Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Inflammatory bowel disease, or IBD, is a chronic health problem that affects three million people in the United States. IBD can cause symptoms such as long-term diarrhea and stomach pain. Many people with IBD also have behavioral health problems such as depression or anxiety, which can decrease quality of life.
Specialty medical homes, or SMHs, are clinics that provide multiple types of care, such as care from a specialist, mental health care, and community services. SMHs aim to give patients care that meets their needs and preferences. In this study, the research team is comparing two SMH programs for treating patients with IBD and behavioral health conditions. The first program uses traditional in-person clinic visits. The second program uses telemedicine, including smart phone apps.
Who can this research help?
Results may help SMHs when considering ways to provide care for patients with IBD and behavioral health conditions.
What is the research team doing?
The research team is enrolling 990 patients with IBD and behavioral health conditions receiving care at IBD clinics in three cities. The team is assigning patients by chance to one of two groups. All patients have an initial in-person visit to assess their IBD and behavioral health needs. Care teams for both groups include a gastroenterologist, a nurse, and a behavioral health specialist.
Patients in both groups take part in visits with their care team as often as needed for physical or behavioral health care. In the first group, patients take part in traditional in-person clinic visits. In the second group, patients take part in video visits. Patients in this group can also use an app to communicate with behavior change coaches, who help patients develop skills to manage anxiety and depression.
At the start of the study and again 6 and 12 months later, the research team is surveying patients about their IBD symptoms, depression, anxiety, physical function, quality of life, and confidence to manage IBD. The team is looking at patients’ medical records to see how often they go to the hospital for IBD treatment. In addition, the team is looking at these results for different groups of patients, including patients in different age groups and patients with low or high levels of IBD symptoms.
Finally, the research team is conducting interviews with patients and members of the clinical teams at each study site to understand their experiences with the SMH programs.
Patients with IBD and behavioral health conditions are helping with all phases of this study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 990 patients ages 18–60 who have an IBD diagnosis of Crohn’s or ulcerative colitis with mild to severe behavioral health symptoms, defined as a score of ≥6 on the Personal Health Questionnaire 4 (PHQ4) |
| Interventions/ Comparators |
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| Outcomes |
Primary: IBD symptom severity, depression, anxiety Secondary: functional impairment, healthcare utilization, IBD self-efficacy, IBD-related quality of life |
| 1-year follow-up for primary outcomes |