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
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
- 否
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
Jennifer Jones
Gastroenterologist, Associate Professor, Department of Medicine, Dalhousie University
Nova Scotia Health Authority
