Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002002268
Ethics application status
Approved
Date submitted
3/12/2018
Date registered
13/12/2018
Date last updated
28/11/2019
Date data sharing statement initially provided
13/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrating Pharmacists within Aboriginal Community Controlled Health Services to improve Chronic Disease Management Project
Scientific title
Integrating Pharmacists within Aboriginal Community Controlled Health Services to improve Chronic Disease Management (IPAC) Project
Secondary ID [1] 296714 0
PHARMACY TRIAL PROGRAM TRANCHE 2 H1617G013
Universal Trial Number (UTN)
Trial acronym
IPAC Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 310622 0
Type 2 diabetes mellitus 310623 0
Chronic kidney disease 310624 0
Polypharmacy 310625 0
Coronary heart disease 310709 0
Stroke 310710 0
Hypertension 310711 0
Dyslipidaemia 310712 0
Condition category
Condition code
Cardiovascular 309288 309288 0 0
Coronary heart disease
Cardiovascular 309339 309339 0 0
Hypertension
Cardiovascular 309340 309340 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 309341 309341 0 0
Diabetes
Renal and Urogenital 309342 309342 0 0
Kidney disease
Cardiovascular 309343 309343 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACCHSs will be offered a pharmacist (aggregated 0.57 FTE across 24 sites, for 15 months duration) under a service agreement. Non-dispensing pharmacists will be integrated within existing primary health care teams, and introduce new services not currently delivered within ACCHS settings. The intervention is for 15 months duration.

Eligibility criteria for pharmacists will include current registration with the Australian Health Practitioners Regulation Agency (AHPRA) as a pharmacist; more than 2 years post-registration experience; and post-graduate clinical qualifications or demonstrated clinical experience (e.g. hospital or HMRs). Accreditation for medication reviews will be desirable but not essential.

The pharmacist will undertake 10 core roles and additional roles as specified by services and the service agreement which will reflect the pragmatic approach to the intervention. The 10 core roles are:
1. Medication Management Reviews - undertakes Home Medicines Reviews (HMR) and non-HMRs (review not conducted in the patient's home)
2. Team-based collaboration - participate in clinic activities that support team-based chronic disease care plans, and cardiovascular risk assessment
3. Medication adherence assessment & support - assess adherence and identify strategies for improvement (self-care)
4. Medication appropriateness audit, and Assessment of Underutilisation - a sample of patients will be assessed for underutilisation of medicines
5. Preventative health care - promote preventive interventions with patients
6. Drug Utilisation Reviews - identify and improve a priority issue at the service
7. Education and training - conduct sessions for staff and patients
8. Medicines information service - provide medicine related advice to staff and respond to queries
9. Medicines stakeholder liaison - develop a stakeholder plan supporting engagement with community pharmacies
10. Transitional care - facilitate care coordination with other relevant health care facilities

The project will adhere to community-based participatory research (CBPR) principles, to ensure clear benefits to project sites, and ensure acceptability and sustainability of the intervention within ACCHSs. Prior to the pharmacist starting a needs assessment will be undertaken with each participating ACCHS and their local priorities used to inform a workplan.

Patients will be able to see the IPAC pharmacist similar to any other health professional within the primary health care team. They will benefit from having immediate access to the on-site pharmacist and receive tailored and appropriate medication reviews and support to optimise their use of medicines. Patients who consent to be part of the project will have their health data extracted from the ACCHS clinical information system, and medication reviews in which they participate, and interactions with the pharmacist, recorded in the pharmacists’ logbook. All data is de-identified and able to be linked using the patient ID number. The information that is collected will only be used for this project.

On site and external training will be delivered to pharmacists to ensure skills in cultural safety, an introduction to the project and the core roles, an overview of clinical information systems and other software used, obtaining patient consent, recording data, and use of evaluation tools. Facilitated training to maintain confidentiality in the clinic setting, teamwork processes, delivering disease-specific services, understanding roles, and how to explain the pharmacists’ role to patients will also be provided.

