Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000224729
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
8/02/2022
Date last updated
20/05/2024
Date data sharing statement initially provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a strategy to facilitate effective medical follow-up for Australian First Nations children hospitalised with chest infections: study protocol
Scientific title
Implementation of a strategy to facilitate effective medical follow-up for Australian First Nations children hospitalised with lower respiratory tract infections: study protocol
Secondary ID [1] 305462 0
None
Universal Trial Number (UTN)
Trial acronym
ACE (Aboriginal Children's Excellent )Lung Health Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lower respiratory tract infection 323841 0
No routine medical follow up for at-risk children, i.e., First Nations children 323843 0
Lack of culturally secure health information given to First Nations families 323844 0
Condition category
Condition code
Respiratory 321350 321350 0 0
Other respiratory disorders / diseases
Public Health 322524 322524 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is implementation of a "strategy" to facilitate optimal follow-up for First Nations children hospitalised with acute lower respiratory tract infections (ALRIs). 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 with healthcare providers (HCPs) in hospitals and primary care, First Nations parents 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: (online modules, podcasts, in-person training). In-person training (1-hour duration x 2 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 Podcast is 30-minutes and is intended for single listening and will be promoted throughout the intervention period. The podcast is intended for once only and is an additional resource, not primary form of teaching. In-person training is provided by a paediatric respiratory physician for doctors and/or paediatric respiratory clinician for other HCPs (e.g. physiotherapist or nurse). The cultural training is integrated into the 1-hour training session and is provided by a First Nations person. 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. Educational resources
(i)culturally secure Flipchart (developed with First Nations parents, consumer endorsed and used at Perth Children's Hospital (PCH) https://www.telethonkids.org.au/globalassets/media/documents/research-topics/wet-cough/acute-lung-sickness-2020_print1.pdf). The 10-page flip chart is written with simple language and pictures. Clinicians will use the tool to teach parents whose children are admitted with acute chest infections when doing routine ward rounds. The flip chart explains a child's acute respiratory illness and the risk of developing chronic lung disease and the need for medical follow-up at 1-month. It takes approximately 5-minutes to go through with the parent/carer.
(ii) health facts pamphlet with discharge information for parent (PCH and consumer endorsed): This 1-page A4 sized document is a summarised version of the flip-chart with the key health message: See local clinic/doctor in 1-month following discharge to follow up on chronic wet cough. The pamphlet is provided by the hospital clinician (nurse, doctor, physiotherapist) during the discharge process and takes approximately 2-minutes to explain. The information is a brief repeat of the flip chart session. The pamphlet would take a parent 2-minutes to read also at a later date.
(iii) letter to local clinic. The letter is for the local primary care doctor/clinician. It contains details of the child's admission (as per standard hospital practice), a link to the on-line training module on management of chronic wet cough, a request to review child at 1-month for ongoing respiratory symptoms, specifically chronic wet cough, with recommended treatment if cough persists. A paper copy of the letter is given to the parent (takes approximately 1-minute as instruction is to give to local clinic) with the information pamphlet and an electronic version is sent to the local clinic with the discharge summary. The letter is
5. Patient admission process: identification of Aboriginal and/or Torres Strait Islander ethnicity and local clinic. The question will be asked either at triage or upon admission to the ward, by the ward or emergency clerk. Adherence is measured via audit of discharge summary to check First Nations identification and local clinic contact
6. SMS follow-up reminder system for parent: The automated text will be sent once only at 4-weeks following the date of discharge. The text will remind the parent to go to their local primary care clinic/doctor for review of their child's lungs following their recent admission to hospital for an acute chest infection. Adherence is measured through the number of SMS reminders sent through the system.
7. Discharge process: discharge summary with all relevant information for HCP to provide appropriate follow-up care. Electronic discharge system complete with auto-populated sections to improve process. Adherence is measured through audit of discharge summary compliance with required information
8. Local champions within hospital and 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 relevant department involved in caring for First Nations children hospitalised with acute chest infections (e.g. department of paediatrics - one doctor, paediatric ward- one nurse, one clerk; physiotherapist - one physiotherapist, emergency - one clerk,). In primary care clinics 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 discharge summaries, identification of ethnicity and clinic details and metrics of online module completions within the department at monthly departmental meetings during the intervention stage of the project (approximately 9 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 about 12-months. Once the intervention commences, core components 3-8 occur simultaneously. Note the first SMS reminder will be sent 1-month following discharge of the first patient, and continue for all subsequent patients.

