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Completed

NCT Number: NCT02084290

Evaluating a Shared Decision Making Program for 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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared Decision Making Program

Behavioral

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.

Primary outcomes

  1. Proportion of patients choosing Combination therapy

    Time frame: Week 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • 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
  • MOUNT SINAI HOSPITAL
  • Minnesota Gastroenterology
  • Ohio Gi and Liver Institute
  • Thomas Jefferson University
  • University of Chicago
  • University of Maryland
  • University of Pittsburgh
  • Winthrop University Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Mar 11, 2014
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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