Project Details - Ended
- Grant Number:R01 HS021747
- Funding Mechanism:
- AHRQ Funded Amount:$2,277,681
- Principal Investigator:
- Project Dates:9/30/2012 to 12/31/2018
- Care Setting:
- Medical Condition:
- Type of Care:
- Health Care Theme:
Crohn’s disease is a chronic inflammatory bowel disease that has significant negative impact on the quality of life of an estimated 500,000 Americans. Treating patients with immunomodulator and anti-tumor necrosis factor soon after diagnosis before complications occur leads to better patient outcomes. However, these medications are associated with life-threatening infections and lymphoma. A challenge of treating Crohn’s disease is identifying those patients who will develop severe disease and need medications without over-treating patients who have mild disease. Additionally, patients are often reluctant to begin treatment until the disease becomes more severe.
To address these concerns, Dr. Siegel and his research team developed two tools. The first is a statistical model that predicts Crohn’s disease severity for an individual patient based on clinical, serologic, and genetic factors. The second tool is a Web-based decision aid to help patients weigh the benefits and risks of available treatments for Crohn’s disease. Together, these two tools comprise the Crohn’s Disease Shared Decision Making Program.
The specific aims of this research are to:
- Validate the previously created Crohn’s disease prediction models.
- Optimize the Crohn’s Disease Shared Decision Making Program.
- Study the impact of the Crohn’s Disease Shared Decision Making Program on patients’ treatment choice, persistence with chosen therapy, decision quality, cost of care, and outcomes.
A randomized controlled trial will be conducted to evaluate the Crohn’s Disease Shared Decision Making Program. The outcomes of interest are how the program: 1) influences patients’ choice of therapy; 2) affects persistence with chosen therapy; 3) affects decision quality; and 4) influences the cost of care and clinical outcomes. The study’s hypothesis is that the Crohn’s Disease Shared Decision Making Program will influence patients’ choice of therapy, persistence with their preferred therapy, and lead to improved clinical outcomes.