Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001299998
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
1/12/2020
Date last updated
4/02/2024
Date data sharing statement initially provided
1/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Strengthening Care for Children
Scientific title
Strengthening Care for Children: A stepped-wedge translational trial to reduce hospital burden
Secondary ID [1] 302117 0
None
Universal Trial Number (UTN)
Trial acronym
SC4C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Paediatric Healthcare 318721 0
Condition category
Condition code
Public Health 316734 316734 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a new model of care that aims to strengthen paediatric primary care. The 12-month intervention consists of an integrated General Practitioner (GP) and Paediatrician model of care, including:

* GP-Paediatrician co-consultations (6 months of weekly, followed by 6 months of fortnightly) with paediatric patients (<18-years). This will involve participating GPs and the study Paediatrician co-consulting with paediatric patients at the GP Practice or via telehealth for the standard consultation time of 30 minutes. For paediatric patients, they will first have an appointment with a GP at the participating practice. If the GP determines that the patient needs to see a Paediatrician, they will be invited to make an appointment for a co-consultation (instead of usual practice where they would be referred to a public or private Paediatrician). The GP who attends the co-consultation will preferably be the same GP who saw the patient for their initial appointment, but this may not always be the case due to scheduling. Follow-up GP-only or co-consultation appointments or referrals to other specialists will be at the clinical discretion of the GP and Paediatrician. For the patient, the co-consultation is designed to result in the benefit of combined specialised paediatric care from the Paediatrician and the knowledge and existing relationship this patient may have with the GP. For the participating GP, the co-consultation is designed to result in a transfer of knowledge from the Paediatrician to the GP.

* Monthly 60-minute case discussions held at the GP practice. GPs in the project will bring topics or patient cases they want to discuss with the Paediatrician and their colleagues. Attendees will be the SC4C Paediatrician, GPs, practices nurses, and any other health professionals who provide paediatric care in the practice including allied health practitioners. The Paeditarician will provide information and advice on care and management related to the topic or case and may direct participating health professionals to relevant resources such as research articles or clinical practice guidelines. In instances where no specific topics or cases are nominated by the participating health professionals, the Paediatrician may present on cases they have recently seen in co-consultations, common childhood conditions, or complex topics such as child protection.

* Weekday phone and email support from the study Paediatrician. Participating GPs will be able to contact the study Paediatrician via telephone or email as many times as they like for the duration of the SC4C Trial within their Practice (12-months). The content of email support will depend upon the support requested by participating GPs, and will be personalised to respond to the query.

As a result of the global pandemic, we will also offer the model of care via telephone/video telehealth. We are preferencing the delivery of the model of the care in the following order:
1. Face to face co consults and case discussions
2. Face to face co consults, online case discussions
3. Telehealth 2-way via telephone or video: GP/Paed in clinic, patient joins online remotely
4. Telehealth 3-way via telephone or video: GP, Paed, and patient all join online remotely
As each practice has different global pandemic policies and telehealth capabilities, we will use a tailored approach.

Monitoring of adherence to the intervention will occur through the study Paediatrician maintaining a comprehensive log of attendance and topics of co-consultations and case study discussion, as well as recording number and topic of phone and email support.
Intervention code [1] 318400 0
Treatment: Other
Comparator / control treatment
The trial is a stepped-wedge design where participating GP Practices will provide control data (standard care) in the period prior to uptake of the intervention (SC4C).

Standard care refers to the clinical practice by GPs for their paediatric patients (<18 years) prior to the SC4C intervention.

