ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001567415

Ethics application status

Approved

Date submitted

7/09/2016

Date registered

14/11/2016

Date last updated

8/02/2019

Date data sharing statement initially provided

8/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

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.

Scientific title

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1186-8329

Trial acronym

PREDICT Bronch KT

Linked study record

Health condition

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

Bronchiolitis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention components will be tailored to the factors influencing practice (barriers and enablers) and the specific needs of intervention sites. Currently a qualitative study of emergency and paediatric medical and nursing staff concerning the barriers and enablers to appropriate bronchiolitis management is being undertaken by the research team and will be analysed in October, this will help refine content and range of interventions.

To date, it is planned that the interventions will involve:

Local stakeholder meetings
- Central research team will meet with site Principal Investigator and potential staff to be champions (clinical opinion leaders) on two scheduled occasions to (i) check understanding of the study and capacity to be involved (ii) Negotiate implementation of the intervention with discussion of particular site related issues that are predicted. These meetings are important for engagement with the study team. Key outcomes will be recorded on a site checklist.

Identification of nursing and medical clinical opinion leaders in each site in the ED and general paediatric area.
- These people will be nominated by the sites according to a role description – provided by the central research team. It is requested to have an ED based nurse and doctor opinion leader and a General Paediatrics nurse and doctor opinion leader, details of each will be recorded.

A one-day train-the-trainer workshop (1 or 2 to be held depending on availability of staff and site recruitment dates)
- Site local opinion leaders from intervention sites will be invited to attend this one day training event. Two events may be held to capture groups in New Zealand and Australia. The day will have a workshop format of small interactive group sessions and lectures.
Topics will be include: scientific evidence behind the PREDICT Australasian Bronchiolitis Guideline, evidence of how to change clinician behaviour, their role as a local opinion leader, content of interventions designed to change bronchiolitis management behaviour. Attendance will be recorded.

Standardised education and interactive workshops delivered by the site based clinical leaders/champions over a 3 month period of time to their departmental staff.
- This will involve the use of standardised power point presentations of the evidence basis for bronchiolitis management delivered in small group presentations at the site. Frequency of these sessions can only be determined by the site but this will be recorded as well as attendance. Sites will be encouraged to complete training of 80% of their staff within the first 4 weeks. The remaining staff will receive training as soon as possible. Sites will choose whether this is done in small groups, on an individual basis or a combination of these methods. All training will be recorded.

Provision of materials to increase the visibility of tools
- This may include provision of posters, clinical pathways, and standardised email reminders by the central research team to the site that contain highly visible reminders of desired bronchiolitis care.

Non-specific reminders to optimise data collection
- The research team member associated with each site will be in regular (at least 2 weekly) contact (email or phone) with the local champions to provide support and answer any queries. Discussion regarding data collection and offering assistance as required will be made. All contact made with sites will be recorded.

Audit and feedback process undertaken at sites
- All sites will be recommended to undertake auditing of the care of 10-12 randomly selected bronchiolitis patients once per fortnight over the bronchiolitis season. The required audit data to be retrieved from records and will be entered into an online database. The blinded data will be presented to sites showing their performance in comparison to other sites. It will also be encouraged that this audit and feedback information be used in training workshops to inform staff of their performance.

General support provided by the central research team.
- The central research team will contact each site on a 2 weekly basis from 1/5/17 to 30/11/17 to monitor progress and provide individualised support as issues arise. The central research team will record this information in a site contact log.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Passive clinical practice guideline dissemination: Participating hospitals randomised to the control group will receive an electronic and a single hard copy of the Australasian Bronchiolitis Guideline. They can disseminate this to staff as per their normal practice.

Control group

Active

Outcomes

Primary outcome [1]

Compliance or non-compliance for each individual patient presentation with the guideline, will be assessed through the review of medical records retrospectively. Records will be assessed with regards to the use of key therapies / management processes known to have no benefit (chest x-ray, salbutamol, glucocorticoids, antibiotics, epinephrine), using a composite outcome, during the first 24 hours after presentation to the ED (acute care period).

Timepoint [1]

24 hours after the patient presentation to the ED.

Secondary outcome [1]

Compliance or non-compliance for each individual patient presentation will be assessed in relation to the guideline with regards to the use of key therapies / management processes known to have no benefit (chest x-ray, salbutamol, glucocorticoids, antibiotics, epinephrine) - whilst in the ED. This is a composite outcome and compliance will be assessed through review of medical records.

Timepoint [1]

From admission to ED until discharge from ED.

