Specific Aim: 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 Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand which treatments are right for them and will lead to a higher acceptance of appropriate therapy, improved persistence with chosen therapy, lower costs and improved clinical outcomes. To accomplish this aim, Investigators will perform a randomized controlled trial to: 1. Determine how the shared decision making program influences patients' choice of therapy 2. Evaluate how the shared decision making program affects persistence with chosen therapy 3. Determine how the shared decision making program affects decision quality 4. Determine how the shared decision making program influences cost of care and clinical outcomes Expected Outcome and Impact: Investigators expect that this program will influence patients' choice of therapy, persistence with their preferred therapy, and lead to improved clinical outcomes. Investigators believe that this product can be successfully operationalized in the clinic to establish a new paradigm of how providers can communicate personalized treatment options to patients across a broad range of diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
204
This study is cluster randomized by study-site, Subjects enrolled at intervention sites will access an educational program and risk prediction tool. Their decisions about treatments will be compared to subjects that did not view the educational program or risk prediction tool.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Minnesota Gastroenterology
Plymouth, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Mount Sinai Medical Center
New York, New York, United States
...and 4 more locations
Proportion of patients choosing Combination therapy
Time frame: Week 1
Time to initiation of therapy
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Patient Choice of therapy
no therapy, immunomodulator monotherapy, anti-TNF monotherapy, Combination therapy
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Persistence (adherence) with chosen therapy
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Quality of Decision
i. Decisional conflict (validated scale) ii. Decision consistent with patient values (i.e., patient receiving the treatment that they want) iii. Trust in physician
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Cost of Care
Crohn's disease related costs at 2 years
Time frame: week 110
Remission
Proportion of patients in clinical remission
Time frame: 6 months, 1 year, 2 years
Patients on Steroids
Proportion of patients taking steroids
Time frame: 6 months, 1 year, 2 years
Surgeries
Proportion of patients requiring Crohn's disease related surgery
Time frame: 6 months, 1 year, 2 years
Crohn's disease related hospitalizations
Number of hospitalizations
Time frame: 6 months, 1 year, 2 years
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