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Trial registered on ANZCTR


Registration number
ACTRN12621001287820
Ethics application status
Approved
Date submitted
21/07/2021
Date registered
23/09/2021
Date last updated
23/09/2022
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Sustainability of evidence-based practices in the care for infants with bronchiolitis in hospitals involved in the Knowledge Translation (KT) in Australasian Paediatric Acute Care Settings Study
Scientific title
Sustainability of evidence-based practices in the management of infants with bronchiolitis in hospitals involved in the Knowledge Translation (KT) in Australasian Paediatric Acute Care Settings study - a PREDICT study
Secondary ID [1] 304282 0
NHMRC Grant - GNT1171228
Universal Trial Number (UTN)
Trial acronym
Bronchiolitis KT Sustainability Study
Linked study record
This record is a follow-up study of ACTRN12616001567415 exploring sustainability of evidence-based practices in the care for infants with bronchiolitis.

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 322015 0
Condition category
Condition code
Emergency medicine 319734 319734 0 0
Other emergency care
Respiratory 320952 320952 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The 2017 PREDICT ‘Knowledge Translation in Australasian Paediatric Acute Care Settings: a multi-centred, cluster-randomised controlled trial comparing a tailored, theory informed Knowledge Translation intervention versus passive dissemination of a bronchiolitis guideline’ study (PREDICT Bronchiolitis Knowledge Translation (KT) Study) (ACTRN12616001567415), successfully implemented a targeted, theory-informed bronchiolitis intervention which reduced the use of five inappropriate therapies (chest X-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline). The intervention included the following components: engagement of local nursing and medical clinical opinion leaders; a one-day train the trainer workshop; educational materials; and audit and feedback.

Our study will undertake medical record audits at the 13 intervention trial hospitals to determine the sustainability of this intervention over time including any improvements. Medical record audits will be conducted on infants who presented to hospital between 1 January 2018 to 31 December 2019, with a diagnosis of bronchiolitis. Data will be extracted on patient demographics; chest x-ray; medication administration (salbutamol, antibiotic, glucocorticoid, adrenaline); respiratory support (non-invasive or invasive ventilation) and disposition from emergency department or inpatient paediatric area (i.e., discharged home or admitted to Intensive Care Unit).

Semi-structured interviews (individual or group - depending on clinician availability, via teleconference or face-to-face) will be conducted at 13 intervention trial hospital sites to determine fidelity and adaptation of the intervention and explore factors which may have contributed to improvements in intervention group hospitals. The semi-structured interviews will be approximately 30-45 minutes in duration and will be conducted by two study researchers with a convenience sample of doctors and nurses who treat infants in the participating EDs and inpatient paediatric areas. There will be a maximum of three to five individuals per site (n=78-130).
Intervention code [1] 320620 0
Not applicable
Comparator / control treatment
A comparison will be made between the 13 intervention hospitals who received the education and training intervention as part of the ‘Knowledge Translation in Australasian Paediatric Acute Care Settings: a multi-centred, cluster-randomised controlled trial comparing a tailored, theory informed Knowledge Translation intervention versus passive dissemination of a bronchiolitis guideline’ study (PREDICT Bronchiolitis KT study) (ACTRN12616001567415), and 13 control hospitals who received electronic and printed copies of the Australasian Bronchiolitis Guideline only and were offered selected intervention materials only at trial completion (November 2018). Medical record audits and semi-structured interviews will be conducted at the 13 control hospitals, in an identical manner to those conducted in the 13 intervention hospitals.
Control group
Active

Outcomes
Primary outcome [1] 327603 0
The proportion of infants presenting to hospital with bronchiolitis at intervention group hospitals, who received care that adhered with all 5 practice Australasian Bronchiolitis Guideline recommendations known to have no benefit (CXR, salbutamol, glucocorticoids, antibiotics, and adrenaline) in the acute care period (first 24 hours of hospitalisation) assessed as a composite outcome of all 5 practices by audit of patient medical records.
Timepoint [1] 327603 0
From completion of PREDICT Bronchiolitis KT study (2017) to 2 years post-completion (2019).
Secondary outcome [1] 395957 0
The proportion of infants presenting to hospital with bronchiolitis at intervention group hospitals, who received care that adhered with all 5 practice Australasian Bronchiolitis Guideline recommendations known to have no benefit (CXR, salbutamol, glucocorticoids, antibiotics, and adrenaline) in the acute care period (first 24 hours of hospitalisation) assessed as a composite outcome of all 5 practices by audit of patient medical records;
Timepoint [1] 395957 0
From completion of PREDICT Bronchiolitis KT study (2017) to 1 year post-completion (2018).
Secondary outcome [2] 395960 0
The proportion of infants presenting to hospital with bronchiolitis at control group hospitals, who received care that adhered with the Australasian Bronchiolitis Guideline recommendations known to have no benefit (CXR, salbutamol, glucocorticoids, antibiotics, and adrenaline) in the acute care period (first 24 hours of hospitalisation) prior to receipt of the selected intervention materials assessed as a composite outcomes of all 5 practices by audit of patient medical records;
Timepoint [2] 395960 0
From completion of PREDICT Bronchiolitis KT study (2017) to 1 year post-completion (2018).
Secondary outcome [3] 400278 0
The proportion of infants presenting to hospital with bronchiolitis at control group hospitals, who received care that adhered with the Australasian Bronchiolitis Guideline recommendations known to have no benefit (CXR, salbutamol, glucocorticoids, antibiotics, and adrenaline) in the acute care period (first 24 hours of hospitalisation) following delivery of study materials, study results, and ‘Train the Trainer’ education (composite outcomes of all 5 practices) assessed by audit of patient medical records;
Timepoint [3] 400278 0
From receipt of the selected PREDICT Bronchiolitis KT study intervention materials (2018) to 1 year post-receipt (2019).
Secondary outcome [4] 400282 0
Fidelity to the PREDICT Bronchiolitis KT Study implementation strategy at intervention and control group hospitals four years following intervention delivery (2018, 2019, 2020, 2021) as assessed by qualitative semi-structured interviews.
Timepoint [4] 400282 0
Assessed at 4 (2021) years post-completion of the PREDICT Bronchiolitis KT study (2017).
Secondary outcome [5] 400283 0
Adaptation to the PREDICT Bronchiolitis KT Study implementation strategy at intervention and control group hospitals four years following intervention delivery (2018, 2019, 2020, 2021) as assessed by qualitative semi-structured interviews.
Timepoint [5] 400283 0
Assessed at 4 (2021) years post-completion of the PREDICT Bronchiolitis KT study (2017).
Secondary outcome [6] 400284 0
Factors that contributed to sustainability of improvements of guideline adherence at intervention group hospitals four years post-implementation assessed through qualitative semi-structured interviews.
Timepoint [6] 400284 0
Assessed at 4 (2021) years post-completion of the PREDICT Bronchiolitis KT study (2017).
Secondary outcome [7] 400285 0
Factors that contributed to improvements/deterioration of guideline adherence at control group hospitals four years post-implementation assessed through qualitative structured interviews.
Timepoint [7] 400285 0
Assessed at 4 (2021) years post-completion of the PREDICT Bronchiolitis KT study (2017).

Eligibility
Key inclusion criteria
Medical Record Audit Inclusion Criteria
Hospital Inclusion Criteria:
Twenty-six hospitals (Australia= 20 and New Zealand = 6) which participated in the PREDICT Bronchiolitis KT study (ACTRN12616001567415) conducted in 2017 will be invited to participate. In addition, to be eligible for this study, hospitals must have the ability to collect the required retrospective patient data from the medical records within a timely fashion and meet local governance requirements.

Patient Inclusion Criteria:
• Infants aged less than 12 months (at time of presentation), AND
• A recorded diagnosis of bronchiolitis on discharge from ED to home, OR
• A diagnosis of bronchiolitis on discharge from inpatient area AND a recorded diagnosis of bronchiolitis in ED.

Qualitative Group Interview Inclusion Criteria
Hospital Inclusion Criteria:
Twenty-six hospitals which participated in the PREDICT Bronchiolitis KT study conducted in 2017 will be invited to participate. In addition, to be eligible for this section of the study, hospitals must have agreed to participate in the retrospective medical records audit.

Clinician Inclusion Criteria:
Participants must be:
• on an active practice roster
• working part-time or full-time
• in a clinical role as either doctors (including trainees) and registered nurses who are responsible for caring for children with bronchiolitis in an Australian or New Zealand EDs or paediatric inpatient areas.

Where possible Clinical Leads from the PREDICT Bronchiolitis KT study will be included in the sample as will clinicians of varying seniority (years since completing training).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical Record Audit Exclusion Criteria:
Hospital Exclusion Criteria:
There are no hospital level exclusion criteria.

Patient Exclusion Criteria:
There are no patient level exclusion criteria.

Clinician Exclusion Criteria:
Hospital Exclusion Criteria:
There are no hospital level exclusion criteria.

Clinician Exclusion Criteria:
Students/interns, locums (medical); agency or bank staff (nurses) and clinicians not currently engaged in clinical practice will be excluded.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Medical Record Audit:
Data will be analysed at the patient level, according to the group (intervention/control) the hospitals were originally randomised to. Descriptive statistics will be used to report the frequency of adherence to the five key clinical practices under consideration (CXR, salbutamol, glucocorticoids, antibiotics and adrenaline). Binary outcomes will be presented as proportions with 95% confidence intervals. Continuous outcomes will be presented as means and standard deviations or medians and interquartile range.

Generalised Linear Mixed (GLM) models will be used to estimate the marginal differences in proportion of bronchiolitis patients compliant with the Australasian Bronchiolitis Guideline between the study groups. Logistic regression with a clustered-robust standard error (hospital level) will be used if the GLM models do not converge, to calculate odds ratios.

Qualitative Group Interviews:
Thematic analysis will be performed on transcribed data imported into NVivo10, using an iterative process. Transcribed interviews will be analysed by a researcher using open coding relating extracts of text to key questions and mapping to relevant theoretical sustainability frameworks.

Sites will be compared and contrasted. When text is relevant to more than one theme, it will be cross indexed. Codes will be collapsed and reduced as analysis progresses. Another researcher will cross-check the coding framework and discrepancies will be discussed to reach consensus. Participant quotes will be linked to the final agreed set of themes and sub-themes. Data will be judged as saturated when no new issues or insights between sites or between participant groups are reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
4/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1800
Accrual to date
155
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA
Recruitment hospital [1] 23188 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [2] 23189 0
Cairns Base Hospital - Cairns
Recruitment hospital [3] 23190 0
Caboolture Hospital - Caboolture
Recruitment hospital [4] 23191 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 23192 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [6] 23193 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 23194 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [8] 23195 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [9] 23196 0
Logan Hospital - Meadowbrook
Recruitment hospital [10] 23197 0
The Northern Hospital - Epping
Recruitment hospital [11] 23198 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [12] 23199 0
Gold Coast University Hospital - Southport
Recruitment hospital [13] 23200 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [14] 23201 0
Sydney Children's Hospital - Randwick
Recruitment hospital [15] 23202 0
The Townsville Hospital - Douglas
Recruitment hospital [16] 23203 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [17] 23204 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 38554 0
3350 - Ballarat Central
Recruitment postcode(s) [2] 38555 0
4870 - Cairns
Recruitment postcode(s) [3] 38556 0
4510 - Caboolture
Recruitment postcode(s) [4] 38557 0
4032 - Chermside
Recruitment postcode(s) [5] 38558 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 38559 0
2500 - Wollongong
Recruitment postcode(s) [7] 38560 0
4350 - Toowoomba
Recruitment postcode(s) [8] 38561 0
2065 - St Leonards
Recruitment postcode(s) [9] 38562 0
4131 - Meadowbrook
Recruitment postcode(s) [10] 38563 0
3076 - Epping
Recruitment postcode(s) [11] 38564 0
4101 - South Brisbane
Recruitment postcode(s) [12] 38565 0
4215 - Southport
Recruitment postcode(s) [13] 38566 0
5006 - North Adelaide
Recruitment postcode(s) [14] 38567 0
2031 - Randwick
Recruitment postcode(s) [15] 38568 0
4814 - Douglas
Recruitment postcode(s) [16] 38569 0
0810 - Tiwi
Recruitment postcode(s) [17] 38570 0
2145 - Westmead
Recruitment outside Australia
Country [1] 23719 0
New Zealand
State/province [1] 23719 0
Hawkes Bay Hospital; Rotorua Hospital; Waikato Hospital; Tauranga Hospital; Southland Hospital; Christchurch Hospital

Funding & Sponsors
Funding source category [1] 308658 0
Government body
Name [1] 308658 0
National Health and Medical Research Council
Country [1] 308658 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
Murdoch Children's Research Institute
The Royal Children's Hospital,
Level 4 West
50 Flemington Road
Parkville, Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 309551 0
None
Name [1] 309551 0
Address [1] 309551 0
Country [1] 309551 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308585 0
Royal Children's Hospital
Ethics committee address [1] 308585 0
Ethics committee country [1] 308585 0
Australia
Date submitted for ethics approval [1] 308585 0
07/05/2021
Approval date [1] 308585 0
08/09/2021
Ethics approval number [1] 308585 0
HREC/72517/RCHM-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111230 0
Dr Emma Tavender
Address 111230 0
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 111230 0
Australia
Phone 111230 0
+61 3 9936 6329
Fax 111230 0
Email 111230 0
emma.tavender@mcri.edu.au
Contact person for public queries
Name 111231 0
Emma Tavender
Address 111231 0
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 111231 0
Australia
Phone 111231 0
+61 3 9936 6329
Fax 111231 0
Email 111231 0
emma.tavender@mcri.edu.au
Contact person for scientific queries
Name 111232 0
Emma Tavender
Address 111232 0
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 111232 0
Australia
Phone 111232 0
+61 3 9936 6329
Fax 111232 0
Email 111232 0
emma.tavender@mcri.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?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.