Automated Clinical Pathway for Inflammatory Bowel Disease Care

Not Applicable

Not yet recruiting

• Conditions: Inflammatory Bowel Disease; Inflammatory Bowel Disease (IBD)

• Registration Number: NCT07167836
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Pragmatic randomized control trial to evaluate the effect of an electronic medical record-based tool on improving on-time follow up and its effects on inflammatory bowel disease outcomes

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Study Start: 2025-10-01
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Alive patients with 2 or more visits to the UT Southwestern adult digestive disease clinic within 3 years of the date of trial commencement including at least one visit within 2 years, and

2. An active IBD-specific medication, and

3. At least one of the following:

   1. Inflammatory bowel disease on the active problem list
   2. An inflammatory bowel disease invoice diagnosis at least twice in the 3 years prior to trial commencement
   3. An inflammatory bowel disease encounter diagnosis at least twice in the 3 years prior to trial commencement

Exclusion Criteria

Patients not meeting inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of days overdue for completion of clinical follow up	12 months	Calculated on a per-patient basis with a denominator of 365 (days in the study period) and a numerator of days overdue for follow up. Definition of overdue follows a patient's risk stratification

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	12 months	Proportion of patients experiencing any event in the composite outcome of: a) acute care utilization, defined as combined incidence of visits to emergency rooms or admissions to the hospital; b) steroid use: incidence of new steroid prescriptions; and c) IBD-related surgery
Bowel-specific inflammatory assessment	12 months	The proportion of patients who completed a bowel-specific inflammatory assessment, defined as calprotectin, CT or MR enterography, or lower endoscopy (colonoscopy, sigmoidoscopy, pouchoscopy, ileoscopy)