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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030882
• Other study ID #: 50757
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Nova Scotia Health Authority
• Contact: Jennifer Jones, MD
• Phone: 902-473-1499
• Email: jljones[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Jennifer Jones	Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HBI Index Score	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	week 0 (baseline), week 12-14, week 30, week 50
Other	HBI Index Score	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	week 0 (baseline)
Other	HBI Index Score	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	week 12
Other	HBI Index Score	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	week 30
Other	HBI Index Score	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	week 50
Other	Partial Mayo Score	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	week 0 (baseline)
Other	Partial Mayo Score	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	week 12
Other	Partial Mayo Score	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	week 30
Other	Partial Mayo Score	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	week 50
Other	Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 0 (baseline)
Other	Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 12
Other	Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 30
Other	Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 50
Other	CRP concentration	serum CRP concentration	week 0 (baseline)
Other	CRP concentration	serum CRP concentration	week 12
Other	CRP concentration	serum CRP concentration	week 30
Other	CRP concentration	serum CRP concentration	week 50
Primary	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)
Primary	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	Emergency room visits	Number of emergency room visits	week 0 (baseline)
Secondary	Emergency room visits	Number of emergency room visits	month 12
Secondary	inpatient hospitalization,	Number of inpatient hospitalizations	week 0
Secondary	inpatient hospitalization,	Number of inpatient hospitalizations	month 12
Secondary	disease-related surgery	Number of disease related surgeries	week 0
Secondary	disease-related surgery	Number of disease related surgeries	month 12
Secondary	ambulatory care visits	number of ambulatory care visits	week 0
Secondary	ambulatory care visits	number of ambulatory care visits	month 12
Secondary	drug therapy	A list of current medications the patient is taking	week 0
Secondary	drug therapy	A list of current medications the patient is taking	month 12