Given the stepped-wedge nature of this trial this period of control data collection will vary for each participating practice depending on their order of randomisation in adopting the SC4C model. The longest period of control data collection will be 11-months (for the last to receive the model), and the shortest will be 1-month (for the first to receive the model).
Control group
Active

Outcomes
Primary outcome [1] 324870 0
Participating GP referrals of paediatric patients (<18 years) to hospital outpatient clinics and EDs assessed by extracting referral information (including no referral made) from GP Electronic Medical Records at the conclusion of each paediatric appointment. Referral information will be extracted from the Medical Records using GRHANITE Software.
Timepoint [1] 324870 0
Referral information will be recorded at the conclusion of each paediatric consultation undertaken by participating GPs i.e. is an immediate outcome.
Secondary outcome [1] 386038 0
GP quality of care (defined as whether care was appropriate) for 5 common childhood conditions (asthma/wheeze, bronchiolitis, constipation/abdominal pain, upper respiratory infections, and infant crying and reflux) measured as the proportion of unnecessary tests or prescriptions collected through GRHANITE-extracted data from patient medical records. For example, for the exemplar condition infant crying and reflux overuse (i.e. the line of management is overused and SC4C would aim to reduce this prescription/test/referral) involves the prescription of Acid Suppression Therapy (Proton pump inhibitors [PPI], Histamine-2 receptor antagonists [H2RA]).
Timepoint [1] 386038 0
Data on tests and prescriptions ordered will be recorded at the time of, or immediately following, the paediatric consultations for all participating GPs.
Secondary outcome [2] 386039 0
GP experience and confidence in paediatric care (measured as program uptake & acceptability; confidence and competence in paediatric care).

Hiscock H, O’Loughlin R, Pelly R, Laird C, Holman J, Dalziel K, Lei S, Boyle D, Freed G. Strengthening care for children: Pilot of an integrated GP-paediatrician model of primary care in Victoria. Aust Health Rev. [In Press] 2020. (Appendices 6 & 7)
Timepoint [2] 386039 0
Control period GP surveys will be collected in the month prior to the intervention commencing within the GP’s Practice and intervention period GP surveys in the twelfth (and final) month of the intervention at that Practice.
Secondary outcome [3] 386040 0
Family experience (measured as participation and experience of the co-consultations; acceptability of the model of care and child health services;

Hiscock H, O’Loughlin R, Pelly R, Laird C, Holman J, Dalziel K, Lei S, Boyle D, Freed G. Strengthening care for children: Pilot of an integrated GP-paediatrician model of primary care in Victoria. Aust Health Rev. [In Press] 2020. (Appendix 5)