Please note there are three groups in the study. Historical controls do not receive any intervention. The second control group are the "health information only controls". This group is recruited prospectively, when the study commences. This group receive lung health information via the researcher as part of the informed consent process. However, no hospital implementation of the "strategy" has commenced yet, as each site is in the process of determining barriers and facilitators to implementing the "strategy" will be for that site. The stakeholder engagement and appointment of a First Nations lead and adaption of the implementation for each site occurs during this period.
Intervention code [1] 321864 0
Early detection / Screening
Intervention code [2] 321865 0
Prevention
Intervention code [3] 321867 0
Behaviour
Comparator / control treatment
"Nil-interventions controls" (children admitted with chest infections) do not receive any intervention as the hospital has not yet implemented the "strategy" to facilitate follow-up. The group of participants will be identified as children admitted with an ALRI in the immediate 6-month period from commencement of the project, i.e., from the 6-months prior to the date of when the first patient is enrolled in the "health-information" group. The participants will be contacted by telephone three weeks following invitation being sent via mail.
Control group
Historical

Outcomes
Primary outcome [1] 329135 0
Paediatric cough-related Quality of Life (PC-QoL) tool
Timepoint [1] 329135 0
Once only at 6-weeks to 3-months after discharge from the hospital
Secondary outcome [1] 401585 0
Follow-up rates of children within 1-month (range 3-6 weeks) post hospitalisation for chest infection. This data is collected by follow-up telephone call to the parents at 6-weeks to 3-months post-discharge via a survey designed for this study (unvalidated but used in Perth Children's Hospital study)
Timepoint [1] 401585 0
Once only at 6-weeks to 3-months after discharge from the hospital
Secondary outcome [2] 401586 0
Cultural competency of HCP while child hospitalized (parent report).
"Did a hospital clinician speak to you about lung health in a way you were able to understand what was happening to your child?"

Timepoint [2] 401586 0
Once only, via a follow-up telephone call 6-weeks to 3-months post-discharge from the hospital via a survey designed for this study (unvalidated but used in Perth Children's Hospital study)
Secondary outcome [3] 401587 0
Discharge summary audit:
a. Aboriginal or Torres Strait Islander ethnicity recorded
b. Local clinic/doctor recorded
c. Instructions given to family to follow up in 1-month with local doctor
d. Instructions to the local clinic/doctor clearly stipulates to check child for ongoing chronic wet cough, absence or presence of ongoing other signs and suggest appropriate management if chronic wet cough is present. Link to appropriate clinical practice guidelines for the management of chronic wet cough provided
This information is audited via data linkage to medical records.
Timepoint [3] 401587 0
Audit completed 1-monthly throughout implementation period until end of post-implementation period
Secondary outcome [4] 405094 0
Instructions for medical follow up given by clinician (parent report). This occurs once and is conducted via a follow-up telephone call to parent at 6-weeks to 3-months post-discharge via a survey designed for this study (unvalidated but used at Perth Children's Hospital study)
Timepoint [4] 405094 0
This occurs once only at 6-weeks to 3-months after discharge from the hospital via a follow-up telephone call to the parent
Secondary outcome [5] 405095 0
In children with chronic wet cough:
a. Antibiotics prescribed at follow-up (parent report).
Timepoint [5] 405095 0
This occurs once and is conducted via a follow-up telephone call to parents at 6-weeks to 3-months post-discharge from the hospital via a survey designed for this study (unvalidated but used in Perth Children's Hospital study)
Secondary outcome [6] 405783 0
In children with chronic wet cough:
b. Adherence to prescribed antibiotics (self-report).
Timepoint [6] 405783 0
This occurs once and is conducted via a follow-up telephone call to parent at 6-weeks to 3-months post-discharge via a survey designed for this study (unvalidated but used at Perth Children's Hospital study)
Secondary outcome [7] 405784 0
In children with chronic wet cough: c. Cough resolution at 6-weeks to 3-months post-discharge (parent report).
Timepoint [7] 405784 0
This occurs once and is conducted via a follow-up telephone call to parent at 6-weeks to 3-months post-discharge via a survey designed for this study (unvalidated but used in Perth Children's Hospital study)
Secondary outcome [8] 405788 0
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 [8] 405788 0
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 [9] 405790 0
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 implementation and the 14-item TCU Workshop Assessment Follow-Up (WAFU) to assess changes 6-months after
Timepoint [9] 405790 0
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 [10] 405791 0
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 discharge system modifications and (ii) the extra cost for caring for a child with bronchiectasis over their lifetime for the ~19% of children hospitalised with ALRI (based on published data on Australian costs on bronchiectasis (Goyal et.al 2020 and Lovie-Toon et.al. 2019)
Timepoint [10] 405791 0
This will occur in the 3-month period following completion of the intervention period
Secondary outcome [11] 405792 0
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 discharge summaries
Timepoint [11] 405792 0
The outcome for the number of HCPs trained will be measured at each training session and for discharge summaries as per audit via data linkage to electronic medical record discharge summaries throughout the intervention period .
Secondary outcome [12] 405793 0

