Evaluating a Prediction Tool and Decision Aid for Patients With Crohn's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 204
- Locations
- 27
- Primary Endpoint
- Proportion of patients choosing Combination therapy
Study Overview
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:
- Determine how the shared decision making program influences patients' choice of therapy
- Evaluate how the shared decision making program affects persistence with chosen therapy
- Determine how the shared decision making program affects decision quality
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Shared Decision Making Program (Behavioral)
Control
Subjects enrolled at sites participating as control arms will access the same web-based surveys as the intervention group, and receive the same contacts from the study coordinator as the subjects enrolled at intervention sites.
Outcomes
Primary Outcomes
Proportion of patients choosing Combination therapy
Time Frame: Week 1
Secondary Outcomes
- 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)
- Persistence (adherence) with chosen therapy(Week 1, Week 2, week 26, week 52, week 78, week 110)
- Cost of Care(week 110)
- Surgeries(6 months, 1 year, 2 years)
- Quality of Decision(Week 1, Week 2, week 26, week 52, week 78, week 110)
- Crohn's disease related hospitalizations(6 months, 1 year, 2 years)
- Remission(6 months, 1 year, 2 years)
- Patients on Steroids(6 months, 1 year, 2 years)
Investigators
Corey Siegel
Section Chief, Section of Gastroenterology
Dartmouth-Hitchcock Medical Center