Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000227291
Ethics application status
Approved
Date submitted
18/02/2009
Date registered
5/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Caring Safely at Home: Are there differences in confidence and safety for lay cares who need to administer subcutaneous injections to their loved one, depending upon whether the lay carer or someone else prepares the injection.
Scientific title
Are there differences in confidence and safety for lay carers administering subcutaneous medications to palliative patients dependent upon whether the lay carer, registered nurse or pharmacist prepares the injection.
Secondary ID [1] 797 0
Nil
Universal Trial Number (UTN)
Trial acronym
CS@H
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptom control in home based palliative patients 4252 0
Condition category
Condition code
Public Health 4474 4474 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of standardised education; Group 1 – Lay carer prepares, labels and stores injections for subsequent administration; Group 2 - Registered nurse prepares, labels and stores injections for subsequent administration by the lay carer.
The visiting registered nurse will deliver the standardised education component face to face, as a one on one session to all lay caregivers participating in the study, occurring once when the need to administer subcutaneous injections becomes apparent. The session is expected to last between 30 – 60 minutes. During this time caregivers will be given the opportunity to prepare and practice giving the injections under the supervision of the registered nurse. The topics covered include: a) how to manage symptoms; b) commonly used medications for symptom control; c) access to medications in the community; and d) Safe storage and disposal of medications. At the completion of the session registered nurses will work through a competency checklist with caregivers.
The standardised education package includes the following resources: a) a DVD “How to prepare and administer a subcutaneous injection”. This DVD demonstrates aspects of subcutaneous injecting and trouble shooting; b) a booklet “Palliative subcutaneous medication administration: a guide for carers”. This booklet covers topics such as frequently asked questions, importance of symptom control, management of common palliative symptoms, commonly used subcutaneous medications and processes of injecting; c) charts – illustrated step by step guides concerning how to prepare and administer subcutaneous injections; d) colour coded medication labels; e) a daily diary to document aspects of care; and f) a practice demonstration kit that includes a cannula and other equipment involved with subcutaneous injections.
Types of injections will depend upon the symptoms displayed by the patient as well as the medications and doses contained within subcutaneous injections.
The trial period is determined by the amount of time the lay carer is required to administer subcutaneous medications up to a maximum of 14 days.
Intervention code [1] 3974 0
Treatment: Other
Comparator / control treatment
Group 3- Pharmacist control group. Pharmacist prepares, labels and delivers injections to lay carer for subsequent administration as required for symptom management.
The visiting registered nurse will deliver the standardised education component face to face, as a one on one session to all lay caregivers participating in the study, occurring once when the need to administer subcutaneous injections becomes apparent. The session is expected to last between 30 – 60 minutes. During this time caregivers will be given the opportunity to prepare and practice giving the injections under the supervision of the registered nurse. The topics covered include: a) how to manage symptoms; b) commonly used medications for symptom control; c) access to medications in the community; and d) safe storage and disposal of medications. At the completion of the session registered nurses will work through a competency checklist with caregivers.
The standardised education package includes the following resources: a) a DVD “How to prepare and administer a subcutaneous injection”. This DVD demonstrates aspects of subcutaneous injecting and trouble shooting; b) a booklet “Palliative subcutaneous medication administration: a guide for carers”. This booklet covers topics such as frequently asked questions, importance of symptom control, management of common palliative symptoms, commonly used subcutaneous medications and processes of injecting; c) charts – illustrated step by step guides concerning how to prepare and administer subcutaneous injections; d) colour coded medication labels; e) a daily diary to document aspects of care; and f) a practice demonstration kit that includes a cannula and other equipment involved with subcutaneous injections.
Types of injections will depend upon the symptoms displayed by the patient as well as the medications and doses contained within subcutaneous injections.
The trial period is determined by the amount of time the lay carer is required to administer subcutaneous medications up to a maximum of 14 days.
Control group
Active

Outcomes
Primary outcome [1] 5353 0
Lay carer confidence that injections were well prepared as rated on a 7 point Likert Scale
Timepoint [1] 5353 0
The trial period is determined by the amount of time the lay carer is required to administer subcutaneous medications up to a maximium of 14 days.
Secondary outcome [1] 9001 0
Lay carer satisfaction with educational process. This will be measure using two lay carer questionnaires. The first will be completed immediately following the delivery of the standardised package. The second will be repeated four weeks after their completion on the trial. The questionnaires will rate the usefulness of the education delivered and resources provided.
Timepoint [1] 9001 0
Timepoint 1 - at completion of standardised education
Timepoint 2 - Maximium of 6 weeks after commencement of subcutaneous injections.

Eligibility
Key inclusion criteria
Unpaid lay carers of palliative patients in the home setting who require subcutaneous medications via a subcutaneous cannula.
Able to speak, read, write and understand english language.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lay carers deemed not competent by the registered nurses to prepare and administer subcutaneous injections.
Paid carers or lay carers with previous experience in administering subcutaneous medications.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone, stratified according to proximity to study pharmacist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by a software system and stratified according to proximity of study pharmacist.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1420 0
4113
Recruitment postcode(s) [2] 1421 0
4355
Recruitment postcode(s) [3] 1422 0
4350
Recruitment postcode(s) [4] 1423 0
4114
Recruitment postcode(s) [5] 1424 0
4129
Recruitment postcode(s) [6] 1425 0
4131
Recruitment postcode(s) [7] 1426 0
4178
Recruitment postcode(s) [8] 1427 0
4165
Recruitment postcode(s) [9] 1428 0
4064
Recruitment postcode(s) [10] 1429 0
4102
Recruitment postcode(s) [11] 1430 0
4179
Recruitment postcode(s) [12] 1431 0
4108
Recruitment postcode(s) [13] 1432 0
4555
Recruitment postcode(s) [14] 1433 0
4030
Recruitment postcode(s) [15] 1434 0
4169
Recruitment postcode(s) [16] 1435 0
4073
Recruitment postcode(s) [17] 1436 0
4567
Recruitment postcode(s) [18] 1437 0
4551
Recruitment postcode(s) [19] 1438 0
4558
Recruitment postcode(s) [20] 1439 0
4573

Funding & Sponsors
Funding source category [1] 4431 0
Government body
Name [1] 4431 0
Department of Health & Ageing
Country [1] 4431 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brisbane South Palliative Care Collaborative
Address
PO Box 4069
Eight Mile Plains Brisbane Queensland 4113
Country
Australia
Secondary sponsor category [1] 3992 0
None
Name [1] 3992 0
Address [1] 3992 0
Country [1] 3992 0
Other collaborator category [1] 544 0
Government body
Name [1] 544 0
Centre for Palliative Care Research & Education
Address [1] 544 0
Royal Brisbane & Women's Hospital
Block 7, Level 7
Herston Rd
Herston Brisbane Queensland 4006
Country [1] 544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6479 0
Princess Alexandra Hospital HumanResearch Ethics Committee
Ethics committee address [1] 6479 0
Level 2 Building 35
Princess Alexandra Hospital
Ipswich Rd Woolloongabba Brisbane QLD 4102
Ethics committee country [1] 6479 0
Australia
Date submitted for ethics approval [1] 6479 0
Approval date [1] 6479 0
08/08/2008
Ethics approval number [1] 6479 0
2008/155
Ethics committee name [2] 6480 0
St Vincents & Holy Spirit Health Human Research Ethics Committee
Ethics committee address [2] 6480 0
Level 14
IBM Building
348 Edwards St, Brisbane, QLD 4004
Ethics committee country [2] 6480 0
Date submitted for ethics approval [2] 6480 0
Approval date [2] 6480 0
12/11/2008
Ethics approval number [2] 6480 0
HREC#08/04
Ethics committee name [3] 6481 0
Blue Care Health Human Research Ethics Committee
Ethics committee address [3] 6481 0
PO Box 1539
Milton BC, QLD 4064
Ethics committee country [3] 6481 0
Australia
Date submitted for ethics approval [3] 6481 0
Approval date [3] 6481 0
07/10/2008
Ethics approval number [3] 6481 0
Reymond 3808
Ethics committee name [4] 6482 0
Karuna Hospice Service Board
Ethics committee address [4] 6482 0
PO Box 2020
Windsor QLD 4030
Ethics committee country [4] 6482 0
Australia
Date submitted for ethics approval [4] 6482 0
Approval date [4] 6482 0
18/09/2008
Ethics approval number [4] 6482 0
N/A
Ethics committee name [5] 6483 0
Cittamani Hospice Service Board
Ethics committee address [5] 6483 0
PO Box 324
Palmwoods QLD 4555
Ethics committee country [5] 6483 0
Australia
Date submitted for ethics approval [5] 6483 0
Approval date [5] 6483 0
10/09/2008
Ethics approval number [5] 6483 0
N/A

Summary
Brief summary
Palliative care services strive to support patients to die within the setting of their choice, usually home, with optimal symptom control and a pattern of care that is supportive of caregivers. Palliative care professionals appreciate that, due to resource constraints, the likelihood of patients remaining symptomatically well managed at home depends upon input from lay carers, usually family members.
This study has been designed to evaluate an intervention that supports and educates caregivers to safely and appropriately administer subcutaneous medications for the purpose of symptom control.

The study has two components:
1. To implement a standardised education and support package for lay carers living in urban, regional and rural settings within Queensland and to evaluate that package across the domains of content, efficacy, safety and satisfaction. The package will be evaluated using two lay carer questionnaires. The first will be completed immediately following the delivery of the standardised package. The second will be repeated four weeks after their completion on the trial. The questionnaires will rate the usefulness of the education delivered and resources provided.

2. To identify possible differences in outcomes for lay carers, in terms of confidence, safety, satisfaction, and stress measures with the preparation and injection of subcutaneous medications across three different conditions.
I. The lay carer prepares, labels and stores daily breakthrough medications for subsequent injection
II. A registered nurse prepares and labels daily breakthrough medications for subsequent storage and injection by lay carers
III. A clinical trial pharmacist prepares and labels daily breakthrough medications for subsequent storage and injection by lay carers.

Differences in outcomes will be measured using surveys and Likert scales and statistically analysed. In addition, caregivers will be invited to record their experience in a daily diary.
Trial website
Trial related presentations / publications
Israel, F., Reymond, L., Charles, M., Healy, S. Caring Safely at Home: Development of a Palliative Medications Education Program for Lay Caregivers 7th Palliative Care Congress, April 29th - May 1st 2008, Glasgow
Healy, S., Reymond, L., Israel, F. Development of Guidelines for the Handling of Medications in Community Based Palliative Care Services in Queensland
Advancing Key Initiatives in Cancer Care Forum, 14th & 15th May 2008, Brisbane
Public notes

Contacts
Principal investigator
Name 29232 0
Address 29232 0
Country 29232 0
Phone 29232 0
Fax 29232 0
Email 29232 0
Contact person for public queries
Name 12479 0
Sue Healy
Address 12479 0
Brisbane South Palliative Care Collaborative
PO Box 4069
Eight Mile Plains Brisbane Queensland 4069
Country 12479 0
Australia
Phone 12479 0
+ 61 7 3169 9876
Fax 12479 0
+ 61 7 3169 9885
Email 12479 0
[email protected]
Contact person for scientific queries
Name 3407 0
A/Prof Liz Reymond
Address 3407 0
Brisbane South Palliative Care Collaborative
PO Box 4069
Eight Mile Plains Brisbane Queensland 4069
Country 3407 0
Australia
Phone 3407 0
+61 7 3169 9867
Fax 3407 0
+61 7 3169 9885
Email 3407 0
[email protected]

No information has been provided regarding IPD availability


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.