Secondary outcome [2]

Compliance or non-compliance for each individual patient presentation will be assessed in relation to the guideline with regards to the use of key therapies / management processes known to have no benefit (chest x-ray, salbutamol, glucocorticoids, antibiotics, epinephrine) - whilst an inpatient outside of the ED. This is a composite outcome. Compliance will be assessed through review of medical records.

Timepoint [2]

From discharge/transfer from ED to discharge from hospital inpatient admission.

Secondary outcome [3]

Compliance or non-compliance for each individual patient presentation will be assessed in relation to the guideline with regards to the use of key therapies / management processes known to have no benefit (chest x-ray, salbutamol, glucocorticoids, antibiotics, epinephrine) - during total ED and inpatient hospitalisation period. This is a composite outcome. Compliance will be assessed through review of medical records.

Timepoint [3]

From admission to the ED to discharge from hospital admission.

Secondary outcome [4]

Compliance or non-compliance for each patient presentation with guideline recommendations during the first 24 hours following presentation to the ED (acute care period) with regards to the use of Chest x-ray. Compliance will be assessed through the review of medical records.

Timepoint [4]

During the first 24 hours after presentation to the ED.

Secondary outcome [5]

Compliance or non-compliance for each patient presentation with guideline recommendations during the first 24 hours following presentation to the ED (acute care period) with regards to the use of Salbutamol. Compliance will be assessed through the review of medical records.

Timepoint [5]

During the first 24 hours after presentation to the ED.

Secondary outcome [6]

Compliance or non-compliance for each patient presentation with guideline recommendations during the first 24 hours following presentation to the ED (acute care period) with regards to the use of Glucocorticoids. Compliance will be assessed through the review of medical records.

Timepoint [6]

During the first 24 hours after presentation to the ED

Secondary outcome [7]

Compliance or non-compliance for each patient presentation with guideline recommendations during the first 24 hours following presentation to the ED (acute care period) with regards to the use of Antibiotics. Compliance will be assessed through the review of medical records.

Timepoint [7]

During the first 24 hours from presentation to the ED.

Secondary outcome [8]

Compliance or non-compliance for each patient presentation with guideline recommendations during the first 24 hours following presentation to the ED (acute care period) with regards to the use of Epinephrine. Compliance will be assessed through the review of medical records.

Timepoint [8]

During the first 24 hours from presentation to the ED.

Secondary outcome [9]

Compliance or non-compliance for each patient presentation with guideline recommendations during their total hospitalization with regards to use of Chest x-ray. This will be assessed through the review of medical records.

Timepoint [9]

From presentation to the ED to time of hospital discharge

Secondary outcome [10]

Compliance or non-compliance for each patient presentation with guideline recommendations during their total hospitalization with regards to use of Salbutamol. This will be assessed through the review of medical records.

Timepoint [10]

From presentation to the ED to time of hospital discharge.

Secondary outcome [11]

Compliance or non-compliance for each patient presentation with guideline recommendations during their total hospitalization with regards to use of Glucocorticoids. This will be assessed through the review of medical records.

Timepoint [11]

From presentation to the ED to time of hospital discharge.

Secondary outcome [12]

Compliance or non-compliance for each patient presentation with guideline recommendations during their total hospitalization with regards to use of Antibiotics. This will be assessed through the review of medical records.

Timepoint [12]

From presentation to the ED to time of hospital discharge.

Secondary outcome [13]

Compliance or non-compliance for each patient presentation with guideline recommendations during their total hospitalization with regards to use of Epinephrine. This will be assessed through the review of medical records.

Timepoint [13]

From presentation to the ED to time of hospital discharge.

Secondary outcome [14]

Process evaluation including measurement of delivery of interventions at the site. This will be assessed by data collected by the site (in study logs) and by the study team about interventions delivered, (eg. number of staff attending, number of audits conducted and cases audited, and number of times the database is accessed to input data).

Timepoint [14]

From study commencement at 1/1/17 through to 30/11/17

Secondary outcome [15]

Process evaluation including measurement of acceptability of the interventions at the site. This will be assessed by data collected by a staff survey after 30/11/2017.

Timepoint [15]

After 30th November 2017

Secondary outcome [16]

Hospital Length of stay data will be assessed through the review of medical records.

Timepoint [16]

From hospital admission to hospital discharge.

Secondary outcome [17]

Death and or intensive care admission data will be assessed through the review of medical records.

Timepoint [17]

At intensive care discharge or at death whilst in hospital.

Secondary outcome [18]

Health care costs including cost associated with guideline development and implementation. Guideline costs will be assessed through the review of guideline development records that are directly available to the research team. Hospital health care costs will be assessed through medical records or informed through imputation conducted by a health economist consultant.

