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临床试验/NCT06030882
NCT06030882撤回不适用

Improving Patient Outcomes Through the Implementation of a Standardized Biologic Care Pathway in the Treatment and Management of Inflammatory Bowel Disease Pathway in the Treatment and Management of Inflammatory Bowel Disease

Jennifer Jones2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2024年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
182
试验地点
2
主要终点
EQ5D Score

研究概览

简要总结

Inflammatory Bowel Disease (IBD) includes a group of chronic inflammatory conditions of the gastrointestinal system and is composed of Crohn's disease and ulcerative colitis. As an immune-mediated disease, IBD treatment options include the use of biologic medicines including anti-tumor necrosis alpha factor (also called anti-TNFs) medication. Despite biologic medicines being an important part of IBD management, there is inconsistency in the way these medications are used. Implementation of evidence-based, standardized biologic care pathways (BCP) can improve treatment related outcomes. Previous research has shown that using a clinical care pathway, such as a BCP, is a feasible method to support clinical decision making and may improve disease-related outcomes for patients. The researchers propose a prospective study to determine how well a BCP can be incorporated into clinical practice, improve patient health outcomes, and reduce healthcare system redundancies. Also, the impact of a BCP on outcomes for patients treated with the help of a standardized BCP compared to those in patients treated without the use of a BCP will be studied. The results of this study will inform how best to incorporate evidence-based BCPs into real-world practice and support the wide-spread adoption of BCPs in clinical practice.

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
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Greater than or equal to age 18
  • Starting an Anti TNF biologic therapy or Biosimilar

排除标准

  • High-grade, symptomatic fibrostenotic strictures
  • Perforating complications
  • Intraabdominal or perianal abscesses
  • Active infection,
  • Known malignancy
  • Any contraindication to biologic therapy

结局指标

主要结局

EQ5D Score

时间窗: week 50

General Quality of life data measured using the Euroqol five dimension (EQ5D) Questionnaire. The EQ5D is a brief self-reported generic measure of current health. It is a 2 page questionnaire which has 5 descriptive questions. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of \<0 represents the worst possible health status.

次要结局

  • ambulatory care visits(month 12)
  • drug therapy(month 12)
  • inpatient hospitalization,(month 12)
  • Emergency room visits(month 12)
  • disease-related surgery(month 12)

研究者

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

Jennifer Jones

Gastroenterologist, Associate Professor, Department of Medicine, Dalhousie University

Nova Scotia Health Authority

研究点 (2)

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