Automated Clinical Pathway for Inflammatory Bowel Disease Care

N/AEnrolling By InvitationNCT07167836

University of Texas Southwestern Medical Center1,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

1,000

Conditions

Inflammatory Bowel Disease Inflammatory Bowel Disease (IBD)

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 Exclusion Criteria: Patients not meeting inclusion criteria

Locations (1)

UT Southwestern

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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)

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.