1. A Project to Enhance Clinician Communication with Imminently Dying Patients and their Families Amy M. Sullivan, EdD VCU Department of Social & Behavioral Health Harris Manchester College - Oxford University Summer Research Institute 2008

2. VCU Office of Research 5 th Thursday April 29, 2009 Project background and overview Harris Manchester experience Ethics in palliative care research

3. Project Overview Aim: To develop the curriculum for intervention Enhancing Clinician Communication with Imminently Dying Hospitalized Cancer Patients and their Families. Work with Dr. Bee Wee and colleagues to learn about their approach to inter-professional education in palliative care. Dr. Wee is Senior Clinical Lecturer in Palliative Medicine, Associate Director of Clinical Studies at the Oxford University medical school, and author of the book Education in Palliative Care: Building a Culture of Learning (2007).

4. Rationale Approximately 2.4 million adults die each year in the U.S. About 40% of deaths occur in the hospital A majority of patients spend at least some time in the hospital, on average 13 days, in the six months prior to death. The hospital setting is therefore a high- impact venue for improving end-of-life (EOL) care.

5. Clinician-patient-family communication is a key factor in providing quality care to patients near the end of life and their families. Aids clinicians in coordinating care (Ellershaw and Ward, 2003; Lamont and Christakis, 2003) “Open awareness” associated with greater likelihood of dying at home, receiving hospice care, and having family members present at death (Seale, Addington-Hall, McCarthy, 1997) Most (though not all) patients and families want to be told when death is imminent, and most say they benefit from this communication. (Clayton, Butow, Arnold, Tattersall, 2005; Steinhauser, Christakis, Clipp, et al., 2001)

6. Some correlates of inadequate communication: Late (or no) referral to hospice or palliative care, Inadequate discussion of goals for care or advance directives, Undertreated pain, unneeded invasive and costly medical interventions. Higher incidence of complicated grief among caregivers who feel unprepared for their loved one’s death.

7.  National studies with physicians and medical trainees show high interest/limited EOL training (Sullivan, Lakoma, Block 2001)  98% of nurses ranked EOL education as important and ranked “how to talk to patients and families about dying” among highest needs (White, Coyne, Patel, 2001)  Fewer than 50% of patients are told when death might be imminent (Sullivan, Lakoma, Matsuyama, Rosenblatt, Arnold, Block, 2007) Evidence of high interest in, and need for, end-of-life care clinical education

8. Harris Manchester Project

9. Develop intervention for R01 study: (1) Target individual-level change by teaching clinicians skills and practices in communicating with dying cancer patients and their families; (2) Address team-level change by training clinicians to facilitate routine within-team discussions, during daily team meetings, about EOL communication with seriously ill inpatients; and (3) Effect hospital unit-level culture change by providing training to all clinician stakeholders to establish a shared framework, values, and skills for communication with patients near the end of life

10. Sir Michael Sobell House, Oxford The Sir Michael Sobell House is an adult specialist palliative care service for people with a life-threatening illness, with 20 beds in the Inpatient Unit and 15 places a day in the Day Hospice. Patient services are enhanced by a dedicated education and research facility. The Study Centre supports training for in-house staff, medical students, postgraduate medical trainees, and senior practitioners working in palliative care nationally and internationally. The Sobell House is a WHO Collaborating Centre for Palliative Care.

11. Dr. Wee & Study Centre Staff

12. Activities Meetings with Bee and her staff Attended multidisciplinary team meetings Shadowed clinicians Consulted with research fellows Met with Robert Twycross, MD (worked with Dame Cecily Saunders, MD, founder of St. Christopher’s Hospice)

13. Progress to date R01 submitted to NCI and RC1 submitted to NINR, with Bee as consultant 2 Pilot studies underway: ◦ Interviews with family caregivers and clinicians ◦ Pilot intervention with residents and nurses

16. Ethics in Palliative Care Research

17. Research evidence is needed in all aspects of end-of-life care Symptom management Communication Ethics and clinical decision-making Caregiver support Context of care delivery Gender and cultural differences

18. Patient and family caregiver participation and perspectives are essential to obtaining valid and meaningful outcomes Quality of life Treatment preferences Pain and symptom management Psychosocial outcomes

19. Does research in end of life or palliative care require special guidelines? Whereas the end of life does present important ethical and moral challenges to researchers and should be scrutinized carefully by institutional review boards (IRBs), special guidelines are not required to promote and ensure the ethical conduct of research at life’s end. (Phipps 2002)

20. Are palliative care patients uniquely vulnerable? Vulnerable population: ◦Patients and loved ones are often facing a challenging, sad, and painful time ◦They may be overwhelmed with emotional, physical, and caregiving burdens ◦Patient decision-making capacity may be impaired ◦Patients and/or caregivers may not fully understand patient prognosis or life expectancy

21. Phipps (2002) and others suggest that these issues are no different for patients near the end of life and their families than for patients who are experiencing other health crises or serious medical condition 1. Are the potential research participants significantly different from other participants? 2. Do the methods and approaches of recruitment and enrollment present significantly different risks or burdens to potential participants? 3. Are there significantly increased concerns about the content and process of informed consent?

