Evaluating a Shared Decision Making Program for Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:March 2014
End Date:December 31, 2018

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

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.


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
We found this trial at
14
sites
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Raymond Cross, MD
Phone: 410-706-3397
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: David Rubin, MD
Phone: 773-702-5055
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Gil Melmed, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Bruce Sands, MD
Phone: 212-659-9380
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Atlanta, Georgia 30342
Principal Investigator: Douglas Wolf, MD
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Atlanta, GA
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Charlotte, North Carolina 28207
Principal Investigator: John Hanson, MD
Phone: 704-375-9485
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Charlotte, NC
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Chestnut Hill, Massachusetts 02467
Principal Investigator: Joshua Korzenik, MD
Phone: 617-732-9173
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Chestnut Hill, MA
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Cincinnati, Ohio 45219
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Cincinnati, OH
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Great Neck, NY
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Corey Siegel, MD, MS
Phone: 603-650-4481
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Raluca Vrabie, MD
Phone: 516-663-6905
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Miguel Regueiro, MD
Phone: 421-648-9173
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Plymouth, Minnesota 55446
Principal Investigator: Ronald Schwartz, MD
Phone: 612-870-5596
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