Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Apr 28;11(4):e041871.
doi: 10.1136/bmjopen-2020-041871.

Effectiveness of interdisciplinary combined dermatology-gastroenterology-rheumatology clinical care compared to usual care in patients with immune-mediated inflammatory diseases: a parallel group, non-blinded, pragmatic randomised trial

Kasper Fjellhaugen Hjuler  1   2 , Anders Dige  2   3 , Jørgen Agnholt  2   3 , Trine Bay Laurberg  2   4 , Anne Gitte Loft  2   4 , Louise Faurskov Møller  5   2 , Robin Christensen  6   7 , Lars Iversen  5   2
Affiliations
Randomized Controlled Trial

Effectiveness of interdisciplinary combined dermatology-gastroenterology-rheumatology clinical care compared to usual care in patients with immune-mediated inflammatory diseases: a parallel group, non-blinded, pragmatic randomised trial

Kasper Fjellhaugen Hjuler et al. BMJ Open. .

Abstract

Introduction: Immune-mediated inflammatory diseases (IMIDs) are associated with reduced health-related quality of life (HRQol), increased risk of somatic and psychiatric comorbidities and reduced socioeconomic status. Individuals with one IMID have an increased risk for developing other IMIDs. The unmet needs in the care of patients with IMIDs may result from a lack of patient-centricity in the usual monodisciplinary siloed approach to these diseases. The advantages of novel interdisciplinary clinics towards the traditional therapeutic approach have not been investigated. The overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared with usual care in a population of patients with the IMIDs: psoriasis, hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and inflammatory bowel disease. Our hypothesis is that an interdisciplinary combined clinic intervention will be more effective than usual care in improving clinical and patient-reported outcomes, and that a more effective screening and management of other IMIDs and comorbidities can be performed.

Methods and analysis: This is a randomised, usual care controlled, parallel-group pragmatic clinical trial. 300 consecutively enrolled participants with co-occurrence of at least two IMIDs are randomly assigned in a 2:1 ratio to either treatment in the interdisciplinary combined clinic or usual care. The study will consist of a 6-month active intervention period and a 6-month follow-up period where no intervention or incentives will be provided by the trial. The primary outcome is the change from baseline to 24 weeks on the Short-Form Health Survey (SF-36) Physical Component Summary. Additional patient-reported outcome measures and clinical measures are assessed as secondary outcomes.

Ethics and dissemination: Ethical approval of this study protocol was established by the institutional review board of the study site. The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with patient organisations.

Trial registration number: NCT04200690.

Keywords: immunology; inflammatory bowel disease; organisation of health services; psoriasis; rheumatology; therapeutics.

PubMed Disclaimer

Conflict of interest statement

Competing interests: AD has received speaking fees from Pfizer. AGL has been a consultant and advisor for the following companies: AbbVie, Eli Lilly, MSD, Novartis, Pfizer and UCB and has received speaking fees from: AbbVie, MSD, Novartis, Pfizer and UCB. JA has been consultant, advisory board member or speaker for the following companies: AbbVie, MSD, Bristol Meyer Squibb, Ferring Pharmaceuticals, Pfizer, Janssen-Cilag and Takeda. KFH has been a consultant and advisor for the following companies: AbbVie, LEO Pharma, Novartis and has received speaking fees from: AbbVie, LEO Pharma, Novartis, Janssen, CSL Behring. LI has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by: AbbVie, Almirall, Amgen, Astra Zeneca, BMS, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Janssen Cilag, Kyowa, Leo Pharma, MSD, Novartis, Pfizer, Samsung, UCB. LFMø has been advisory board member for Janssen and has received speaking fees from LEO Pharma. Robin Christensen reports no conflicts of interest. TBL has been a consultant and advisor for UCB.

Figures

Figure 1
Figure 1
Trial design. Two-arm, randomised, usual care controlled, parallel-group pragmatic clinical trial.
Figure 2
Figure 2
Study flow diagram.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Bayry J, Radstake TR. Immune-mediated inflammatory diseases: progress in molecular pathogenesis and therapeutic strategies. Expert Rev Clin Immunol 2013;9:297–9. 10.1586/eci.13.10 - DOI - PubMed
    1. Bakland G, Gran JT, Nossent JC. Increased mortality in ankylosing spondylitis is related to disease activity. Ann Rheum Dis 2011;70:1921–5. 10.1136/ard.2011.151191 - DOI - PubMed
    1. Boehncke W-H, Menter A. Burden of disease: psoriasis and psoriatic arthritis. Am J Clin Dermatol 2013;14:377–88. 10.1007/s40257-013-0032-x - DOI - PubMed
    1. Hjuler KF, Böttcher M, Vestergaard C, et al. . Increased prevalence of coronary artery disease in severe psoriasis and severe atopic dermatitis. Am J Med 2015;128:1325–34. 10.1016/j.amjmed.2015.05.041 - DOI - PubMed
    1. Kimball AB, Guérin A, Tsaneva M, et al. . Economic burden of comorbidities in patients with psoriasis is substantial. J Eur Acad Dermatol Venereol 2011;25:157–63. 10.1111/j.1468-3083.2010.03730.x - DOI - PubMed

Publication types

Associated data