A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility.

Background: Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery.

Objective: This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery.

Methods: We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures.

Results: This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024.

Conclusions: Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery.

Trial registration: ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002.

International registered report identifier (irrid): PRR1-10.2196/60575.