Evaluating a Shared Decision Making Program for Crohn's Disease

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

Sponsors

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Collaborator: Agency for Healthcare Research and Quality (AHRQ)
University of Pittsburgh
MOUNT SINAI HOSPITAL
Cedars-Sinai Medical Center
University of Maryland, College Park
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

Source Dartmouth-Hitchcock Medical Center
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.

Overall Status Completed
Start Date 2014-03-01
Completion Date 2018-12-31
Primary Completion Date 2017-08-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of patients choosing Combination therapy Week 1
Secondary Outcome
Measure Time Frame
Time to initiation of therapy Week 1, Week 2, week 26, week 52, week 78, week 110
Patient Choice of 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 Week 1, Week 2, week 26, week 52, week 78, week 110
Cost of Care week 110
Remission 6 months, 1 year, 2 years
Patients on Steroids 6 months, 1 year, 2 years
Surgeries 6 months, 1 year, 2 years
Crohn's disease related hospitalizations 6 months, 1 year, 2 years
Enrollment 204
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Shared Decision Making Program

Description: 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.

Arm Group Label: Shared Decision Making Program

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Corey A Siegel, MD Principal Investigator Dartmouth-Hitchcock Medical Center
Location
Facility:
Cedars-Sinai Medical Center | Los Angeles, California, 90048, United States
Atlanta Gastroenterology Associates | Atlanta, Georgia, 30342, United States
University of Chicago | Chicago, Illinois, 60637, United States
University of Maryland Medical Center | Baltimore, Maryland, 21043, United States
Brigham and Women's Hospital | Chestnut Hill, Massachusetts, 02467, United States
Minnesota Gastroenterology | Plymouth, Minnesota, 55446, United States
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
Long Island Clinical Research Associates, LLP | Great Neck, New York, 11021, United States
Winthrop University Hospital | Mineola, New York, 11501, United States
Mount Sinai Medical Center | New York, New York, 10029, United States
Charlotte Gastroenterology and Hepatology, PLLC | Charlotte, North Carolina, 28207, United States
Ohio GI and Liver Institute | Cincinnati, Ohio, 45219, United States
Thomas Jefferson University | Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, 15261, United States
Location Countries

United States

Verification Date

2019-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Dartmouth-Hitchcock Medical Center

Investigator Full Name: Corey Siegel

Investigator Title: Section Chief, Section of Gastroenterology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Shared Decision Making Program

Type: Experimental

Description: 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.

Label: Control

Type: No Intervention

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: None (Open Label)

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