NCT06030882

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jennifer Jones · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Ulcerative Colitis
• Crohn Disease

Interventions

Type	Name	Description
OTHER	Biologic Care Pathway	Receiving care administered through a biologic care pathway.The central biologic intake nurse will touch base with the IBD program nurse navigator at preselected time points as per the pathway in order to coordinate the baseline pre- biologic work-up, clinical and biomarker assessments, and clinical assessments. Clinical management decisions will be informed by a combination of data points including clinical risk factors, TDM, fecal calprotectin concentrations, endoscopic and clinical disease activity indices as well as drug tolerance and adverse events. Within the care pathway, time- bound clinical and biomarker data will be provided to the treating clinician to help inform their clinical decisions.

Timeline

• Start date: 2024-03-25
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-09-11
• Last updated: 2025-07-09

Locations

1 site across 1 country: Canada