Evaluating a Shared Decision Making Program for Crohn's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating a Prediction Tool and Decision Aid for Patients With Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Behavioral: Shared Decision Making Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared Decision Making Program<br>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. | Behavioral: Shared Decision Making Program<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients choosing Combination therapy |  | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initiation of therapy |  | 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 | 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 | 
| 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 | Week 1, Week 2, week 26, week 52, week 78, week 110 | 
| Cost of Care | Crohn's disease related costs at 2 years | week 110 | 
| Remission | Proportion of patients in clinical remission | 6 months, 1 year, 2 years | 
| Patients on Steroids | Proportion of patients taking steroids | 6 months, 1 year, 2 years | 
| Surgeries | Proportion of patients requiring Crohn's disease related surgery | 6 months, 1 year, 2 years | 
| Crohn's disease related hospitalizations | Number of hospitalizations | 6 months, 1 year, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Shared Decision Making, Decision Aid