Research Coordinator Training Part 1

1. Research Coordinator TrainingPart 1

2. Study design Screening Obtaining Consent Enrollment Tools Overview

3. CERU Contacts

4. Study Procedures Manual REB documents Site Agreement Instructions Templates Patient Binders Tabs for 60 respondents Tab labels File are respondent documentation Site Packages

5. Advance Care Planning Evaluation in Hospitalized Elderly Patients: A multicenter, prospective 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.

6. Advance Care Planning (ACP) • ACP is a process by which a person considers options about ‘future’ health care decisions and identifies what his/her wishes are. Patient’s personal values & wishes related to EOL care Prognosis Treatment options (risks, benefits, expected outcomes) Deciding on future care or goals of care Documenting decisions and discussions

7. Study Design • Multicenter, prospective, observational study • Conducted annually x 3 • Acute care institutions in Ontario, Alberta, BC and Quebec • Patients who are at high risk of dying and/or their families (where available) • Administer ACP questionnaire, chart abstraction • Benchmark reports to institutions

8. Study Start-up Obtain ethics approvals at participating sites Obtain fully executed site agreements for participating sites Audit Cycle #1 (Year 1) Data Collection for 60 respondents Benchmark Reports Develop local action plans Generate knowledge translation and communication strategies Implementation of action plans to improve ACP Audit Cycle #2 (Year 2) Data Collection for 60 respondents Audit Cycle #3 (Year 3) Data Collection for 60 respondents

9. ACCEPT Team

10. Setting the Stage

11. Finding the Correct Patient Population • Target patient units: • General medical • Oncology • We are NOT recruiting ICU patients/family members

12. Creating Study Awareness • Education of unit staff is an important aspect to initiating the study at your site. • In-services • Letter of information • Ongoing promotion to house staff residents and nurses (poster) • Identify research team to unit staff

14. Audit Cycle Begins

15. Institution Level Data

16. Degree of System of Implementation Catalogue the nature of the hospital and larger system level integration of ACP implementation • To be filled out by each site once at the beginning of the audit period • Two versions: • Acute Care Site • Health Care Organization Level

17. Individual most responsible for ACP at your hospital

18. Individual(s) who is responsible for ACP across the health care system. Palliative care team Smaller institutions may not have a respondent for this version of the questionnaire

19. Patient/Family Member Recruitment

20. Screening for Patients/Family Members • Time initial approach 48-96 hrs after admission to hospital. • Check for new admissions to the unit • Assess eligibility

21. Screen ward again tomorrow

22. Inclusion Criteria Patients who are: • 55 years or older with one or more of the following diagnoses: • Chronic obstructive lung disease • Congestive heart failure • Cirrhosis • Cancer • End-stage dementia • Any patient 80 years of age or older admitted to hospital from the community because of an acute medical or surgical condition. OR

23. Exclusion Criteria • Non English/French speaking (patient and/or family member) • Cognitive impairment (patient)

24. Types of Respondents Patient only Family Member only Patient & Family Member (both) Family Member can be included if: >18 yrs old Visited the patient in hospital at least once Provides the most care to the patient and is not paid to do so

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

26. Informed Consent Form (ICF) Patient version & Family Member version Only use REB approved version

27. Consent Procedures • The research site should always adhere to local REB procedures when obtaining informed consent. • Assess the patient/family members competence to consent to research • Review the study details with the patient/family member in a quiet and private location • Fully inform the Patient/Family Member of all pertinent aspects of research, in non-technical language that is easy to understand.

