ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000965101

Ethics application status

Approved

Date submitted

18/06/2019

Date registered

8/07/2019

Date last updated

7/09/2020

Date data sharing statement initially provided

8/07/2019

Date results information initially provided

7/09/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Point-of-Care C-Reactive Protein Test for Supporting the Management of Respiratory Tract Infections in Western Australian Community Pharmacy: A Feasibility Study

Scientific title

Point-of-Care C-Reactive Protein Test for Supporting the Management of Respiratory Tract Infections in Western Australian Community Pharmacy: A Feasibility Study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1235-5831

Trial acronym

N/A

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Upper Respiratory Tract Infections

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients with symptoms of respiratory tract infections (RTIs) or requesting a product to treat RTIs will be provided pharmacist advice based on the presenting symptoms and patient assessment based upon questioning. Currently, there are no further objective tests available in the community pharmacy setting to assist pharmacists in supporting clinical decision-making as to whether the infection is a bacterial or viral RTI, and therefore, whether the patient should to be referred to a GP for further assessment and timely access to antibiotics.
C-reactive protein (CRP) is a biomarker that can be used to identify bacterial infection and to monitor response to treatment in chronic inflammatory diseases. A Point-of-Care (POC) CRP result may be produced by the pharmacist in less than five minutes, using a capillary blood sample from a finger prick. The feasibility and impact of this single, once off test result, in conjunction with pharmacists' routine assessment and questioning will be assessed using a validated guide. CRP levels will be assessed using the Alere Afinion AS100 Analyzer with the Alere Afinion CRP Test Cartridges.
The study will involve five community pharmacies, each with at least two pharmacists and an assistant/intern pharmacist, trained to deliver the service. Each pharmacy will recruit approximately 30 patients, offered and provided the CRP testing service. To assess patient satisfaction and feasibility of service provision, training material is provided during the study period, validated by an Infectious Diseases specialist clinician, patient and pharmacist questionnaires, 3-day follow ups by the pharmacist and 5-day follow ups by the Research Assistant. Importantly, all patients will be provided with the following disclaimer: "This CRP reading only reflects a patient’s condition at the time of testing. If symptoms persist or worsen, see your GP."

Intervention code [1]

Early detection / Screening

Comparator / control treatment

No control group. A control group is not required as part of this study as it is a feasibility study, investigating the implementation of CRP Testing service in addition to routine assessment in community pharmacies.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Acceptability of CRP testing to pharmacists as assessed by a combined response to a series of 5-point Likert scale questions

Timepoint [1]

Eight weeks after trial commencement

Primary outcome [2]

Acceptability of CRP testing to consumers as assessed by a combined response to a series of 5-point Likert scale questions

Timepoint [2]

Immediately after testing and the overall service provision

Secondary outcome [1]

Pharmacists' confidence in reporting tests using study specific questionnaire

Timepoint [1]

Eight weeks after trial commencement

Secondary outcome [2]

Pharmacists' confidence in delivering the service using validated resources and protocols provided, using study specific questionnaire

Timepoint [2]

Eight weeks after trial commencement

Secondary outcome [3]

Pharmacists' knowledge about point-of-care CRP testing using study specific questionnaire

Timepoint [3]

Eight weeks after trial commencement

Secondary outcome [4]

Consumers' experience with the service using study specific questionnaire

Timepoint [4]

Immediately after testing and the overall service provision

Eligibility

Key inclusion criteria

• At least 18 years of age, AND
• Less than 65 years of age, AND
• Able to provide informed consent to participate
• Presenting to the pharmacy with either an RTI-related product request OR RTI symptom, AND
• Seeking advice regarding the need for antibiotics or need to visit a GP

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Under 18 years of age
• 65 years and above
• Presenting with a medical condition that may cause an underlying rise in CRP levels, such as rheumatoid arthritis or other autoimmune conditions
• Immuno-compromised or on a medication that could affect their immune response

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

N/A

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

N/A

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

N/A

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This is a feasibility study. The findings will provide valuable information to answer some key questions and assist with the design of the large implementation study.
Success of this pilot (feasibility) study would lead to a larger clinical trial involving a broader range of pharmacies (including rural, remote and regional areas) and experimental design.

The pilot study will be conducted over a period of six to eight weeks, over the months of the flu season. Each pharmacy will recruit 25-30 adult patients into the study; the total sample of = 125 patients will enable descriptive analysis appropriate for a pilot study, with some comparison of patient outcomes.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

17/06/2019

Date of last participant enrolment

Anticipated

18/08/2019

Actual

11/08/2019

Date of last data collection

Anticipated

18/08/2019

Actual

23/10/2019

Sample size

Target

125

Accrual to date

Final

131

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

J M O'Hara Research Fund

Address [1]

Pharmaceutical Society of Western Australia.
21 Hamilton Street
Subiaco, Western Australia, 6008

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Curtin University
Kent Street,
Bentley, Western Australia, 6102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee (HREC)

Ethics committee address [1]

Curtin University:
Kent Street, Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/02/2019

Approval date [1]

21/03/2019

Ethics approval number [1]

HRE2019-0139

Summary

Brief summary

This study aims to evaluate the feasibility of point-of-care (POC) C-reactive protein (CRP) testing to support pharmacists’ management of respiratory tract infections (RTIs) in community pharmacies in Western Australia. POC CRP testing provides a result in less than five minutes, using a capillary blood sample from a finger prick and is a biomarker of inflammation used to assist differentiation between bacterial from viral infections in some circumstances. The study hypothesis is that CRP testing in community pharmacies, in addition to pharmacists' routine assessment, following a validated clinical guideline and protocol, is feasible in the community pharmacy setting and acceptable by consumers and pharmacists.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tin Fei Sim

Address

Curtin University
Kent Street, Bentley,
Western Australia 6102

Country

Australia

Phone

+61 8 92663812

Fax

+61 8 92662769

[email protected]

Contact person for public queries

Name

Mrs Rebecca Iacob

Address

Curtin University
Kent Street, Bentley,
Western Australia 6102

Country

Australia

Phone

+61 0466 681 008

Fax

[email protected]

Contact person for scientific queries

Name

Dr Tin Fei Sim

Address

Curtin University
Kent Street, Bentley WA 6102

Country

Australia

Phone

+61 8 92663812

Fax

+61 8 92662769

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

As participants will be recruited from five sites, to maintain privacy and confidentiality and to avoid identifying any trial participants, individual participant data will not be made available.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2371	Ethical approval					377380-(Uploaded-18-06-2019-13-20-44)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Results of this study is currently embargoed.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Point-of-care C-reactive protein testing service for respiratory tract infections in community pharmacy: a qualitative study of service uptake and experience of pharmacists.	2022	https://dx.doi.org/10.1007/s11096-021-01368-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically