Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000188235
Ethics application status
Approved
Date submitted
22/01/2018
Date registered
6/02/2018
Date last updated
14/10/2021
Date data sharing statement initially provided
29/05/2019
Date results provided
29/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of pharmacist advice and culturally appropriate services on medication management for Aboriginal and Torres Strait Islanders: a feasibility study
Scientific title
Improved medication management for Aboriginal and Torres Strait Islanders through pharmacist advice and culturally appropriate services: a feasibility study
Secondary ID [1] 293807 0
None
Universal Trial Number (UTN)
U1111-1207-9639
Trial acronym
IMeRSe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication Review Services 306222 0
Condition category
Condition code
Public Health 305323 305323 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Indigenous Medication Review Service.
Although the current 6th Community Pharmacy Agreement (CPA) medication management services are effective strategies for preventing medication-related problems, they are not well utilised by Aboriginal and Torres Strait Islander peoples despite their higher burden of chronic disease. Barriers to access include lack of cultural appropriateness, language, geographical isolation, restrictive referral pathways and eligibility criteria, and the short-term focus of the services.
This 2-year IMeRSe study will develop and evaluate the feasibility of a complex medication management intervention. This intervention aims to optimises an individual consumer’s medication management via a culturally responsive service, which will be delivered collaboratively by community pharmacists and Aboriginal and Torres Strait Islander health services (both Aboriginal Community Controlled Health Services [ACCHS] and government Indigenous Health Services [IHS]). This feasibility study will pilot and evaluate the service to ensure it is acceptable and deliverable across remote, rural and urban settings. A total of 540 adults with a long-term condition, or who are pregnant, or within two years postpartum AND who are at risk of medication-related problems will work with pharmacists and staff from nine Aboriginal and Torres Strait Islander health services across Queensland, New South Wales and Northern Territory to resolve medication-related problems. Data will be collected at baseline and 6-months for all consumers and additionally at 12-months follow-up for 60 participants recruited at two start-up sites (one each in Queensland and the Northern Territory).
The intervention involves a medication management review conducted by community pharmacists in co-ordination with ACCHS/IHS staff which will initially be tested in two start-up sites prior to the feasibility study implementation in the seven remaining sites.
The intervention comprises a two-tiered service conducted at a location nominated by the consumer.
– Tier 1 will involve an initial review of medication–related problems by the community pharmacist, together with the consumer, an ACCHS/IHS clinician, such as an Aboriginal Health Worker (AHW), nurse and/or translator or other nominated support person, as appropriate. This first meeting will support the consumer having a conversation with the pharmacist and ACCHS/IHS clinician about all of their medicines, adherence practices, and identification of their problems. It will provide an opportunity for the pharmacist to explain their role in the healthcare team. Resolution of some problems may occur during this initial review (e.g. through explanation/education and resource provision). For consumers with complex needs, however, recommendations will also be made for follow-up by other health professionals such as the general practitioner (GP). It is expected that that this initial interview will take 60 minutes.
– Tier 2 will comprise any additional community pharmacist follow-up and review if needed to address ongoing problems such as adherence strategies, administration technique (such as inhalers, spacers etc), monitoring, side effects and symptom management/resolution, smoking cessation, and other health-related goals. It may also involve recommendations for other services, such as Dose Administration Aids or referral to other health professionals. The actual content of Tier 2 follow-up will be flexible and consumer-centred to enable individual problems to be identified and achievable goals to be set. It will be delivered in a form agreed upon by the consumer e.g. telephone, text messaging, telehealth, email or at a face-to-face meeting at a convenient location over the next six months. It is expected that for those consumers requiring 3-4 follow-ups to check on adherence, administration technique and health-related goals such as weight that this may take a total of 30 minutes; and for those requiring more intensive or time-consuming follow-ups for monitoring or side-effect and symptom management/resolution plus referral and communication with other health providers that this may take a total of 60 minutes over six months.
Intervention code [1] 300061 0
Prevention
Intervention code [2] 300062 0
Other interventions
Comparator / control treatment
Events occurring during the six-months after the implementation of intervention (eg., incidence of serious medication-related problems) will be compared with those that occurred six-months prior to the intervention for all participants.
Control group
Historical

