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

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

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 Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Other: Biologic Care Pathway

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Willett, BSc; Phone Number: 902-473-7074; Email: natalie.willett@nshealth.ca
• Study Contact Backup: Name: Jennifer Jones, MD; Phone Number: 902-473-1499; Email: jljones@dal.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • QEII Health Sciences Centre
      • Contact: Jennifer Jones, MD; Phone Number: 902-473-1499; Email: jljones@dal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Care as usual
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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
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
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)
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
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
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
Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 0 (baseline)
Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 12
Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 30
Fecal calprotectin	Fecal calprotectin concentration, assayed by stool sample	week 50
CRP concentration	serum CRP concentration	week 0 (baseline)
CRP concentration	serum CRP concentration	week 12
CRP concentration	serum CRP concentration	week 30
CRP concentration	serum CRP concentration	week 50

Collaborators and Investigators

• Sponsor: Jennifer Jones
• Collaborators: Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: September 2, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: IBD; Biologics; Care Pathway
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: 50757

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No