跳至主要内容
临床试验/NCT02707133
NCT02707133已完成不适用

Validation of a Virtual Clinic for Choroidal Nevomelanocytic Lesions: Safety, Patient Acceptability and Health Economics Analysis

Manchester University NHS Foundation Trust0 个研究点目标入组 199 人开始时间: 2016年6月8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
199
主要终点
Degree of agreement (kappa co-efficient) between management decisions reached clinically as opposed to those reached on the basis of imaging tests alone (virtual model)

研究概览

简要总结

Choroidal nevomelanocytic lesions have a high prevalence affecting up to 7% of the entire population and are increasingly incidentally identified during routine eye check- ups in community optometry services. Given the tendency to err on the side of caution, there is evidence of excessive referrals challenging service delivery in both tertiary eye units and specialist ocular oncology services. Although previous studies have examined the natural history and risk factors for growth of choroidal nevomelanocytic lesions, optimal delivery of management remains uncertain. Management approaches display diversity with respect to the number and type of baseline investigations, the duration and frequency of monitoring of relevant patients. Utilisation of the skills of allied health professionals in appropriate cases would allow streamlining service delivery in a socialised healthcare system, maximise capacity, and allow community services to play an enhanced role. However, the evidence for this model of delivery is lacking. Within existing models of care for these lesions, patients are faced with delays, need for more than one attendances to the hospital and increased anxiety around prognosis.

This project aims to answer the question of whether these low-risk, bland incidental findings might possibly be managed by allied health professionals with the use of clinical imaging and specific algorithms to make appropriate management decisions. We aim to validate a model of service delivery on a virtual basis that will accommodate for capacity pressures to accept all relevant referrals, while offering a safe service and optimising patient experience of care. We will thus validate the setting up of a virtual choroidal nevomelanocytic clinic in terms of safety and patient acceptability. More specifically, the degree of agreement between management decisions made by non-medical graders on the basis of imaging data alone as opposed to gold standard decisions (clinical and imaging tests combined) is examined. Health economics analysis of the proposed service delivery model will be undertaken to demonstrate cost-effectiveness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Degree of agreement (kappa co-efficient) between management decisions reached clinically as opposed to those reached on the basis of imaging tests alone (virtual model)

时间窗: 18 months

Validation of the virtual model of service delivery will be sought by calculating the degree of agreement (kappa co-efficient) between management decisions (Discharge, Review or Refer patients) reached by direct clinical examination as opposed to decisions reached through assessing imaging tests only.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

相似试验