Outcomes
Primary outcome [1] 304482 0
Proportion of eligible consumers recruited into the study.
This outcome will be used as one of the outcome measures to assess the feasibility.
Timepoint [1] 304482 0
Six-months post introduction of intervention
At two start-up sites, six-months (primary time point) and 12-months post introduction of intervention
Primary outcome [2] 304599 0
Retention rate of the consumers
Timepoint [2] 304599 0
Six-months post introduction of intervention
At two start-up sites, six-months (primary time point) and 12-months post introduction of intervention
Primary outcome [3] 304600 0
Proportion of participants for whom prospective and historical data on “Serious medication related problems” could be recorded and extracted from the health records
Timepoint [3] 304600 0
Six-months post introduction of intervention

At two start-up sites, six-months (primary time point) and 12-months post introduction of intervention
Secondary outcome [1] 342506 0
Difference in mean serious medication-related problems (MRPs) that occurred in the six-months after IMeRSe introduction compared with the mean serious MRPs that occurred in the six-months prior to IMeRSe intervention.
The list of serious MRPs will be pre-specified by reviewing the existing literature which will be tested and refined during the start-up phase of the feasibility study. Any occurrence of serious MRPs will be extracted from clinical records.
Timepoint [1] 342506 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.
Secondary outcome [2] 342507 0
Psychological distress (Kessler 6 will be used for this purpose)
Timepoint [2] 342507 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.
Secondary outcome [3] 342508 0
Difference in mean potentially preventable medication-related hospitalisations (PPMRHs).
A pre-specified list will be used to identify and record PPMRHs
Timepoint [3] 342508 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.
Secondary outcome [4] 342509 0
Difference in mean MRPs (all types)
DOCUMENT which is a classification system for drug-related problems and their resolution will be used to record and evaluate all MRPs
Timepoint [4] 342509 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.
Secondary outcome [5] 342510 0
Beliefs about medicines will be assessed using validated Beliefs about Medicines questionnaire
Timepoint [5] 342510 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.
Secondary outcome [6] 342511 0
Medication adherence will be assessed using Reported Adherence to Medication Scale (RAMS)
Timepoint [6] 342511 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.
Secondary outcome [7] 342512 0
Difference in government health resource use
Measured as a total of all MBS items, PBS items, Section 100, PBS Close the gap (CTC) co-payments, laboratory tests and hospitalisations.
Timepoint [7] 342512 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.
Secondary outcome [8] 342513 0
Psychological and social empowerment will be assessed using a validated Aboriginal and Torres Strait Islander specific questionnaire Growth and Empowerment Measure (GEM)
Timepoint [8] 342513 0
Six-months post introduction of intervention (n=540)
For participants recruited in two start-up sites (n=60), six-months (primary time point) and 12-months post introduction of intervention.

Eligibility
Key inclusion criteria
Aboriginal and Torres Strait Islander peoples receiving health care from an Aboriginal Community Controlled Health Service (ACCHS) or Indigenous Health Services (IHS) in Australia:
• Who are aged 18 years and over;
• Living in the community;
• Who have used the clinical services of the ACCHO or IHS at least three times in the past two years
• Who use a community pharmacy that is participating in the trial;
AND
• Who have a chronic condition OR are pregnant OR are within two years postpartum;
AND
• Who are at risk of medication-related problem(s) (as identified by any health professional
involved in their care) including but not limited to the following:
– instability of health status and/or medicines therapy;
– using a high risk medicine(s);
– likelihood of compromised adherence;
– new therapeutic goals;
– potentially incomplete understanding of patient’s pattern of medicine use by health professionals; or
– failure to respond to treatment in the expected way;
AND
• Who provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consumer participants who have received any existing Medication Management Review services in the previous 12 months will be excluded.

Study design
Purpose of the study
Prevention
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
Completed
Date of first participant enrolment
Anticipated
16/04/2018
Actual
8/06/2018
Date of last participant enrolment
Anticipated
31/01/2019
Actual
30/04/2019
Date of last data collection
Anticipated
30/04/2020
Actual
31/07/2020
Sample size
Target
540
Accrual to date
Final
291
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD

