NCT02084290

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. 1.Determine how the shared decision making program influences patients' choice of therapy
  2. 2.Evaluate how the shared decision making program affects persistence with chosen therapy
  3. 3.Determine how the shared decision making program affects decision quality
  4. 4.Determine how the shared decision making program influences cost of care and clinical outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

3.5 years

First QC Date

January 29, 2014

Last Update Submit

February 5, 2019

Conditions

Crohn's Disease

Keywords

Crohn's diseaseShared Decision MakingDecision Aid

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients choosing Combination therapy

    Week 1

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Shared Decision Making Program

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Shared Decision Making ProgramBEHAVIORAL

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.

Shared Decision Making Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21043, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Minnesota Gastroenterology

Plymouth, Minnesota, 55446, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Charlotte Gastroenterology and Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Ohio GI and Liver Institute

Cincinnati, Ohio, 45219, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • 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.

    PMID: 36377259DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Corey A Siegel, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Chief, Section of Gastroenterology

Study Record Dates

First Submitted

January 29, 2014

First Posted

March 11, 2014

Study Start

March 1, 2014

Primary Completion

August 31, 2017

Study Completion

December 31, 2018

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations

US(14)