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Trial registered on ANZCTR

Registration number

ACTRN12622000430730

Ethics application status

Approved

Date submitted

3/03/2022

Date registered

16/03/2022

Date last updated

28/04/2024

Date data sharing statement initially provided

16/03/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Change in health outcomes for Aboriginal children with chronic wet cough: a multi-centre implementation study

Scientific title

Change in health outcomes for Aboriginal children with chronic wet cough rationale and study protocol for a multi-centre implementation science study

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

APPLE

Linked study record

Health condition

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

Protracted bacterial bronchitis

Delayed or misdiagnosis

bronchiectasis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is implementation of a "strategy" to facilitate early recognition and management of chronic wet cough in First Nations children at the primary care level. The strategy has seven core components for each site. The core components of the strategy include:
1. First Nations Lead: appointed at each site to advise on all cultural components of project, ensure culturally secure operations with First Nations knowledge being privileged. A First Nations officer is available for all First Nations participants from recruitment to all participation components. Adherence is measured by a First Nations lead being appointed and employed for the duration of the study.
2. Stakeholder engagement - with healthcare providers (HCPs) in primary care and local hospitals, First Nations parents to generate buy-in and ascertain and address local barriers and facilitators to implementation. Engagement occurs with in-person focus groups and interviews for the purpose of identifying current state, barriers and facilitators to providing the strategy. Qualitative experts (content expert and First Nations cultural expert, who are research team members) will lead the interviews and focus groups. Focus groups will be scheduled for 30-60 minutes, and interviews will be scheduled for 10-30minutes, with an expected single attendance only by participants. There is no limit to the number of attendees for focus groups, but numbers are not expected to exceed 25 per group based on size of departments. Stakeholder engagement can occur during the pre-intervention period (approximately 12-months). Adherence is measured via a written, published report summarising the key findings, process map and tailored implementation of strategy for each site.
3. Training of HCPs (3-month period). Training via online modules, podcasts, in-person training. In-person (or virtual in-person) training (1-hour duration x 3 occasions) will be scheduled for relevant HCPs during preferred departmental time allocation by managers. The on-line module will be promoted to all staff throughout the intervention period. The module takes 45 minutes to complete and is only completed once. The 30-min podcast is intended for single listening and will be promoted throughout intervention period. The podcast is an additional resource, not primary form of teaching. In-person (or virtual) training is provided by a paediatric respiratory physician for doctors and/or paediatric respiratory clinician for other HCPs (e.g. physiotherapist or nurse). All trainers are part of the research team. Adherence is measured by metrics of completions at each site (electronic capture system) for online training and calculation of the percentage or proportion of HCPs trained out of the total number who could be trained at each site.
4. Practice changes: Easily accessible, clear clinical practice guidelines will be placed in each clinic (Source: CARPA manual p134, i.e., https://healthinfonet.ecu.edu.au/healthinfonet/getContent.php?linkid=592687&title=CARPA+standard+treatment+manual%3A+a+clinic+manual+for+primary+health+care+practitioners+in+remote+and+Indigenous+health+services+in+central+and+northern+Australia. Call-back option operational (ability to schedule follow-up with same clinician),i.e.(to be determined at each site as per need and coordinated with local Information technology department); Flow chart on wall in clinic to prompt clinicians (designed for study, source: supplementary File 3 of protocol); Electronic decision support, which includes pop-up reminder to ask about cough and link to cough guidelines within electronic medical records (designed during nil-intervention period if required and if feasible). Coordination will be facilitated by clinical practice manager. Adherence will be measured through record if booking option is operational and the total number of record flow chart placements in each clinic room per room available. Practice changes will be implemented anytime during the same 3-month period of the intervention, i.e., during the teaching period)
