Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

Not Applicable

Completed

• Conditions: Kidney Disease, Chronic; End Stage Renal Disease
• Interventions: Behavioral: Usual Care Visit; Behavioral: Telemedicine Visit

• Registration Number: NCT03189212
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to determine whether a telemedicine follow-up visit at the NYU Langone Transplant Institute is a feasible and acceptable alternative to a traditional in-center follow-up visit.

Detailed Description

A six-month prospective randomized-controlled clinical pilot study to evaluate a new intervention for the transplant program: telemedicine (TM) visits. Researchers will target patients on the transplant waiting list who are currently undergoing dialysis. Currently, there are 234 patients on the transplant waiting list who receiving care at dialysis centers in the New York City area. Researchers will select the 10 dialysis centers having the highest number of patients on the transplant list in order to yield a target sample of 45.

Eligible participants will be randomized to 1 of 2 groups: (1) usual care (UC) which is the routine 6-month follow up appointment at the NYULMC transplant center or (2) TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit. Patients will be followed for 4 months post randomization to determine the number of days that elapse between randomization and routine transplant evaluation. As new clinic appointments are currently experiencing 80-day wait, a 4-month follow-up should be more than adequate to evaluate this primary outcome.

The intervention will be evaluated primarily in terms of efficiency, and secondarily in terms of patient/physician experiences, changes in waiting list status, and referral for living donation.

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-16
• Study Start: 2017-10-01
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Receiving thrice-weekly hemodialysis treatment for 6 months
• On NYULMC kidney transplant wait list

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Exclusion Criteria

• Unable or unwilling to provide informed consent
• Unable to read or otherwise use an iPad (e.g. blind)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Visit	Usual Care Visit	-
Telemedicine Visit	Telemedicine Visit	-

Primary Outcome Measures

Name	Time	Method
Missed visits	4 Months	Using the medical record, researchers will capture the frequency of no-shows, cancellations, and rescheduled visits. At the 4-month time point, researchers will interview patients to collect qualitative data regarding the reasons for missed or rescheduled appointments. They will also collect data regarding the frequency with which TM visits result in transplant coordinator requests for an additional in-person appointment in order to conduct a physical assessment.
Waiting time	4 Months	The study is powered to evaluate wait time for the next transplant clinic appointment, abstracted from the patient's electronic record at the conclusion of the study.
Cost	4 Months	Researchers will estimate cost of UC and TM in terms of costs borne by the patient (transportation, childcare, missed employment time, missed leisure) using an investigator-developed instrument. They will estimate health care service delivery costs using standard accounting methods to estimate facility costs, wage and fringe rates for staff involved in care (including receptionist, nurse, TM staff), and technology costs (including the iPads, data plans, maintenance and replacement costs).

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States