Protocol for a randomised crossover trial to evaluate patient and nurse satisfaction with electronic and elastomeric portable infusion pumps for the continuous administration of antibiotic therapy in the home: the Comparing Home Infusion Devices (CHID) study

Abstract

IntroductionPrevious studies comparing satisfaction with electronic and elastomeric infusion pumps are limited, and improvements in size and usability of electronic pumps have since occurred. The Comparing Home Infusion Devices (CHID) study plans to assess patient and nurse satisfaction with an elastomeric and electronic pump for delivering intravenous antibiotic treatment in the home. Secondary objectives are to determine pump-related complications and actual antibiotic dose administered, evaluate temperature variation and compare pump operating costs.Methods and analysisThe CHID study will be a randomised, crossover trial. A trained research nurse will recruit patients with infectious disease aged ≥18 years and prescribed ≥8 days of continuous intravenous antibiotic therapy from the Royal Adelaide Hospital (RAH) (Adelaide, Australia). Patients will be randomised to receive treatment at home via an elastomeric (Baxter Infusor) or an electronic (ambIT Continuous) infusion pump for 4–7 days, followed by the other for a further 4–7 days. Patient satisfaction will be assessed by a 10-item survey to be completed at the end of each arm. Nurse satisfaction will be assessed by a single 24-item survey. Patient logbooks and case notes from clinic visits will be screened to identify complications. Pumps/infusion bags will be weighed to estimate the volume of solution delivered. Temperature sensors will record skin and ambient temperatures during storage and use of the pumps throughout the infusion period. Costs relating to pumps, consumables, antibiotics and servicing will be determined. Descriptive statistics will summarise study data.Ethics and disseminationThis study has been approved by the RAH Human Research Ethics Committee (HREC/16/RAH/133 R20160420, version 6.0, 5 September 2016). Study results will be disseminated through peer-reviewed publications and conference presentations. The CHID study will provide key insights into patient and provider satisfaction with elastomeric and electronic infusion pumps and inform future device selection.Trial registration numberACTRN12617000251325; Pre-results.

Stability of vincristine sulfate, doxorubicin hydrochloride and etoposide phosphate admixtures in polyisoprene elastomeric pump supporting transition of the EPOCH regimen to outpatient care

“…Of relevance to the proposed outpatient model, a trial which aims to evaluate patient and nurse satisfaction with elastomeric portable infusion pumps is ongoing. 25 We believe all the information gathered from different studies will support the transition of EPOCH-containing regimens to be administered in the outpatient setting, which may result in improved patient acceptability and health related cost savings. 26…”

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“… 8 However, the use of elastomeric devices had higher costs than bolus dosing via gravity infusion. 8 The CHID (Comparing Home Infusion Devices) study protocol included pump operating costs of electronic versus elastomeric pumps for CI as a secondary outcome measure, 9 but the results of this trial are not yet published. In the United States, insurance coverage for these elastomeric devices and ambulatory electronic infusion pumps varies, which may create disparities in patient access.…”