5. Educational resources for HCPs: (i)culturally secure Flipchart (developed with First Nations parents, consumer endorsed and used at Perth Children's Hospital (PCH) and Broome Regional Aboriginal Medical Service. https://www.telethonkids.org.au/globalassets/media/documents/research-topics/wet-cough-flipchart.pdf. The 10-page flip chart is written with simple language and pictures. Clinicians will use the tool to teach parents whose children suspected or at high risk of protracted bacterial bronchitis who attend primary care clinic. The flip chart explains a child's chronic wet cough and the risk of developing bronchiectasis and the need for medical care. It takes approximately 5-minutes to go through with the parent/carer.
(ii)Animated film version of flip chart. (time: 3min 12 sec; https://www.youtube.com/watch?v=822rxbYIZcU; Use will be by choice of clinician and/or family - in addition to flip chart or instead of flip chart). Adherence will be measured by record of adaptions of materials if required for each site and record of whom resources are provided to at each site.
6.Information campaign (Same 3-month period as HCP training). Note all materials currently available (https://www.telethonkids.org.au/our-research/research-topics/wet-cough/) and can be used in current version or may be adapted for each site during nil-intervention phase) i) Posters in clinic (3-6 posters per clinic in high traffic areas such as family centre, waiting room and paediatric areas) and community (where agreed within the community, e.g., day care centres, library, local town noticeboard). Posters depict child coughing +/- sports hero: Copy states: "Lil one got wet cough long time? Get 'em to clinic'. Local clinic logo, phone and website with more information listed (ii) Social media- advertising and information page. The page contains links to the Flipchart, local video clips, film, wet cough audio file and information about chronic wet cough - relevance and need for health seeking. Messenger service is offered where community can ask questions, responses by respiratory clinician researcher who has manager rights on Facebook page. Information given will only advise on the health message to seek medical help for chronic wet cough and will not involve specific medical advice. Targeting advertising will be on Facebook only, as per posters, which pop up in news feed of community using social media. We will target the location of the sites in the project and the surrounding areas (within 100km radius), and expect daily pop-ups if a local person is using Facebook during the 3-month campaign. Facebook Ads Manager will be used to post targeted advertisements - with 6 "boosted" posts from the page, which run for a 28-day cycle. All analytics for reach of post are collected via Facebook Ads Manager. pagehttps://www.facebook.com/wetcough/); (iii) Health promotion discussions i.e. “yarning”. (at playgroups x3 sessions/site, 30-minutes; day-cares x1 30-min session per daycare (~2-3 centres per site); small groups in homes (for remote communities only with <600 population) ~15 home visits for 15 minutes each. Trained health promotion officers from local clinic provides sessions. Officers trained during the nil-intervention period by clinician researcher. (half day course with theoretical and practical component on chronic wet cough recognition and management); (iv) Advertising- radio (3 x 30sec), television (1x 30sec) (optional) on local Indigenous stations (topic chronic wet cough) (v) Other information materials and booklets (optional) A5 booklet version of Flipchart (and child version) can be provided to family during yarning sessions or during consultations with child with respiratory illness./chronic wet cough in local clinic. Members of the research team will coordinate campaign in liaison with local champions/stakeholders. Adherence is measured by (i) Check posters placed as required; (ii) Facebook page live and reach and engagement of ads recorded and (iii) Record of number of yarning groups and attendees for each community.
7. Local champions within primary care system identified and mobilised to improve uptake of systems changes and provide audit and feedback to staff. One or two local champions will be identified per primary care clinics (at least one clinician champion will be recruited per clinic). Champions will be recruited during the focus group sessions by invitation from the clinical lead at each site. The champions will provide feedback of audited clinician medical record entries of children presenting with respiratory illness if clinician asked about cough presence, quality and duration and metrics of online module completions within the clinic at monthly departmental meetings during the intervention stage of the project (3-months). The feedback is expected to take no more than 5-minutes and will be collated for the local champion by the local research leader. Adherence is measured through recording and reporting the number of champions and interactions recorded at each site.

Timeline: The intervention components 1 and 2 commence prior to the implementation period to ensure appropriate tailoring for each site. This period will take approx 12-months. Once the intervention commences, core components 3-6 occur simultaneously.

