Evaluating a Shared Decision Making Program for Crohn's Disease

Completed · Not applicable

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02084290

Run by

Dartmouth-Hitchcock Medical Center

People needed

204

Starts

2014-03-01

Expected to finish

2018-12-31

Last updated by the study team

2019-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• Minnesota Gastroenterology — Plymouth, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Long Island Clinical Research Associates, LLP — Great Neck, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Charlotte Gastroenterology and Hepatology, PLLC — Charlotte, North Carolina, United States
• Ohio GI and Liver Institute — Cincinnati, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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