Freed G, Turbitt E, Kunin M, Gafforini S, Sanci L, Spike N. Children referred for specialty care: Parental perspectives and preferences on referral, follow-up and primary care. J Paediatr Child Health 2017;53(1):18-
Timepoint [3] 386040 0
Family experience surveys will be collected in the month prior to the intervention (control month) for each GP Practice and in the twelfth (and final) month of the intervention at that Practice (intervention month). We will preference collecting family experience surveys in at participating practices. In the event of the global pandemic lockdowns/restrictions impacting the number of patients in practice waiting rooms, we will offer participating GP practices non-face-to-face options to collect family surveys:
- SMS broadcast message to all caregivers of patients <18 years seen in the last 4 months during the control period
- Paper surveys and QR codes displayed in waiting rooms
Secondary outcome [4] 386041 0
The incremental cost-effectiveness and cost-benefit of SC4C compared with standard GP care will be assessed by undertaking a health economic evaluation. The economic evaluation will use study protocols, clinician logs and project budgets to construct the cost of conducting the SC4C model of care relative to usual care. The incremental cost associated with SC4C outcomes (ED presentations, outpatient attendances) will be sourced from the trial database, GHRANITE software and trial hospitals (cost of ED and hospital visits). Parental time, productivity, travel and child school attendance will be self-reported by parents through the parent survey. In order to estimate national budget impacts, further numbers of children and health service use data will be required from the ABS, AIHW and Independent Hospital Pricing Authority (IHPA).
Timepoint [4] 386041 0
At the time of/immediately following paediatric consultations for all participating GPs (GRHANITE extracted data) and immediately following their consultation (Family surveys) in the month prior to the intervention commencing within the GP’s Practice and in the twelfth (and final) month of the intervention at that Practice.
Secondary outcome [5] 386042 0
Assess the fidelity of the SC4C program from the perspectives of practitioners and families (including number and reasons for co-consults, case discussions, email and phone support)
Timepoint [5] 386042 0
Case-discussion and co-consultation proformas will be completed at the time of/immediately following co-consultations with paediatric patients, case discussions and contact with participating GPs for phone/email support. Qualitative interviews with participating GPs, Practice managers and Practice staff will occur from the twelfth (and final) month of the intervention at their Practice and in the months immediately following this as their availabilities permit. Qualitative interviews with families will occur at a time soon after the families have competed the Family Survey and consented to being contacted for an interview. Interviews will be scheduled in accordance with families’ availabilities.
Secondary outcome [6] 386043 0
Explore the sustainability and enduring effects of the intervention on the proportion of children and young people’s completed appointments that result in a referral to OP clinics or EDs
Timepoint [6] 386043 0
The referral and quality of care data will be collected at the conclusion of paediatric appointment in the sustainability period (post-intervention period in each practice, for a minimum of 7 months and a maximum of 16 months).
Secondary outcome [7] 389257 0
Use of and adherence to HealthPathways guidelines assessed using GP surveys based on surveys used in the pilot SC4C study.
Timepoint [7] 389257 0
Control period GP surveys will be collected in the month prior to the intervention commencing within the GP’s Practice and intervention period GP surveys in the twelfth (and final) month of the intervention at that Practice.
Secondary outcome [8] 389258 0
Change in family comfort and confidence in GP care measured using Family surveys based on surveys used in the pilot SC4C study
Timepoint [8] 389258 0
Family Surveys will be collected immediately after their consultation in the month prior to the intervention commencing within the GP’s Practice and in the twelfth (and final) month of the intervention at that Practice.
Secondary outcome [9] 389259 0
change in preference for follow-up care; and change in desire to seek referral to a pediatrician measured using Family surveys based on surveys used in the pilot SC4C study
Timepoint [9] 389259 0
Family Surveys will be collected immediately after their consultation in the month prior to the intervention commencing within the GP’s Practice and in the twelfth (and final) month of the intervention at that Practice.
Secondary outcome [10] 389260 0
Change in desire to seek referral to a pediatrician measured using Family surveys based on surveys used in the pilot SC4C study
Timepoint [10] 389260 0
Family Surveys will be collected immediately after their consultation in the month prior to the intervention commencing within the GP’s Practice and in the twelfth (and final) month of the intervention at that Practice.
Secondary outcome [11] 389261 0
GP quality of care for common childhood conditions to a maximum of 16 months post-implementation assessed by extracting referral information (including no referral made) and the proportion of unnecessary tests or prescriptions from GP Electronic Medical Records at the conclusion of each paediatric appointment.
Timepoint [11] 389261 0
The referral and quality of care data will be collected at the conclusion of paediatric appointment in the sustainability period (post-intervention period in each practice, for a minimum of 7 months and a maximum of 16 months).
Secondary outcome [12] 389402 0
Acceptability outcome: Do practitioners, parents and children view the SC4C as agreeable
Timepoint [12] 389402 0
Case-discussion and co-consultation proformas will be completed at the time of/immediately following co-consultations with paediatric patients, case discussions and contact with participating GPs for phone/email support. Qualitative interviews with participating GPs, Practice managers and Practice staff will occur from the twelfth (and final) month of the intervention at their Practice and in the months immediately following this as their availabilities permit. Qualitative interviews with families will occur at a time soon after the families have competed the Family Survey and consented to being contacted for an interview. Interviews will be scheduled in accordance with families’ availabilities.
Secondary outcome [13] 389403 0
Assess sustainability: what factors will help or hinder this program to inform scalability in the future
Timepoint [13] 389403 0
Case-discussion and co-consultation proformas will be completed at the time of/immediately following co-consultations with paediatric patients, case discussions and contact with participating GPs for phone/email support. Qualitative interviews with participating GPs, Practice managers and Practice staff will occur from the twelfth (and final) month of the intervention at their Practice and in the months immediately following this as their availabilities permit. Qualitative interviews with families will occur at a time soon after the families have competed the Family Survey and consented to being contacted for an interview. Interviews will be scheduled in accordance with families’ availabilities.
Secondary outcome [14] 431372 0
Participating GP referrals of paediatric patients (<18 years) to other health care service providers (private paediatricians; mental health specialists, allied health professionals) assessed by extracting referral information (including no referral made) from GP Electronic Medical Records at the conclusion of each paediatric appointment. Referral information will be extracted from the Medical Records using GRHANITE Software.
Timepoint [14] 431372 0
Secondary outcome [15] 431373 0
Participating GP referrals of paediatric patients (<18 years) to other health care service providers (private paediatricians; mental health specialists, allied health professionals) assessed by extracting referral information (including no referral made) from GP Electronic Medical Records at the conclusion of each paediatric appointment. Referral information will be extracted from the Medical Records using GRHANITE Software.
Timepoint [15] 431373 0
Referral information will be recorded at the conclusion of each paediatric consultation undertaken by participating GPs i.e. is an immediate outcome.

