None listed
Conditions
Brief 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.
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 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
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.
Sponsors
Flinders university
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years of age or older Inpatient of the Royal Adelaide Hospital Patient can provide voluntary informed consent Has been given Infectious Diseases approval for home antibiotic therapy To receive a minimum of 8 days of intravenous therapy post discharge from Hospital Patient must have the capacity to provide formal feedback on device satisfaction by using a questionnaire and log book.
Exclusion criteria
Not referred to the Infectious Diseases unit for home intravenous antibiotic therapy. Patient is unable or unwilling to fill out the patient questionnaire survey and or log book. Skin allergy or contact dermatitis to stainless steel. Patient’s primary clinician is unwilling to enrol patient. Pregnancy. Patient is totally dependent upon care for all daily needs and/or is immobile. The following antibiotics are excluded due to restricted shelf life: Ceftazadime, Ticarcillin/Clavulanate.
Outcome results
None listed