An interventional study of Shared Decision Making Program in Crohn's Disease, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Other
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:
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 204 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
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
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center