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NCT06030882Withdrawn

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

Source: ClinicalTrials.gov · Last updated 9 Jul 2025

Reason given: Intervention (Biologic care pathway) was implemented outside of the context of a research study at our care centre, the QEII, as quality improvement. It became infeasible to consent all physicians to use the tool, and carry out this study.

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Study type
Interventional
Enrollment
0 (actual)
First submitted
10 Jul 2023
Start date
25 Mar 2024
Primary completion date
Jul 2025
Lead sponsor
Jennifer Jones
NCT number
NCT06030882

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any contraindication to biologic therapy

Other illness

  • Active infection,
  • Known malignancy

Other

  • High-grade, symptomatic fibrostenotic strictures
  • Perforating complications
  • Intraabdominal or perianal abscesses

Who the study is looking for

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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
QEII Health Sciences CentreHalifaxCanadaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.