Does bolusing intravenous administration sets with monoclonal antibodies reduce chair time in the oncology outpatient setting? A protocol for a randomized controlled trial

Introduction: Commencing prescribed drugs at the prescribed rate without bolusing the intravenous (IV) administration set with the drug, can increase the time patients spend receiving their treatment. There is an absence of research reporting on bolusing practices in the oncology setting. Clinical Oncology Society of Australia (COSA) guidelines mandate that IV administration sets should not be primed with chemotherapy, this results in patients receiving only saline or other priming solution during the initial stages of each infusion and extends chair time. This study seeks to evaluate the effect, of delivering this priming solution as a bolus, on length of stay. 

Methods and analysis: A single-centre, randomized controlled trial with a two-group design will compare the chair times for patients receiving IV monoclonal antibodies via two methods: (1) priming of IV administration sets (standard care); and (2) priming the IV administration set followed by a 16 mL drug bolus (intervention). There will be a sample size of 128 participants. The primary outcome will evaluate whether bolusing an IV administration set with a monoclonal antibody will reduce chair time. The secondary outcome is incidence of hypersensitivity reaction. 

Ethics and dissemination: This randomized controlled trial has ethical approval from the Royal Brisbane and Women’s Hospital Human Research and Ethics Committee (HREC/2020/QRBW/68664) and Queensland University of Technology Human Research and Ethics Committee (2021000281). Recruitment commenced 12^th of July 2021. Trial registration: ACTRN12621000933853 Strengths and Limitations • Use of computer-generated randomization and allocation concealment will avoid risk of selection and allocation bias. • The first randomized controlled trial to evaluate whether bolusing IV administration sets with monoclonal antibodies will reduce chair time in the outpatient setting. • Data collected from patient’s progress notes, and the nursing data collection form, rely on accurate and complete documentation. • Exclusion of patients receiving the inclusion drugs in combination with chemotherapy, supportive therapies, or other monoclonal antibody agents. Résumé.