Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000056796
Ethics application status
Approved
Date submitted
22/11/2021
Date registered
18/01/2022
Date last updated
18/01/2022
Date data sharing statement initially provided
18/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility study for a novel approach to delivery of breakthrough analgesics in palliative care
Scientific title
Feasibility study for a novel approach to delivery of breakthrough analgesics in palliative care
Secondary ID [1] 305857 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 324392 0
Breakthrough Pain 324394 0
Condition category
Condition code
Anaesthesiology 321876 321876 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to evaluate the safety, efficacy, usability, and acceptance of a novel modality to administer breakthrough analgesics in palliative care patients using a computerised patient controlled analgesia device.

Once consent has been granted an Agilia device will be ordered, programmed, and attached via subcutaneous cannula to the participant. While the device is insitu it will automatically collect data, including number of times the device was accessed, number of doses delivered, total amount of medication delivered and if any device associated adverse events or errors occurred (these include disruption to flow in the line, increase in pressure in the syringe, for example).
Palliative care physicians, palliative care nurses in collaboration with the research nurse, will administer the intervention. The duration of the intervention/use of device for administration will be determined by end of life period of the patient.

Participants will receive their usual breakthrough medication using the device, with no changes to their medications involved in this study. The medication in the device is the same medication they would normally receive if the device was not in use. The staff caring for the patient in the hospice will assess their pain regularly and discuss the need for the patient to have medication to help with pain as they normally would.

A time in motion audit will be repeated to enable a comparison to the pre-intervention data
Intervention code [1] 322250 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329633 0
Pre and post intervention medication audit collected via data extraction of electronic medical records
Timepoint [1] 329633 0
Pre intervention is completed

Post intervention: from time of commencement of intervention to 7 days post-completion of intervention,
Primary outcome [2] 329634 0
Patient and family will be interviewed to understand their experience (feasibility and usability) using this device. The interview data will be assessed using a descriptive analysis technique. Responses to question will be coded to find common responses, which will be grouped into categories
Timepoint [2] 329634 0
During intervention and 14 days post intervention
Primary outcome [3] 329637 0
Staff satisfaction will be assessed using questionnaire software, this will be done automatically through the software Qualtrics.
Timepoint [3] 329637 0
2 months post completion of intervention.
Secondary outcome [1] 404005 0
Nil
Timepoint [1] 404005 0
Nil

Eligibility
Key inclusion criteria
Staff- employed as a Registered Nurse or Medical Officer at Flinders Medical Centre and working at Laurel Hospice

Patients - Admitted patients to the Laurel Hospice receiving intermittent analgesics via subcutaneous or intravenous injection who are over 18.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not receiving breakthrough analgesia

Patient receiving less than four breakthrough analgesia doses per 24 hours.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21174 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 36038 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310209 0
Charities/Societies/Foundations
Name [1] 310209 0
The Hospital Research Foundation Group
Country [1] 310209 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Briffa
Address
Flinders Medical Centre (RAP Building)
Flinders Drive,
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 311301 0
Individual
Name [1] 311301 0
Dr Caroline Phelan
Address [1] 311301 0
Flinders Medical Centre (RAP Building)
Flinders Drive,
Bedford Park SA 5042
Country [1] 311301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309891 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309891 0
Flinders Medical Centre
Flinders Drive,
Bedford Park SA 5042
Ethics committee country [1] 309891 0
Australia
Date submitted for ethics approval [1] 309891 0
Approval date [1] 309891 0
21/12/2020
Ethics approval number [1] 309891 0
OFR number: 130.20

Summary
Brief summary
Pain is the most common symptom experienced by people at the end of life in an inpatient hospice setting. In nearly all cases, a person who is dying receives analgesics, usually opioid, including bolus injection of breakthrough analgesic to manage incidental pain. Our
aim is to evaluate the safety, efficacy, usability and acceptance of a novel modality to administer breakthrough analgesics in palliative care patients.
1. Safety – evaluate the safety of a novel method for administering breakthrough analgesics by monitoring
adverse events associated with equipment, adherence to regulatory practices, audit of prescribing and
administration practices
2. Efficacy – assessment and comparison of opioid dose, total MED, time in motion and use of other medications
for breakthrough dosing such as anti emetics and anxiolytics
3. Usability – survey of staff about use of equipment and the method of administration
4. Acceptability- survey of staff, family, carers about experience
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115742 0
Dr Michael Briffa
Address 115742 0
Flinders Medical Centre (RAP Building)
Flinders Drive,
Bedford Park,
SA 5042
Country 115742 0
Australia
Phone 115742 0
+61 8 84042058
Fax 115742 0
Email 115742 0
micahel.briffa@sa.gov.au
Contact person for public queries
Name 115743 0
Dr Caroline Phelan
Address 115743 0
Flinders Medical Centre (RAP Building)
Flinders Drive,
Bedford Park,
SA 5042
Country 115743 0
Australia
Phone 115743 0
+61 8 82012616
Fax 115743 0
Email 115743 0
caroline.phelan@flinders.edu.au
Contact person for scientific queries
Name 115744 0
Dr Caroline Phelan
Address 115744 0
Flinders Medical Centre (RAP Building)
Flinders Drive,
Bedford Park,
SA 5042
Country 115744 0
Australia
Phone 115744 0
+61 8 82012616
Fax 115744 0
Email 115744 0
caroline.phelan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.