Evaluating a Shared Decision Making Program for Crohn's Disease

Dartmouth Health

Status: Completed

Conditions: Crohn's Disease

Treatments: Behavioral: Shared Decision Making Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02084290

AHRQR01 HS21747 D13129

R01HS021747 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Shared Decision Making Program

Experimental group

Description:

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.

Treatment:

Behavioral: Shared Decision Making Program

Control

No Intervention group

Description:

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.