Clinical trial NCT06030882: Improving Patient Outcomes Through the Implementation of an IBD Biologic Care Pathway
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Keywords: IBD
Biologics
Care Pathway
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2023-09-11
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: EQ5D Score
timeFrame: week 0 (baseline)
measure: EQ5D Score
timeFrame: week 50
Secondary outcomes:
measure: Emergency room visits
timeFrame: week 0 (baseline)
measure: Emergency room visits
timeFrame: month 12
measure: inpatient hospitalization,
timeFrame: week 0
measure: inpatient hospitalization,
timeFrame: month 12
measure: disease-related surgery
timeFrame: week 0
measure: disease-related surgery
timeFrame: month 12
measure: ambulatory care visits
timeFrame: week 0
measure: ambulatory care visits
timeFrame: month 12
measure: drug therapy
timeFrame: week 0
measure: drug therapy
timeFrame: month 12
Other outcomes:
measure: HBI Index Score
timeFrame: week 0 (baseline), week 12-14, week 30, week 50
measure: HBI Index Score
timeFrame: week 0 (baseline)
measure: HBI Index Score
timeFrame: week 12
measure: HBI Index Score
timeFrame: week 30
measure: HBI Index Score
timeFrame: week 50
measure: Partial Mayo Score
timeFrame: week 0 (baseline)
measure: Partial Mayo Score
timeFrame: week 12
measure: Partial Mayo Score
timeFrame: week 30
measure: Partial Mayo Score
timeFrame: week 50
measure: Fecal calprotectin
timeFrame: week 0 (baseline)
measure: Fecal calprotectin
timeFrame: week 12
measure: Fecal calprotectin
timeFrame: week 30
measure: Fecal calprotectin
timeFrame: week 50
measure: CRP concentration
timeFrame: week 0 (baseline)
measure: CRP concentration
timeFrame: week 12
measure: CRP concentration
timeFrame: week 30
measure: CRP concentration
timeFrame: week 50
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
References: