Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000893707
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
22/06/2022
Date last updated
22/06/2022
Date data sharing statement initially provided
22/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a paediatric inter-facility transfer initiative for acutely unwell children in regional Queensland: Standardised Workflow for Inter-Facility Transfer of Kids [SWIFTKids]
Scientific title
Evaluation of a paediatric inter-facility transfer initiative for acutely unwell children in regional Queensland: Standardised Workflow for Inter-Facility Transfer of Kids [SWIFTKids]
Secondary ID [1] 304271 0
Children's Hospital Foundation grant reference number 50327
Universal Trial Number (UTN)
Trial acronym
SWIFTKids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adverse events during inter-facility transfer 322081 0
Deteriorating general paediatric patient requiring transfer 322227 0
Condition category
Condition code
Public Health 319800 319800 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The SWIFTKids workflow algorithm was implemented across the Sunshine Coast Hospital and Health service (SCHHS) in early 2019 with the education package rolled out in May 2019 and Sunshine Coast HHS Paediatric Inter-Facility Transfer Procedure (workflow algorithm) was rolled out in July 2019. The strategy is now a part of routine care for all paediatric patients being transferred across the Hospital and Health Service. The risk of deterioration was identified as a clinical risk concern and need for improvement for patient safety.

Implementation of the SWIFTKids Strategy
SWIFTKids was developed based on the local identification of factors influencing sub-optimal outcomes and existing literature. SWIFTKids involves:

*Development and implementation of a standardised workflow algorithm for paediatric inter-facility transfers; including a risk stratification approach to triage transfer requirements [traffic lights], and fit-for purpose documentation.
*Introduction of standardised tele/video-conferencing for consultation between senior medical staff of the referral and accepting facilities.
*Development of an interdisciplinary education package for staff involved in the referral and transfer of paediatric patients.

The workflow algorithm is a Sunshine Coast Hospital and Health Service (SCHHS) instruction on how to properly execute a transfer of a paediatric patient from outlying hospitals to Sunshine Coast University Hospital (SCUH) or to Queensland Children's Hospital that was implemented in October 2018. The purpose is to ensure patients "receive care in the most appropriate setting and that their right to safety and access in health care is best supported" and "that access is coordinated, clinically prioritised, safe and patient-centric" (Sunshine Coast University Hospital and Health Service, 2021). It includes a traffic light triage tool to assist providers in choosing the most appropriate mode of transfer (i.e. Retrieval Services Queensland, Queensland Ambulance Service [with or without a nurse escort] or via privately owned vehicle). The workflow algorithm also stipulates the manner of communication between sending and receiving hospital teams and the documentation that is required for each transfer.

The workflow algorithm is available on the Sunshine Coast University Hospital and Health Service's area of the intranet site Queensland Health Electronic Publishing Service. It has a checklist that is to be completed by staff prior to the patient's departure for transfer. The workflow algorithm contains hyperlinks to the required forms for staff to complete in preparation for and during transfer.

The workflow algorithm is intended for use by medical and nursing staff involved in paediatric inter-hospital transfers (PIHT) and should be utilised for each transfer from outlying emergency departments.

Adherence to the workflow algorithm will be assessed in Phase 1, Objective 2 of the SWIFTKids study. Two investigators will perform reviews on 30 patient charts to assess adherence to structure measures and process measures. Structure measures to be assessed include:
*Compliance with PIHT forms by nurse escorts
*Use of phone/video consult forms by paediatrician/receiving medical officer
*Documentation of the 3 or 4 way-conversation in the integrated electronic Medical Record (ieMR)
Process measures to be assessed include:
*Phone consultation pathway (acceptability of tele- and/or video-health process; number of calls required to arrange transfer; possible barriers due to complication with the technology)
*Accuracy of applying the risk-stratification process in categorising children's care prior to transfer (clinical deterioration en-route, need for nurse escort, alteration to intended arrival location)
*Record of algorithm violations and missing data eg patient transferred without utilisation of 3 or 4-way conversation
*Accuracy of risk stratification in identifying level of escort required as defined in the workflow algorithm
*Unexpected deterioration en route and/or escalation to the paediatric critical care unit on arrival to SCUH

Phase One: Structure and Process Study
The structures and processes involved in the SWIFTKids strategy will be evaluated using a multi-methods design. The study will be set within the Sunshine Coast Hospital and Health Service [SCHHS]. Aim: Determine the acceptability and feasibility of SWIFTKids by staff and patients and or family Part 1: Patient and staff experiences will be explored using a qualitative descriptive study. This will involve semi-structured interviews with parents and children, of their perceptions and experiences relating to inter-facility transfer. Data will be thematically analysed. Part 2: The usability and compliance with the implemented structure and process of the SWIFTKids strategy will be examined using a descriptive quantitative study through in-depth electronic medical record chart review by two experienced clinicians.
Phase Two: Outcomes Study
The aim of this study phase is to evaluate patient health outcomes and health service cost delivery associated with the SWIFTKids strategy. The outcomes of the SWIFTKids strategy will be determined using a pre-post design that tracks eligible patients before and after the strategy implementation (October 2018). Data for all patients aged 0-16 years who have been transferred to SCUH from a referring Sunshine Coast health facility from 1 September 2017- 30 August 2018 AND 1 September 2019 – 30 August 2020

Sunshine Coast University Hospital and Health Service. (2021). Paediatric inter-hospital transfers.
Intervention code [1] 322283 0
Not applicable
Comparator / control treatment
The comparator group is the cohort of patients who were transferred between 1/09/2017 to 30/08/2018. These patients were PIHTs prior to the implementation of the SWIFTKids strategy. This is a pre-/post-intervention comparison study.
Control group
Historical

Outcomes
Primary outcome [1] 327730 0
Phase One-
To determine the acceptability and feasibility of SWIFTKids process by staff and patients and/or families using a multi-methods design. Multiple outcomes will be assessed as a composite. Multi-methods will include qualitative descriptive interviews as well as a validated mixed method survey using the theoretical framework of acceptability (TFA). Staff and patients will be independently interviewed.
Timepoint [1] 327730 0
Staff and families participating in transfers after January 2020
Primary outcome [2] 327804 0
Phase Two-
To evaluate patient health service outcomes and costs associated with the SWIFTKids strategy. We will compare clinical outcomes of eligible patients before and after the implementation of the SWIFTKids strategy and estimate the cost effectiveness of the SWIFTKids strategy.
Individual level costs associated with hospital utilization (including transfer time) will be collected from the Queensland Health Statistical Services Branch as a data linkage between identified National Hospital Costs data collection and medical records.
Timepoint [2] 327804 0
Data for all patients aged 0-16 years who have been transferred to SCUH from a referring Sunshine Coast health facility (Gympie Hospital, Maleny Hospital, Nambour General Hospital) from 1 September 2017- 30 August 2018 (pre-implementation of SWIFTKids strategy) will be compared to those transferred between 1 September 2019 – 30 August 2020 (post-implementation)
Secondary outcome [1] 396654 0
Phase 1 Part 1- Explore the patient and/or family perceptions of the PIHT process using qualitative descriptive interviews. The interviews will be semi-structured, include the use of a quantitative questionnaire assessing acceptability and be conducted by one of the research team and audio recorded. Interviews are anticipated to last up to an hour and be conducted either face-to-face or via video call. A research team member skilled in interviewing children will undertake the semi-structured interviews involving the paediatric patient and their parents/guardian to ensure psychological safe interviews are conducted.
Timepoint [1] 396654 0
Patients and families participating in transfers after January 2020
Secondary outcome [2] 396655 0
Phase 1 Part 1- Explore the staff perceptions of (including usability of the workflow algorithm) the PIHT process using qualitative descriptive interviews. The interviews will be semi-structured, include the use of a quantitative questionnaire assessing acceptability and be conducted by one of the research team and audio recorded. Interviews are anticipated to last up to an hour and be conducted face-to-face or via video call.
Timepoint [2] 396655 0
Staff participating in transfers after January 2020
Secondary outcome [3] 403452 0
Phase 1 Part 2- Investigate the adherence to the components of SWIFTKids strategy by clinical staff involved in PIFT. Two investigators will perform reviews on 30 patient charts to assess adherence to structure measures and process measures as a composite..
Structure measures to be assessed include:
*Compliance with PIHT forms by nurse escorts
*Use of phone/video consult forms by paediatrician/receiving medical officer
*Documentation of the 3 or 4 way-conversation in the integrated electronic Medical Record (ieMR)
Process measures to be assessed include:
*Record of algorithm violations and missing data e.g., patient transferred without utilisation of 3 or 4-way conversation
*Phone consultation pathway (acceptability of tele- and/or video-health process; number of calls required to arrange transfer; possible barriers due to complication with the technology)

