Training Module 1: Study Overview, Background and Preparation

1. Training Module 1:Study Overview, Background and Preparation

2. This training session contains information regarding: Background Study Overview Study Preparation Activities

3. Coordinating Centre Contacts The ACCEPT study is coordinated centrally by the Clinical Evaluation Research Unit in Kingston, Ontario, Canada. All queries can be directed to: Jennifer Korol Project Leader Office: 613.548.6051 korolj@kgh.kari.net

4. Background The Need for ACP Evaluation

5. Our health care system is under siege- an aging population, patients living longer with chronic illness, and an increasing demand for services at end of life contribute to escalating costs and utilization patterns that are unsustainable. Advance Care Planning (ACP) may offer some assistance with reducing health care costs for older Canadians and yet, at the same time, improving quality of care.

6. There has been no evaluation of the effectiveness of previous ACP strategy implementation efforts from the perspective of patients and families; many questions pertaining to the barriers and facilitators to implementation and the impact of ACP on outcomes remain. This study is not primarily about whether ACP works, it is more about how best to implement it.

7. Decision-makers in these and other regions need this critical feedback from end users to inform future initiatives designed to improve the quantity and quality of ACP. We propose to conduct a prospective audit of current practice related to ACP in elderly patients at high-risk of dying. The insights we gain from evaluating and improving ACP will be disseminated throughout Canada and other participating regions.

8. Significance This will be the first large scale evaluation of ACP in Canada and abroad. The results will provide information on the current successes (and challenges) of ACP which will strengthen ACP implementation efforts across the country. By increasing the quality and quantity of ACP, we stand to make huge improvements in quality of EOL care in Canada and across the world and reduce overall health costs.

9. Study Overview The Research Question & Study Design

10. Audit of Communication, CarEPlanning, and DocumenTation: 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).

11. 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

12. Primary Objective To determine, from the patient and families’ perspectives: • Prevalence of ACP and its various components • Satisfaction with end of life communication and decision-making • What barriers to improving the quantity and quality of ACP exist

13. Study Design • This is a multicenter, prospective, design that will involve audit of current practice, followed by several audit-feedback cycles with tailored interventions designed to improve ACP practice. • Setting: Hospitals and acute care institutions in Canada and the United States. • We will enroll patients who are at high risk of dying and/or their families (where available). We will approach consecutive, eligible patients and their family members from participating hospital units for enrollment into this study.

14. Intervention We will time our initial approach to patient/family member to be after the patient has been in the hospital for at least 48 hours up until the 120th hour (i.e. between 48 – 120 hours following hospital admission) to allow for symptoms present at the time of admission to have abated enough for the patient and family to complete a questionnaire. Upon enrollment, the research coordinator will give the patients and family caregivers questionnaires to complete. If both the patient and family member are participating, we ask that they complete the questionnaire on their own. It is important they do not influence each other’s responses.

15. The Implementation phase of the study will include distinct audit cycles conducted annually. Each Audit Cycle consists of a data collection/entry period followed by the generation of reports and development and implementation of action plans.

16. Team Responsibilities CERU Coordinating Centre Research Site Recruitment Data Collection Data Entry Implementing Action Plans Procedures Training REDCap (data) Benchmark reports

17. Study Preparation Activities

18. Finding the Correct Patient Population • Focus on patients admitted to the hospital from outside (ER, home, other hospital) • Target patient units: • General medical • Oncology • Renal • We are NOT recruiting: • ICU patients/family members • Patient/family members under the palliative care service

19. 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 • Engage key opinion leaders and champions

20. Training Module 1 Complete