicsPatient Demographics Frailty IndexFrailty Index

Section 2Section 2 Section 3Section 3 Section 4Section 4 Section 5Section 5 Section 6Section 6

Complete if patient not enrolled in study

Documentation Documentation RequirementsRequirements

Hard copies of all study Hard copies of all study documentation should be filed in the documentation should be filed in the Patient BinderPatient Binder Consent formConsent form Enrollment Confirmation FormEnrollment Confirmation Form ACP Questionnaire WorksheetACP Questionnaire Worksheet

Tools of the Tools of the TradeTrade

Degree of System Degree of System Implementation Implementation

WorksheetsWorksheets Health Care Health Care

Organization Organization LevelLevel

Acute Care Acute Care SiteSite

Patient Family Member

Laminated CardsLaminated Cards

What Comes Next?What Comes Next?

Research Coordinator Training Part Research Coordinator Training Part 22 Chart abstractionChart abstraction REDCap (electronic data capture REDCap (electronic data capture

system)system) Data entryData entry Data queriesData queries