Inflammatory Bowel Disease, Inflammatory Bowel Disease (IBD)
Conditions
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
Interventions
OTHERElectronic 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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of days overdue for completion of clinical follow up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite clinical outcome: acute care utilization, steroid use, or inflammatory bowel disease-related surgery | 12 months | 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 |
| Proportion of patients with bowel-specific inflammatory assessment | 12 months | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with C-reactive protein measurement | 12 months | Proportion of patients completing a measurement of C-reactive protein |
Countries
United States
Outcome results
None listed