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Enrolling by Invitation

NCT Number: NCT07167836

Automated Clinical Pathway for Inflammatory Bowel Disease Care

Pragmatic randomized controlled 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

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • An active inflammatory bowel disease-specific medication, and
  • At least one of the following:
  • Inflammatory bowel disease on the active problem list
  • An inflammatory bowel disease invoice diagnosis at least twice in the 3 years prior to trial commencement
  • An inflammatory bowel disease encounter diagnosis at least twice in the 3 years prior to trial commencement

Exclusion criteria

Patients not meeting inclusion criteria

Treatment and study plan

Electronic medical record-based care pathway

Other

Participants will undergo initial automated risk stratification to direct tailored follow-up intervals. If exceeding the maximum time interval, participants in the intervention arm will be contacted by scheduling personnel using a standardized protocol to schedule a follow-up visit. In contrast, patients in the control arm who are overdue will not be made known to any staff and will not be proactively contacted, instead continuing to be managed according to standard of care. To maximize generalizability and understanding among staff and patients, risk stratification will be based on inflammatory bowel disease medication use.

Primary outcomes

  1. Proportion of days overdue for completion of clinical follow up

    Time frame: 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 outcomes

  1. Composite clinical outcome: acute care utilization, steroid use, or inflammatory bowel disease-related surgery

    Time frame: 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) inflammatory bowel disease-related surgery

  2. Proportion of patients with bowel-specific inflammatory assessment

    Time frame: 12 months

    The proportion of patients who completed a bowel-specific inflammatory assessment, defined as calprotectin, computed tomography or magnetic resonance enterography, or lower endoscopy (colonoscopy, sigmoidoscopy, pouchoscopy, ileoscopy)

Other outcomes

  1. Proportion of patients with C-reactive protein measurement

    Time frame: 12 months

    Proportion of patients completing a measurement of C-reactive protein

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Effect of an Automated Clinical Pathway Utilizing Tailored Risk Stratification on Rates of Overdue Follow up and Outcomes in Patients With Inflammatory Bowel Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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