Resources around the 10 core roles will be developed and available to support the pharmacists' work. Online training will be facilitated for the pharmacists. Modules are Collaboration (PSA); Motivational Interviewing (PSA); and Chronic Disease Management (Aust Govt Dept Human Services Medicare Benefits Schedule). Peer support for all participating pharmacists will be provided through a Mentoring Program facilitated by the PSA in collaboration with NACCHO. The program will source mentor pharmacists from the joint NACCHO-PSA ACCHO Pharmacist Leadership Group and other pharmacists with relevant experience in the ACCHS sector. Mentees will be matched with appropriate mentors by NACCHO and PSA. A minimum of four meetings will be held via teleconference over the project. Peer interaction is also enabled through an online discussion board and other appropriate technological applications. Mentors and mentees can confer, provide support and share resources, as a group or one-on-one.
Intervention code [1] 313061 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308297 0
Proportion of participants with reduction in systolic blood pressure measurements as recorded in the clinical information system
Timepoint [1] 308297 0
Baseline and 15-months post-baseline
Primary outcome [2] 308298 0
Proportion of participants with reduction in HbA1Cs as recorded in the clinical information system
Timepoint [2] 308298 0
Baseline and 15-months post-baseline
Primary outcome [3] 308378 0
Proportion of participants with reduced serum lipids as recorded in the clinical information system
Timepoint [3] 308378 0
Baseline and 15-months post-baseline
Secondary outcome [1] 354566 0
Change in Medication Appropriateness Index (MAI) scores as measured by the the MAI tool
Timepoint [1] 354566 0
Baseline and 15-months post-baseline
Secondary outcome [2] 354567 0
Change in proportion of participants with unnecessary medication use as measured by the MAI
Timepoint [2] 354567 0
Baseline and 15-months post-baseline
Secondary outcome [3] 354568 0
Change in number of Home Medication Reviews (HMRs) as assessed by MBS claims for item number 900 recorded in the clinical information system.
Timepoint [3] 354568 0
Baseline and 15-months post-baseline
Secondary outcome [4] 354569 0
Change in self-reported patient experiences with medicines assessed by focus groups and individual interviews.

Patient experiences will be assessed through field work visits to 3 participating sites (nominate voluntarily). A focus group discussion will be held with 6-8 participants who have experience with the IPAC Pharmacist. The focus group will run for approx. 45-60 minutes and be audio-recorded, In addition an in-depth semi-structured interview will be held with one patient who has experience with the IPAC Pharmacist. It will run for approx. 45-60 minutes and be audio-recorded.
Timepoint [4] 354569 0
15-months post-baseline
Secondary outcome [5] 354570 0
Change in self-assessed health status as measured by the SF1 question (from the SF36 instrument)
Timepoint [5] 354570 0
Baseline and 15-months post-baseline
Secondary outcome [6] 354814 0
Change in medication adherence scores as assessed by a validated Aboriginal-specific self-reported assessment tool
Timepoint [6] 354814 0
Baseline and 15.months post-baseline
Secondary outcome [7] 354815 0
Determine cost-effectiveness by assessing how much it costs to have one less patient with medication under-utilisation.

Costs will cover the value of resources involved in providing the intervention. Medication under-utilisation will be assessed by the pharmacists using the Assessment of Under-utilisation (AoU) tool and recorded in a logbook. The incremental benefit (underutilisation) will be compared with the incremental costs.
Timepoint [7] 354815 0
15-months post baseline
Secondary outcome [8] 354900 0
Change in number of Domiciliary Medication Management Reviews (DMMRs) as assessed by MBS claims for item number 900 recorded in the clinical information system.
Timepoint [8] 354900 0
Baseline and 15-months post-baseline
Secondary outcome [9] 377423 0
Change in estimated glomerular filtration rate
Timepoint [9] 377423 0
Baseline mean eGFR compared with end of study (15-months post-baseline)

Eligibility
Key inclusion criteria
Aged 18 years of age and over with:
• Cardiovascular disease (coronary heart disease, stroke, hypertension, dyslipidaemia and any other CV disease)
• Type 2 diabetes mellitus,
• Chronic kidney disease,
• Other chronic conditions at high risk of developing medication-related problems (e.g. polypharmacy).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and youth under 18 years of age are not eligible to participate. Individuals who are not regular patients of the ACCHS should not be enrolled to participate as follow-up and regular support are key aspects of the project.

