Many patients in the United States face substantial barriers in access to kidney transplantation. Barriers include patient-, provider-, and health system–level factors that contribute to delays in completing the steps necessary for transplant referral, start of the medical evaluation, waitlisting, and receipt of a living or deceased donor transplant. For example, important patient-level barriers include low socioeconomic status such as lower educational levels, lower income, and public insurance.
Over the last decade, several strategies have been tested to improve patients' access to transplant, including interactive educational tools to improve patient knowledge, engagement, and shared decision-making during the transplant evaluation.1-3 More recently, studies have adapted a strategy that was originally successful in improving access to cancer treatment4-7—patient navigators. In 2012, Sullivan et al8 tested this strategy in transplantation. Using a single-center, cluster-randomized design, trained transplant-recipient navigators, called “peers,” were randomized to 1 of 23 hemodialysis facilities in Ohio to meet monthly with dialysis patients interested in transplantation. Results were promising; patients in dialysis facilities with the navigator completed more than twice the number of transplant access steps (eligible for referral; interested; referred; first visit to transplant center; transplant evaluation completion; successful candidate; waitlist or evaluation of living donor; transplanted) as patients receiving usual care (3.5 versus 1.6). Following the promise of this small trial (N = 167 patients), the researchers expanded their protocol to a pragmatic-based, multisite, cluster-randomized trial involving 40 dialysis facilities and 4 transplant centers. Contrary to the small trial, in the recently published study,9 the researchers found no difference in outcomes of first visit to the transplant center, waitlisting, or transplantation by the treatment group.9
In our own transplant center in the Southeastern United States, where poverty rates are among the highest in the nation, our patient population faces unique barriers. In 2012, about half of the patients referred for transplant evaluation did not show up to our transplant center, and the most substantial risk factors for not completing the evaluation included African American race, non–English language, and limited education.10 After the initial success of Sullivan et al, we adapted their dialysis facility-based strategy and utilized a transplant center-based social worker navigator to help this higher-risk population. The social worker aided patients from the time of referral through waitlisting decision in a variety of ways, including identifying patient-specific barriers and working with clinical staff, their home dialysis unit, and the community to better meet the needs of the patients. After the 2.4-year follow-up, results were somewhat disappointing. Patients with a navigator took longer to get through the evaluation process than patients receiving usual care, although the navigator did help a subset of patients who likely would not have started the transplant evaluation.11
Given these results, the transplant community might conclude that the barriers to transplant are too intractable for one transplant center to address and that use of navigators may not be an effective solution. Outside of changing state or federal policies that might impact the social determinants of health, what can we do? It may not yet be time to abandon navigators as a potential solution to improving access to transplantation. First, it is important to note the limitations of the existing trials that have been conducted to determine whether the studies have been a failure of the navigator concept, a failure of implementation of the navigator, too small of a sample, or a combination of these potential explanations. Both the Sullivan et al 2018 pragmatic trial and our recent trial were underpowered to detect differences in primary outcomes. This is important to note, as the effect estimates were generally supportive of an effect of the navigator but were not statistically significant.11 For example, in the Sullivan pragmatic trial, power calculations were based on estimates that 18% of patients would be waitlisted in the control group. However, in the trial, only 13.8% of control participants were waitlisted versus 16.3% in the intervention group.9 In addition, exploratory analyses suggested a positive impact on secondary outcomes. For example, at our center, patients who worked with the social worker navigator were more likely to have had a living-donor inquiry (15% versus 9% in control).11 Second, a major challenge in the conduct of interventions to address barriers to transplantation is that the causes of these inequities are multilevel (eg, patient-, provider-, and health system–level) and multifactorial. Thus, it is unlikely that a single intervention will resolve the many barriers that patients face. A combination of interventions targeting multiple levels (eg, provider and patient education), as well as a change in a transplant-center policy (eg, required tracking of education), could also be helpful. Third, a navigator is a service, and its implementation can vary widely. For example, in the Sullivan et al trial, the navigator was a nonclinical transplant recipient; in our recent trial, the navigator was a trained social worker. Implementation of the navigator protocol is highly dependent on the environment and clinical setting. The limited success to date could be a result of a mismatch between these factors.
Rather than forgo future research investigating the impact of a navigator on access to transplant, we should consider a return to establishing some basics. In drug trials, there is a phased approach to assessing pharmacokinetics (phase 0) and dose, safety, and side effects (phase 1) before testing efficacy (phase 2). Given the promise of patient navigators in other fields and the challenge of funding large-scale pragmatic trials to test efficacy for small effects, we should consider a multiphase evaluation of a patient navigator. For example, phase 1 could involve pilot testing different types of navigators (eg, social workers vs peer) in various settings (eg, dialysis facilities or transplant centers). Phase 2 studies could test the implementation of the best strategy in a larger efficacy or effectiveness trial. Alternatively, the combination of a navigator based on phase 1 evidence with other effective methods to improve access to transplantation could also increase effect sizes and decrease the need for the larger sample sizes that have been necessary for the navigator trials in transplant to date.
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11. Basu M, Petgrave-Nelson L, Smith KD, et al. Transplant Center patient navigator and access to transplantation among high-risk population: a randomized, controlled trial. Clin J Am Soc Nephrol. 2018;13:620–627.