Automated Clinical Pathway for Inflammatory Bowel Disease Care

NCT07167836 | Enrolling By Invitation

• 1 other identifier: STU-2024-1013
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Disease (IBD); Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of days overdue for completion of clinical follow up

  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

  12 months

Secondary Outcomes (2)

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

  12 months

• Proportion of patients with bowel-specific inflammatory assessment

  12 months

Other Outcomes (1)

• Proportion of patients with C-reactive protein measurement

  12 months

Study Arms (2)

Care pathway arm

EXPERIMENTAL

Use of an electronic medical record-based, risk-stratified tool that automates the identification of patients who are overdue for follow up and facilitates a proactive scheduling plan

Other: Electronic medical record-based care pathway

Usual care

NO INTERVENTION

Standard disease management, monitoring, and follow-up as directed by clinical team

Interventions

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.

Care pathway arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): December 13, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)