Hemodialysis patients guided through the transplant process by trained navigators completed more steps toward kidney transplantation than those who received usual care, reported a cluster randomized, controlled trial published in the Clinical Journal of the American Society of Nephrology (2012;7:1639–1645).
“We had done some work previously where we mapped out the steps that patients have to go through in order to get a transplant, and we found that patients were held up at several steps in the transplant process,” said senior author Ashwini R. Sehgal, MD, the Duncan Neuhauser Professor of Community Health Improvement and Professor of Medicine, Bioethics, and Epidemiology & Biostatistics at Case Western Reserve University.
“We thought we needed to develop an intervention that would work across all the steps. We came across the idea of navigators because they've been used successfully for cancer treatment and screening, and so we tried to adapt that to the kidney transplant area.”
‘Bridge the Gap’
Three navigators—kidney transplant recipients themselves—were hired for the study and trained in the kidney transplant process, the barriers and catalysts to progression through that process, motivational interviewing, the principles of clinical trials, and human subject protection, Dr. Sehgal said.
The trial included 167 patients from all 23 hemodialysis facilities belonging to the three largest chains in Cuyahoga County, OH. A random number generator was used to assign facilities to an intervention or control group.
Participants were recruited between January 2009 and August 2009, and they were followed for up to 24 months or until they died, moved, withdrew, or reached the end of the study in February 2011.
A transplant navigator met monthly during a dialysis treatment with each of the 92 participants in the intervention group. The navigator determined their step in the transplant process and offered tailored information and help in finishing the step. The eight steps of the transplant process are: medical suitability, interest in transplant, referral to a transplant center, first visit to a center, transplant workup, successful transplant candidate, on waiting list or living donor identified, and receive transplant.
“The greatest value was that they had the shared experience of end-stage renal disease, and so they were able to almost immediately connect with the dialysis patients that they were talking to and helping,” Dr. Sehgal said. “The other value was they had already been through the transplant process themselves, and so they had that experience also.”
In addition to sharing their personal perspectives with the intervention participants, these trained transplant recipients provided details such as the phone numbers of local transplant centers and a list of the information that might be requested during the referral call to a transplant center, travel directions and appointment reminders for the first visit to the transplant center, encouragement to complete the transplant workup in a timely fashion, and tips on discussing living donation with potential donors. The 75 control participants received usual care.
The primary outcome was the number of transplant process steps taken. Intervention patients completed about twice as many steps as control patients did—3.5 versus 1.6 steps. The effect of the intervention was similar across race and sex subgroups, and there were no adverse effects or adverse events associated with the intervention.
The work was supported by grants from the National Institutes of Health.
Problem Solving, Education
“Navigator interventions can be very positive in that they may provide patients in need of a transplant with a trusted advocate or guide to help them complete the multiple steps needed to obtain a transplant,” said L. Ebony Boulware, MD, MPH, Associate Professor of Medicine at Johns Hopkins University and Associate Director of the Welch Center for Prevention, Epidemiology, and Clinical Research. “They may also help patients solve problems they may encounter with completing steps.”
Another role of navigators is explaining a process that can be confusing for patients.
“There is certainly evidence that many patients lack the understanding of all the steps that are necessary to complete these processes,” said Jesse Schold, PhD, Director of Outcomes Research and Medical Informatics for Kidney and Kidney/Pancreas Transplantation at the Cleveland Clinic Glickman Urological & Kidney Institute. “This lack of education and lack of knowledge is a barrier for them to receive care, so certainly navigators seem to be one opportunity to bridge this gap.”
Despite the benefits of the intervention, many participants still did not become successful transplant candidates.
At the end of the study, 17 (18%) intervention participants and six (8%) control participants were on a deceased-donor waiting list, for a P value of 0.07. Potential living donors were identified for three (3%) intervention participants and zero control participants, for a P value of 0.06.
“We have to remember that it's a significant minority of dialysis patients who are actually eligible for transplantation,” Dr. Schold said. “It's on the order of 10 to 15 percent of dialysis patients actually become listed for transplantation nationally, and that's not necessarily just because they don't complete steps. It's because the majority of dialysis patients simply aren't eligible for transplantation based on medical criteria, and there's also documentation that there is a nontrivial proportion of the dialysis population who are simply not interested in transplantation.”
No transplants had occurred by the end of the trial.
“The study was small, and it was difficult for the researchers to identify whether the intervention would help patients accomplish transplantation,” Dr. Boulware said. “Larger studies are probably needed to understand how much of an impact the navigator intervention could have to improve patients' receipt of transplants.”
In the trial, navigators were paid the same salaries as study coordinators.
“I think if there were a limitation of these findings it is the feasibility and the sustainability in having navigators throughout the process of care for any medical context, really,” Dr. Schold said. “The question is, can it be implemented in such a way that is economically feasible, and I think there are possible opportunities.
“At many transplant centers, the care is delivered in segments. There's care delivered in the pretransplant phase, from the time of a referral to evaluation, and then in the posttransplant phase. Many times, the personnel are segmented according to those different phases.
“I think one opportunity to consider with these data and the work done by this group is whether we need to think about a new model in which to facilitate care, such that rather than having different people at different phases of care, we would have single individuals throughout the whole process.
“That wouldn't necessarily be cost prohibitive but just would be a reallocation of resources, and it might be a better model. I think that's not necessarily answered by this study directly, but it's one potential ramification.”
The use of navigators doesn't necessarily have to cost money, Dr. Sehgal agreed.
“Transplantation is definitely cheaper than dialysis, so I think it has the potential for saving money. I think that this is something that the Medicare program should think about funding. In other words, they should think about funding navigators at all the dialysis facilities in the country.”
It is possible that the concept of navigators could spread successfully to other areas of focus, like chronic kidney disease, Dr. Boulware said.
“Chronic kidney disease is complex, and patient-centered interventions to help patients better understand their care and accomplish goals of care could help improve patients' health outcomes.”