Implementation outcomes:
e) 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 [12] 405793 0
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
Aboriginal and Torres Strait Islander children (henceforth respectfully called First Nations) and adolescents aged 0-16 years hospitalised at the study site with ALRIs
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non-First Nations children.
- First Nations children over the age of 16 years.
- Children with a diagnosis of cystic fibrosis.
- Children and adolescents who have undergone a tracheostomy or have been admitted to hospital to undergo this procedure.

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 three groups of participants
1. Nil-intervention: Patients who have been previously (6 weeks-6-months) hospitalised at hospital site with ALRIs. This group will not have received any “intervention” as it is prior to the implementation of the strategy. This group will not receive the lung health information via the research assistant during their admission as recruitment occurs retrospectively. Note: Any child admitted once the trial commences and prior to the intervention, but is missed for recruitment in the "health information only" group is eligible to be recruited as per the "nil intervention group".
2. Health information only controls: First Nations children admitted to hospital site with ALRIs after commencement of the study but before the intervention has been commenced.
3. Post-intervention group: First Nations children admitted to hospital site with ALRIs after commencement of the study and after the strategy period has commenced.
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 follow-up
(ii) the percentage of discharge summaries with ethnicity recorded, local clinic listed, instructions to local clinic and discharge instructions given to parents.
(iii) the percentage of children who were instructed to follow-up with local clinic at 1-month post discharge from hospital (parent report)
(iv) In children with chronic wet cough: a) the percentage of children who were prescribed
antibiotics; b) the percentage of children with a chronic wet cough who adhered to prescribed antibiotic treatment; c) the percentage of children with a chronic wet cough who had resolution of cough at 6-weeks to 3-months post-discharge.

Significance is set to 0.05 .

Implementation outcomes will be measured as per protocol

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
31/07/2027
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
400
Accrual to date
193
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20659 0
Broome Hospital - Broome
Recruitment hospital [2] 20660 0
Hedland Health Campus - South Hedland
Recruitment hospital [3] 21511 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 21512 0
Cairns Base Hospital - Cairns

