跳至主要内容
临床试验/NCT02325635
NCT02325635已完成不适用

A Prospective Randomized Controlled Trial of an Endoscopic Quality Improvement Project-2 (EQUIP-2) to Improve Adenoma Detection in Screening and Surveillance Colonoscopy

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
10
试验地点
1
主要终点
Change in adenoma detection rates.

研究概览

简要总结

Randomized prospective multi-site validation study.

详细描述

GI practice sites that have recently agreed to participate in the GIQuIC program will be randomized on a site-basis, to the EQUIP intervention or control.

Baseline ADR and polyp/surveillance predication accuracy will be collected for approximately 3 months.

Sites randomized to the EQUIP intervention will undergo face-to-face training by a study investigator, followed by active monitoring and feedback.

Control sites will not receive supplemental training and will be monitored by with no feedback. After completion of the study all sites will be offered the intervention (as is standard feedback in GIQuIC ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Endoscopy centers that are new to GIQuIC and have not yet received training
  • •All endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate

排除标准

  • •Cases that involve acute indications such as bleeding and active colitis will not be included in data pool
  • •Patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded
  • •Procedures that are deemed incomplete will be excluded
  • •Patients with surgically altered anatomy (i.e. prior colectomy) and with poor bowel preparation (Boston bowel preparation score <5, or inadequate to exclude polyps >5mm) will be excluded

研究组 & 干预措施

Training of Endoscopist

Experimental

A series of 1 hour classes with ongoing monitoring and feedback to endoscopist only.

干预措施: Educational Training (Other)

Deferred Training of Endoscopist

No Intervention

No intervention during the data collection period. Training will be deferred to end of study.

结局指标

主要结局

Change in adenoma detection rates.

时间窗: 6 months

The primary outcome will be the change in adenoma detection rates between baseline and the intervention. Validate the effect of a quality improvement training program on the proportion of patients among whom at least one adenoma is detected

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Wallace

PI

Mayo Clinic

研究点 (1)

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