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临床试验/NCT03189212
NCT03189212已完成不适用

Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Missed visits

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Missed visits

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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