Evaluating a Shared Decision Making Program for Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Behavioral: Shared Decision Making Program
- Registration Number
- NCT02084290
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- Clinical diagnosis of Crohn's Disease based on standard clinical, radiographic, endoscopic, and histologic criteria
- Age 18 or older
- Fluent, English Speaking
- A candidate to receive immunomodulators or anti-TNF therapy based on their providers recommendation
- not currently taking immunomodulators (6-mercapropurine, azathioprine, methotrexate) or anti-TNF agents (infliximab, adalimumab, certolizumab pegol)
- Participant in a pilot study/focus group for development of Crohn's Shared Decision Making Program
- Currently taking any medication that is contraindicated to take together with an immunomodulator or anti-TNF agent
- Known intolerance to either immunomodulators or anti-TNF agents
- Lack of accessibility to e-mail for follow-up surveys
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Shared Decision Making Program Shared Decision Making Program Patients will have access to an educational decision making program and a risk prediction model, this web based program will be sent subjects in the intervention arm upon enrollment, they can access the program as many times as they wish.
- Primary Outcome Measures
Name Time Method Proportion of patients choosing Combination therapy Week 1
- Secondary Outcome Measures
Name Time Method Time to initiation of therapy Week 1, Week 2, week 26, week 52, week 78, week 110 Patient Choice of therapy Week 1, Week 2, week 26, week 52, week 78, week 110 no therapy, immunomodulator monotherapy, anti-TNF monotherapy, Combination therapy
Persistence (adherence) with chosen therapy Week 1, Week 2, week 26, week 52, week 78, week 110 Cost of Care week 110 Crohn's disease related costs at 2 years
Surgeries 6 months, 1 year, 2 years Proportion of patients requiring Crohn's disease related surgery
Quality of Decision Week 1, Week 2, week 26, week 52, week 78, week 110 i. Decisional conflict (validated scale) ii. Decision consistent with patient values (i.e., patient receiving the treatment that they want) iii. Trust in physician
Crohn's disease related hospitalizations 6 months, 1 year, 2 years Number of hospitalizations
Remission 6 months, 1 year, 2 years Proportion of patients in clinical remission
Patients on Steroids 6 months, 1 year, 2 years Proportion of patients taking steroids
Trial Locations
- Locations (14)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Charlotte Gastroenterology and Hepatology, PLLC
🇺🇸Charlotte, North Carolina, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Ohio GI and Liver Institute
🇺🇸Cincinnati, Ohio, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Minnesota Gastroenterology
🇺🇸Plymouth, Minnesota, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Brigham and Women's Hospital
🇺🇸Chestnut Hill, Massachusetts, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Long Island Clinical Research Associates, LLP
🇺🇸Great Neck, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States