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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Other: Biologic Care Pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to age 18 Starting an Anti TNF biologic therapy Exclusion Criteria: High-grade, symptomatic fibrostenotic strictures Perforating complications Intraabdominal or perianal abscesses Active infection, Known malignancy Any contraindication to biologic therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biologic Care Pathway<br>Care through a biologic care pathway | Other: Biologic Care Pathway<br>* 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.<br>|
| No Intervention: Control<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ5D Score | 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. | week 0 (baseline) | 
| EQ5D Score | 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. | week 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency room visits | Number of emergency room visits | week 0 (baseline) | 
| Emergency room visits | Number of emergency room visits | month 12 | 
| inpatient hospitalization, | Number of inpatient hospitalizations | week 0 | 
| inpatient hospitalization, | Number of inpatient hospitalizations | month 12 | 
| disease-related surgery | Number of disease related surgeries | week 0 | 
| disease-related surgery | Number of disease related surgeries | month 12 | 
| ambulatory care visits | number of ambulatory care visits | week 0 | 
| ambulatory care visits | number of ambulatory care visits | month 12 | 
| drug therapy | A list of current medications the patient is taking | week 0 | 
| drug therapy | A list of current medications the patient is taking | month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, Biologics, Care Pathway