Timepoint [3] 403452 0
Random selection of 30 charts of patients who were PIHTs between 1/09/2019 to 30/08/2020
Secondary outcome [4] 403777 0
Phase 2 Part 1- Compare clinical outcomes such as clinical deterioration, medical emergency calls, clinical incident reporting of PIHT patients as assessed by review of medical records, medical emergency team/code blue calls and clinical incident reporting. These will be assessed as a composite outcomes.
Timepoint [4] 403777 0
Data for all patients aged 0-16 years who have been transferred to SCUH from a referring Sunshine Coast health facility (Gympie Hospital, Maleny Hospital, Nambour General Hospital) from 1 September 2017- 30 August 2018 will be compared to those transferred between 1 September 2019 – 30 August 2020
Secondary outcome [5] 403806 0
Phase 2 Part 2: Estimate cost-effectiveness of the SWIFTKids strategy. This will encompass cost savings to the health system and saved quantity and quality of life to determine the cost-effectiveness of the new intervention. . Data will be drawn from Queensland Ambulance Service, National Hospital Cost Data Collection/CostPro, and Queensland Hospital Admitted Patient Data Collection. The data will be linked by the Statistical Services Branch and will be added to data collected from patient charts by the research team.
Timepoint [5] 403806 0
Data for all patients aged 0-16 years who have been transferred to SCUH from a referring Sunshine Coast health facility (Gympie Hospital, Maleny Hospital, Nambour General Hospital) from 1 September 2017- 30 August 2018 will be compared to those transferred between 1 September 2019 – 30 August 2020
Secondary outcome [6] 409674 0
Phase 1 Part 2- Investigate the intervention fidelity to the components of SWIFTKids strategy by clinical staff involved in PIFT. Two investigators will perform reviews on 30 patient charts to assess intervention fidelity via a composite of structure measures and process measures.
Structure measures to be assessed include:
*Completion fidelity with PIHT forms by nurse escorts
*Sufficient Documentation of the 3 or 4 way-conversation in the integrated electronic Medical Record (ieMR)
Process measures to be assessed include:
*Accuracy of applying the risk-stratification process in categorising children's care prior to transfer (clinical deterioration en-route, need for nurse escort, alteration to intended arrival location)
*Accuracy of risk stratification in identifying level of escort required as defined in the workflow algorithm
*Unexpected deterioration en-route and/or escalation to the paediatric critical care unit on arrival to SCUH.
Timepoint [6] 409674 0
Random selection of 30 charts of patients who were PIHTs between 1/09/2019 to 30/08/2020

Eligibility
Key inclusion criteria
Paediatric patients transferred to Sunshine Coast University Hospital (SCUH) from Maleny Soldiers Memorial Hospital, Nambour General Hospital or Gympie Hospital

The pre-implementation (comparator) cohort will include patients transferred between 1/09/2017 and 30/08/2018
The post-implementation cohort will include patients transferred between 1/09/2019 and 30/08/2020.
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric patients transferred from a private hospital to SCUH

