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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
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.
Time frame: 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.
Time frame: week 50
Emergency room visits
Number of emergency room visits
Time frame: week 0 (baseline)
Emergency room visits
Number of emergency room visits
Time frame: month 12
inpatient hospitalization,
Number of inpatient hospitalizations
Time frame: week 0
inpatient hospitalization,
Number of inpatient hospitalizations
Time frame: month 12
disease-related surgery
Number of disease related surgeries
Time frame: week 0
disease-related surgery
Number of disease related surgeries
Time frame: month 12
ambulatory care visits
number of ambulatory care visits
Time frame: week 0
ambulatory care visits
number of ambulatory care visits
Time frame: month 12
drug therapy
A list of current medications the patient is taking
Time frame: week 0
drug therapy
A list of current medications the patient is taking
Time frame: month 12
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