Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000543684
Ethics application status
Approved
Date submitted
29/03/2023
Date registered
22/05/2023
Date last updated
22/05/2023
Date data sharing statement initially provided
22/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
SUSTAIN- Strengthening Care for Children (SC4C),
Strengthening Care for Children, A stepped-wedge translational trial of paediatric care in GP practice to assess the impact on hospital burden.
Scientific title
SUSTAIN- Strengthening Care for Children (SC4C), A stepped-wedge translational trial of an integrated paediatric-GP model of care to evaluate the impact on GP paediatric care provided by GPs
Secondary ID [1] 309329 0
N/A
Universal Trial Number (UTN)
Trial acronym
SC4C-Strengthening Care for Children.
Linked study record
This study is a follow-up to ACTRN12620001299998. SUSTAIN SC4C is a follow-up study of SC4C, it follows the same design and intervention, but offers an online vesrion of the GP-paediatric model of care.

Health condition
Health condition(s) or problem(s) studied:
Paediatric Asthma
 329527 0
Bronchiolitis 329674 0

infant reflux
 329675 0
Upper respiratory tract infection
 329676 0
constipation 329677 0
Condition category
Condition code
Public Health 326466 326466 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SUSTAIN study aims to strengthen child healthcare provided by general practitioners (GPs) through an intervention providing virtual support by paediatricians to GPs across urban and rural NSW. The online support provided to GPs in their practices, includes; fortnightly telehealth GP-paediatrician co-consultations lasting up to 30 minutes each for a maximum of 3 hours per GP cluster, monthly hour-long online lunch and learn sessions led by the paediatrician, and weekday access by GPs directly to the paediatrician via phone/email. GPs who take part in the study will also enrol in the Sydney Child Health Program (SCHP), a modular online GP educational course in child health, usually taking a year to complete. The SUSTAIN study is likely to can directly change standard of care for families/paediatric patients in that they may undergo co-consultations with their GP and a paediatrician in the GP practice.

A stepped-wedge cluster randomised control trial design will be used to evaluate the SUSTAIN intervention of care compared with standard GP care. This study design has the rigor of a cluster randomised controlled trial but allows all participating GP practices to be exposed to the SUSTAIN care model. Every GP practice will provide control period data (referral and medical record data) including; standard GP care, no SC4C model operating before being exposed to the SUSTAIN intervention which will be rolled out sequentially across the practices and will last 11 months in each practice (the intervention period). Every month, 3 GP practices one each in Central Eastern Sydney (CESPHN) Southwestern Sydney (SWSPHN) and South Eastern NSW (SENSWPHN) will be randomly selected to switch from standard GP care to the SUSTAIN model of care. The intervention will be rolled out concurrently in each of these areas.
The population to be studied includes GP practices which represent the cluster (consisting of a single large GP practice or 2-3 small GP practices together), GPs who consent to participate, and families of children under 18 years of age attending the practices who consent to complete surveys. In each PHN 6 GP practices will be selected with a minimum of 3 and up to 6 GPs in participating practices, eligible to participate. The research team will visit each GP practice to explain the study and answer any questions the GPs and practice staff have (nurses, administrative support, practice managers etc.). The roles and expectations of the GPs, administrative staff (e.g., arrange co-consult bookings) and practice manager (e.g., ensure GPs have time for case discussion sessions) will be clearly explained. Every GP practice provides control period data (referral and medical record data) during a control period (standard GP care, no SC4C model operating) before being exposed to the SUSTAIN intervention which will be rolled out sequentially across the practices and will last 11 months in each practice (the intervention period.
We will allow a one-month transition period to embed SUSTAIN into a GP practice, where data will not contribute to the analysis. The one-month transition and embedding period will involve one month of working with and training practice staff and GPs to implement the model of care into their practice. Data will then be extracted throughout the 11-month intervention period for each practice. Collecting this data will allow us to look at referral and quality of care trends across the period of the intervention
In order to measure our primary outcome (i.e., referrals to hospitals) quickly, reliably and validly, we will use GRHANITE. GRHANITE is developed and managed by the HaBIC Research Information Technology Unit, Dept General Practice, the University of Melbourne. GRHANITE is a computer software program that allows researchers, managers, and health professionals across Australia to ethically extract de-identified GP Practice data from GP electronic medical records for research purposes. Also installed on GP desktops is a pop-up referral box which GPs check after each consultation to reflect whether and where the patient was referred. The GP practices will sign an MOU agreeing to have GRHANITE software installed to support the trial. GP data for research purposes during the trial will be collected on every child’s consultation diagnosis, referrals made, tests ordered, and medications prescribed. Data will be de-identified at the level of the patient although the identity of the GP will be supplied to the research team. GRHANITE is compatible with the most common GP practice software vendors - Best Practice and Medical Director. Informed consent will be obtained from 3-6 interested GPs per practice. Consented GPs will be asked to attend co-consults and case discussions, enroll into the Sydney Child Health program, complete surveys, participate in implementation evaluation and record consultation diagnosis and referral details via the GRHANITE system. Identified data reflecting participating GPs referral practices will be used. Paediatricians record in Redcap every encounter they have with participating GP’s including through co-consultation, case discussions and phone/email conversations, providing data about the engagement of the partipating GP. Likewise, GPs participation in the SCHP can be gauged through attendance of the modular online training sessions.
GPs are required to complete an online survey prior to and at the end of the intervention seeking to assess the level of confidence in paediatric care; level of knowledge and skill in navigating the health system for children; reported use of clinical guidelines; reported feasibility/acceptability of the model. GP surveys will take around 20-30 minutes to complete.

It would not be feasible to obtain individual consent from parents of children attending GP consultations (2,000 children per month were seen by the 41 GPs in our pilot). As such, we have a waiver of consent to collect de-identified data on GP care during the child’s consultation. Nevertheless, families of children under 18 years of age attending the GP practices will be asked to complete an anonymous online survey about their perception of paediatric care at the practice in the 3 months before and leading up to the cessation of the intervention. This will not necessarily include the same families. These surveys take about 5-10 minutes to complete. At the time of the post-intervention survey, families who have had exposure to the intervention will be asked to participate in an interview about their experience of the model. Interviews will voluntary, and last 20-30 minutes in duration, anonymity of families will be preserved, only known to research staff.

GPs practice staff, paediatricians and families may also consent to participate in the implementation evaluation consisting of interviews and/or focus groups, during and after the intervention to determine acceptability and sustainability of the model. Focus groups will be conducted with each cluster from 6 months into the intervention. Post-intervention, paediatricians and GPs are also invited to be interviewed to gauge their views on the factors that enable or hinder the intervention.

Following the 11-month intervention period in each practice, sustainability data collection will continue until 6 months after the last GP practice completes the model of care. This data will allow us to examine sustainability of changes post-running of the SUSTAIN model. Sustainability data will be collected to examine referral patterns of GPs including the number and proportion of children referred to OP clinics and EDs, as well as GP quality of care for five common childhood conditions (asthma/wheeze, bronchiolitis, constipation/abdominal pain, upper respiratory infections, infant crying and reflux), compared to pre-intervention GP care.
Intervention code [1] 325765 0
Treatment: Other
Comparator / control treatment
A stepped-wedge cluster randomised control trial design will be used to evaluate the SUSTAIN model of care compared with standard GP care. Every GP practice will provide control period data (referral and medical record data) including; standard GP care, no SC4C model operating before being exposed to the SUSTAIN intervention. This study design has the rigor of a cluster randomised controlled trial but allows all participating GP practices to contribute control data, to be exposed to the SUSTAIN care model, and to contribute to post intervention sustainability data.
Control group
Active