Please note there are two groups in the study. Nil-intervention controls do not receive any intervention. The second group is the post-intervention group who are recruited following the 3-month intervention period. This group have been exposed to the lung health promotion campaign and clinicians have received training and practices have implemented required changes. The stakeholder engagement and appointment of a First Nations lead and adaption of the implementation for each site occurs during the nil-intervention period.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Prevention

Intervention code [3]

Behaviour

Comparator / control treatment

"Nil-interventions controls" (children with chronic wet cough presenting to primary care) do not receive any intervention as the health promotion and clinic intervention has not yet been implemented. The group of participants will be identified via medical record audit or local clinician knowledge of children presenting with respiratory illness, where parents report they sought help for their child's chronic wet cough anytime during the pre-intervention period. The participants will be contacted by telephone or mail, 6-12 weeks following presentation for their chronic wet cough.
The period of the historical data for the PC-QoL tool will be collected at any point during the nil-intervention period, i.e., up to 12 months prior to the intervention period, to allow time to recruit enough children to complete at least 12-PC-QoL tools.

Control group

Historical

Outcomes

Primary outcome [1]

Paediatric cough-related Quality of Life (PC-QoL) tool

Timepoint [1]

Once at 6-12 weeks following presentation to clinic for chronic wet cough

Primary outcome [2]

Health seeking of parents: The number of parents seeking help at the local clinic for their child’s chronic wet cough during a six-month period pre- and post-intervention

Timepoint [2]

Clinic record audit will be used to compare numbers in a 6-month period the year before implementing the intervention to numbers during 6-months directly after implementation. To reduce the effect of seasonal factors influencing results, the same 6-calendar months will be audited pre- and post-implementation

Secondary outcome [1]

Clinicians’ proficiency in assessing and managing children presenting with respiratory illness will also be assessed via medical record audit of clinicians recording cough presence

Timepoint [1]

The number of respiratory presentations during a six-month period pre- and post-intervention where clinician asked about cough presence. Clinic record audit will be used to compare numbers in a 6-month period the year before implementing the solution, to numbers during 6-months directly after implementation

Secondary outcome [2]

Clinicians’ proficiency in assessing and managing children presenting with respiratory illness will also be assessed via medical record audit of clinicians recording cough quality (wet or dry or other)

Timepoint [2]

The number of respiratory presentations during a six-month period pre- and post-intervention where clinician asked about cough quality. Clinic record audit will be used to compare numbers in a 6-month period the year before implementing the solution, to numbers during 6-months directly after implementation

Secondary outcome [3]

Clinicians’ proficiency in assessing and managing children presenting with respiratory illness will also be assessed via medical record audit of clinicians recording cough duration

Timepoint [3]

The number of respiratory presentations during a six-month period pre- and post-intervention where clinician asked about cough duration. Clinic record audit will be used to compare numbers in a 6-month period the year before implementing the solution, to numbers during 6-months directly after implementation

Secondary outcome [4]

Clinicians’ proficiency in assessing and managing children presenting with respiratory illness will also be assessed via medical record audit of clinicians recording: correct management if suspected protracted bacterial bronchitis

Timepoint [4]

The number of respiratory presentations during a six-month period pre- and post-intervention where clinician prescribed correct management for suspected protracted bacterial bronchitis.. Clinic record audit will be used to compare numbers in a 6-month period the year before implementing the solution, to numbers during 6-months directly after implementation

Secondary outcome [5]

Implementation outcomes:
a) Fidelity to core components of the strategy will be assessed.
Acceptability (“the perception among implementation stakeholders that the strategy is agreeable, palatable and satisfactory”) will be assessed for health care providers (HCPs) and parents through semi-structured interviews.

Timepoint [5]

This outcome will be measured during the final 3-months of the intervention period and 3-months after the intervention period has concluded.

Secondary outcome [6]

Implementation outcome
b) Appropriateness (“the perceived fit of the strategy for the given practice setting”) will be assessed with the 22-item TCU Workshop Evaluation (WEVAL) form to assess the perceptions of the strategy directly after intervention and the 14-item TCU Workshop Assessment Follow-Up (WAFU) to assess changes 6-months after

Timepoint [6]

The WECAL form will be given to attendees of the -in-person training session at the time of attendance and will occur once only. The same attendees will be provided with the WAFU form 6-months later and will be asked to complete. These forms will be completed electronically, via an emailed link sent to the participant or via a paper version if preferred by the participant.