Study design
Purpose of the study
Treatment
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
A sample size of 732 patients with chronic disease will achieve power in excess of 80% to detect (1) an absolute CVD risk reduction of 1% (1-point difference) from baseline if a standard deviation (SD) of 2.7% was assumed; (2) a clinically relevant reduction of 10mmHg (SD 20 mmHg) in systolic blood pressure and (3) 5mmHg (SD 10 mmHg) in diastolic blood pressure; (4) a reduction in total cholesterol (-0.3mmol/L; SD 1 mmol/l), (5) an increase in high-density lipoproteins (0.1 mmol/L; SD 0.4 mmol/l), and (6) a reduction in low-density lipoproteins (-0.3 mmol/L; SD 0.9 mmol/l); (7) a reduction in triglycerides (-0.9mmol/L; SD 1.5 mmol/l); and (8) a 30% decrease in ACR (SD: 23 mg/mmol); with an overall level of significance of 0.05 (adjusted for multiple testing k=8) using two-sided one-sample paired t-tests. A total of 119 T2DM patients will achieve power in excess of 80% to detect a decrease in HbA1c (in % units) from baseline of at least 0.5% with an assumed SD for change of 1% with an overall level of significance of 0.05 using two-sided one-sample paired t-tests.

Our sample size calculations allow for an attrition rate (including missing values) of 50% and assumed a design effect of 1.75 to adjust for the cluster sampling approach. Calculations are based on a comparison of mean values in a paired analysis, and were conducted with PASS 2008 (NCSS, Kaysville, Utah, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/08/2018
Date of last participant enrolment
Anticipated
28/02/2019
Actual
1/09/2019
Date of last data collection
Anticipated
1/11/2019
Actual
1/11/2019
Sample size
Target
1500
Accrual to date
Final
1600
Recruitment in Australia
Recruitment state(s)
NT,QLD,VIC
Recruitment postcode(s) [1] 25000 0
0830 - Palmerston
Recruitment postcode(s) [2] 25001 0
0850 - Katherine
Recruitment postcode(s) [3] 25004 0
3215 - Bell Park
Recruitment postcode(s) [4] 25005 0
3250 - Colac
Recruitment postcode(s) [5] 25006 0
3305 - Portland
Recruitment postcode(s) [6] 25007 0
3500 - Mildura
Recruitment postcode(s) [7] 25008 0
3501 - Mildura Centre Plaza
Recruitment postcode(s) [8] 25009 0
3550 - Bendigo
Recruitment postcode(s) [9] 25010 0
3585 - Swan Hill
Recruitment postcode(s) [10] 25011 0
4350 - Toowoomba
Recruitment postcode(s) [11] 25012 0
4405 - Dalby
Recruitment postcode(s) [12] 25013 0
4487 - St George
Recruitment postcode(s) [13] 25014 0
4605 - Cherbourg
Recruitment postcode(s) [14] 25015 0
4825 - Mount Isa
Recruitment postcode(s) [15] 25016 0
4869 - Edmonton
Recruitment postcode(s) [16] 25017 0
4870 - Cairns
Recruitment postcode(s) [17] 25018 0
4871 - Yarrabah
Recruitment postcode(s) [18] 25019 0
4876 - Injinoo
Recruitment postcode(s) [19] 25020 0
0800 - Darwin
Recruitment postcode(s) [20] 25021 0
0812 - Malak
Recruitment postcode(s) [21] 25022 0
0810 - Rapid Creek
Recruitment postcode(s) [22] 25023 0
0820 - Bagot
Recruitment postcode(s) [23] 25024 0
0822 - Milingimbi
Recruitment postcode(s) [24] 25025 0
0822 - Galiwinku
Recruitment postcode(s) [25] 25026 0
0880 - Nhulunbuy
Recruitment postcode(s) [26] 25027 0
0880 - Yirrkala
Recruitment postcode(s) [27] 25028 0
0852 - Lajamanu
Recruitment postcode(s) [28] 25029 0
0852 - Kalkarindji

