Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
IBD, Biologics, Care Pathway
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.
Interventions
OTHERBiologic Care Pathway
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.
Sponsors
Nova Scotia Health Authority
Jennifer Jones
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EQ5D Score | week 0 (baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inpatient hospitalization, | week 0 | Number of inpatient hospitalizations |
| Emergency room visits | week 0 (baseline) | Number of emergency room visits |
| disease-related surgery | week 0 | Number of disease related surgeries |
| ambulatory care visits | week 0 | number of ambulatory care visits |
| drug therapy | week 0 | A list of current medications the patient is taking |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal calprotectin | week 0 (baseline) | Fecal calprotectin concentration, assayed by stool sample |
| CRP concentration | week 0 (baseline) | serum CRP concentration |
| Partial Mayo Score | week 0 (baseline) | IBD disease activity (as measured by the Partial Mayo Score). Partial Mayo Score measures disease activity of Ulcerative colitis. The following are strata for final score results: Total Partial Mayo Index Score Remission: 0-1 Mild Disease: 2-4 Moderate Disease: 5-6 Severe Disease: 7-9 |
| HBI Index Score | week 0 (baseline), week 12-14, week 30, week 50 | IBD disease activity measured by the Harvey Bradshaw Index (HBI index). The HBI involves patients answering five questions which are summed to produce a final score. The following are potential final score results: Remission: \<5 Mild Disease: 5-7 Moderate Disease: 8-16 Severe Disease: \>16 |
Countries
Canada
Outcome results
None listed