Secondary outcome [7]

Implementation outcome
c) Implementation cost will be addressed through an economic analysis. Costs data will be collected by (i) determining the cost of providing the new service, including staffing costs, consumables, cost of training, electronic system modifications; health promotion training and campaign costs and (ii) the extra cost for caring for a child with bronchiectasis over their lifetime for children predicted to develop bronchiectasis) (based on published data on Australian costs on bronchiectasis (Goyal et.al 2020 and Lovie-Toon et.al. 2019)

Timepoint [7]

This will occur in the 3-month period following completion of the intervention period

Secondary outcome [8]

Implementation outcome
d) Penetration and adoption will be assessed as i) the number of HCPs who participated in training out of the total number of HCPs, and ii) audit of medical records of respiratory presentations

Timepoint [8]

The outcome for the number of HCPs trained will be measured at each training session and for respiratory presentations medical records as per audit via data linkage to electronic medical record discharge summaries throughout the intervention period .

Secondary outcome [9]

Implementation outcomes: Sustainability will be addressed through focus groups and interviews with HCPs and parents in the final months of the project and feedback questionnaires for HCPs.

Timepoint [9]

This will be conducted during the final 3-months of the intervention period and in the 3-months following conclusion of recruitment of children.

Eligibility

Key inclusion criteria

1. Parents help seeking and clinician management of chronic wet cough: Australian First Nations children aged 0-8 years who attend local primary care clinic for medical care during a 6-month period pre-intervention and the same 6-month period post-intervention.

2. Clinician management of chronic wet cough for PC-QoL tool): First Nations children who presented to primary care clinic with a chronic wet cough, aged 0-17 years, 6-12 weeks prior to recruitment.

Minimum age

0 Years

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Parents help seeking: Non-First Nations children, First Nations children aged over eight years or who do not attend local clinic.

2.Clinician management of chronic wet cough for PC-QoL tool: Non-First Nations children or children who present outside the study period.

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

Other

Other design features

There will be two groups of participants
1. Nil-intervention: Children and clinicians pre-intervention who are not exposed to any interventions.
2. Post-intervention group:Children and clinicians post-intervention who are exposed to the interventions.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Primary outcome measure: Un-paired Student T-tests used to analyse the change in PC-QoL-8 scores (normally distributed and the minimum important difference is 0.9). Single site analysis with at least 12 participants with chronic wet cough in each period will have >80% power to detect a nil-intervention (2.7) v post-intervention (4.3) difference of 1.6, alpha 0.05. Full sample (clustered) analysis with at least 5 participants per cluster (4) per period (assuming COV 0.65, ICC 0.01) will have >95% power to detect a nil-intervention (2.7) v post-intervention (4.3) difference of 1.6, alpha 0.05; at least 10 participants per cluster (4) per period will be required to have >80% power to detect a difference of 0.9 (alpha 0.05). Adjustments for multiple comparisons were not made as calculations are to provide guidance only, with final sample size being dependent on cohort sizes and diagnosis counts during observation periods; sample size calculations were carried out using PASS.

Secondary outcome measures: Chi Squared tests and 95% Wald CIs will be used for categorical data, i.e., pre-and post-intervention comparison of
(i) the percentage of children who attended clinic for chronic wet cough in pre and post 6-month periods
(ii) the percentage of respiratory presentations were doctor asks about cough presence, quality and duration
(iii) the percentage of respiratory presentations were doctor manages suspected protracted bacterial bronchitis correctly.

Significance is set to 0.05 .

Implementation outcomes will be measured as per protocol

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

10/05/2021

Date of last participant enrolment

Anticipated

27/12/2024

Actual

Date of last data collection

Anticipated

28/02/2025

Actual

Sample size

Target

140

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NT,QLD,WA

Recruitment postcode(s) [1]

6770 - Halls Creek

Recruitment postcode(s) [2]

6770 - Tanami

Recruitment postcode(s) [3]

6000 - Perth

Recruitment postcode(s) [4]

4350 - North Toowoomba

Recruitment postcode(s) [5]

0822 - Daly River

Recruitment postcode(s) [6]

0880 - Gapuwiyak

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Child and Adolescent Health Service

