Electronic Care Pathway for Inflammatory Bowel Disease

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Inflammatory bowel disease medication

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an electronic tool can improve care for people with inflammatory bowel disease (IBD). The tool uses a computerized system, called an Automated Clinical Pathway, to remind patients to schedule timely follow-ups, potentially improving symptom management. The trial includes two groups: one using the new tool and another continuing with usual care. Individuals who have visited the UT Southwestern adult digestive disease clinic at least twice in the past three years and are taking IBD medication might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative care solutions for IBD.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it requires that you are on an active inflammatory bowel disease-specific medication to participate.

What prior data suggests that this electronic medical record-based tool is safe for improving follow-up in inflammatory bowel disease patients?

Research has shown that automated systems in electronic medical records have succeeded in similar studies. These systems track medication use and other health information to identify patients needing follow-up visits.

Most studies on these tools focus on improving health management rather than directly on safety. However, since this tool schedules follow-ups without involving new medications or procedures, no physical side effects have been reported.

In summary, automated systems are safe as they enhance care organization using existing technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the electronic care pathway for inflammatory bowel disease because it uses an innovative, automated system to streamline patient management. Unlike traditional care, which relies on manual follow-up and scheduling by clinical teams, this pathway leverages electronic medical records to automatically identify patients who need attention. This proactive approach aims to ensure timely follow-ups and better disease management, potentially improving patient outcomes and reducing the burden on healthcare providers.

What evidence suggests that this electronic care pathway is effective for inflammatory bowel disease?

Research has shown that automated systems can improve the management of inflammatory bowel disease (IBD). In this trial, participants in the care pathway arm will use an electronic medical record-based, risk-stratified tool. This tool automates the identification of patients overdue for follow-up and facilitates a proactive scheduling plan. As a result, doctors can schedule timely appointments, enhancing disease management. Studies suggest these tools effectively ensure patients receive necessary care when needed. However, few clinical trials have focused on digital health tools for IBD, indicating a need for more research to fully understand their impact. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for living patients with Inflammatory Bowel Disease (IBD) who have been to the UT Southwestern adult digestive disease clinic at least twice in the last 3 years, including once within the past 2 years. They must be on an active IBD-specific medication and have a history of IBD diagnosis.

Inclusion Criteria

I have visited the UT Southwestern digestive disease clinic at least twice in the last 3 years.

I am currently taking medication for my inflammatory bowel disease.

I have active inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are managed using an electronic medical record-based tool for risk stratification and follow-up scheduling

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Automated Clinical Pathway

Trial Overview

The study is testing an electronic medical record-based care pathway tool designed to improve timely follow-ups for IBD care. It's a pragmatic randomized controlled trial that looks at how this tool affects patient outcomes.

How Is the Trial Designed?

Group I: Care pathway arm Experimental Treatment 1 Intervention

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 II: Usual care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07167836

Automated Clinical Pathway for Inflammatory Bowel ...

To maximize generalizability and understanding among staff and patients, risk stratification will be based on inflammatory bowel disease medication use.

2.

trial.medpath.com

trial.medpath.com/clinical-trial/167b63db69782d21/nct07167836-automated-clinical-pathway-inflammatory-bowel-disease

Automated Clinical Pathway for Inflammatory Bowel Disease ...

Pragmatic randomized control trial to evaluate the effect of an electronic medical record-based tool on improving on-time follow up and its effec...

3.

journals.lww.com

journals.lww.com/ajg/fulltext/2021/10001/s816_automated_clinical_pathway_utilizing_custom.817.aspx

S816 Automated Clinical Pathway Utilizing Custom Risk...

We identified a large proportion of patients overdue for follow up using a clinical pathway integrated into the electronic medical record.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36866408/

Automated Clinical Pathway Utilizing Custom Risk ...

Automated Clinical Pathway Utilizing Custom Risk Stratification Identifies Substantial Rates of Overdue Follow-up Among Patients With Inflammatory Bowel Disease ...

5.

thelancet.com

thelancet.com/journals/landig/article/PIIS2589-7500%2824%2900290-5/fulltext

Efficacy of digital health technologies in the management ...

Clinical trials assessing available health tools for the management of patients with inflammatory bowel disease (IBD) are sparse, with limited ...

6.

gastrojournal.org

gastrojournal.org/article/S0016-5085(25)00541-4/fulltext

Artificial Intelligence–Enabled Clinical Trials in ...

Clinical trials for inflammatory bowel diseases (IBDs) are the foundation of evidence that substantiate therapeutic efficacy, safety, and management pathways ...