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

doi:10.1111/apt.17286

Randomized Controlled Trial

. 2023 Jan;57(2):205-214.

doi: 10.1111/apt.17286. Epub 2022 Nov 14.

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

Yaara Zisman-Ilani^{1

2}, Kimberly D Thompson³, Lori S Siegel⁴, Todd Mackenzie⁵, Damara J Crate³, Joshua R Korzenik⁶, Gil Y Melmed⁷, Patricia Kozuch⁸, Bruce E Sands⁹, David T Rubin¹⁰, Miguel D Regueiro¹¹, Raymond Cross¹², Douglas C Wolf¹³, John S Hanson¹⁴, Ronald M Schwartz¹⁵, Raluca Vrabie¹⁶, Michael D Kreines¹⁷, Timothy Scherer¹⁸, Marla C Dubinsky¹⁹, Corey A Siegel³

Affiliations

¹ Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.
² Department of Clinical, Educational and Health Psychology, Division of Psychology and Language Sciences, University College London, London, UK.
³ Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
⁴ Climate Interactive, Hanover, New Hampshire, USA.
⁵ Geisel School of Medicine at Dartmouth, Biomedical Data Science, Hanover, New Hampshire, USA.
⁶ Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁷ Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁸ Inflammatory Bowel Disease Program, Jefferson University Hospitals, Philadelphia, Pennsylvania, USA.
⁹ Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
¹⁰ Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, Illinois, USA.
¹¹ Cleveland Clinic, Cleveland, Ohio, USA.
¹² Department of Medicine, Division of Gastroenterology & Hepatology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
¹³ Atlanta Gastroenterology Associates, Atlanta, Georgia, USA.
¹⁴ Atrium Health Gastroenterology and Hepatology, Charlotte, North Carolina, USA.
¹⁵ MNGI Digestive Health, Minneapolis, Minnesota, USA.
¹⁶ Gastroenterology Division, New York University, New York City, New York, USA.
¹⁷ Gastro Health, Cincinnati, Ohio, USA.
¹⁸ Southern New Hampshire Health, Nashua, New Hampshire, USA.
¹⁹ Department of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine Mount Sinai, New York City, New York, USA.

PMID: 36377259
PMCID: PMC9790033
DOI: 10.1111/apt.17286

Randomized Controlled Trial

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

Yaara Zisman-Ilani et al. Aliment Pharmacol Ther. 2023 Jan.

. 2023 Jan;57(2):205-214.

doi: 10.1111/apt.17286. Epub 2022 Nov 14.

Authors

Affiliations

¹ Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.
² Department of Clinical, Educational and Health Psychology, Division of Psychology and Language Sciences, University College London, London, UK.
³ Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
⁴ Climate Interactive, Hanover, New Hampshire, USA.
⁵ Geisel School of Medicine at Dartmouth, Biomedical Data Science, Hanover, New Hampshire, USA.
⁶ Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁷ Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁸ Inflammatory Bowel Disease Program, Jefferson University Hospitals, Philadelphia, Pennsylvania, USA.
⁹ Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
¹⁰ Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, Illinois, USA.
¹¹ Cleveland Clinic, Cleveland, Ohio, USA.
¹² Department of Medicine, Division of Gastroenterology & Hepatology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
¹³ Atlanta Gastroenterology Associates, Atlanta, Georgia, USA.
¹⁴ Atrium Health Gastroenterology and Hepatology, Charlotte, North Carolina, USA.
¹⁵ MNGI Digestive Health, Minneapolis, Minnesota, USA.
¹⁶ Gastroenterology Division, New York University, New York City, New York, USA.
¹⁷ Gastro Health, Cincinnati, Ohio, USA.
¹⁸ Southern New Hampshire Health, Nashua, New Hampshire, USA.
¹⁹ Department of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine Mount Sinai, New York City, New York, USA.

PMID: 36377259
PMCID: PMC9790033
DOI: 10.1111/apt.17286

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.

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Figures

**FIGURE 2**
Proportion of patients selecting combination therapy

**FIGURE 3**
Trust in the doctor’s decisions about which medical treatments are best for you

See this image and copyright information in PMC

Comment in

Editorial: shared decision-making intervention in patients with Crohn's disease-a personalised, patient-centred approach.
Scribano ML. Scribano ML. Aliment Pharmacol Ther. 2023 Jan;57(2):263-264. doi: 10.1111/apt.17314. Aliment Pharmacol Ther. 2023. PMID: 36565000 No abstract available.
Letter: expanding the role for decision aids in IBD into pregnancy-related topics.
Chan P, Connor S, Huang V, Karimi N, Williams AJ. Chan P, et al. Aliment Pharmacol Ther. 2023 Jul;58(1):141-142. doi: 10.1111/apt.17545. Aliment Pharmacol Ther. 2023. PMID: 37307542 No abstract available.