22. 1. Are the potential research participants significantly different from other participants? Similar concerns can be applied to experiences of other patient populations: e.g., those receiving a devastating diagnosis, amputation, organ transplant, or severe brain injury Recognizing the impact of health crises and medical events on the lives of potential research subjects is something that needs to be applied across all research with human subjects, not just with those in the various trajectories associated with the end of life. (Phipps 2002)

23. 2. Do the methods and approaches of recruitment and enrollment present significantly different risks or burdens to potential participants? Need to attend to issues of privacy, sensitive information, not improperly disclosing medical information that patients/families It is important also to recognize that many patients benefit from this research, as well, e.g., having someone to talk with about these issues, making a contribution to research

24. 3. Are there significantly increased concerns about the content and process of informed consent? Some patients may not be decisionally capable, may need surrogates to consent for them. Investigators should use the same approaches as those used for patients with dementia, psychiatric illness, or in ICU settings

25. Guidelines from the National Bioethics Advisory Committee recommends that cognitive capacity should be assessed formally whenever subjects are likely to be cognitively impaired and the research poses more than minimal risk. When research involves only interviews or behavioral interventions that pose minimal risks, formal capacity assessments should not be required. ( Casarett & Karlawish, 2000)

26. Recommendations: IRBs will be better able to weigh the risks and benefits of research if they include at least one HCP or researcher who is familiar with palliative care IRB members need to be aware of tendencies to be overprotective of patients with life- threatening illness. Bottom line: “… [E]ven though concerns about vulnerability are legitimate, they do not justify special restrictions for palliative care research.” ( Casarett & Karlawish, 2000)

27. And while it is important to protect patients and families from harm, one interviewee noted, some doctors “have declined to let their patients take part in studies without asking the patient even though the study has had ethical review …Generally speaking in terms of cancer treatment and palliative care, a lot of patients are quite altruistic, they want to be able to make some sort of contribution and they shouldn’t be deprived of that opportunity.” (Stevens et al 2003)

28. What about interviewing bereaved caregivers? Research suggests caregivers can be contacted as soon as 8 to 12 weeks after patient death (Morrison 2002, Seamark et al. 2000) 75% of caregiver interviewees answered “very helpful” or “helpful” to the question, “Did you find the interview helpful?” (Seamark et al. 2000)

29. In our experience, interviewing bereaved caregiver often helps caregivers to process emotions: ◦Note from a recent interviewee: Thank you for asking me to participate in your study. I sincerely hope that I contributed information that was helpful in some way. Our conversation was a great help to me as well.

30. It is also important to protect clinician participants In our research with clinicians, the same ethical principles apply as in other studies where professional standing and reputation need to be protected. E.g. Clinician members of the research staff do not have access to identifiable clinician data; clinicians do not enroll trainees into research studies

31. Acknowledgements Research Team: Amy Nichols-Belo Thomas Smith Patrick Coyne Laurel Lyckholm Tim Ford Kirk Brown Alan Dow Aaron Anderson Stephanie Call

32. Gratitude Office of the Vice President for Research Frank Macrina Ann Nichols- Casebolt Jane Lalich

33. Discussion and questions

34. Bibliography Casarett, DJ, Karlawish, JHT. 2000. “Are special ethical guidelines needed for palliative care research?” Journal of Pain and Symptom Management 20: 130-139. de Raeve, L. 1994. “Ethical issues in palliative care research.” Palliative Medicine 8: 298-305. Seamark, DA, Gilbert, J, Lawrence, CJ, and Williams, S. 2000. “Are postbereavement research interviews distressing to carers? Lessons learned from palliative care research.” Palliative Medicine 14: 55-56. Stevens, T, Wilde, D, Paz, S, Ahmedzai, SH, Rawson, A, and Wragg, D. 2003. “Palliative care research protocols: a special case for ethical review.” Palliative Medicine 17: 482-490.