Dataset Information

Impact of navigators on completion of steps in the kidney transplant process: a randomized, controlled trial.

ABSTRACT:

Background and objectives

Many patients with ESRD, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These eight sequential steps are as follows: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. This study sought to determine the effect of navigators on completion of steps.

Design, setting, participants, & measurements

Cluster randomized, controlled trial at 23 Ohio hemodialysis facilities. One hundred sixty-seven patients were recruited between January 2009 and August 2009 and were followed for up to 24 months or until study end in February 2011. Trained kidney transplant recipients met monthly with intervention participants (n=92), determined their step in the transplant process, and provided tailored information and assistance in completing the step. Control participants (n=75) continued to receive usual care. The primary outcome was the number of transplant process steps completed.

Results

Starting step did not significantly differ between the two groups. By the end of the trial, intervention participants completed more than twice as many steps as control participants (3.5 versus 1.6 steps; difference, 1.9 steps; 95% confidence interval, 1.3-2.5 steps). The effect of the intervention on step completion was similar across race and sex subgroups.

Conclusions

Use of trained transplant recipients as navigators resulted in increased completion of transplant process steps.

SUBMITTER: Sullivan C

PROVIDER: S-EPMC3463214 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND AND OBJECTIVES:Many patients with ESKD face barriers in completing the steps required to obtain a transplant. These eight sequential steps are medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. This study sought to determine the effect of navigators on helping patients complete these steps. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:Our study was a cluster randomized, controlled trial involving 40 hemodialysis facilities and four transplant centers in Ohio, Kentucky, and Indiana from January 1, 2014 to December 31, 2016. Four trained kidney transplant recipients met regularly with patients on hemodialysis at 20 intervention facilities, determined their step in the transplant process, and provided tailored information and assistance in completing that step and subsequent steps. Patients at 20 control facilities continued to receive usual care. Primary study outcomes were waiting list placement and receipt of a deceased or living donor transplant. An exploratory outcome was first visit to a transplant center. RESULTS:Before the trial, intervention (1041 patients) and control (836 patients) groups were similar in the proportions of patients who made a first visit to a transplant center, were placed on a waiting list, and received a deceased or living donor transplant. At the end of the trial, intervention and control groups were also similar in first visit (16.1% versus 13.8%; difference, 2.3%; 95% confidence interval, -0.8% to 5.5%), waitlisting (16.3% versus 13.8%; difference, 2.5%; 95% confidence interval, -1.2% to 6.1%), deceased donor transplantation (2.8% versus 2.2%; difference, 0.6%; 95% confidence interval, -0.8% to 2.1%), and living donor transplantation (1.2% versus 1.0%; difference, 0.1%; 95% confidence interval, -0.9% to 1.1%). CONCLUSIONS:Use of trained kidney transplant recipients as navigators did not increase first visits to a transplant center, waiting list placement, and receipt of deceased or living donor transplants.

Project description:BACKGROUND:Prior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval. In the present study, we aimed to evaluate the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system for increasing medication adherence among Korean KTRs. METHODS:In this prospective, multicenter, randomized controlled study, enrolled KTRs were randomized to either the ICT-based centralized monitoring group or control group. The ICT-based centralized monitoring system alerted both patients and medical staff with texts and pill box alarms if there was a missed dose or a dosage/time error. We compared the two groups in terms of medication adherence and transplant outcomes over 6?months, and evaluated patient satisfaction with the ICT-based monitoring system. RESULTS:Among 114 enrolled KTRs, 57 were assigned to the ICT-based centralized monitoring group and 57 to the control group. The two groups did not significantly differ in mean adherence at each follow-up visit. The intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes did not differ between the intervention and control groups, or between the intervention group with feedback generation and the intervention group without feedback generation. Patients showed high overall satisfaction with the ICT-based centralized monitoring system, which significantly improved across the study period (p?=?0.012). CONCLUSIONS:Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs. However, patients were highly satisfied with the system. Our results suggest that the ICT-based centralized monitoring system could be successfully applied in clinical trials. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03136588. Registered 20 April 2017 - Retrospectively registered.

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