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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.
usual step care practice
Proportion of patients in remission at the end of 12 months.
Remission is defined as 1) a Mayo Clinic Score of ≤2 with rectal bleeding and stool frequency sub-scale scores of 0) with no use of corticosteroids, and 3) normalization of the subject's index inflammatory marker (c-reactive protein or calprotectin). The primary endpoint will be assessed at Month 12.
Time frame: 12 months
Proportion of patients in remission over the course of the study
The time in remission over the course of the study; occurrence of surgery or hospitalization for Ulcerative Colitis; occurrence of disease-related complications; health related QoL (Short-Form 36 questionnaire \[SF-36\] and EuroQoL instrument \[EQ-5D\]); and, subject
Time frame: 18 months
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