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临床试验/NCT07167836
NCT07167836Enrolling By Invitation不适用

Effect of an Automated Clinical Pathway Utilizing Tailored Risk Stratification on Rates of Overdue Follow up and Outcomes in Patients With Inflammatory Bowel Disease

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,000
试验地点
2
主要终点
Proportion of days overdue for completion of clinical follow up

研究概览

简要总结

Pragmatic randomized controlled trial to evaluate the effect of an electronic medical record-based tool on improving on-time follow up and its effects on inflammatory bowel disease outcomes

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Alive patients with 2 or more visits to the UT Southwestern adult digestive disease clinic within 3 years of the date of trial commencement including at least one visit within 2 years, and
  • An active inflammatory bowel disease-specific medication, and
  • At least one of the following:
  • Inflammatory bowel disease on the active problem list
  • An inflammatory bowel disease invoice diagnosis at least twice in the 3 years prior to trial commencement
  • An inflammatory bowel disease encounter diagnosis at least twice in the 3 years prior to trial commencement

排除标准

  • Patients not meeting inclusion criteria

结局指标

主要结局

Proportion of days overdue for completion of clinical follow up

时间窗: 12 months

Calculated on a per-patient basis with a denominator of 365 (days in the study period) and a numerator of days overdue for follow up. Definition of overdue follows a patient's risk stratification

次要结局

  • Composite clinical outcome: acute care utilization, steroid use, or inflammatory bowel disease-related surgery(12 months)
  • Proportion of patients with bowel-specific inflammatory assessment(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Fudman

Associate Professor

University of Texas Southwestern Medical Center

研究点 (2)

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