Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

End Stage Renal Disease Clinical Trial

Official title:

Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189212
• Other study ID #: 16-02146
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: January 19, 2021

Study information

• Verified date: January 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Receiving thrice-weekly hemodialysis treatment for 6 months

• On NYULMC kidney transplant wait list

Exclusion Criteria:

• Unable or unwilling to provide informed consent

• Unable to read or otherwise use an iPad (e.g. blind)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Usual Care Visit
Routine 6-month follow up appointment at the NYULMC transplant center
• Telemedicine Visit
TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waiting time	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.	4 Months
Primary	Missed visits	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.	4 Months
Primary	Cost	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).	4 Months