Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001297910
Ethics application status
Approved
Date submitted
26/10/2020
Date registered
30/11/2020
Date last updated
30/11/2020
Date data sharing statement initially provided
30/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
LISTEN UP – An Ear Health Intervention for Rural Community Pharmacy
Scientific title
LISTEN UP – An Ear Health Intervention to evaluate feasibility, acceptability and effectiveness for Rural Community Pharmacy (Locally Integrated Screening and Testing Ear aNd aUral Program)
Secondary ID [1] 302630 0
None
Universal Trial Number (UTN)
U1111-1260-2013
Trial acronym
LISTEN UP (Locally Integrated Screening and Testing Ear aNd aUral Program)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ear disease 319527 0
Hearing impairment 319528 0
Condition category
Condition code
Ear 317478 317478 0 0
Normal ear development and function
Public Health 317768 317768 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This mixed-methods study is a pilot of a clinical intervention. The intervention will be piloted for 6 weeks at each pharmacy and then refinement and improvements will be made before the impact study is conducted for 12 months. Total duration of the intervention is 13.5months.

Advisory Panel
An advisory panel will be formed to provide expert advice on developing inclusion/exclusion criteria and indicators for referral. Experts in the field of ear health, general practice and pharmacy practice will be contacted via email with an invitation to participate in the advisory panel.

Phase 1 – Enrolment of Participating Pharmacies, Pharmacists and General Practitioners
Two pharmacies will be enrolled in the study. These two pharmacies have participated in earlier research and have expressed interest and capacity to participate in this project. Each pharmacy will be linked with at least one participating general practitioner.
Phase 2 – Pharmacist Training
Each participating pharmacist will undertake nationally credentialed training in otoscopy and tympanometry. This training is mixed mode with online and face-to-face components. Only pharmacists who have achieved the required training will be eligible to participate in the research. Completed certificates of training will need to be provided to the PI.

Phase 3 – Pharmacy Preparation
Each participating pharmacy will prepare their private consultation room to ensure privacy, and adequate personal protective equipment provisions (e.g. gloves, masks, sanitiser).
Each participating pharmacy will prepare their computer to ensure capacity to generate and send immediate referrals appropriately. Pharmacy computers will be able to generate referrals electronically and print in paper form. Referrals to GPs will be sent via secure email at the time of the consultation with an appointment made for the patient via GP online booking system. The patient will also be provided a paper copy of the referral.

Phase 4 – Service Delivery
Participants will be recruited into the study when they present to a participating pharmacy with an ear complaint. If they meet the eligibility criteria and provide informed consent the pharmacist will perform a temperature measurement, otoscopic examination, tympanometry assessment and determine the appropriate treatment. Intervention may include no treatment, recommended treatment with products available in pharmacy without prescription (patient to pay cost of these products) or referral to GP (patient to pay cost of GP appointment). The patients will then be contacted 7 days later for follow up and either completion of the service or referral to GP. The expected duration of pharmacist assessment is 20 minutes.
Intervention code [1] 318915 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325512 0
To evaluate the feasibility, acceptability and effectiveness of a community pharmacy-based intervention for ear health by exploring:
a. Pharmacist views of:
i. Pharmacist capacity and competence to provide the intervention (motivation, confidence, competence, experience of training, capacity (workflow/workload)).[One-on-one semi-structured interview]
ii. Patient acceptance [One-on-one semi-structured interview]
iii. Pathway to GP service (timeliness of appointment, GP staff attitudes). [One-on-one semi-structured interview]
b. Patient views of the service in terms of access, alternative health care options, satisfaction and willingness to pay (confidence/acceptance of pharmacist service, referral process, timeliness of pharmacists consult/GP consult). [Patient satisfaction survey and One-on-one semi-structured interview]
c. GP views on appropriateness of pharmacist referrals, collaborative care with pharmacists (use of telehealth). [One-on-one semi-structured interview]
Timepoint [1] 325512 0
Twelve months post-service delivery commencement.
Primary outcome [2] 325513 0
Composite outcome: To evaluate the role of otoscopy and tympanometry to improve specificity of ear condition management in community pharmacy by comparing:
a. Usual care data with intervention data pertaining to pharmacist recommendations. [Usual care data will be collected on a template with tick boxes for recording]
b. Pharmacist recommendations on the patient service summary record compared to GP prescriptions and referrals described by patients at the seven-day follow up phone call. [Pharmacy recommendations will be collected for service summary record at pharmacy and compared to patient reported outcomes collected during patient semi-structured interview]
c. Patient acceptance of pharmacists performing examinations with an otoscope and tympanometer equipment. [Data collected via patient satisfaction survey and patient semi-structured interview]
(Patient satisfaction survey is designed specifically for this study based on a UK Trial - Mantzourani E, Evans A, Cannings-John R, et alImpact of a pilot NHS-funded sore throat test and treat service in community pharmacies on provision and quality of patient careBMJ Open Quality 2020;9:e000833. doi: 10.1136/bmjoq-2019-000833)
Timepoint [2] 325513 0
Twelve months post-service delivery commencement.
Secondary outcome [1] 389280 0
To evaluate how study findings may be applied to future professional pharmacy services in rural practice.
This will be collected from pharmacist semi-structured interviews post-intervention and thematically analysed in the context of future considerations.
Timepoint [1] 389280 0
Six months post-intervention completion.

Eligibility
Key inclusion criteria
Members of the public attending a rural community pharmacy who are aged 13 or older.
Adequate health literacy and English language to provide informed consent.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
<13 years of age
Inadequate health literacy or English language to provide informed consent
Obvious major trauma to the ear
High COVID risk patient

Study design
Purpose of the study
Prevention
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This intervention will be evaluated on multiple levels;
- Qualitative analysis of GP and Pharmacist perspectives of the intervention from Pre and Post Interviews.
- Quantitative analysis of patient satisfaction and accessibility from Patient Satisfaction Survey. Descriptive statistics
- Qualitative/quantitative analysis of patient/consumer 7 day follow-up interviews post –service
- Comparative analysis of pharmacist documented hypothetical treatments and referrals versus patient received treatment and referrals recorded during 7 day follow-up interview.
Expected sample size 200.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 31760 0
4390 - Goondiwindi
Recruitment postcode(s) [2] 31759 0
4825 - Mount Isa

Funding & Sponsors
Funding source category [1] 307060 0
University
Name [1] 307060 0
Centre for Rural and Remote Health - James Cook University
Country [1] 307060 0
Australia
Primary sponsor type
Individual
Name
Selina Taylor
Address
Centre for Rural and Remote Health - Mount Isa
100 Joan Street
Mount Isa
QLD 4825
Country
Australia
Secondary sponsor category [1] 307629 0
None
Name [1] 307629 0
Address [1] 307629 0
Country [1] 307629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307184 0
Human Research Ethics Committee James Cook University
Ethics committee address [1] 307184 0
Angus Smith Drive
Townsville QLD 4811
Ethics committee country [1] 307184 0
Australia
Date submitted for ethics approval [1] 307184 0
08/07/2020
Approval date [1] 307184 0
18/08/2020
Ethics approval number [1] 307184 0
H8187

Summary
Brief summary
Ear disease is a major cause of preventable hearing loss and is very common in rural communities, estimated to affect 1.3 million Australians. Rural community pharmacists are well placed to provide improved ear health care to people who are unable to easily access a general practitioner (GP). The purpose of this study is to apply an ear health intervention to the rural community-pharmacy setting to improve the management of ear disease. Two rural community pharmacies will be recruited for the pilot study.

Rural community pharmacists have been identified as highly qualified and easily accessible health professionals in rural and remote communities. They are often the first point of call for many people with minor ailments. Training pharmacists to perform otoscopy (visual examination of the ear canal and the eardrum with an otoscope), tympanometry (testing that measures the function and movement of the ear drum and middle ear) and generate appropriate referrals to general practitioners, may see patients receive ear health care in the most appropriate locations and result in economic savings by avoiding attending emergency departments unnecessarily. An ear health intervention in rural community pharmacy is anticipated to provide additional avenue for patients to access ear care which may result in ear complaints being managed in a more timely manner and thus a reduction in complications with associated financial and societal benefits. Utilising rural community pharmacists to provide an ear health program may improve health outcomes for rural and remote populations.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106322 0
Ms Selina Taylor
Address 106322 0
Centre for Rural and Remote Health Mount Isa
100 Joan Street
Mount Isa QLD 4825
Country 106322 0
Australia
Phone 106322 0
+61 0408 544 974
Fax 106322 0
Email 106322 0
selina.taylor@jcu.edu.au
Contact person for public queries
Name 106323 0
Ms Selina Taylor
Address 106323 0
Selina Taylor
Centre for Rural and Remote Health Mount Isa
100 Joan Street
Mount Isa QLD 4825
Country 106323 0
Australia
Phone 106323 0
+61 0408 544 974
Fax 106323 0
Email 106323 0
selina.taylor@jcu.edu.au
Contact person for scientific queries
Name 106324 0
Ms Selina Taylor
Address 106324 0
Selina Taylor
Centre for Rural and Remote Health
100 Joan Street
Mount Isa QLD 4825
Country 106324 0
Australia
Phone 106324 0
+61 0408 544 974
Fax 106324 0
Email 106324 0
selina.taylor@jcu.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9537Informed consent form    380816-(Uploaded-26-10-2020-16-20-39)-Study-related document.docx
9538Ethical approval    380816-(Uploaded-26-10-2020-16-20-55)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDeveloping an ear health intervention for rural community pharmacy: Application of the precede-proceed model.2021https://dx.doi.org/10.3390/ijerph18126456
EmbaseLISTEN UP (Locally Integrated Screening and Testing Ear aNd aUral Programme): a feasibility study protocol for a community pharmacy-based ear health intervention.2021https://dx.doi.org/10.1186/s40814-021-00856-6
N.B. These documents automatically identified may not have been verified by the study sponsor.