Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial.

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

Journal: Alimentary pharmacology & therapeutics 2022;57(2):205-214

PMID: 36377259

Abstract

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, ClinicalTrials.gov Identifier NCT02084290 https://clinicaltrials.gov/ct2/show/NCT02084290.

© 2022 John Wiley & Sons Ltd.

Address: Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.; Department of Clinical, Educational and Health Psychology, Division of Psychology and Language Sciences, University College London, London, UK.; Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.; Climate Interactive, Hanover, New Hampshire, USA.; Geisel School of Medicine at Dartmouth, Biomedical Data Science, Hanover, New Hampshire, USA.; Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.; Inflammatory Bowel Disease Program, Jefferson University Hospitals, Philadelphia, Pennsylvania, USA.; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.; Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, Illinois, USA.; Cleveland Clinic, Cleveland, Ohio, USA.; Department of Medicine, Division of Gastroenterology & Hepatology, University of Maryland School of Medicine, Baltimore, Maryland, USA.; Atlanta Gastroenterology Associates, Atlanta, Georgia, USA.; Atrium Health Gastroenterology and Hepatology, Charlotte, North Carolina, USA.; MNGI Digestive Health, Minneapolis, Minnesota, USA.; Gastroenterology Division, New York University, New York City, New York, USA.; Gastro Health, Cincinnati, Ohio, USA.; Southern New Hampshire Health, Nashua, New Hampshire, USA.; Department of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine Mount Sinai, New York City, New York, USA.
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