Outcomes
Primary outcome [1] 334309 0
The impact of SUSTAIN on GP referral to hospital outpatient clinics and EDs will be assessed as a composite primary outcome using a Pop-up software supported through GRHANITE technologies installed on each GP's desktop which allows data extraction of referral destination (including no referral made) for each paediatric visit to participating GPs.
Timepoint [1] 334309 0
These data will be collected as part of paediatric GP consults at the beginning of the control data period and throughout the intervention period. of 12 months.
Secondary outcome [1] 420209 0
The quality of paediatric care provided by GP s that is adherent to best practice guidelines for five common childhood conditions (i.e., asthma/wheeze, bronchiolitis, constipation/abdominal pain, upper respiratory infections, infant crying and reflux will be assessed indepedently through analysis of GP medical records extracted through GHRANITE.
Timepoint [1] 420209 0
These data will be collected as part of paediatric GP consults at the beginning of the control data period and throughout the 12 month intervention period.
Secondary outcome [2] 420210 0
The costs of conducting the model of care compared to usual care; costs/savings of change in OP/ED referrals; costs/savings to families compared with accessing usual care will be evaluated. This will be assessed as a composite outcome using trial data on the model of care, health service costs, health service use and patient costs and outcomes will be combined with relevant unit costs to produce a cost-effectiveness analysis.
Timepoint [2] 420210 0
These data will be collected as part of paediatric GP consults at the beginning of the control data period and throughout the 12 month intervention period.
Secondary outcome [3] 420217 0
Aspects of the model of care that make it effective or ineffective at producing system change will be evaluated using the Consolidated Framework for Implementation Research; qualitative interviews with families, children and practitioners; online surveys. Interview methods include; semi-structured, one-on-one face-to-face interview with a member of the research team, and focus groups. Paediatricians will collect unidentifiable data on the patient characteristics (e.g., age, sex) and nature of paediatric support provided (e.g., reason for visit, topic of case study discussion).
Timepoint [3] 420217 0
Qualitative and online survey data will be collected upon completion of the model of care in each GP Practice (12 months post-intervention implementation period). Online surveys used have been designed specifically for this study. Paediatrician data will be collected as part of the co-consultations, case study discussions and phone/email support throughout the model of care. Interim qualitative data will be collected via focus groups with GP practice, 6 months into the model of care (iterative data collection process).
Secondary outcome [4] 420218 0
An assessment of the sustainability and enduring effects of SUSTAIN post-implementation on proportion of GP paediatric referrals to OP clinics or EDs and GP quality of care compared with pre-intervention GP care will be conducted as a composite outcome using GP medical records through ongoing GHRANITE data extraction of referral destination (including no referral made) for each paediatric visit to participating GPs and of care quality based on the measurement of care provided for the five common childhood conditions.
Timepoint [4] 420218 0
Data will be collected on paediatric GP consults following completion of the model of care in each GP practice (i.e., once the paediatrician has left the GP practice) until the end of the study (6 months post-intervention implementation period).
Secondary outcome [5] 420581 0
The impact of SUSTAIN on GP's level of confidence in paediatric care; level of knowledge and skill in navigating the health system for children; reported use of clinical guidelines; reported feasibility/acceptability of the model will be measured as a composite outcome, This will be assessed through a GP survey conducted during the control and post-intervention period and completed online via Redcap. The online surveys used have been designed specifically for this study.
Timepoint [5] 420581 0
Control surveys are collected in the month prior to the implementation commencing in each practice. Intervention surveys are collected in the 12th month of the implementation at each practice
Secondary outcome [6] 420583 0
The impact of SUSTAIN on patients and family experience ie level of confidence in GP care, level of satisfaction with GP care, desire for referral to specialist care, preference for GP or specialist review. This will be conducted using data from control and intervention surveys completed by families online. The online surveys used have been designed specifically for this study.
Timepoint [6] 420583 0
Control surveys are collected in the month prior to the implementation commencing in each practice. Intervention surveys are collected in the 12th month of the implementation at each practice.

Eligibility
Key inclusion criteria
GP Practices
- Be located within either the SWSPHN, SENSWPHN or CESPHN.
- Have Best Practice or Medical Director 3 as their electronic medical record.
- Be accredited or working towards accreditation
- Manage bookings and reminders for paediatrician appointments.
- Agree to display material such as posters informing patients that the research is taking place in the practice
- Install GRHANITE software (for extracting GP medical record data).
- Sign a PEN CAT plus agreement (PHN required audit software);
- Record coded diagnosis and referral activities for all children and young people (<18)
- Complete all evaluation requirements, including GP surveys.
- Receive regular GP support visits from the project team; and
- Provide protected time
GPs
- Must sign a Consent Form
- See patients < 18-years
- Provide a minimum of 2 weeks of referral data during the control period
- Small GP practices with less than 3 GPs may participate as part of a cluster 2-3 small GP practices
Families Control and Intervention Surveys
- Families of children < 18 of age who have received care at the GP practice in the prior 3 months for both the control and the intervention period
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Families:
- Children or young people who present to the GP practice without a parent/guardian
- Insufficient capabilities to complete the survey in languages other than English
Practice Managers:
- Practice managers who are also participating GPs will not be further recruited to participate as a practice manager.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
According to the stepped wedge design, the SUSTAIN intervention will be rolled out sequentially across the practices (one practice each month in each district ie 3 practices per month) and will last 12 months in each practice (the intervention period).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313527 0
Government body
Name [1] 313527 0
Ministry of Health Translational Research Grants Scheme NSW (TRGS)
Country [1] 313527 0
Australia
Funding source category [2] 313530 0
Hospital
Name [2] 313530 0
Sydney Children’s Hospital Network
Country [2] 313530 0
Australia
Funding source category [3] 313531 0
Other Collaborative groups
Name [3] 313531 0
Central and Eastern Sydney PHN,
Country [3] 313531 0
Australia
Funding source category [4] 313613 0
Other Collaborative groups
Name [4] 313613 0
Southwestern Sydney PHN
Country [4] 313613 0
Australia
Funding source category [5] 313614 0
Other Collaborative groups
Name [5] 313614 0
Southern NSW PHN
Country [5] 313614 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Women’s & Children’s Health
Level 8 Bright Alliance Building, High Street, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 315303 0
Hospital
Name [1] 315303 0
Sydney Children’s Hospital Network
Address [1] 315303 0
High Street, Randwick NSW 2031
Country [1] 315303 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312712 0
Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 312712 0
The Bright Alliance Level 8, Corner High and Avoca Street, Randwick NSW 2031, Australia
Ethics committee country [1] 312712 0
Australia
Date submitted for ethics approval [1] 312712 0
30/09/2022
Approval date [1] 312712 0
18/11/2022
Ethics approval number [1] 312712 0
2022/ETH02068

Summary
Brief summary
Paediatric referrals to hospital emergency (ED) and outpatient departments (OP) have been increasing over the past years, overburdening emergency services and often resulting in long waiting times for non-urgent appointments. Inappropriate paediatric referrals to ED or OP requiring long distance travel or extended waiting times to see a specialist could be avoided, with more children potentially benefitting from better quality of healthcare provided closer to home.

