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Evaluating a Shared Decision Making Program for Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02084290
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
University of Pittsburgh
MOUNT SINAI HOSPITAL
Cedars-Sinai Medical Center
University of Maryland
Brigham and Women's Hospital
Thomas Jefferson University
University of Chicago
Atlanta Gastroenterology Associates
Long Island Clinical Research Associates
Center for Digestive and Liver Diseases
Charlotte Gastroenterology and Hepatology
Minnesota Gastroenterology
Ohio Gi and Liver Institute
Winthrop University Hospital
Information provided by (Responsible Party):
Corey Siegel, Dartmouth-Hitchcock Medical Center

Study Description
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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:

  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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Behavioral: Shared Decision Making Program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating a Prediction Tool and Decision Aid for Patients With Crohn's Disease
Study Start Date : March 2014
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: Shared Decision Making Program
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.
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients choosing Combination therapy [ Time Frame: Week 1 ]

Secondary Outcome Measures :
  1. Time to initiation of therapy [ Time Frame: Week 1, Week 2, week 26, week 52, week 78, week 110 ]
  2. Patient Choice of therapy [ Time Frame: Week 1, Week 2, week 26, week 52, week 78, week 110 ]
    no therapy, immunomodulator monotherapy, anti-TNF monotherapy, Combination therapy

  3. Persistence (adherence) with chosen therapy [ Time Frame: Week 1, Week 2, week 26, week 52, week 78, week 110 ]
  4. Quality of Decision [ Time Frame: Week 1, Week 2, week 26, week 52, week 78, week 110 ]
    i. Decisional conflict (validated scale) ii. Decision consistent with patient values (i.e., patient receiving the treatment that they want) iii. Trust in physician

  5. Cost of Care [ Time Frame: week 110 ]
    Crohn's disease related costs at 2 years

  6. Remission [ Time Frame: 6 months, 1 year, 2 years ]
    Proportion of patients in clinical remission

  7. Patients on Steroids [ Time Frame: 6 months, 1 year, 2 years ]
    Proportion of patients taking steroids

  8. Surgeries [ Time Frame: 6 months, 1 year, 2 years ]
    Proportion of patients requiring Crohn's disease related surgery

  9. Crohn's disease related hospitalizations [ Time Frame: 6 months, 1 year, 2 years ]
    Number of hospitalizations


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084290


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21043
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Minnesota Gastroenterology
Plymouth, Minnesota, United States, 55446
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States, 11021
Winthrop University Hospital
Mineola, New York, United States, 11501
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States, 28207
United States, Ohio
Ohio GI and Liver Institute
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Agency for Healthcare Research and Quality (AHRQ)
University of Pittsburgh
MOUNT SINAI HOSPITAL
Cedars-Sinai Medical Center
University of Maryland
Brigham and Women's Hospital
Thomas Jefferson University
University of Chicago
Atlanta Gastroenterology Associates
Long Island Clinical Research Associates
Center for Digestive and Liver Diseases
Charlotte Gastroenterology and Hepatology
Minnesota Gastroenterology
Ohio Gi and Liver Institute
Winthrop University Hospital
Investigators
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Principal Investigator: Corey A Siegel, MD Dartmouth-Hitchcock Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corey Siegel, Section Chief, Section of Gastroenterology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02084290    
Other Study ID Numbers: AHRQR01 HS21747 D13129
R01HS021747 ( U.S. AHRQ Grant/Contract )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Keywords provided by Corey Siegel, Dartmouth-Hitchcock Medical Center:
Crohn's disease
Shared Decision Making
Decision Aid
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases