NCT01882426

Care Path for the Management of Ulcerative Colitis

A Cluster Randomized Controlled Trial of a Care-Path for the Management of Ulcerative Colitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: University of Western Ontario, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess if standardized care-path that features objective evaluations of disease activity and time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.

Detailed description

Step-care based on symptomatic response remains the overwhelming algorithm of choice in clinical practice. Many subjects receive infliximab only as a last resort, when the subject is very ill and has failed repeated attempts of corticosteroid induction therapy. Although this situation is far from ideal, to change such entrenched physician behavior will require compelling evidence that Step-care results in inferior outcomes to earlier introduction of effective therapy. Based on these considerations, we will perform a cluster randomization trial in which 40 gastroenterology practices will be randomly assigned to a treatment algorithm featuring the early use of combination therapy, treatment intensification guided by objective assessments of inflammation and the use of remission as a therapeutic goal or a conventional Step-care approach.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Enhanced treatment algorithm	Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.
OTHER	Usual Care	usual step care practice

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-11-01
• Completion: 2016-05-01
• First posted: 2013-06-20
• Last updated: 2016-05-13