Address

15 Hospital Ave
Nedlands, WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Australian Aboriginal Health Ethics Committee

Ethics committee address [1]

450 Beaufort Street
Highgate
Western Australia
6003

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/01/2021

Approval date [1]

02/03/2021

Ethics approval number [1]

HREC774

Ethics committee name [2]

Child and Adolescent Health Service Ethcis Committee

Ethics committee address [2]

15 Hospital Ave
Nedlands WA 6009

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

17/06/2020

Approval date [2]

28/07/2020

Ethics approval number [2]

RGS4136

Ethics committee name [3]

Human research ethics committee of the Northern Territory Department of Health and Menzies School of Health Research

Ethics committee address [3]

PO Box 40596, Casuarina NT 0811

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

25/01/2021

Approval date [3]

23/03/2021

Ethics approval number [3]

HREC 2021-3954

Ethics committee name [4]

University of Queensland's Human Reserach Ethics Committee

Ethics committee address [4]

Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

27/10/2020

Approval date [4]

09/11/2020

Ethics approval number [4]

2020002563

Summary

Brief summary

Overview:  
Chronic wet cough in children can be a sign of underlying lung disease such as protracted bacterial bronchitis (PBB) or bronchiectasis.  In the absence of pointers to alternative diagnoses, chronic (>4 weeks duration) wet cough that responds to antibiotic treatment typically indicates a diagnosis of PBB. Timely recognition and management of PBB can potentially prevent progression of disease to irreversible bronchiectasis with lifelong consequences3. However, detection and management requires both timely health seeking by parents/families and optimal management by clinicians. 
Our study’s overall aim is to improve (a) parent/family health seeking for chronic wet cough in their children and (b) clinician management of chronic wet cough in First Nations children. We hypothesize that implementation of a culturally integrated strategy, which is informed by barriers and facilitators identified by parents and health care providers, will improve respiratory health of First Nations children and thereby reduce the burden of bronchiectasis by preventing the progression of protracted bacterial bronchitis to bronchiectasis in First Nations children.
Methods
The trial is a multi-center, pseudorandomized stepped wedge design where the implementation of the intervention (a strategy) is adapted to each site through a combined Participatory Action Research and Implementation Science approach informed by the Consolidated Framework of Implementation Research. Outcome measures will consist of three categories related to (i) health (ii) economics and (iii) implementation. Health seeking will be measured as the proportion of parents seeking help for their child in a 6-month period before and the same 6-month period after the intervention.   The Cough-specific Quality of Life (PC-QoL) will be the primary health related outcome measure.
Discussion
We hypothesise that tailored intervention based on identified barriers and facilitators identified through engagement with parents and health service providers will result in improved health seeking for parents of children with chronic wet cough and improved clinician management of chronic wet cough. We expect this will result in improve lung health outcomes for children with chronic wet cough.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof André Schultz

Address

Department of Respiratory and Sleep Medicine
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009

Country

Australia

Phone

+61 8 6456 8452

Fax

[email protected]

Contact person for public queries

Name

André Schultz

Address

Department of Respiratory and Sleep Medicine
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009

Country

Australia

Phone

+61 8 6456 8452

Fax

[email protected]

Contact person for scientific queries

Name

André Schultz

Address

Department of Respiratory and Sleep Medicine
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009

Country

Australia

Phone

+61 8 6456 8452

Fax

[email protected]

Data sharing statement

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

Yes

What data in particular will be shared?

database: individual participant data of published results only

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years following main results publication;

Available to whom?

Researchers who provide a methodologically sound proposal with appropriate institutional and/or ethical approval as required

Available for what types of analyses?

only to achieve the aims in the approved proposal

How or where can data be obtained?

access subject to approvals by Principal Investigator [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
15254	Study protocol		To be published in BMC Pulmonary Medicine
15256	Informed consent form		Provided in published protocol
15257	Ethical approval		Will be provided in published protocol
15258	Statistical analysis plan	[email protected]	will be provided in published protocol

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	Change in health outcomes for First Nations children with chronic wet cough: rationale and study protocol for a multi-centre implementation science study.	2022	https://dx.doi.org/10.1186/s12890-022-02219-0

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

Trial Review

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