Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

Conditions
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End Stage Renal Disease, Kidney Disease, Chronic

Intervention / Treatment
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* Behavioral: Usual Care Visit
* Behavioral: Telemedicine Visit


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Visit<br> | Behavioral: Usual Care Visit<br>* Routine 6-month follow up appointment at the NYULMC transplant center<br>|
| Experimental: Telemedicine Visit<br> | Behavioral: Telemedicine Visit<br>* TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine