Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000006741
Ethics application status
Approved
Date submitted
19/12/2012
Date registered
4/01/2013
Date last updated
4/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of a core medicines list on access to medicines for palliative patients within their home environment
Scientific title
The impact of a core medicines list on access to medicines for palliative patients within their home environment
Secondary ID [1] 281701 0
Nil
Universal Trial Number (UTN)
U1111-1137-9975
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 287989 0
Pain 287990 0
Dyspnoea 287991 0
noisy Breathing 287992 0
nausea and vomiting 287993 0
delirium and agitation 287994 0
Condition category
Condition code
Public Health 288373 288373 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To provide educational support, in the form of academic detailing, to general practitioners to guide prescribing for palliative symptoms to 1 of 5 medicines: metoclopramide 10mg/2mL injection, morphine 10mg/mL injection, hyoscine butylbromide 20mg/mL injection, haloperidol 5mg/mL injection or clonazepam 1mg injection
The academic detailing will involve individual appointments with each general practitioner in the study area, to deliver consistent education messages. These will occur within a 30 minute time period and as a single visit for each practitioner.
Intervention code [1] 286238 0
Not applicable
Comparator / control treatment
This is a quality improvement study to see if we can increase the likelihood of community pharmacies to hold a range of medicines if the prescribers are aware of the types of medicines that they hold. We will compare the rates of holding these medicines prior to and after the intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288545 0
increase in the stock holding of all 5 core medicines in community pharmacies within a defined geographical area.
this will be assessed through monthly questionnaires to each of the community pharmacies. all data will be documented in a secure database.
Timepoint [1] 288545 0
3 months
Secondary outcome [1] 300436 0
improved communication between general practitioners , community nurses and community pharmacists about palliative patients.
All general practitioners , community nurses and community pharmacists will be asked to complete a survey that will measure their perceived communication. we have data from a previous study that only 20% of community pharmacists learned of the palliative status of a patient through a health care provider.
Timepoint [1] 300436 0
6 months

Eligibility
Key inclusion criteria
Patients will not be enrolled into this study
general practitioners , community nurses and community pharmacists will be voluntarily enrolled and the inclusion criteria is that they are based in the City of Victor Harbor (council zone).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be enrolled into this study

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286489 0
Hospital
Name [1] 286489 0
Southern Adelaide Palliative Service
Country [1] 286489 0
Australia
Primary sponsor type
Individual
Name
Kate Swetenham
Address
700 Goodwood Road
Daw Park
SA 5041
Country
Australia
Secondary sponsor category [1] 285279 0
None
Name [1] 285279 0
Address [1] 285279 0
Country [1] 285279 0
Other collaborator category [1] 277229 0
Other
Name [1] 277229 0
Southern Adelaide-Fleurieu-Kangaroo Island Medicare Local
Address [1] 277229 0
Box 1, Level 2A, Mark Oliphant Building
5 Laffer Drive
Bedford Park SA 5042
Country [1] 277229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288567 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288567 0
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 288567 0
Australia
Date submitted for ethics approval [1] 288567 0
Approval date [1] 288567 0
21/11/2012
Ethics approval number [1] 288567 0
024.12

Summary
Brief summary
A recent survey of community pharmacies across South Australia (unpublished) concluded that it is difficult for community pharmacies to anticipate which medicines to stock for the treatment of symptoms commonly seen in the terminal phase of a palliative illness. This information ties in with other published qualitative studies
As a result, a South Australian Palliative Care Formulary Working Party formed and subsequently developed an End of Life Essential Medicines List. This list of medicines was determined following a review of the 6 most frequently encountered symptoms noted in the terminal phase of a palliative illness - nociceptive pain, agitation, nausea/vomiting, dyspnoea, delirium and noisy breathing. The final list of medications was informed by the Working Party’s experience, the Palliative Care Therapeutic Guidelines and other locally used guidelines. The Working Party settled on these medications based on their efficacy, their usefulness in managing more than one symptom and availability on the Schedule of Pharmaceutical Benefits (PBS):
- Morphine 10mg/mL Injection
- Haloperidol 5mg/mL Injection
- Metoclopramide 10mg/2mL Injection
- Hyoscine butylbromide 20mg/mL Injection
-Clonazepam 1mg Injection

A hub pharmacy will be selected in the Victor Harbor Statistical Local Area (SLA): postcode: 5211

The location of the hub pharmacy will be shared with all other community pharmacies within the SLA to encourage quick access to medicines. The location of the hub pharmacy will not be shared with GPs, Nursing homes or patients and their carers. This is a quality improvement initiative.

The aim of this audit is to evaluate the impact of this quality improvement strategy on:
-Supporting local community clinicians to provide palliative care for non-complex patients through the standardisation of prescribing;
-The viability for community pharmacies to stock medicines from an end of life essential medicines list; and
-The impact of having a pharmacy hub in a SLA to support prompt and efficient supply of palliative medicines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36706 0
Mr Paul Tait
Address 36706 0
Daw House Hospice
700 Goodwood Road
Daw Park SA 5041
Country 36706 0
Australia
Phone 36706 0
+61 478 407 877
Fax 36706 0
Email 36706 0
Paul.tait@health.sa.gov.au
Contact person for public queries
Name 36707 0
Mr Paul Tait
Address 36707 0
Daw House Hospice
700 Goodwood Road
Daw Park SA 5041
Country 36707 0
Australia
Phone 36707 0
+61 478 407 877
Fax 36707 0
Email 36707 0
Paul.tait@health.sa.gov.au
Contact person for scientific queries
Name 36708 0
Mr Paul Tait
Address 36708 0
Daw House Hospice
700 Goodwood Road
Daw Park SA 5041
Country 36708 0
Australia
Phone 36708 0
+61 478 407 877
Fax 36708 0
Email 36708 0
Paul.tait@health.sa.gov.au

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.