Estimating Indirect and OOP Costs in Pediatric Inflammatory Bowel Disease: a National Study
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|ClinicalTrials.gov Identifier: NCT03522623|
Recruitment Status : Unknown
Verified October 2018 by Wael El-Matary, University of Manitoba.
Recruitment status was: Recruiting
First Posted : May 11, 2018
Last Update Posted : October 12, 2018
inflammation of the gastrointestinal tract. A recent Canadian study from found that Canada has amongst highest incidence rates of childhood-onset IBD (10 per 100,000 for children <16y). In 2012, Crohn's and Colitis Canada estimated that direct medical costs of IBD in Canada were >$1 billion, and estimated indirect costs amounting to $1.8 billion. An American study demonstrated the direct costs of caring for children with IBD was double those for adults. Indirect health care costs in children with IBD have not been well-described. The Canadian Gastro-Intestinal Epidemiology Consortium (CanGIEC) is a pan-Canadian network of new and established IBD clinician-researchers and methodologists from 6 provinces experienced in the use of health administrative data. CanGIEC is evaluating variation in care of children with IBD, and will expand this research stream to assess direct and indirect cost of care. This will involve a collaboration with the CIHR/CHILD Foundation Canadian Children IBD Network (CIDsCaNN), which comprises an inception cohort of children diagnosed at all 12 pediatric IBD centres across Canada.
Hypothesis: Direct health costs are dominated by medication expenses (particularly biologics), with resulting variation within and across provinces in costs and out-of-pocket expenses to the families due to coverage disparity. Indirect costs include school and parental absenteeism, and productivity losses.
Determine the cost of care of children with IBD, incurred by caregivers,across Canada. Costs include:
a Indirect costs - costs to the patient or family related to having the disease but not to direct health care.
b. Out of pocket (OOP) - costs paid in cash or credit for health-related expenses not covered by the public health or private insurance systems.
- Determine the sociodemographic and disease characteristics associated with higher costs
Population: Incident cases of IBD (<16y) over 12 months (est. enrollment 250-300).
Indirect and OOP disease-related costs will be determined with surveys conducted one year following diagnosis and every 6mo for 2y. These will be conducted querying families on the preceding 4 weeks including: school and work days missed, out-of-pocket expenses, distance travelled to appointments, medications expenses incurred, and disability benefits collected. Indirect costs will be calculated using the Human Capital Approach (gross income not earned due to disease).
|Condition or disease||Intervention/treatment|
|IBD||Other: Non-interventional study|
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Estimating Indirect and OOP Costs in Pediatric Inflammatory Bowel Disease: a National Study|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||November 7, 2019|
|Estimated Study Completion Date :||May 1, 2020|
Children and families with IBD will be surveyed
Other: Non-interventional study
- Costs of care of children with IBD incurred by caregivers [ Time Frame: 24 months ]Questionnaire: mean one month cost per patient in Canadian dollars
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522623
|Contact: WAEL EL-MATARY, MD||2047871039||welmatary@HSC.MB.CA|
|Contact: Vini Deora, MScemail@example.com|
|Winnipeg Children's Hospital||Recruiting|
|Winnipeg, Manitoba, Canada, R3A 1S1|
|Contact: Wael El-Matary, MD|
|Principal Investigator:||WAEL EL-MATARY, MD||Associate Professor, Section Head, Pediatric Gastroenterology|