Timepoint [18]

During period of guideline development (prior to cluster RCT).

Secondary outcome [19]

Median number of medication doses given during the acute inpatient care period. This will be assessed through the review of medical records.

Timepoint [19]

From hospital inpatient admission to hospital discharge.

Secondary outcome [20]

Median number of medication doses given during the total period of hospitalisation. This will be assessed through the review of medical records.

Timepoint [20]

From admission to ED to discharge from hospital.

Secondary outcome [21]

Predictors of bronchiolitis management assessed through Clinician self-report via survey at baseline and at the end of the 2017 bronchiolitis season. Survey is designed for this study.
(a) Cognitions in relation to bronchiolitis-related team climate (e.g. participative safety, support for innovation, vision, task orientation) (Team Climate Inventory, 12-item short version)

Timepoint [21]

Baseline and at the end of the 2017 bronchiolitis season.

Secondary outcome [22]

Timepoint [22]

Baseline and at the end of the 2017 bronchiolitis season.

Secondary outcome [23]

Predictors of bronchiolitis management assessed through Clinician self-report via survey at baseline and at the end of the 2017 bronchiolitis season.
(c) Other cognitions such as knowledge and beliefs about capabilities (for bronchiolitis only) (Survey items designed for this study)

Timepoint [23]

Baseline and at the end of the 2017 bronchiolitis season.

Eligibility

Key inclusion criteria

Hospitals:
1. Have an ED census of >135 cases of bronchiolitis per year.
2. Be willing to participate (either in the control or intervention arm).
3. A signed department agreement by both ED and inpatient clinical directors.
4. Have the ability to collect the required retrospective patient data from clinical notes.

Staff Cohort
Medical
* Current ED or general paediatric employee
* On active practice roster
* Registrars, House Officers (or equivalent) or consultants
Nursing:
* Current ED or general paediatric employee
* On active practice roster
* Registered or enrolled nurse

Patient Medical Record Cohort
1. Aged less than 12 months (at time of presentation), AND
2. A recorded diagnosis of bronchiolitis on discharge from ED to home, OR
3. A diagnosis of bronchiolitis on discharge from inpatient area AND a recorded diagnosis of bronchiolitis in ED

Minimum age

No limit

Maximum age

12 Months

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Hospitals
1. Inability to audit clinical notes.
2. Be averse to participating if randomised to the control arm.
3. Royal Children’s Hospital, Melbourne; Perth Children’s Hospital (formerly known as Princess Margaret), Perth; Starship Children’s Health, Auckland - due to potential bias..

Staff Cohort
Medical and Nursing
* Students / interns
* Clinicians not currently engaged in clinical practice
* Agency or bank staff (nurses) or locums (medical)

Patient Medical Record Cohort
Nil (must meet all inclusion criteria)

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Nil. Randomisation of hospitals within both strata (by country as well as tertiary or secondary hospital) into either KT intervention or control group will be completed using randomisation computer software, by a statistician who is not affiliated with the study. This information will then be passed on to the Study Management Team who will then inform hospitals if they have been assigned to the intervention or control arms.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A statistician who is not affiliated with the study will prepare the randomisation schedule using block randomisation to maintain balance between the two groups. Randomisation will be stratified by country as well as tertiary or secondary hospital with variable block sizes.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Cluster randomised trial (EDs unit of randomisation).

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The sample size calculations took the nature of the outcome (binary variable outcome variable: guideline-conform treatment yes/no) as well as the issue of clustering (heterogeneity in estimated proportions between sites that exceed variability being explained by random sampling) into account.
The power calculations revealed a necessary group sample size of 1620 individuals, assuming an average cluster size of 135 patients (24 sites). A total of 3240 patients will be required to detect a clinically meaningful absolute difference of 15% in the proportion of non-compliance patients between the two study groups (power of 80%, two-sided type I error level: 0.05). These sample size calculations assumed (informed by preliminary data), an intra-cluster correlation coefficient of <0.06 as well as a proportion relative frequency of the primary outcome of 50% in the control arm.

Staff survey data:
Data from the staff surveys will be coded and analysed using descriptive statistics to obtain frequencies, means and standard deviations for variables of interest. Means scores will be compared pre and post intervention to determine change.

Process evaluation data:
Process data will be analysed using descriptive statistics to obtain frequencies, means and standard deviations for variables of interest.

