Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000550606
Ethics application status
Approved
Date submitted
27/04/2023
Date registered
23/05/2023
Date last updated
30/08/2024
Date data sharing statement initially provided
23/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Strengthening Care for Rural Children (SC4RC): the impact on quality of care for childhood conditions in rural Victoria and New South Wales.
Scientific title
Strengthening care for rural children: investigating the impact of a stepped-wedge randomised controlled trial on paediatric quality of care in rural Victoria and New South Wales
Secondary ID [1] 308652 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SC4RC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Paediatric Healthcare 328572 0
Condition category
Condition code
Public Health 325586 325586 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SC4RC model of care intervention comprises of three components to be offered to all participating GPs:
(1) Paediatrician primary and secondary co-consulting sessions with GP practices.
Paediatricians will be allocated to GP practices and made available for in-person or telehealth co-consultations for half a day a week over a 11-month period. Primary consultations includes GP-paediatrician co-consultation sessions with the paediatric patient in-person or via telehealth. Secondary consultation includes informal GP-paediatrician consultations in-person or telehealth on patient advice and/or clinical queries.
The study paediatricians will preferentially see children referred by participating GPs. Paediatricians will record the nature and outcome of primary and secondary consultations provided (e.g., patient age, sex, presenting problem, patient outcome) through a secure online databased (REDCap software).

(2) Dedicated weekday Paediatrician phone and email support for participating GPs.
Participating GPs will have access to dedicated phone and email support from study Paediatricians throughout the intervention period on all weekdays. GPs will be able to seek same day advice on children they would normally refer to OP clinics or the ED. Paediatricians will record the number and nature of emails and phone calls received through REDCap.

(3) Case based discussion Community of Practice
Continuing professional development will be delivered through the Project ECHOTM (Extension for Community Healthcare Outcomes) online telementoring programme. Facilitated by UoM and WVPHN (accredited ECHO replication sites), this programme aims to create communities of practice by bringing together healthcare providers and subject matter experts using videoconference technology, brief presentations and case-based learning. The community of practice session will be held monthly with all participating GPs where they will engage in knowledge network by sharing clinical challenges and learnings from experts and peers.
The project team will attend each session and record attendance as well as the nature of cases discussed. Adherence to the components of the model will be measured through weekly audit of data entries by the project team. Any missing recorded consultations and clinical notes will be followed up with each paediatrician
Intervention code [1] 325287 0
Treatment: Other
Comparator / control treatment
A stepped-wedge cluster randomised control trial (cRCT) will be used to evaluate the SC4RC model of care compared with standard GP care. Each GP practice will provide one month of standard GP care (control data via referral and medical record data) before being exposed to the SC4RC intervention. The first GP practices (1 in each state) to commence the intervention will complete one month of standard GP care before introducing the model, with one practice per state to commence the model per month after that.
Control group
Active

Outcomes
Primary outcome [1] 333658 0
Assess the impact of SC4RC on GP quality of care for 15 common childhood conditions (e.g asthma/wheeze, bronchiolitis, constipation/abdominal pain, upper respiratory infections, infant crying and reflux); measured as change in proportion of unnecessary tests or prescriptions during the intervention period compared with pre-intervention GP care. This will be measured via GRHANITE extraction of GP medical records as part of paediatric GP consultations at the beginning of the control data period and throughout the intervention period
Timepoint [1] 333658 0
Collected as part of paediatric GP consults at the beginning of the control data period and throughout the intervention period.
Primary outcome [2] 333659 0
To assess the impact of SC4RC on the proportion of children and young people’s completed appointments that result in a referral to OP clinics or EDs at their appointment during the intervention period compared with the control period. This will be assessed via extraction of GP referral data (including no referral made) from GP electronic medical records at the conclusion of each pediatric appointment.
Timepoint [2] 333659 0
Collected as part of paediatric GP consults at the beginning of the control data period and throughout the intervention period.
Secondary outcome [1] 417872 0
Assess the impact of SC4RC on GP experience and confidence in paediatric care compared with standard GP care. This measure will be assessed using study-designed questions adapted from the SC4C pilot study: 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.
Timepoint [1] 417872 0
Control surveys are collected in the month prior to the implementation commencing in each practice. Intervention surveys are collected in the last month of the implementation at each practice.
Secondary outcome [2] 417873 0
Assess the impact of SC4RC on family experience and trust in GP care compared with standard GP care. This measure will be assessed using study-designed questions adapted from the SC4C pilot study: 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.
Timepoint [2] 417873 0
Control surveys are collected in the month prior to the implementation commencing in each practice. Intervention surveys are collected in the last month of the implementation at each practice.
Secondary outcome [3] 417874 0
Assess the cost-effectiveness and cost-benefit of the SC4RC model of care compared with standard GP care 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 SC4RC model of care relative to usual care. The incremental cost associated with SC4RC outcomes (Quality of care; ED/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.


Timepoint [3] 417874 0
Data will be collected throughout the model of care.
Secondary outcome [4] 417876 0
Assess the implementation of the SC4RC program including fidelity from the perspectives of practitioners and families and factors that help or hinder this implementation. This will be a composite outcome measured using the Consolidated Framework for implementation Research measure (CFIR) and the Normalisation Process Theory measure.
Timepoint [4] 417876 0
1. Interim qualitative data will be collected via focus groups with GP practice, 6 months into the model of care (iterative data collection process). Focus group data collection will include recorded GP self-reported experience data 2. Qualitative interviews will also be collected upon completion of the model of care in each GP Practice; paediatrician data will be collected as part of the co-consultations, case study discussions and phone/email support throughout the model of care). 3. Online survey data will be collected upon completion of the model of care for each GP practice using the Normalisation Process Theory measure 4. Sustainability online survey data will be collected 4 months post-completion of the model of care in each GP Practice using study-designed questions to measure use of intervention recourses, changes in clinical practice, and long-term confidence in paediatric care.
Secondary outcome [5] 417877 0
Assess the sustainability effects of SC4RC post-implementation on the proportion of GP paediatric referrals to OP clinics or EDs and GP quality of care compared with standard GP care using extracted GP medical records.
Timepoint [5] 417877 0
Data will be collected on paediatric GP consults via extracted GP medical records 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.