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Health Communication Research Informs Inflammatory Bowel Disease Practice and Research: A Narrative Review.
Karimi N, Moore AR, Lukin A, Connor SJ. Karimi N, et al. Crohns Colitis 360. 2023 Apr 21;5(3):otad021. doi: 10.1093/crocol/otad021. eCollection 2023 Jul. Crohns Colitis 360. 2023. PMID: 37162798 Free PMC article.

References

1. Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn’s disease. Lancet. 2017;389(10080):1741–55. 10.1016/S0140-6736(16)31711-1 - DOI - PubMed
1. D’Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial. Lancet. 2008;371(9613):660–7. 10.1016/S0140-6736(08)60304-9 - DOI - PubMed
1. Siegel CA, Yang F, Eslava S, Cai Z. Treatment pathways leading to biologic therapies for ulcerative colitis and Crohn’s disease in the United States. Clin Transl Gastroenterol. 2020;11(2):e00128. 10.14309/ctg.0000000000000128 - DOI - PMC - PubMed
1. Siegel CA, Refocusing IBD. Patient management: personalized, proactive, and patient-centered care. Am J Gastroenterol. 2018;113(10):1440–3. 10.1038/s41395-018-0246-x - DOI - PubMed
1. Bewtra M, Reed SD, Johnson FR, Scott FI, Gilroy E, Sandler RS, et al. Variation among patients with Crohn’s disease in benefit vs risk preferences and remission time equivalents. Clin Gastroenterol Hepatol. 2020;18(2):406–414.e7. 10.1016/j.cgh.2019.05.010 - DOI - PubMed

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[1] Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn’s disease. Lancet. 2017;389(10080):1741–55. 10.1016/S0140-6736(16)31711-1 - DOI - PubMed

[2] Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn’s disease. Lancet. 2017;389(10080):1741–55. 10.1016/S0140-6736(16)31711-1 - DOI - PubMed

[3] D’Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial. Lancet. 2008;371(9613):660–7. 10.1016/S0140-6736(08)60304-9 - DOI - PubMed

[4] D’Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial. Lancet. 2008;371(9613):660–7. 10.1016/S0140-6736(08)60304-9 - DOI - PubMed

[5] Siegel CA, Yang F, Eslava S, Cai Z. Treatment pathways leading to biologic therapies for ulcerative colitis and Crohn’s disease in the United States. Clin Transl Gastroenterol. 2020;11(2):e00128. 10.14309/ctg.0000000000000128 - DOI - PMC - PubMed

[6] Siegel CA, Yang F, Eslava S, Cai Z. Treatment pathways leading to biologic therapies for ulcerative colitis and Crohn’s disease in the United States. Clin Transl Gastroenterol. 2020;11(2):e00128. 10.14309/ctg.0000000000000128 - DOI - PMC - PubMed

[7] Siegel CA, Refocusing IBD. Patient management: personalized, proactive, and patient-centered care. Am J Gastroenterol. 2018;113(10):1440–3. 10.1038/s41395-018-0246-x - DOI - PubMed

[8] Siegel CA, Refocusing IBD. Patient management: personalized, proactive, and patient-centered care. Am J Gastroenterol. 2018;113(10):1440–3. 10.1038/s41395-018-0246-x - DOI - PubMed

[9] Bewtra M, Reed SD, Johnson FR, Scott FI, Gilroy E, Sandler RS, et al. Variation among patients with Crohn’s disease in benefit vs risk preferences and remission time equivalents. Clin Gastroenterol Hepatol. 2020;18(2):406–414.e7. 10.1016/j.cgh.2019.05.010 - DOI - PubMed

[10] Bewtra M, Reed SD, Johnson FR, Scott FI, Gilroy E, Sandler RS, et al. Variation among patients with Crohn’s disease in benefit vs risk preferences and remission time equivalents. Clin Gastroenterol Hepatol. 2020;18(2):406–414.e7. 10.1016/j.cgh.2019.05.010 - DOI - PubMed

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

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

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