ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 information initially 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]

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

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

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]

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]

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]

Retention rate of the consumers

Timepoint [2]

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]

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]

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]

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]