Clinical trial NCT02084290: Evaluating a Shared Decision Making Program for Crohn's Disease
Official title: Evaluating a Prediction Tool and Decision Aid for Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
Shared Decision Making
Decision Aid
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: University of Pittsburgh
name: MOUNT SINAI HOSPITAL
name: Cedars-Sinai Medical Center
name: University of Maryland
name: Brigham and Women's Hospital
name: Thomas Jefferson University
name: University of Chicago
name: Atlanta Gastroenterology Associates
name: Long Island Clinical Research Associates
name: Center for Digestive and Liver Diseases
name: Charlotte Gastroenterology and Hepatology
name: Minnesota Gastroenterology
name: Ohio Gi and Liver Institute
name: Winthrop University Hospital
First posted: 2014-03-11
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients choosing Combination therapy
timeFrame: Week 1
Secondary outcomes:
measure: Time to initiation of therapy
timeFrame: Week 1, Week 2, week 26, week 52, week 78, week 110
measure: Patient Choice of therapy
timeFrame: Week 1, Week 2, week 26, week 52, week 78, week 110
measure: Persistence (adherence) with chosen therapy
timeFrame: Week 1, Week 2, week 26, week 52, week 78, week 110
measure: Quality of Decision
timeFrame: Week 1, Week 2, week 26, week 52, week 78, week 110
measure: Cost of Care
timeFrame: week 110
measure: Remission
timeFrame: 6 months, 1 year, 2 years
measure: Patients on Steroids
timeFrame: 6 months, 1 year, 2 years
measure: Surgeries
timeFrame: 6 months, 1 year, 2 years
measure: Crohn's disease related hospitalizations
timeFrame: 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Plymouth
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: Ohio GI and Liver Institute
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Corey A Siegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.