Funding & Sponsors
Funding source category [1] 309824 0
Government body
Name [1] 309824 0
Western Australian Future Health Research and Innovation Fund, Government of Western Australia, Department of Health
Country [1] 309824 0
Australia
Funding source category [2] 313832 0
Government body
Name [2] 313832 0
Medical Research Future Fund
Country [2] 313832 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
15 Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 311066 0
None
Name [1] 311066 0
Address [1] 311066 0
Country [1] 311066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309563 0
Child and Adolescent Health Service Reserach Ethics Committee RGS3220
Ethics committee address [1] 309563 0
15 Hospital Ave
Nedlands WA 6009
Ethics committee country [1] 309563 0
Australia
Date submitted for ethics approval [1] 309563 0
17/05/2019
Approval date [1] 309563 0
12/07/2019
Ethics approval number [1] 309563 0
RGS 3867
Ethics committee name [2] 309567 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 309567 0
450 Beaufort Street
Highgate
Western Australia
6003
Ethics committee country [2] 309567 0
Australia
Date submitted for ethics approval [2] 309567 0
24/04/2019
Approval date [2] 309567 0
04/06/2019
Ethics approval number [2] 309567 0
HREC920

Summary
Brief summary
Background: First Nations children hospitalised with acute lower respiratory infections (ALRIs) are at increased risk of future bronchiectasis (up to 15-19%) within 24-months post-hospitalisation. An identified predictive factor is persistent wet cough a month after hospitalisation and this is likely related to protracted bacterial bronchitis which can progress to bronchiectasis, if untreated. Thus, screening for, and optimally managing, persistent wet cough one-month post-hospitalisation potentially prevents bronchiectasis in First Nations’ children. Our study aims to improve the post-hospitalisation medical follow-up for First Nations children hospitalised with ALRIs and thus lead to improved respiratory health. We hypothesize that implementation of a strategy, conducted in a culturally secure manner, that is informed by barriers and facilitators identified by both families and health service providers, will improve medical follow-up and management of First Nations children hospitalized with ALRIs.

Methods: Our trial is a multi-centre, pseudo-randomized stepped wedge design where the implementation of the strategy is tailored for each study 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. The primary outcome measure will be Cough-specific Quality of Life (PC-QoL). Outcomes will be measures at each study site/cluster in three different stages i.e., (i)Nil-intervention control group, (ii)Health information only control group and (iii)Post-intervention group.

Discussion: If our hypothesis is correct, our study findings will translate to improved health outcomes (cough related quality of life) in children who have persistent wet cough a month after hospitalization for an ALRI.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114602 0
Dr Pamela Laird
Address 114602 0
Telethon Kids Institute
Wal-yan centre for respiratory health
BREATH team
15 Hospital Ave
Nedlands WA 6009
Country 114602 0
Australia
Phone 114602 0
+61 8 6319 1614
Fax 114602 0
Email 114602 0
Pamela.laird@health.wa.gov.au
Contact person for public queries
Name 114603 0
Dr Pamela Laird
Address 114603 0
Telethon Kids Institute
Wal-yan centre for respiratory health
BREATH team
15 Hospital Ave
Nedlands WA 6009
Country 114603 0
Australia
Phone 114603 0
+61 8 6319 1614
Fax 114603 0
Email 114603 0
Pamela.laird@health.wa.gov.au
Contact person for scientific queries
Name 114604 0
Dr Pamela Laird
Address 114604 0
Telethon Kids Institute
Wal-yan centre for respiratory health
BREATH team
15 Hospital Ave
Nedlands WA 6009
Country 114604 0
Australia
Phone 114604 0
+61 8 6319 1614
Fax 114604 0
Email 114604 0
Pamela.laird@health.wa.gov.au

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 andre.schultz@health.wa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13439Study protocol    To be submitted upon acceptance of this clinical t... [More Details] 382886-(Uploaded-01-02-2022-18-40-49)-Study-related document.docx
13441Informed consent form    Will be provided in published protocol
13443Ethical approval    Will be provided in published protocol
14894Statistical analysis plan    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
SourceTitleYear of PublicationDOI
EmbaseImplementation of a strategy to facilitate effective medical follow-up for Australian First Nations children hospitalised with lower respiratory tract infections: study protocol.2022https://dx.doi.org/10.1186/s12890-022-01878-3
N.B. These documents automatically identified may not have been verified by the study sponsor.