Perianal Fistula (PAF) Validation and Burden of Illness Study

Completed

• Conditions: Crohns Disease; Perianal Fistula; Inflammatory Bowel Disease
• Interventions: Other: No intervention

• Registration Number: NCT03981939
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.

Detailed Description

This is a retrospective follow-up observational study of participants with CD with and without complex perianal fistula (CPAF) from January 2002 to March 2017. The study will verify the potential of using procedure codes to reliably identify participants with CPAF in Validation Study (Objective 1), compare Crohn's participants with CPAF (cases) to matched participants without CPAF (controls) to determine the disease burden and healthcare resource utilization of Crohn's related CPAF in Ontario, and will describe the participant's journey among Crohn's participants following the first diagnosis of CPAF (Objective 3).

The study will enroll approximately 600 participants (300 participants with CPAF and 300 participants without CPAF). All participants will be enrolled in 2 observation groups:

* CD Participants with/without CPAF (ICES data)

* CD Participants with CPAF - The Ottawa Hospital (TOH)

The data will be collected through Ontario health administrative data. Participants will be observed retrospectively who were diagnosed with CD with and without fistula between index period: April 2002 and July 2013. Participants will be followed up retrospectively from the index period (that is onset of CPAF) to the end of study (Objective 2), and for 5 years following the (Objective 3) index date defined as onset of CPAF will be selected based on the first time they meet the first code in the case definition identified in Objective 1 between April 1, 2005 to March 31, 2012. The overall time for data collection in this study will be approximately 7 months.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-11
• Study Start: 2019-07-02
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-31
• Results First Submitted: 2020-12-11
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Results First Posted: 2021-04-21
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3032

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CD Participants with CPAF - The Ottawa Hospital (TOH)	No intervention	Participants diagnosed with Complex Perianal Fistula (CPAF) from the Ottawa Hospital (TOH) were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
CD Participants without CPAF (ICES database)	No intervention	Participants diagnosed with CD and without CPAF from Institute for Clinical Evaluative Sciences (ICES) database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
CD Participants with CPAF (ICES database)	No intervention	Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).

Primary Outcome Measures

Name	Time	Method
Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database	From the date of CD diagnosis up to the index date (approximately 5 years)	Index date first time participant meets case definition(diagnosis of CD with CPAF in index period).Participants divided as:2 diagnosis/imaging codes(IC),2 codes must be in 2 year(yr) period of each other;3 diagnosis/IC/intervention code/EUA+seton;3 diagnosis/IC/intervention code/EUA+seton,diagnosis/IC requirements are satisfied,codes must be in 2yr period of each other;2 diagnosis/IC;3 diagnosis/IC,3 codes must be in 2yr period of each other;3 diagnosis/IC;diagnosis/IC+(EUA+Seton);diagnosis/IC+(EUA+Seton),2 codes must be in 2yr period of each other;3 diagnosis /IC+intervention code 4 codes must be in 2 yr period of each other;2 IC/intervention code/diagnosis code/EUA+seton;2 IC/intervention code/diagnosis code/EUA+seton,IC requirements are satisfied, codes must be in 2yr period of each other;2 diagnosis/IC+intervention code;3 diagnosis/IC+intervention code;2 diagnosis/IC+intervention code,3 codes must be in 2yr period of each other;diagnosis/imaging/intervention codes;diagnosis/IC.
Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF	From the index date up to end of study (approximately 5 years post-index)	Impact of total disease burden on participants CD with and without CPAF was measured as total cost and cost by sector which included general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, dialysis, cancer, and radiation, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period.
Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database	From the index date up to end of study (approximately 5 years post-index)	Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period.
Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database	From the index date up to 5 years post-index	Impact of total disease burden on participants CD with CPAF was based on three procedures which included total cost, total cost (without ODB) and cost by sector i.e. general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, Dialysis, Cancer, and Radiation, non-hospital based residential care, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention.
Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF	From the index date up to 5 years post-index	Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention.

Trial Locations

Locations (1)

Takeda Canada; 🇨🇦 Oakville, Ontario, Canada