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

Jennifer Jones

Status: Withdrawn

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Biologic Care Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT06030882

50757

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Biologic Care Pathway

Experimental group

Description:

Care through a biologic care pathway

Treatment:

Other: Biologic Care Pathway

Control

No Intervention group

Description:

Care as usual