Evaluating a Shared Decision Making Program for Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084290
• Other study ID #: AHRQR01 HS21747 D13129
• Secondary ID: R01HS021747
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 31, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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.

Locations

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

Sponsors (16)

Lead Sponsor

Collaborator

Dartmouth-Hitchcock Medical Center

Agency for Healthcare Research and Quality (AHRQ), Atlanta Gastroenterology Associates, Brigham and Women's Hospital, Cedars-Sinai Medical Center, Center for Digestive and Liver Diseases, Charlotte Gastroenterology and Hepatology, Long Island Clinical Research Associates, Minnesota Gastroenterology, MOUNT SINAI HOSPITAL, Ohio Gi and Liver Institute, Thomas Jefferson University, University of Chicago, University of Maryland, University of Pittsburgh, Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients choosing Combination therapy		Week 1
Secondary	Time to initiation of therapy		Week 1, Week 2, week 26, week 52, week 78, week 110
Secondary	Patient Choice of therapy	no therapy, immunomodulator monotherapy, anti-TNF monotherapy, Combination therapy	Week 1, Week 2, week 26, week 52, week 78, week 110
Secondary	Persistence (adherence) with chosen therapy		Week 1, Week 2, week 26, week 52, week 78, week 110
Secondary	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	Week 1, Week 2, week 26, week 52, week 78, week 110
Secondary	Cost of Care	Crohn's disease related costs at 2 years	week 110
Secondary	Remission	Proportion of patients in clinical remission	6 months, 1 year, 2 years
Secondary	Patients on Steroids	Proportion of patients taking steroids	6 months, 1 year, 2 years
Secondary	Surgeries	Proportion of patients requiring Crohn's disease related surgery	6 months, 1 year, 2 years
Secondary	Crohn's disease related hospitalizations	Number of hospitalizations	6 months, 1 year, 2 years