The SUSTAIN project aims to strengthen child healthcare provided by general practitioners (GPs) through virtual support offered by paediatricians to GPs across urban and rural NSW. The online support provided to GPs in their practices, includes; fortnightly telehealth GP-paediatrician co-consultations, monthly online lunch and learn sessions led by the paediatrician, and weekday access by GPs directly to the paediatrician via phone/email. GPs who take part in the study will also enrol in the Sydney Child Health Program (SCHP), a modular online GP educational course in child health, usually taking a year to complete.

The study aims to determine whether support offered by the paediatrician and the SCHP can alter GP referral practices and improve quality of care and GP confidence. The study will also evaluate whether there is a change in families’ trust in GP-provided healthcare for their children. Long term sustainability and cost effectiveness of this model of care will also be evaluated. If the results of the study demonstrate improvements in these areas, the evidence may be used to convince government and policymakers to support this model of paediatrician-GP integrated care state-wide and even nationally.
Trial website
Trial related presentations / publications
Public notes
GRHANITE is designed to work in any environment where data are being routinely collected, and addresses the many complex legal, ethical, organizational, and technical barriers that prevent or hinder such vital activities in Australia. GRHANITE in its current form is already being used in conjunction with other research projects across Australia and was used in the Strengthening Care for Children (SC4C) pilot (RCH HREC 37282A), and currently in use for the SC4C trial (ACTRN12620001299998, HREC no. 65955). For SUSTAIN, we will work with the GRHANITE developer, AI Douglas Boyle, to install a pop-up window by which the software is able to extract information regarding whether the GP referred a child to specific OP clinics or a hospital ED or not. The pop-up has been demonstrated to be acceptable to GPs. The ability to record referral information and manage de-identification and consent processes are principal rationales for the utilization of the GRHANITE tool.

ACI-Agency for Clinical Innovation (NSW Health)
AI-Associate Investigator
AIHI-Australian Institute of Health Innovation
CESPHN-Central & Eastern Sydney Primary Health Network
CFIR-Consolidated Framework for Implementation Research
CI-Chief Investigator
CPG-Clinical Practice Guideline
DHHS-Department of Health and Human Services (Victorian Government)
ED-Emergency Department
EMR-Electronic Medical Record
EOI-Expression of Interest
GP-General Practitioner
HREC-Human Research Ethics Committee
MCRI-Murdoch Children’s Research Institute
MOU-Memorandum of Understanding
NHMRC-National Health and Medical Research Council
NSW-New South Wales
OP-Outpatient clinic
PHN-Primary Health Network
QI-Quality Improvement
RACGP-Royal Australian College of General Practitioners
RCH-Royal Children’s Hospital
SC4C-Strengthening Care for Children
SCHN-Sydney Childrens Hospitals Network
SCHP-Sydney Child Health Program
SENWSPHN-South Eastern New South Wales Primary Health Network
SPHERE-Sydney Partnership for Health, Education, Research and Enterprise
SUSTAIN - SUSTAIN Strengthening Care for Children (SC4C)
SW-CRT- Stepped-wedge cluster randomised controlled trial
SWSPHN-Southwestern Sydney Primary Health Network
TGA-Therapeutic Goods Administration
TRGS-Translational Research Grants Scheme NSW
UNSW-University of New South Wales

Contacts
Principal investigator
Name 125638 0
Prof Raghnu Lingam
Address 125638 0
Rm 814, Level 8, The Bright Alliance, Avoca Street, Randwick, NSW 2031
Country 125638 0
Australia
Phone 125638 0
+610293825904
Fax 125638 0
Email 125638 0
r.lingam@unsw.edu.au
Contact person for public queries
Name 125639 0
Dr Tamara Morris
Address 125639 0
Level 8, The Bright Alliance Building, Avoca St, Randwick, NSW 2031
Country 125639 0
Australia
Phone 125639 0
+61 0452494461
Fax 125639 0
Email 125639 0
tammy_meyers.morris@unsw.edu.au
Contact person for scientific queries
Name 125640 0
Dr Tamara Morris
Address 125640 0
Level 8, The Bright Alliance Building, Avoca St, Randwick, NSW 2031
Country 125640 0
Australia
Phone 125640 0
+61 0452494461
Fax 125640 0
Email 125640 0
tammy_meyers.morris@unsw.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.