The primary analysis will be on an “intention to treat” basis.
The principal analysis will examine compliance or non-compliance for each individual patient with the guideline in the acute care period, ED and as an inpatient with regards to key therapies/management processes known to have no benefit.
A Generalized Linear Mixed Models (GLMM) will be used to estimate the marginal difference in the proportion of bronchiolitis patients treated in accordance with the existing guideline between the study arms. The GLMM approach will employ a logit link function and will include random effect terms for study site. Based on the GLMM, risk differences with 95% confidence internals will be computed. Missing outcome data will be imputed using multiple imputation models.
The details of the primary and secondary statistical analyses will be specified in a separate statistical analysis plan (SAP) which will be finalised before study data base lock. The SAP will detail covariates to be considered in the primary analysis model as well as subgroup and sensitivity analyses to be performed. The SAP will also outline the multiple imputation strategy to handle missing data.

An economic analysis will be carried out with costs associated to the payer (hospital). This will include: cost of ED presentation, cost of admission and cost of therapies/management known to be of no benefit. Additionally, the costs associated with the development of the Australasian Bronchiolitis Guideline and the KT intervention development and implementation will be analysed.

Process evaluation will occur to assess fidelity in the delivery of the KT interventions (what was delivered, to whom and how) as well as staff questionnaires. See section 9. Mixed methods will be used including qualitative interviews and quantitative surveys.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

28/10/2016

Date of last participant enrolment

Anticipated

30/05/2018

Actual

19/01/2017

Date of last data collection

Anticipated

30/06/2018

Actual

21/11/2018

Sample size

Target

10440

Accrual to date

Final

11772

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

N/A

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Stuart Dalziel

Address

Starship Childrens Hospital
Park Road
Auckland 1142, New Zealand

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Associate Professor Ed Oakley

Address [1]

Emergency Research
Murdoch Childrens Research Institute
Royal Childrens Hospital
Flemington Road
Parkville 3052, Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Children’s Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

Research Ethics and Governance Officer
Research Ethics and Governance
The Royal Children’s Hospital Melbourne
Flemington Road
Parkville 3052, Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/07/2016

Approval date [1]

01/08/2016

Ethics approval number [1]

HREC/16/RCHM/84 & 36184A

Ethics committee name [2]

Health and Disability Ethics Committees

Ethics committee address [2]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

31/08/2016

Approval date [2]

21/09/2016

Ethics approval number [2]

16/NTA/146

Summary

Brief summary

The aim of this study is to determine if tailored, theory informed Knowledge Translation (KT) interventions can increase the uptake of an Australasian bronchiolitis guideline in reducing the use of therapies/management known to be of no benefit in the management of infants with bronchiolitis.  This will be done by conducting a cluster randomised controlled trial - randomising hospitals to either intervention or control groups with focus on Emergency Department and General Paediatrics units.  Results from this study will influence the implementation of other guidelines and evidence based practise in paediatric settings.

Trial website

http://www.predict.org.au/projects/bronchiolitis/

Trial related presentations / publications

Implementing evidence-based practices in the care of infants with bronchiolitis in Australasian acute care settings: study protocol for a cluster randomised controlled study.
Published in BMC Pediatrics 2018.
https://doi.org/10.1186/s12887-018-1187-7

Public notes

Contacts

Principal investigator

Name

Dr Stuart Dalziel

Address

Starship Children's Hospital
Park Road
Auckland 1142 New Zealand

Country

New Zealand

Phone

+64 21 869 068

Fax

[email protected]

Contact person for public queries

Name

Libby Haskell

Address

Starship Children's Hospital
Park Road
Auckland 1142 New Zealand

Country

New Zealand

Phone

+64 21 670550

Fax

[email protected]

Contact person for scientific queries

Name

Libby Haskell

Address

Starship Children's Hospital
Park Road
Auckland 1142 New Zealand

Country

New Zealand

Phone

+64 21 670550

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

We don't have ethics for this.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1318	Study protocol				https://doi.org/10.1186/s12887-018-1187-7

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	Implementing evidence-based practices in the care of infants with bronchiolitis in Australasian acute care settings: Study protocol for a cluster randomised controlled study.	2018	https://dx.doi.org/10.1186/s12887-018-1187-7
Embase	Can targeted interventions change the factors influencing variation in management of infants with bronchiolitis? A survey of Australian and New Zealand clinicians: A paediatric research in emergency departments international collaborative (PREDICT) study.	2022	https://dx.doi.org/10.1111/jpc.15710
Embase	Prevalence of high flow nasal cannula therapy use for management of infants with bronchiolitis in Australia and New Zealand.	2022	https://dx.doi.org/10.1111/jpc.16199

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

Trial Review

Documents added manually

Documents added automatically