28. Explain the Study Procedures • Collection information from the patient’s medical record • Ask some questions: • Demographics (might affect your perspectives and responses to subsequent questions) • ACP • Satisfaction with communication and decision making regarding current and future medical care

29. Consent Procedures Con’t • Ensure the patient/family member fully understands the information • If the Patient/Family Member is showing signs of stress, ask if they would like you to come back at another time. • Ascertain the Patient/Family Member’s willingness to participate. • Consent = Yes = Sign/date ICF • Place original ICF in study files • Copy of ICF in medical chart • Copy of ICF to respondent

30. Consent Scenarios

31. Confidentiality • Confidentiality refers to prevention of disclosure, to unauthorized individuals, of a Patient/Family Member’s identity and of records that could identify a Patient/Family Member. • Follow your hospital policies • All enrolled patients/family members will be identified with a unique study enrollment number

32. Enrollments • 60 respondents/hospital/audit period • At a minimum, 20 patient and 20 family member respondents Example: 35 patients & 25 family members 20 patients & 40 family members etc…

33. Screening Logs Live Demo

34. Administration the ACP Questionnaire Patient version 24-Aug-2011 Family Member version 12-Sep-2011

35. Interview Tips • Have the appropriate version of the ACP Questionnaire on-hand (i.e. Pt or FM) • Use the respondent’s name • Introduce yourself and your role • Ensure the respondent is ready and try to have a private location to conduct the interview • Ensure comfort and put the respondent at ease

36. ~60 minutes May be conducted over a few shorter sessions The questionnaires should be administered in-person with the respondent. Do not give the questionnaires to the respondent to fill out at their leisure.

37. Read each question to the respondent. If the respondent does not understand, repeat the question. The researcher administering the questionnaire should not interpret the questions for the respondent.

38. When the question is open-ended, do not paraphrase or change the respondent’s answer. Record the answer verbatim. If the respondent says “I don’t know” provide them with the applicable laminated reference card. Ask the respondent to look at the options presented on the card.

39. Use the correct card set for the respondent: Blue = patient Orange = family member Laminated Cards

40. Audit Period Enrollment # Interview Date Inclusion Criteria

41. Section 1: Patient Demographics • Enable us to adequately describe the patients involved in this study • Will help us explain if certain types of patients are or are not involved in ACP ACP pg. 2

42. Health Literacy • Health Literacy is a key determinant to preferences for EOL treatment. We are using a validated short item questionnaire to measure health literacy, the REALM tool. • Provide the respondent with the laminated card (CARD 1) • Ask them to read down the list, pronouncing aloud as many words as they can. • Interviewer scores the number of correctly pronounced words ACP pg. 2

43. Ethnicity & Language • Impact of ethnicity on access to healthcare resources • Disparities are most related to whether you appear as a visible minority and speak another language, other than the 2 official languages of Canada. • Categorize patients/family members as to whether they appear to be Caucasian (by appearance) and by asking the patient/family member if the are proficient in another language other than English (or French if in Quebec).

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

45. Frailty Index • Consider the patient’s overall condition two weeks prior to admission to the hospital

46. Section 2: Determinants of Decision Making • Questions that may relate to the respondent’s preferences for EOL care • We will analyze and to see if we can better understand the key determinants to preferred care at EOL. ACP pg. 4-5

47. 6.8 Lifetime Line - Question 6 • Patient indicates where they see themselves between life and death. • Measure the distance from the Birth anchor to the patient’s mark. Round to the nearest millimeter. ACP pg. 5

48. Life Sustaining Treatments, question 7 • Provide the patient with the laminated card (CARD 2) • Before reading the options to them, ask them to consider which of these options they would prefer at this point in time. ACP pg. 5

49. Section 3: Decisions About Your Health Care Prior to Hospitalization • Whether the respondent has engaged in ACP PRIOR to hospitalization • Someone assigned to make decisions for them • Patient’s preferred care at EOL • Types of desired life-sustaining treatments (CARD 2) ACP pg. 6-10

50. Section 3: Decisions About Your Health Care Prior to Hospitalization • Laminated cards can be provided to the patient if they answer “I don’t know” to the following questions: • Question 2, CARD 3 • Question 3A, CARD 4 • Question 3B, CARD 5 • Question 3C, CARD 6 • Question 4, CARD 7 • Question 5, CARD 8 ACP pg. 6-10