Evaluating a Shared Decision Making Program for Crohn's Disease

Evaluating a Prediction Tool and Decision Aid for Patients With 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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Behavioral: Shared Decision Making Program

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients choosing Combination therapy	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to initiation of therapy		Week 1, Week 2, week 26, week 52, week 78, week 110
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
Persistence (adherence) with chosen therapy		Week 1, Week 2, week 26, week 52, week 78, week 110
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
Cost of Care	Crohn's disease related costs at 2 years	week 110
Remission	Proportion of patients in clinical remission	6 months, 1 year, 2 years
Patients on Steroids	Proportion of patients taking steroids	6 months, 1 year, 2 years
Surgeries	Proportion of patients requiring Crohn's disease related surgery	6 months, 1 year, 2 years
Crohn's disease related hospitalizations	Number of hospitalizations	6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: University of Maryland; University of Chicago; University of Pittsburgh; Brigham and Women's Hospital; Cedars-Sinai Medical Center; Thomas Jefferson University; MOUNT SINAI HOSPITAL; Winthrop University Hospital; Agency for Healthcare Research and Quality (AHRQ); 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

Publications and helpful links

General Publications

• Zisman-Ilani Y, Thompson KD, Siegel LS, Mackenzie T, Crate DJ, Korzenik JR, Melmed GY, Kozuch P, Sands BE, Rubin DT, Regueiro MD, Cross R, Wolf DC, Hanson JS, Schwartz RM, Vrabie R, Kreines MD, Scherer T, Dubinsky MC, Siegel CA. Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial. Aliment Pharmacol Ther. 2023 Jan;57(2):205-214. doi: 10.1111/apt.17286. Epub 2022 Nov 14.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): August 31, 2017
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (ESTIMATE): March 11, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Crohn's disease; Decision Aid; Shared Decision Making
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: AHRQR01 HS21747 D13129; R01HS021747 (AHRQ)