Improving Patient Outcomes Through the Implementation of an IBD Biologic Care Pathway
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Biologic Care Pathway Care through a biologic care pathway |
Other: Biologic 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.
|
| No Intervention: Control Care as usual |
Outcome Measures
Primary Outcome Measures
- 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.
- EQ5D Score [week 50]
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 Outcome Measures
- Emergency room visits [week 0 (baseline)]
Number of emergency room visits
- Emergency room visits [month 12]
Number of emergency room visits
- inpatient hospitalization, [week 0]
Number of inpatient hospitalizations
- inpatient hospitalization, [month 12]
Number of inpatient hospitalizations
- disease-related surgery [week 0]
Number of disease related surgeries
- disease-related surgery [month 12]
Number of disease related surgeries
- ambulatory care visits [week 0]
number of ambulatory care visits
- ambulatory care visits [month 12]
number of ambulatory care visits
- drug therapy [week 0]
A list of current medications the patient is taking
- drug therapy [month 12]
A list of current medications the patient is taking
Other Outcome Measures
- 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
- HBI Index Score [week 0 (baseline)]
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
- HBI Index Score [week 12]
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
- HBI Index Score [week 30]
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
- HBI Index Score [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 strata for final score results: Remission: <5 Mild Disease: 5-7 Moderate Disease: 8-16 Severe Disease: >16
- 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
- Partial Mayo Score [week 12]
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
- Partial Mayo Score [week 30]
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
- Partial Mayo Score [week 50]
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
- Fecal calprotectin [week 0 (baseline)]
Fecal calprotectin concentration, assayed by stool sample
- Fecal calprotectin [week 12]
Fecal calprotectin concentration, assayed by stool sample
- Fecal calprotectin [week 30]
Fecal calprotectin concentration, assayed by stool sample
- Fecal calprotectin [week 50]
Fecal calprotectin concentration, assayed by stool sample
- CRP concentration [week 0 (baseline)]
serum CRP concentration
- CRP concentration [week 12]
serum CRP concentration
- CRP concentration [week 30]
serum CRP concentration
- CRP concentration [week 50]
serum CRP concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Greater than or equal to age 18
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Starting an Anti TNF biologic therapy
Exclusion Criteria:
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High-grade, symptomatic fibrostenotic strictures
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Perforating complications
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Intraabdominal or perianal abscesses
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Active infection,
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Known malignancy
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Any contraindication to biologic therapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jennifer Jones
- Nova Scotia Health Authority
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 50757