Abstract

Abstract Background IBD nurses play an important role in the Multidisciplinary Team of managing patients with IBD. IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by an IBD nurse specialist in improving health-related quality of life (QoL) in IBD patients on biologic therapy in an outpatient setting in Germany. Methods In total, 1086 IBD patients on biologic therapy were randomly assigned to either a control group (CG) receiving usual IBD care or an intervention group (IG) receiving additional care from an IBD nurse. Two IBD nurses per site received an extra study specific IBD training before including patients. The primary outcome was disease-specific QoL (sIBDQ) assessed at months (M) 6, 12, and 18. In addition, IBD nurses provided a final assessment of various aspects of their work in the context of the study at M6 (T0) and M15 (T1), and patients were asked about their satisfaction level with the IBD nurses. Results The analysis of patients with impaired QoL at baseline (EQ-VAS < 75 [median]), showed an improvement in sIBDQ over 6 M that became significant at M12 and remained significant through M18 (baseline: IG 4.24; CG 4.31; M18: IG 5.02; CG 4.76; P= .017) (Table 1). Regarding the 5 aspects of fun, usefulness, successful discussions in consultations with patients, successful support of patients, and appreciation by patients, the nurses expressed positive assessments (“completely” and “rather”) at both measurement points, with values of more than 90% (Fig. 1). About 20% to 30% of the nurses reported being rather dissatisfied with two aspects of their jobs: time and space resources for discussions and recognition by physicians. 94% of patients in the IG felt that the additional care provided by the IBD nurses was highly beneficial. Conclusion IBD patients with impaired QoL derived a significant benefit from the additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term. The survey results from the IBD nurses and patients in the IG revealed a very positive perception of the new form of care. It is noteworthy that an improvement in care provision was reported both by the nurses and the participating patients. Some physicians also experienced benefits from the intervention as they were relieved of certain time-consuming tasks by the IBD nurses. It should be noted that more than 20% of the IBD nurses did not feel sufficiently appreciated by physicians, and about 30% criticised the lack of time and space resources. When introducing the IBD nurse-led care concept into usual practice, these aspects should be considered.

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