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Trial registered on ANZCTR


Registration number
ACTRN12617000251325
Ethics application status
Approved
Date submitted
7/02/2017
Date registered
17/02/2017
Date last updated
12/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing home infusion devices for antibiotic treatment - CHID Study
Scientific title
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.
Secondary ID [1] 289265 0
None
Universal Trial Number (UTN)
Trial acronym
CHID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any infectious disease requiring intravenous antibiotic therapy and suitable for treatment via a continuous infusion in the home setting 298845 0
Condition category
Condition code
Infection 298911 298911 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294813 0
Treatment: Devices
Comparator / control treatment
Control arm: Patients will be administered antibiotics with a Baxter elastomeric 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 infusion pump is provided for each of the days. The medication type, dose, rate and home care are as per normal clinical practice. Education on the use of the elastomeric 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 and change the elastomeric pump as per normal practice
Control group
Active

Outcomes
Primary outcome [1] 298381 0
Patient satisfaction of infusion pumps in the home assessed by surveys specifically designed for this study.
Timepoint [1] 298381 0
Completion of 4 - 7 days with each infusion pump.
Primary outcome [2] 301097 0
Nurse satisfaction with infusion pumps in the home assessed by a survey specifically designed for this study.
Timepoint [2] 301097 0
Completion of survey after providing a home visit to at least one patient on this trial. To be completed at the convenience of each nurse, but prior to the conclusion of the trial.
Secondary outcome [1] 323984 0
Total number of infusion system related complications including occlusions, disconnections, leaks, infections, repairs or replacements of the line and/or device itself. These will be evaluated from a case record form and patient log book.
Timepoint [1] 323984 0
At the completion of each 4 - 7 day period.
Secondary outcome [2] 323985 0
Through RAH pharmacy and CPIE Pharmacy Services, the data on purchase cost of pumps, disposables (including batteries) and medication will be recorded and calculated on a per patient basis. Service and cleaning cost of the reusable electronic pump will be obtained from CPIE records. Weight of the returned pumps will be used to calculate unused drug quantities, extra costs of medication not administered due to prescription changes will also be included.
The outcome is a comparison of the operating costs associated with each type of pump.
Timepoint [2] 323985 0
At the completion of both arms.
Secondary outcome [3] 323986 0
The dose of antibiotic received by the patient over a 24-hour period will be estimated based on the volume of initial infusion solution minus the quantity remaining in each returned infusion pump. The estimated dose received will be compared to the total daily dose prescribed by the physician, and an approximate flow rate calculated based on the connection and disconnection times recorded in the patient log book.
The outcome is an estimated average flow rate and dose of the antibiotic administered with each type of pump.
Timepoint [3] 323986 0
Calculated per day, at the end of each arm.
Secondary outcome [4] 323989 0
Temperature data recorded from the patient’s skin will be compared to calibration conditions for peripheral skin temperature utilised by manufacturers of elastomeric pumps. This data will be recorded every 10 minutes with an iButton temperature sensor attached to the patient's skin proximal to the infusion site.
Timepoint [4] 323989 0
At the end of each day for the period of both arms.
Secondary outcome [5] 331721 0
The average and peak ambient temperatures surrounding the infusion pump will be determined during (i) storage prior to patient connection and (ii) while connected to the patient. This data will be recorded every 10 minutes with an iButton temperature sensor attached to the surface of each elastomeric pump or medication cassette.
Timepoint [5] 331721 0
At the end of each day for the period of both arms.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5825 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 13277 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293646 0
Government body
Name [1] 293646 0
Government of South Australia, Department of Further Education, Employment, Science and Techonology (now Department of State Development)
Address [1] 293646 0
Level 4, 11 Waymouth Street, Adelaide, South Australia 5000
Country [1] 293646 0
Australia
Funding source category [2] 295564 0
Commercial sector/Industry
Name [2] 295564 0
CPIE Pharmacy Services
Address [2] 295564 0
2 Crittenden Road
Findon
SA 5023
Country [2] 295564 0
Australia
Primary sponsor type
University
Name
Flinders university
Address
Sturt Road, Bedford Park 5042, South Australia
Country
Australia
Secondary sponsor category [1] 294390 0
None
Name [1] 294390 0
Address [1] 294390 0
Country [1] 294390 0
Other collaborator category [1] 279004 0
Commercial sector/Industry
Name [1] 279004 0
CPIE Pharmacy Services
Address [1] 279004 0
2 Crittenden Road
FINDON SA 5024
Country [1] 279004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295084 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 295084 0
Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 295084 0
Australia
Date submitted for ethics approval [1] 295084 0
15/04/2016
Approval date [1] 295084 0
25/05/2016
Ethics approval number [1] 295084 0
R20160420

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66010 0
Dr Brett Ritchie
Address 66010 0
Infectious Diseases Unit,
Royal Adelaide Hospital
Level 1 IMVS Building
North Terrace
Adelaide
SA, 5000
Country 66010 0
Australia
Phone 66010 0
+61 8 82225340
Fax 66010 0
Email 66010 0
brett.ritchie@sa.gov.au
Contact person for public queries
Name 66011 0
Dr Brett Ritchie
Address 66011 0
Infectious Diseases Unit
Royal Adelaide Hospital
Level 1 IMVS Building
North Terrace
Adelaide
SA, 5000
Country 66011 0
Australia
Phone 66011 0
+61 8 82225340
Fax 66011 0
Email 66011 0
brett.ritchie@sa.gov.au
Contact person for scientific queries
Name 66012 0
Dr Brett Ritchie
Address 66012 0
Infectious Diseases Unit,
Royal Adelaide Hospital
Level 1 IMVS Building
North Terrace
Adelaide
SA, 5000
Country 66012 0
Australia
Phone 66012 0
+61 8 82225340
Fax 66012 0
Email 66012 0
brett.ritchie@sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results