Value-based healthcare for Inflammatory Bowel Disease: improving (cost-)effectiveness

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21751

Enrollment

3200

Registered

2020-01-09

Start date

2020-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease, Ulcerative colitis, Crohn's disease

Interventions

The care pathway will contain indications for starting, switching and stopping biologic agents, and recommendations for follow-up (laboratory tests, colonoscopy, etc).

Eligibility

Inclusion criteria

Inclusion criteria: Treated in one of the eight hospitals At least eighteen years of age Have had a diagnosis of IBD for at least three months Receive a biologic agent or tofacitinib as treatment for IBD. These are the biologics currently registered for the treatment of IBD (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), and new treatments registered during the study period.

Exclusion criteria

Exclusion criteria: Insufficient mastery of the Dutch language to fill in the questionnaires No access to the internet to fill in the questionnaires

Design outcomes

Primary

Measure	Time frame
Patient-reported, disease control, measured using the IBD-Control questionnaire (sum of questions 1,2 and 3)	—

Secondary

Measure	Time frame
The rest of the IBD Standard Set of outcomes, as defined by by ICHOM, which concerns: Incidence of mortality and proportion attributable to IBD Proportion in remission, both clinician-reported (biochemical, histological, endoscopic, radiological) and patient-reported (Manitoba IBD Index/MIBDI) Incidence of colorectal cancer, with incidence of preceding colorectal dysplasia and proportion participating in a surveillance program. Incidence of anemia Number of emergency room visits Number and length of hospital admissions Incidence of complications of any intervention of IBD Incidence of any steroid use and long-term steroid use Incidence of fistulae symptoms BMI as a proxy for nutritional status Quality of life as defined by the EQ-5D-5L (both visual analog scale as well as the Dutch tariffs) and the PROMIS-10 General Health Patient experience as defined by the modified and translated Picker questionnaire for use in Dutch healthcare Costs from a societal perspective (healthcare costs, productivity costs and patient costs) as advised by the Dutch healthcare authority Cost-effectiveness of the interventions, as defined by the incremental cost-effectiveness ratio	—

Measure

Time frame

The rest of the IBD Standard Set of outcomes, as defined by by ICHOM, which concerns: Incidence of mortality and proportion attributable to IBD Proportion in remission, both clinician-reported (biochemical, histological, endoscopic, radiological) and patient-reported (Manitoba IBD Index/MIBDI) Incidence of colorectal cancer, with incidence of preceding colorectal dysplasia and proportion participating in a surveillance program. Incidence of anemia Number of emergency room visits Number and length of hospital admissions Incidence of complications of any intervention of IBD Incidence of any steroid use and long-term steroid use Incidence of fistulae symptoms BMI as a proxy for nutritional status Quality of life as defined by the EQ-5D-5L (both visual analog scale as well as the Dutch tariffs) and the PROMIS-10 General Health Patient experience as defined by the modified and translated Picker questionnaire for use in Dutch healthcare Costs from a societal perspective (healthcare costs, productivity costs and patient costs) as advised by the Dutch healthcare authority Cost-effectiveness of the interventions, as defined by the incremental cost-effectiveness ratio

—

Contacts

Public ContactReinier van Linschoten

Franciscus Gasthuis

r.linschoten@franciscus.nl010-4617838

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 24, 2026