Funding & Sponsors
Funding source category [1] 301294 0
Government body
Name [1] 301294 0
Australian Government Department of Health
Country [1] 301294 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Sophia Couzos
Address
General Practice and Rural Medicine
College of Medicine and Dentistry
Division of Tropical Health and Medicine
James Cook University, 1 James Cook Drive
Townsville QLD 4811
Country
Australia
Secondary sponsor category [1] 301018 0
None
Name [1] 301018 0
Address [1] 301018 0
Country [1] 301018 0
Other collaborator category [1] 280450 0
Other Collaborative groups
Name [1] 280450 0
National Aboriginal Community Controlled Health Organisation
Address [1] 280450 0
Level 3
2 Constitution Ave,
Canberra ACT 2601
Country [1] 280450 0
Australia
Other collaborator category [2] 280451 0
Other Collaborative groups
Name [2] 280451 0
Pharmaceutical Society of Australia
Address [2] 280451 0
Level 1,
17 Denison Street,
Deakin ACT 2600
Country [2] 280451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302035 0
St Vincents Hospital Melbourne, Human Research Ethics Committee
Ethics committee address [1] 302035 0
Ethics committee country [1] 302035 0
Australia
Date submitted for ethics approval [1] 302035 0
15/12/2017
Approval date [1] 302035 0
15/03/2018
Ethics approval number [1] 302035 0
252/17 (SERP HREC/17/SVHM/280)
Ethics committee name [2] 302090 0
James Cook University, Human Ethics Research Committee
Ethics committee address [2] 302090 0
Ethics committee country [2] 302090 0
Australia
Date submitted for ethics approval [2] 302090 0
22/03/2018
Approval date [2] 302090 0
13/04/2018
Ethics approval number [2] 302090 0
H7348
Ethics committee name [3] 302091 0
Northern Territory Department of Health and Menzies School of Health Research, Human Research Ethics Committee
Ethics committee address [3] 302091 0
Ethics committee country [3] 302091 0
Australia
Date submitted for ethics approval [3] 302091 0
23/03/2018
Approval date [3] 302091 0
30/05/2018
Ethics approval number [3] 302091 0
2018-3072
Ethics committee name [4] 302092 0
Central Australian Human Research Ethics Committee
Ethics committee address [4] 302092 0
Ethics committee country [4] 302092 0
Australia
Date submitted for ethics approval [4] 302092 0
23/03/2018
Approval date [4] 302092 0
30/08/2018
Ethics approval number [4] 302092 0
CA-18-3085

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

Contacts
Principal investigator
Name 88918 0
A/Prof Sophia Couzos
Address 88918 0
General Practice and Rural Medicine
College of Medicine and Dentistry
Division of Tropical Health and Medicine
James Cook University,
1 James Cook Drive
Townsville QLD 4811
Country 88918 0
Australia
Phone 88918 0
+61747816062
Fax 88918 0
+61747813183
Email 88918 0
[email protected]
Contact person for public queries
Name 88919 0
Deb Smith
Address 88919 0
College of Medicine and Dentistry
Division of Tropical Health and Medicine
James Cook University,
1 James Cook Drive
Townsville QLD 4811
Country 88919 0
Australia
Phone 88919 0
+61747816861
Fax 88919 0
+61747813183
Email 88919 0
[email protected]
Contact person for scientific queries
Name 88920 0
Sophia Couzos
Address 88920 0
General Practice and Rural Medicine
College of Medicine and Dentistry
Division of Tropical Health and Medicine
James Cook University,
1 James Cook Drive
Townsville QLD 4811
Country 88920 0
Australia
Phone 88920 0
+61747816062
Fax 88920 0
+61747813183
Email 88920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.