Evaluating a Shared Decision Making Program for Crohn's Disease

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.

Conditions

• Crohn's Disease

Interventions

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.

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ)

  collaborator FED

• University of Pittsburgh

  collaborator OTHER

• MOUNT SINAI HOSPITAL

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Atlanta Gastroenterology Associates

  collaborator OTHER

• Long Island Clinical Research Associates

  collaborator UNKNOWN

• Center for Digestive and Liver Diseases

  collaborator UNKNOWN

• Charlotte Gastroenterology and Hepatology

  collaborator UNKNOWN

• Minnesota Gastroenterology

  collaborator UNKNOWN

• Ohio Gi and Liver Institute

  collaborator UNKNOWN

• Winthrop University Hospital

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  lead OTHER

Principal Investigators

• Corey A Siegel, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2017-08-31

Completion

2018-12-31

Countries

• United States

Study Locations