The End is Not What it Seems – Feasibility of Conducting Prospective Research in Critically Ill, Dying Patients.

Guest Post by Amanda Van Beinum

Re: Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

Collecting information about how people die in the intensive care unit is important. Observations about what happens during the processes of withdrawal of life sustaining therapies (removal of breathing machines and drugs used to maintain blood pressure) can be used to improve the care of dying patients. This information can also be used to improve processes of organ donation. But when the Determination of Death Practices in Intensive Care Units (DDePICT) research group first proposed to start collecting prospective data on dying and recently dead patients, a common response from other clinical researchers was, “You’re going to do what?” The research community did not believe that prospective research using an informed consent model would be possible in patients dying after withdrawal of life sustaining therapies in the intensive care unit.

While the clinical research community supported the “big picture” idea behind conducting this research, they were skeptical about our prospective research design and our intent to obtain full informed consent from all families prior to the patient’s death. Some also felt that we would have a hard time obtaining institutional ethics board approval or would encounter barriers from research coordinators uncomfortable with approaching families for consent at a difficult and emotional time in the patient’s care. However, the DDePICt group was persistent, and succeeded in their efforts to design the first prospective, observational pilot study in Canada of patients dying in the intensive care unit after withdrawal of life sustaining therapies. As part of the study design, the DDePICt pilot study collected data for an ethics sub-study to investigate how these anticipated challenges were overcome. The ethics sub-study sought an answer to the question; can we conduct ethical, prospective, observational research on a critically ill and imminently dying population in the intensive care unit?

The results of the ethics sub-study provided a resounding “Yes” to this question, as described in the recent publication in JME. The DDePICt pilot study obtained approval at all 5 study site research ethics boards, and demonstrated general acceptance through an accompanying staff satisfaction survey. Most importantly, the study demonstrated that “the end is not what it seems” – it is indeed possible to design prospective observational research studies that include a priori consent from the families of critically ill, dying patients. Furthermore, these studies may provide a benefit to families of patients who were unable to fulfill wishes of being an organ donor. Future research by the DDePICt group will investigate the experiences and motivations of families for consenting or refusing research at the end of life.

Results from this ethics sub-study were instrumental in informing the design of our larger study, now ongoing, which is gathering detailed physiologic information about the natural history of death in dying patients in the intensive care unit. The Death Prediction and Physiology after Removal of Therapy (DePPaRT) study is being conducted at over 15 sites across Canada, and now includes centers in Prague, the United Kingdom, and the Netherlands. Information collected as part of the DePPaRT study will be used to inform guidelines about deceased organ donation, and could also be used to improve end-of-life care in the intensive care unit.