Trial Review

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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] 297947 0
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 312341 0
Condition category
Condition code
Respiratory 310904 310904 0 0
Other respiratory disorders / diseases
Infection 311885 311885 0 0
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] 314205 0
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] 319721 0
Acceptability of CRP testing to pharmacists as assessed by a combined response to a series of 5-point Likert scale questions
Timepoint [1] 319721 0
Eight weeks after trial commencement
Primary outcome [2] 320615 0
Acceptability of CRP testing to consumers as assessed by a combined response to a series of 5-point Likert scale questions
Timepoint [2] 320615 0
Immediately after testing and the overall service provision
Secondary outcome [1] 369296 0
Pharmacists' confidence in reporting tests using study specific questionnaire
Timepoint [1] 369296 0
Eight weeks after trial commencement
Secondary outcome [2] 372083 0
Pharmacists' confidence in delivering the service using validated resources and protocols provided, using study specific questionnaire
Timepoint [2] 372083 0
Eight weeks after trial commencement
Secondary outcome [3] 372084 0
Pharmacists' knowledge about point-of-care CRP testing using study specific questionnaire
Timepoint [3] 372084 0
Eight weeks after trial commencement
Secondary outcome [4] 372085 0
Consumers' experience with the service using study specific questionnaire
Timepoint [4] 372085 0
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?
No
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)
WA

Funding & Sponsors
Funding source category [1] 302462 0
Charities/Societies/Foundations
Name [1] 302462 0
J M O'Hara Research Fund
Country [1] 302462 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
Kent Street,
Bentley, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 302474 0
None
Name [1] 302474 0
Address [1] 302474 0
Country [1] 302474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303130 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 303130 0
Curtin University:
Kent Street, Bentley WA 6102
Ethics committee country [1] 303130 0
Australia
Date submitted for ethics approval [1] 303130 0
18/02/2019
Approval date [1] 303130 0
21/03/2019
Ethics approval number [1] 303130 0
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 92578 0
Dr Tin Fei Sim
Address 92578 0
Curtin University
Kent Street, Bentley,
Western Australia 6102
Country 92578 0
Australia
Phone 92578 0
+61 8 92663812
Fax 92578 0
+61 8 92662769
Email 92578 0
[email protected]
Contact person for public queries
Name 92579 0
Rebecca Iacob
Address 92579 0
Curtin University
Kent Street, Bentley,
Western Australia 6102
Country 92579 0
Australia
Phone 92579 0
+61 0466 681 008
Fax 92579 0
Email 92579 0
[email protected]
Contact person for scientific queries
Name 92580 0
Tin Fei Sim
Address 92580 0
Curtin University
Kent Street, Bentley WA 6102
Country 92580 0
Australia
Phone 92580 0
+61 8 92663812
Fax 92580 0
+61 8 92662769
Email 92580 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
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.TypeCitationLinkEmailOther DetailsAttachment
2371Ethical approval    377380-(Uploaded-18-06-2019-13-20-44)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Results of this study is currently embargoed.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePoint-of-care C-reactive protein testing service for respiratory tract infections in community pharmacy: a qualitative study of service uptake and experience of pharmacists.2022https://dx.doi.org/10.1007/s11096-021-01368-2
N.B. These documents automatically identified may not have been verified by the study sponsor.