Crohn's Disease Shared Decision Making Intervention Leads to More Patients Choosing Combination Therapy

A Cluster Randomised Controlled Trial

Yaara Zisman-Ilani; Kimberly D. Thompson; Lori S. Siegel; Todd Mackenzie; Damara J. Crate; Joshua R. Korzenik; Gil Y. Melmed; Patricia Kozuch; Bruce E. Sands; David T. Rubin; Miguel D. Regueiro; Raymond Cross; Douglas C. Wolf; John S. Hanson; Ronald M. Schwartz; Raluca Vrabie; Michael D. Kreines; Timothy Scherer; Marla C. Dubinsky; Corey A. Siegel


Aliment Pharmacol Ther. 2023;57(2):205-214.. 

In This Article

Abstract and Introduction


Background: Crohn's disease requires effective patient-clinician communication for successful illness and medication management. Shared decision making (SDM) has been suggested to improve communication around early intensive therapy. However, effective evidence-based SDM interventions for Crohn's disease are lacking, and the impact of SDM on Crohn's disease decision making and choice of therapy is unclear.

Aim: To test the impact of SDM on choice of therapy, quality of the decision and provider trust compared to standard Crohn's disease care.

Methods: We conducted a multi-site cluster randomised controlled trial in 14 diverse gastroenterology practices in the US.

Results: A total of 158 adult patients with Crohn's disease within 15 years of their diagnosis, with no prior Crohn's disease complications, and who were candidates to receive immunomodulators or biologics, participated in the study. Among these, 99 received the intervention and 59 received standard care. Demographics were similar between groups, although there were more women assigned to standard care, and a slightly shorter disease duration among those in the intervention group. Participants in the intervention group more frequently chose combination therapy (25% versus 5% control, p < 0.001), had a significantly lower decisional conflict (p < 0.05) and had greater trust in their provider (p < 0.05).

Conclusions: With rapidly expanding medication choices for Crohn's disease and slow uptake of early intensive therapy, SDM can personalise treatment strategies and has the potential to move the field of Crohn's disease management forward with an ultimate goal of consistently treating this disease early and intensively in appropriate patients.

Trial Registration: Evaluating a Shared Decision Making Program for Crohn's Disease, Identifier NCT02084290


One of the many challenging aspects of Crohn's disease management is the variable nature of the disease course.[1] Some patients rapidly progress to developing complications within months of diagnosis, and others have a more indolent course without anything more than mild symptoms. Historically, Crohn's disease was managed with a "step-up" approach, starting with milder and less effective medications and escalating medical therapy only once it became obvious that the disease was progressing. Over a decade ago, the landmark "top down" study was published showing significantly better disease control with an early intensive approach by starting patients on combination therapy with azathioprine and infliximab as compared to the more typical step-up approach.[2] This seemed as it would be a turning point in Crohn's disease management and would create a sea change in how we approach patients with a recent diagnosis. However, this has not been the case as noted in recent literature,[3] and there remain a number of barriers to further progress.[4]

Two of the most significant barriers to move towards early intensive therapy for patients with Crohn's disease are (1) being able to risk stratify patients for low versus high risk to rapidly progress to disease complications and (2) a framework in which to communicate this risk to patients. This communication is often hampered by patients' concerns about side effects of medications and their hesitance to take a "powerful" medication before their disease proves to be bad enough to warrant these immune-modifying medications.[5,6] To address these barriers, we have created a shared decision-making (SDM) programme (i.e. the intervention) that incorporates both a decision aid to review the basics of Crohn's disease and management options, and a risk prediction tool to stratify patients from a low to high risk of developing disease complications over a period of 3 years.[7]

SDM is a health communication approach that focuses on improving patient–clinician interactions around medical decisions by providing decision support and sharing evidence-based information with patients with the ultimate goal of improving clinical and functional outcomes.[8–10] In the last two decades, SDM has become a national and international priority[11–13] and has been recognised as part of value-based care by the Institutes of Medicine[14] for people with various chronic conditions[11,15–17] such as diabetes,[18] heart disease,[19] cancer[20] and IBD.[21–23] The premise of SDM in the management of chronic conditions and IBD in particular is to help clinicians communicate easily to comprehend evidence-based data to support a preference-based decision by their patient.[24,25] The intent is to recognise that individual patients perceive risk and benefit data differently, and also come with their own set of preferences based on what is important to them. To test the impact of this new SDM programme on choice of therapy and quality of the decision, we designed a randomised controlled trial for patients with Crohn's disease to compare patients who received the SDM programme to standard of care patient education by their provider.