Aliment Pharmacol Ther. 2024 May;59(9):1082-1095.doi: 10.1111/apt.17926. Epub 2024 Mar 1.

Bernd Bokemeyer ^1 2 3, Sandra Plachta-Danielzik ^1 4, Isa Maria Steiner ⁵, Daniela Pohlschneider ¹, Eugen Urzica ¹, Petra Hartmann ⁶, Jennifer Zemke ⁷, Ulrich Tappe ⁸, Stefan Schreiber ³, Nadine Steinkat ⁹, Jana Langbrandtner ^10 11, Angelika Hüppe ^10 11, Tom Stargardt ⁵

Author information

¹Competence Network IBD, Kiel, Germany.

²Interdisciplinary Crohn Colitis Centre, Minden, Germany.

³Clinic of General Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Germany.

⁴Institute of Human Nutrition and Food Science, Christian-Albrechts University, Kiel, Germany.

⁵Hamburg Centre for Health Economics, University of Hamburg, Hamburg, Germany.

⁶Gastroenterology Practice, Minden, Germany.

⁷Gastroenterology Practice, Herne, Germany.

⁸Gastroenterology Practice, Hamm, Germany.

⁹Techniker Krankenkasse, Hamburg, Germany.

¹⁰Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.

¹¹Centre for Population Medicine and Health Services Research, University of Lübeck, Lübeck, Germany.

Abstract

Background: IBD_BIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by IBD nurse specialists in Germany in improving health-related quality of life (QoL) in IBD patients on biologic therapy.

Aim: To evaluate patient-related outcomes and economic consequences associated with integrating IBD nurses into usual care.

Methods: We randomly assigned 1086 patients with IBD on biologic therapy to a control group (CG) receiving usual care or an intervention group (IG) receiving additional care from an IBD nurse specialist. The primary outcome was disease-specific QoL (sIBDQ) assessed at 6, 12 and 18 months.

Results: At baseline, patients in both groups were highly satisfied with their treatment situation and had relatively high sIBDQ values (range: 1-7; CG: 5.12; IG: 4.92). In the intention-to-treat (ITT) analysis of the overall sample, there was no significant difference in sIBDQ between groups at the assessment time points. However, a per-protocol analysis of patients with impaired QoL at baseline (EQ-VAS < 75 [median]), showed improvement in sIBDQ over 6 months that became significant at month 12 and remained significant through month 18 (baseline: IG 4.24; CG 4.31; 18 months: IG 5.02; CG 4.76; p = 0.017).

Conclusion: High baseline satisfaction of IBD patients with treatment and the relatively high baseline sIBDQ values may have contributed to the lack of significant difference in sIBDQ scores for the overall sample. However, patients with impaired QoL derived significant benefit from additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term.