Inflammatory Bowel DiseaseNCT07167836
Automated Clinical Pathway for Inflammatory Bowel Disease Care
A study testing Electronic medical record-based care pathway in people with Inflammatory Bowel Disease and Inflammatory Bowel Disease (IBD), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Disease, Inflammatory Bowel Disease (IBD)
- What is being tested?
- Electronic medical record-based care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 13 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- Electronic medical record-based care pathway
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic medical record-based care pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Electronic medical record-based care pathway |
| Usual care | No intervention | Standard disease management, monitoring, and follow-up as directed by clinical team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Composite clinical outcome: acute care utilization, steroid use, or inflammatory bowel disease-related surgery
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
Measured: 12 months
Proportion of patients with bowel-specific inflammatory assessment
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start12 Dec 2025
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Fudman, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167836
- Sponsor's protocol ID
- STU-2024-1013
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07167836
- Acronym / sponsor ID
- STU-2024-1013
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care pathway arm | Experimental | Other: Electronic medical record-based care pathwayUse 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 |
| Usual care | No intervention | –Standard disease management, monitoring, and follow-up as directed by clinical team |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- Patients not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic medical record-based care pathwayParticipants 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. | Other | Care pathway arm |
Primary outcome
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
2 secondary outcomes
Composite clinical outcome: acute care utilization, steroid use, or inflammatory bowel disease-related surgery
Time frame: 12 months
Proportion of patients with bowel-specific inflammatory assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic medical record-based care pathway in people with Inflammatory Bowel Disease and Inflammatory Bowel Disease (IBD), run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of days overdue for completion of clinical follow up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.