Eligibility
Key inclusion criteria
To be included in the study, GP practices must:
• Be located within either the North Western Melbourne Primary Health Network or Central and Eastern Sydney Primary Health Network;
• Have Best Practice or Medical Director 3 as their electronic medical record (requirement of the data collection software);
• Be accredited or working towards accreditation
• Have > 900 active < 18-year old patients, attending their clinic in the past 12 months

GPs- Inclusion Criteria
We will include all GPs at participating GPs clinics who:
• Sign a Consent Form (Appendix B)
• Sign a MCRI/GP practice MOU (Appendix Y)
• Be accredited or working towards accreditation
• Work a minimum of 2 clinical sessions per week in the practice
• See patients < 18-years
• Must provide a minimum of one-month control pop-up referral data or retrospective control referral data

Families
All paediatric patients (<18-years) that attend a participating Practice who have been invited to attend an appointment by a participating GP will be eligible to receive a co-consultation.

All families that present to the GP practices and receive care for their child (<18-years) from a participating GP during the data collection periods will have their referral information and GP quality of care data extracted. All caregivers who attend an appointment for a paediatric patient in the month prior to the intervention commencing within the GP’s Practice and in the twelfth (and final) month of the intervention at that Practice will be eligible to participate in the family experience surveys. In order to be invited to participate in semi-structured interviews these family members must signal their consent to be contacted for a follow up interview in the family surveys and must have attended a co-consultation with a GP and paediatrician.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for GP practices:
• Less than 3 GPs working in the practice are willing to participate in the study, unless they met the inclusion threshold for active patients

Exclusion criteria for GPs:
• New GPs who join the practice during intervention and cannot provide control referral data

Exclusion criteria for family participation in the survey and interview will include:
• Children or young people who present to the GP practice without a parent/guardian
• Insufficient capabilities to complete the survey in the offered languages

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)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
The stepped-wedge structure of this trial will see that all GP Practices receive the intervention for the same period of time (11 months), however this will occur across a 22-month period (with two Practices taking on the intervention each month).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will follow the ‘intention to treat’ principle and will be conducted on available data. The primary outcome (referral to hospital services) and secondary outcome 14 (referral to private paediatricians; referral to public mental health specialists; referral to allied health professionals) will be analysed using mixed effects logistic regression fitted at the child level. The model will include a fixed effect of group (intervention vs control) and calendar time, and a random effect for practice. We will also consider whether there is a group by time and group by practice interaction. Secondary outcomes collected at the child level (e.g. quality of care indicators, parent satisfaction, and family experience) will be analysed similarly using mixed effects linear and logistic regression, with separate models for the 5 conditions for quality of care. GP outcomes will be analysed using mixed effects linear regression, again including a fixed effect for group and calendar time, and a random effect for practice, exploring the presence of interactions.

