Crohn's Disease
Conditions
Keywords
Crohn's disease, Shared Decision Making, Decision Aid
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.
Interventions
BEHAVIORALShared Decision Making Program
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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
University of Pittsburgh
MOUNT SINAI HOSPITAL
Cedars-Sinai Medical Center
University of Maryland
Brigham and Women's Hospital
Thomas Jefferson University
University of Chicago
Atlanta Gastroenterology Associates
Long Island Clinical Research Associates
Center for Digestive and Liver Diseases
Charlotte Gastroenterology and Hepatology
Minnesota Gastroenterology
Ohio Gi and Liver Institute
Winthrop University Hospital
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients choosing Combination therapy | Week 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| Cost of Care | week 110 | Crohn's disease related costs at 2 years |
| Time to initiation of therapy | Week 1, Week 2, week 26, week 52, week 78, week 110 | — |
| Patients on Steroids | 6 months, 1 year, 2 years | Proportion of patients taking steroids |
| Surgeries | 6 months, 1 year, 2 years | Proportion of patients requiring Crohn's disease related surgery |
| 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 |
Countries
United States
Outcome results
None listed