Automated Clinical Pathway for Inflammatory Bowel Disease Care

NCT ID: NCT07167836

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-12

Study Completion Date

2026-12-13

Brief Summary

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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

Detailed Description

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Conditions

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Inflammatory Bowel Disease Inflammatory Bowel Disease (IBD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Care pathway arm

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

Group Type EXPERIMENTAL

Electronic medical record-based care pathway

Intervention Type 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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronic medical record-based care pathway

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.

Intervention Type OTHER

Eligibility Criteria

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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 inflammatory bowel disease-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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Fudman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UT Southwestern

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2024-1013

Identifier Type: -

Identifier Source: org_study_id

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