Integrating pharmacists into Aboriginal Community Controlled Health Services (IPAC project): Protocol for an interventional, non-randomised study to improve chronic disease outcomes

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Abstract

Background

Aboriginal and Torres Strait Islander peoples experience a higher burden of chronic disease yet have poorer access to needed medicines than other Australians. Adverse health outcomes from these illnesses can be minimised with improved prescribing quality. This project aims to improve quality of care outcomes for Aboriginal and Torres Strait Islander adult patients with chronic disease by integrating a pharmacist within primary health care teams in Aboriginal Community Controlled Health Services (ACCHSs).

Methodology

This non-randomised, prospective, pre and post quasi-experimental study, will be pragmatic, community-based and participatory, comparing outcomes and costs using paired patient data. Pharmacists will be integrated at 22 sites for approximately 15 months to conduct patient-related and practice-related activities through 10 core roles: providing medication management reviews, assessing adherence and medication appropriateness, providing medicines information and education and training, collaborating with healthcare teams, delivering preventive care, liaising with stakeholders, providing trnsitional care, and undertaking a drug utilisation review. With patients’ consent, de-identified client-level data will be extracted from clinical information systems and pharmacists will record deidentified activity in an electronic logbook. Primary expected outcomes include improvements in biometric indices (glycated haemoglobin, systolic and diastolic blood pressure, lipids, cardiovascular risk, albumin-creatinine ratio) from baseline to end of study. Expected secondary outcomes include improvements in estimated glomerular filtration rate, prescribing indices (appropriateness, overuse and underuse), medication adherence, self-assessed health, and health service utilisation indices. A qualitative assessment of stakeholder and patient perceptions and a cost-effectiveness analysis will be undertaken.

Discussion

Numerous inquiries have recommended evaluating the impact of pharmacists integrated within primary health care settings. This study is the first to explore this impact on the health of Aboriginal and Torres Strait Islander peoples who are medically underserved. Evaluation of innovative integrated workforce models is necessary to address the challenges of delivering quality care together with this population.

Introduction

Aboriginal and Torres Strait Islander peoples’ in Australian communities face many barriers accessing medicines including financial and geographic constraints, failed patient-clinician interactions, poor healthcare delivery systems and complex therapeutic medication regimens.1,2 The physical settings of community pharmacies and informational continuity challenges with Aboriginal health services that limit the sharing of patient information, have made it difficult for some Aboriginal and Torres Strait Islander people to have productive relationships with pharmacists.3,4 While Australian initiatives under the 6th Community Pharmacy Agreement (6CPA), the section 100 program for remote area Aboriginal health services, and the Closing the Gap (CTG) Pharmaceutical Benefits Scheme (PBS) Co-payment Measure have removed some of the financial barriers to accessing medicines,5 the 2013-14 PBS per person expenditure for Indigenous Australians was only 33% of the expenditure for non-Indigenous Australians.5 There is still considerable need to improve medicines access, as well as the quality use of medicines for populations that are medically underserved. Medication adherence, in general for anyone with chronic disease is poor, resulting in disease-related complications, higher levels of hospitalisation, and increased morbidity and mortality,6 whilst the economic costs of non-adherence are very high.7

Innovative and culturally appropriate models of care to enhance the quality use of medicines for Aboriginal and Torres Strait Islander peoples are necessary. One model is to better integrate pharmacists within primary health care services. The National Health Service in the UK have invested heavily in such an initiative,8 whilst New Zealand, Canada and the USA already have pharmacists providing clinical services within general practice settings.9 In Australia, the concept has received endorsement from leading medical organizations such as the Australian Medical Association,10 general practice groups,11 and pharmacists.12,13 Currently, registered pharmacists provide only limited clinical pharmacy services to Indigenous Australians due to several barriers.14,15 These include prohibitive Home Medication Review (HMR) business rules including processes that are not always possible nor culturally acceptable.15,16 Many Aboriginal health services provide few HMR referrals due to issues with the cultural responsiveness of pharmacists, and lack of pharmacist relationships with ACCHSs.16,17 Yet, when medication reviews are delivered in culturally appropriate settings (such as in Aboriginal health services) there is great potential to increase patients’ medication knowledge, medication adherence and to improve chronic disease management.16

Public inquiries,18 pharmacists,19 and independent statutory bodies such as the Australian Productivity Commission,20 have recommended exploring better ways to utilise the full scope of pharmacist roles within collaborative clinical models. Co-location of pharmacists within general practice has enabled greater communication, collaboration and relationship building among health professionals.12,21 Pharmacist integration within primary health care services can also improve clinical health outcomes and quality prescribing. Pharmacists that are fully integrated offer improved outcomes especially when providing holistic services to patients on multiple medications and co-morbidities.22 Integrated pharmacists can also significantly reduce medicine errors as shown in UK general practices.23 An economic analysis found that the integration of pharmacists in Australian general practice has the potential to be cost-effective through broader heath savings at a federal, state and consumer level.24

Despite the substantial interest in health reform, the impact of pharmacists on patient health outcomes when working within their scope of practice and integrated within Aboriginal health settings has never been evaluated. In order to investigate the potential gains in health outcomes arising from integrated models of care within Aboriginal health settings, the Integrating Pharmacists within Aboriginal Community Controlled Health Services (ACCHSs) to improve Chronic Disease Management (IPAC) Project was developed. The project is funded by the Australian Government Department of Health, under the Pharmacy Trials Program (Tranche 2) funding as part of the Sixth Community Pharmacy Agreement (6CPA) that seeks to improve clinical outcomes for patients utilizing the full scope of pharmacists role in delivering primary health care services. This Program is also supporting a study of the feasibility of a 6-step medication review service to be delivered by community pharmacy with pharmacists trained to work with clients of Aboriginal health services.25

The IPAC project will determine if including a non-dispensing registered pharmacist as part of the primary health care (PHC) team within ACCHSs (the intervention) leads to improvements in the quality of the care received by Aboriginal and Torres Strait Islander peoples with chronic diseases. The project will target adult patients with chronic diseases to optimise the pharmacological management of their condition given that coronary heart disease and diabetes contribute 22% and 12% respectively of the mortality gap with other Australians.26 ACCHSs provide comprehensive culturally appropriate primary health care to predominantly Aboriginal and Torres Strait Islander clients and form the vast majority of Aboriginal health services in Australia. They share a community governance model of care employing local Aboriginal and Torres Strait Islander staff, governed by elected Aboriginal and Torres Strait Islander leaders. Although funded largely by the Australian Government, they are independent not-for-profit agencies established by Aboriginal leaders from 1971 in response to significant unmet health needs.27

The IPAC Project makes two clinical claims. Firstly, Aboriginal and/or Torres Strait Islander adult patients with chronic disease who are managed by this model of care, receiving pharmacist services integrated within ACCHSs, will experience superior quality of care outcomes compared to usual care. Secondly, services provided by pharmacists within ACCHSs is likely to lead to superior health care service utilization (towards equity) by patients with chronic disease compared to usual care. This paper describes the development and planned evaluation of the intervention within a community-based participatory research model and complies with the SPIRIT 2013 guidelines for clinical trial protocols (Supplementary File A).28

Section snippets

Study design

The IPAC project is a pragmatic, non-randomized, prospective, pre and post quasi-experimental study (Trial Registration Number and Register: ACTRN12618002002268). The intervention is the integration of a registered pharmacist within the ACCHS primary healthcare team for a 15-month period. Up to 22 ACCHS sites will be recruited for the project across three jurisdictions: Victoria, Queensland and the Northern Territory to ensure a sampling frame that best informs external validity of the outcomes

Discussion

Healthcare reform depends on ways to improve productivity and ensure the triple aim of: clinically effective healthcare, improved patient experience, and cost-effectiveness (‘better health, better health care, and better value’).60 This project aims to evaluate a new integrated care model where Australian pharmacists work collaboratively with healthcare staff and patients to improve the quality use of medicines within primary health care settings that target Aboriginal peoples and Torres Strait

Funding body

The project is funded by the Australian Government Department of Health, under the Pharmacy Trials Program (Tranche 2) funding as part of the Sixth Community Pharmacy Agreement (6CPA). The project funder had no role in study design, data collection, management of the project, analysis and interpretation, writing of the report, or the decision to submit the report for publication. The project funder has a role in approving reports for publication.

CRediT authorship contribution statement

Sophia Couzos: Conceptualization, Methodology, Formal analysis, Investigation, Writing - original draft, Visualization, Supervision, Funding acquisition. Deborah Smith: Methodology, Formal analysis, Investigation, Writing - review & editing, Visualization, Project administration. Mike Stephens: Conceptualization, Methodology, Writing - review & editing, Supervision, Funding acquisition. Robyn Preston: Methodology, Formal analysis, Investigation, Writing - review & editing. Delia Hendrie:

Declaration of competing interest

None.

Acknowledgments

The IPAC Operational Team wishes to acknowledge Ms Dawn Casey, Deputy Chief Executive Officer for NACCHO in her role as Chair of the Project Reference Group and member of the IPAC Steering Committee, and the NACCHO Affiliates for their assistance in this project and their staff: Dr Nadia Lusis, Dr Elizabeth Moore, and Mr Roderick Wright in the early stages of project design. The team also acknowledges Ms Priscilla Page for her assistance with planning the qualitative analysis, Mr Mitch Russell

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