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Data Analysis:
Phase 1 Part 1: Interviews will be transcribed and analysed by three of the research team. Using an inductive approach, data will be initially coded by each researcher and preliminary themes identified. Descriptive statistical analysis of the surveys will also be conducted.
Phase 1 Part 2: Descriptive statistical methods will be employed to provide an initial baseline. Associations between factors will use univariable analysis.
Phase 2 Part 1: There is no primary outcome, but we will explore all outcomes including costs, length of stays, readmissions within six month period, adverse events and other clinical indicators as given above. We will conduct post-hoc analyses to examine if there are differences in outcomes between pre and post implementation of SWIFTKids strategy.
Phase 2 Part 2: A cost-effectiveness analysis will be used to produce new evidence about the economic benefits of SWIFTKids strategy. This will encompass cost savings to the health system and saved quantity and quality of life to determine the cost-effectiveness of the new intervention. There are other highly significant costs including parents prolonged absence from work, associated travel and loss of productivity which will be measured and used in the analysis. A Markov model will be developed by the team taking into account patients’ typical clinical pathways. The model will be evaluated against standard reporting guidelines for cost-effectiveness and will use statistical distributions such as the normal, beta and gamma to describe uncertainty in the costs incurred and saved, and natural units of effectiveness measures (e.g. avoided readmissions, length of stay). The flexibility of a Markov model will be used, with different costing perspectives taken to allow for meaningful results to be produced for different stakeholders. For example, analysis from the healthcare system perspective will produce results that are of use to healthcare policymakers and will include costs associated with treatment, administration and monitoring, Incremental Cost-Effectiveness Ratio will be used and the economic evaluation will compare any incremental costs of the intervention (costs accrued in the new SWIFTKids strategy compared to those in the standard care before implementation) to the full list of incremental clinical outcome measures , all expressed in their natural units of measurement.
As all patients who were transferred during the specified study dates will be included, no calculations were done to determine sample size.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/10/2021
Date of last participant enrolment
Anticipated
Actual
17/02/2022
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
1341
Accrual to date
Final
1341
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19585 0
Nambour General Hospital - Nambour
Recruitment hospital [2] 19586 0
Gympie Hospital - Gympie
Recruitment hospital [3] 19587 0
Maleny Hospital - Maleny
Recruitment postcode(s) [1] 34192 0
4560 - Nambour
Recruitment postcode(s) [2] 34193 0
4570 - Gympie
Recruitment postcode(s) [3] 34194 0
4552 - Maleny

Funding & Sponsors
Funding source category [1] 308648 0
Charities/Societies/Foundations
Name [1] 308648 0
Children's Hospital Foundation
Country [1] 308648 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
6 Doherty Street
Birtinya QLD 4575
Country
Australia
Secondary sponsor category [1] 309523 0
University
Name [1] 309523 0
Queensland University of Technology
Address [1] 309523 0
2 George Street
Brisbane City QLD 4000
Country [1] 309523 0
Australia
Other collaborator category [1] 281818 0
University
Name [1] 281818 0
Griffith University
Address [1] 281818 0
170 Kessels Road
Nathan QLD 4111
Country [1] 281818 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308574 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 308574 0
Ethics committee country [1] 308574 0
Australia
Date submitted for ethics approval [1] 308574 0
20/07/2020
Approval date [1] 308574 0
17/08/2020
Ethics approval number [1] 308574 0
HREC/20/QCHQ/66192

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

Contacts
Principal investigator
Name 111190 0
Dr Clare Thomas
Address 111190 0
Sunshine Coast University Hospital
Director, Paediatrics
Women's and Families Service Group
6 Doherty St
Birtinya QLD 4575
Country 111190 0
Australia
Phone 111190 0
+61 07 52023269
Fax 111190 0
Email 111190 0
[email protected]
Contact person for public queries
Name 111191 0
Clare Thomas
Address 111191 0
Sunshine Coast University Hospital
Director, Paediatrics
Women's and Families Service Group
6 Doherty St
Birtinya QLD 4575
Country 111191 0
Australia
Phone 111191 0
+61 07 52023269
Fax 111191 0
Email 111191 0
[email protected]
Contact person for scientific queries
Name 111192 0
Clare Thomas
Address 111192 0
Sunshine Coast University Hospital
Director, Paediatrics
Women's and Families Service Group
6 Doherty St
Birtinya QLD 4575
Country 111192 0
Australia
Phone 111192 0
+61 07 52023269
Fax 111192 0
Email 111192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Retrospective viewing of data does not allow for prospective consent


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11974Study protocol  [email protected]
11975Informed consent form  [email protected]
11976Ethical approval  [email protected]
11977Statistical analysis plan  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.