RecruitingACTRN12617000251325

Comparing home infusion devices for antibiotic treatment - CHID Study

A randomised crossover trial evaluating patient and nurse satisfaction of the electronic portable infusion device (Ambit) versus elastomeric delivery (Baxter) for the continuous administration of antibiotic in the home in patients with infectious disease.


Sponsor

Flinders university

Enrollment

100 participants

Start Date

Feb 20, 2017

Study Type

Interventional

Conditions

Summary

The purpose of this study is to compare and contrast patient and nurse satisfaction with the Baxter(Registered Trademark) device and the Ambit(Registered Trademark) device for delivery of intravenous antibiotics in the home setting. The secondary aims are to examine any complications that occur with this these infusion pumps, the quantity of medication they deliver and the temperature during storage and use of these devices. The proposed research design is to allocate patients to receive home antibiotic infusion with one of two infusion devices for one week, then continue that treatment with the other device for one week. At the end of both periods the patients will be asked to fill in a questionnaire regarding their satisfaction with the device and any problems that arose. A survey will also be conducted of RDNS nursing staff that have provided home care to these patients to assess nurse satisfaction. In addition to the surveys, all infusion devices/bags will be weighed after their use to determine the quantity of any drug remaining. Each pump/bag will be equipped with a temperature sensor to determine the storage temperature of the drugs when kept in patients’ homes, as well as the ambient temperature during pump use. A temperature sensor will be placed on each patients arm to measure skin temperature during pump use, as this has an impact on elastomeric infusion pump accuracy. Patient case note data will also be monitored to collect statistics on infusion related complications, such as occlusions, disconnections, infections or repairs required.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of portable infusion pumps — the Baxter device and the Ambit device — used to deliver intravenous antibiotics at home. Researchers want to know which device is easier and more satisfying for both patients and nurses to use, and whether there are any differences in how they deliver medication. You may be eligible if: - You are 18 years of age or older - You are a patient at the Royal Adelaide Hospital - You have been approved to receive home antibiotic therapy by the Infectious Diseases team - You are expected to need intravenous therapy for at least 8 days after leaving hospital - You are able to complete questionnaires and a logbook You may NOT be eligible if: - You are not referred to the Infectious Diseases unit for home antibiotic therapy - You are unable or unwilling to complete the questionnaire or logbook - You have a skin allergy or contact dermatitis to stainless steel - You are pregnant - You are totally dependent on others for all daily needs and cannot move around - You are being treated with certain antibiotics with a short shelf life (Ceftazidime or Ticarcillin/Clavulanate) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention arm: Patients will be administered antibiotics with an AmbIT Continuous electronic infusion pump, in the home for 4 - 7 days. This duration is variable due to the need to align with stan

Intervention arm: Patients will be administered antibiotics with an AmbIT Continuous electronic infusion pump, in the home for 4 - 7 days. This duration is variable due to the need to align with standard outpatient appointment times and will be determined by the time between discharge and appointment, or from one appointment to the next. A separate cassette with attached tubing and connector is provided for each day with a single pump used for the intervention period. The medication type, dose, rate and home care are as per normal clinical practice. Education on the use of the electronic pump will be via written information sheets provided by the pump manufacturers and verbal information from the study nurse. Education and delivery of the pump will occur prior to leaving hospital or during a clinic visit by the study nurse. A home care nurse (Royal District Nursing Service, RDNS) will visit each patient daily in their home as per normal practice and change the infusion cassette for the pump. As these nurses may not have previous experience using the AmbIT pump, all nurses who provide home care to patients on this trial will receive training via a 4 minute custom-made video, available on-line, prior to first enrolment. They will also receive a written information sheet about the trial, and a 24-hour technical support telephone number has been provided should any pump-related issues occur (e.g. alarm of the AmbIT pump). Due to the need to maintain continuous administration of antibiotics, a wash out period between devices is not part of this study. Patient intervention adherence will be checked by the study nurse at each clinic visit. Nurses will be contacted via email and phone by the study nurse to confirm training has been undertaken and remind them of the survey.


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12617000251325