Development of a complex nursing intervention for the management of patients with a stoma complicated by a parastomal bulge.

Background: The focus on late complications after colorectal surgery has increased in the last decade, including the difficulty of surgical and non-surgical management of parastomal bulging. Parastomal bulging is the most significant complication of a stoma, affecting half of ostomy patients in the long term and negatively impacting on quality of life. Stoma care nurses mainly manage a parastomal bulge, although most stoma care nurses find treatment complex and symptoms related to the bulge difficult to handle. Evidence-based guidelines and a structured approach to the many symptoms patients present are limited. Thus, this paper aimed to describe the development of a complex nursing intervention program for the management of parastomal bulges.

Methods: The study was based on the Medical Research Council (MRC) framework for Complex Interventions. To strengthen the clinical applicability and relevance of the program, Bleijenberg's approach was integrated into the MRC framework. The program development followed three phases outlined by the MRC framework: 1) identifying the evidence base, 2) developing theory and 3) modelling process and outcomes. The intervention was designed for stoma care nurses working in hospital ostomy clinics.

Results: The intervention was developed through an iterative process over 12 months and comprised a Scoping review, workshops and a Consensus Conference. Feedback from clinical experts was integrated throughout the development process. The program, named Parastomal Bulging Intervention (PBI) - a nurse-led intervention for identifying, assessing and managing symptoms in patients with parastomal bulge, consisted of three components: A) Systematic approach to the nursing consultation, B) Symptom-specific nursing treatment algorithms and C) Supplemental information and guidance.

Conclusion: The MRC framework was successfully applied to develop a program for complex nursing interventions for patients with a parastomal bulge. By incorporating elements from Bleijenberg during the development phase, we ensured that the needs of recipients and providers were addressed, thereby enhancing the program's suitability for clinical practice. The feasibility and acceptability of the PBI will be tested in future studies.

Clinical Trail Number: Not applicable.