For objective 5, the economic evaluation will be assessed using a standard economic evaluation framework to determine the costs of conducting SC4C (paediatrician time and supervision, GP training, practice administrative support, co-consults, and case-study discussions) relative to usual care. This information will be combined with the incremental cost associated with SC4C outcomes (ED presentations, outpatient attendances).

For objective 6, the implementation evaluation will be assessed using questionnaire data and open-ended questions from surveys exported into SPSS for analysis. Descriptive statistics will be calculated for each of the 20 practices recruited in the study including information about inner and outer context and the intervention use and its acceptability. The study team will thematically analyse transcripts identify, interpret and report on the repeated patterns of meaning within the data, influenced by the CFIR constructs and drawing from Braun and Clark’s27 thematic analysis approach.

For objective 7, the sustainability of the intervention effects will be assessed using mixed effects logistic regression of the referral data fitted at the child level applied to data collected during the sustainability, control and intervention periods.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2021
Actual
12/01/2021
Date of last participant enrolment
Anticipated
28/03/2021
Actual
6/04/2021
Date of last data collection
Anticipated
30/09/2023
Actual
28/10/2023
Sample size
Target
22
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 306519 0
Government body
Name [1] 306519 0
National Health and Medical Research Council
Country [1] 306519 0
Australia
Funding source category [2] 306540 0
Hospital
Name [2] 306540 0
The Royal Children's Hospital
Country [2] 306540 0
Australia
Funding source category [3] 306542 0
Hospital
Name [3] 306542 0
Sydney Children's Hospital Network
Country [3] 306542 0
Australia
Funding source category [4] 306543 0
Government body
Name [4] 306543 0
North Western Melbourne Primary Health Network
Country [4] 306543 0
Australia
Funding source category [5] 306544 0
Government body
Name [5] 306544 0
Central and Eastern Sydney Primary Health Network
Country [5] 306544 0
Australia
Funding source category [6] 306546 0
Government body
Name [6] 306546 0
Agency for Clinical Innovation
Country [6] 306546 0
Australia
Funding source category [7] 306547 0
Other Collaborative groups
Name [7] 306547 0
Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)
Country [7] 306547 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
The Royal Children's Hospital, 50 Flemington Road, Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 307070 0
University
Name [1] 307070 0
University of New South Wales
Address [1] 307070 0
High St, Kensington, NSW 2052
Country [1] 307070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306723 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 306723 0
Ethics committee country [1] 306723 0
Australia
Date submitted for ethics approval [1] 306723 0
02/07/2020
Approval date [1] 306723 0
19/08/2020
Ethics approval number [1] 306723 0
65955

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

Contacts
Principal investigator
Name 104798 0
Prof Harriet Hiscock
Address 104798 0
Health Services, Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 104798 0
Australia
Phone 104798 0
+61 3 9345 6910
Fax 104798 0
Email 104798 0
Harriet.Hiscock@rch.org.au
Contact person for public queries
Name 104799 0
Harriet Hiscock
Address 104799 0
Health Services, Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 104799 0
Australia
Phone 104799 0
+61 3 9345 6910
Fax 104799 0
Email 104799 0
Harriet.Hiscock@rch.org.au
Contact person for scientific queries
Name 104800 0
Harriet Hiscock
Address 104800 0
Health Services, Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 104800 0
Australia
Phone 104800 0
+61 3 9345 6910
Fax 104800 0
Email 104800 0
Harriet.Hiscock@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to privacy restrictions of health data and the potentially sensitive and identifiable nature of this data no IPD will be publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8902Ethical approval  sonia.khano@mcri.edu.au RCH HREC project reference number: 65955 380435-(Uploaded-22-11-2023-11-48-53)-Study-related document.pdf



Results publications and other study-related documents

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