Improving Patient Outcomes Through the Implementation of an IBD Biologic Care Pathway

Not Applicable

Withdrawn

• Conditions: Ulcerative Colitis; Crohn Disease; Inflammatory Bowel Diseases

• Registration Number: NCT06030882
• Lead Sponsor: Jennifer Jones

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-09-02
• Study First Posted: 2023-09-11
• Study Start: 2024-03-25
• Status Verified: 2025-07
• Primary Completion: 2025-07
• Study Completion: 2025-07-01
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
EQ5D Score	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.

Secondary Outcome Measures

Name	Time	Method
ambulatory care visits	month 12	number of ambulatory care visits
drug therapy	month 12	A list of current medications the patient is taking
inpatient hospitalization,	month 12	Number of inpatient hospitalizations
Emergency room visits	month 12	Number of emergency room visits
disease-related surgery	month 12	Number of disease related surgeries

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada