ANZCTR - Registration

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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]

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

Hearing impairment

Condition category

Condition code

Ear

Normal ear development and function

Public Health

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]

Early detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Twelve months post-service delivery commencement.

Primary outcome [2]

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]

Twelve months post-service delivery commencement.

Secondary outcome [1]

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]

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]

4825 - Mount Isa

Recruitment postcode(s) [2]

4390 - Goondiwindi

Funding & Sponsors

Funding source category [1]

University

Name [1]

Centre for Rural and Remote Health - James Cook University

Address [1]

100 Joan Street
Mount Isa
QLD 4825

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee James Cook University

Ethics committee address [1]

Angus Smith Drive
Townsville QLD 4811

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/07/2020

Approval date [1]

18/08/2020

Ethics approval number [1]

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

Ms Selina Taylor

Address

Centre for Rural and Remote Health Mount Isa
100 Joan Street
Mount Isa QLD 4825

Country

Australia

Phone

+61 0408 544 974

Fax

[email protected]

Contact person for public queries

Name

Selina Taylor

Address

Selina Taylor
Centre for Rural and Remote Health Mount Isa
100 Joan Street
Mount Isa QLD 4825

Country

Australia

Phone

+61 0408 544 974

Fax

[email protected]

Contact person for scientific queries

Name

Selina Taylor

Address

Selina Taylor
Centre for Rural and Remote Health
100 Joan Street
Mount Isa QLD 4825

Country

Australia

Phone

+61 0408 544 974

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9537	Informed consent form					380816-(Uploaded-26-10-2020-16-20-39)-Study-related document.docx
9538	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Developing an ear health intervention for rural community pharmacy: Application of the precede-proceed model.	2021	https://dx.doi.org/10.3390/ijerph18126456
Embase	LISTEN UP (Locally Integrated Screening and Testing Ear aNd aUral Programme): a feasibility study protocol for a community pharmacy-based ear health intervention.	2021	https://dx.doi.org/10.1186/s40814-021-00856-6

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

Trial Review

Documents added manually

Documents added automatically