Funding & Sponsors
Funding source category [1] 298423 0
Government body
Name [1] 298423 0
Australian Government, Department of Health
Country [1] 298423 0
Australia
Primary sponsor type
Individual
Name
Amanda Wheeler
Address
Room 1.02, Building N70
Menzies Health Institute Queensland
Nathan Campus, Griffith University
170 Kessels Road, QLD 4111
Country
Australia
Secondary sponsor category [1] 297563 0
Individual
Name [1] 297563 0
Jean Spinks
Address [1] 297563 0
Room 1.04, Building N70
Menzies Health Institute Queensland
Nathan Campus, Griffith University
170 Kessels Road, QLD 4111
Country [1] 297563 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299419 0
Griffith University Human Research Ethics Committee [EC00162]
Ethics committee address [1] 299419 0
Ethics committee country [1] 299419 0
Australia
Date submitted for ethics approval [1] 299419 0
22/03/2018
Approval date [1] 299419 0
23/03/2018
Ethics approval number [1] 299419 0
2018/251
Ethics committee name [2] 301595 0
Metro South Human Research Ethics Committee [EC00167]
Ethics committee address [2] 301595 0
Ethics committee country [2] 301595 0
Australia
Date submitted for ethics approval [2] 301595 0
15/02/2018
Approval date [2] 301595 0
20/03/2018
Ethics approval number [2] 301595 0
HREC/18/QPAH/109
Ethics committee name [3] 301596 0
Aboriginal Health & Medical Research Council Ethics Committee [EC00342]
Ethics committee address [3] 301596 0
Ethics committee country [3] 301596 0
Australia
Date submitted for ethics approval [3] 301596 0
02/03/2018
Approval date [3] 301596 0
16/04/2018
Ethics approval number [3] 301596 0
1381/18
Ethics committee name [4] 301597 0
Central Australian Human Research Ethics Committee [EC00155]
Ethics committee address [4] 301597 0
Ethics committee country [4] 301597 0
Australia
Date submitted for ethics approval [4] 301597 0
29/03/2018
Approval date [4] 301597 0
22/05/2018
Ethics approval number [4] 301597 0
CA-18-3090
Ethics committee name [5] 301598 0
Far North Queensland Human Research Ethics Committee [EC00157]
Ethics committee address [5] 301598 0
Ethics committee country [5] 301598 0
Australia
Date submitted for ethics approval [5] 301598 0
04/06/2018
Approval date [5] 301598 0
29/06/2018
Ethics approval number [5] 301598 0
HREC/18/QCH/86 – 1256
Ethics committee name [6] 303472 0
Australian Institute of Health and Welfare Ethics Committee
Ethics committee address [6] 303472 0
Ethics committee country [6] 303472 0
Australia
Date submitted for ethics approval [6] 303472 0
06/08/2018
Approval date [6] 303472 0
25/09/2018
Ethics approval number [6] 303472 0
EO2018/4/486
Ethics committee name [7] 303473 0
Australian Government Department of Human Services EREC
Ethics committee address [7] 303473 0
Ethics committee country [7] 303473 0
Australia
Date submitted for ethics approval [7] 303473 0
23/03/2018
Approval date [7] 303473 0
20/04/2018
Ethics approval number [7] 303473 0
MI9435

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80338 0
Prof Amanda Wheeler
Address 80338 0
Room 1.02, Building N70
Menzies Health Institute Queensland
Nathan Campus, Griffith University
170 Kessels Road, QLD 4111
Country 80338 0
Australia
Phone 80338 0
+61 7 338 21068
Fax 80338 0
Email 80338 0
a.wheeler@griffith.edu.au
Contact person for public queries
Name 80339 0
Anni Bohn
Address 80339 0
Room 1.10, Building N70
Menzies Health Institute Queensland
Nathan Campus, Griffith University
170 Kessels Road, QLD 4111
Country 80339 0
Australia
Phone 80339 0
+61 7 3735 8056
Fax 80339 0
Email 80339 0
a.bohn@griffith.edu.au
Contact person for scientific queries
Name 80340 0
Amanda Wheeler
Address 80340 0
Room 1.02, Building N70
Menzies Health Institute Queensland
Nathan Campus, Griffith University
170 Kessels Road, QLD 4111
Country 80340 0
Australia
Phone 80340 0
+61 7 338 21068
Fax 80340 0
Email 80340 0
a.wheeler@griffith.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
Consent for publication of raw data was not obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2163Study protocol    Wheeler AJ, Spinks J, Kelly F, Ware RS, Vowles E, ... [More Details] 374320-(Uploaded-24-05-2019-09-56-05)-Study-related document.pdf
13559Ethical approval  a.wheeler@griffith.edu.au



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a feasibility study of an Indigenous Medication Review Service (IMeRSe) in Australia.2018https://dx.doi.org/10.1136/bmjopen-2018-026462
Dimensions AIAdaptation of potentially preventable medication-related hospitalisation indicators for Indigenous populations in Australia using a modified Delphi technique2019https://doi.org/10.1136/bmjopen-2019-031369
EmbaseMedication-related problems identified by community pharmacists: a descriptive case study of two Australian populations.2023https://dx.doi.org/10.1186/s40545-023-00637-x
N.B. These documents automatically identified may not have been verified by the study sponsor.