Eligibility
Key inclusion criteria
To be included in the study, GP practices must:
• Be located within either the Western Victoria PHN (WVHN) and Murrumbidgee PHN (MPHN)
• Have, as a preference, Best Practice or Medical Director 3 as their practice software
• Be accredited or working towards accreditation
In addition, GP practices must be willing to:
• Manage bookings and reminders for paediatrician appointments;
• Install GRHANITE software GP extraction of medical record data
• Record coded diagnosis and referral activities for all children and young people (<18 years)
• Complete all evaluation requirements, including GP surveys;
• Receive regular GP support visits from the project team; and
• Provide protected time for staff and clinicians to participate in grant activity, e.g. case discussion sessions.

We will include all GPs at participating GPs clinics who:
• Sign a memorandum of understanding between the project and the practice
• Sign a Consent Form
• See patients aged 0-18 years
• Must provide a minimum of one month of referral data

We will invite all practice managers and all practice administrative staff for clinics participating in the trial.

All families that present to the GP practices and receive care for their child aged 0-18 years of age during the data collection periods will be eligible to participate in the family experience surveys. In order to be invited to participate in semi-structured interviews families must present to the GP practices and receive care for their child aged 0-18 years of age during the intervention period. These family members must sign their consent to be contacted for a follow up interview in family surveys and must have attended a co-consultation with a GP and paediatrician.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GP practices will be excluded from participating if:
• Do not have any active patients aged 0-18 years attending their clinic in the past 12 months

Practice managers who are also participating GPs will not be further recruited to participate as a practice manager.

For families, exclusion criteria 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 is 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?



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).
Participating GP practices within each state will be randomly ordered in terms of when they switch from standard GP care to the SC4RC model by the independent statistician. Practices will switch to the SC4RC model on a month-by-month basis over an 12-month period (one practice switching in each state per month)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will follow the ‘intention to treat’ principle. The primary outcome of quality care indicators assessed will be analysed using mixed effects logistic regression models with a random effect to account for the clustering of the indicators within the same GP practice. The effects of intervention status (intervention period versus control period) and indicator for calendar time (having association with both the intervention status and the outcome) will be analysed as fixed effects.
Secondary outcomes collected at the consult level (e.g. referral to paediatric services, GP confidence, and family trust) will also be analysed using mixed effects linear and logistic regression models with fixed effects for intervention status and calendar time, and a random effect for the clustering of the consults within the GP practice. We will explore the potential clustering at the consult, patient and GP level, however as aforementioned from our previous work, variation is predominantly accounted for at the practice level.
These regression analyses will be conducted for all the 15 conditions simultaneously and for each of the 15 conditions separately. Where relevant, we will control for factors at patient (eg, sex, age) and GP practice level e.g size of practice that may have a plausible confounding effect on the relationship between the intervention and the outcomes. We will also examine if the intervention effect changes with the GP practice’s length of exposure to the intervention by including in the regression analyses the interaction term between intervention status and the length of exposure to the intervention. Participants with missing values will be included in the regression analyses, as data missing is assumed to be at random under these models. The statistician responsible for the data analysis will be blinded to the data collection to reduce the risk of bias.
Economic Evaluation
The economic evaluation will be assessed using a standard economic evaluation framework to determine the costs of conducting SC4RC (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 SC4RC outcomes (ED presentations, outpatient attendances). The costs of implementing the model will be scaled to national level along with a budget impact analysis from the perspective of potential payers (Medicare, PHNs, Hospitals, Families) to guide translation of findings and sustainable implementation.

Implementation Evaluation
A mixed method implementation evaluation, using the Consolidated Framework for Implementation Research (CFIR; www.cfirguide.org), will be undertaken to understand how and why our intervention was effective or ineffective in producing systems change. The study team will thematically analyse transcripts to identify, interpret and report on the repeated patterns of meaning within the data, influenced by the CFIR constructs. All interview data will be digitally audio recorded, transcribed verbatim and transcripts will be analyzed thematically using qualitative software (Nvivo 10) to sort emerging themes.

Questionnaire data and open-ended questions from surveys will be exported into STATA for analysis.. Describing the number and proportion of children seen in GP-Paediatrician co-consultations, reasons for co-consultations, number of phone and emails to the paediatrician support, number and topic of case study discussions as part of the SC4RC program over the study period, will be assessed using summary measures of the variables of interest during the intervention period only.

Sustainability
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
Active, not recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
22/12/2023
Date of last participant enrolment
Anticipated
3/07/2023
Actual
31/03/2024
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
22
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 39368 0
3353 - Ballarat
Recruitment postcode(s) [2] 39369 0
3220 - Geelong
Recruitment postcode(s) [3] 39370 0
2650 - Wagga Wagga

Funding & Sponsors
Funding source category [1] 312885 0
Government body
Name [1] 312885 0
Department of Health and Aged Care
Country [1] 312885 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne,
Parkville
Victoria 3010
Country
Australia
Secondary sponsor category [1] 314562 0
None
Name [1] 314562 0
Address [1] 314562 0
Country [1] 314562 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312164 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 312164 0
Ethics committee country [1] 312164 0
Australia
Date submitted for ethics approval [1] 312164 0
21/12/2022
Approval date [1] 312164 0
06/04/2023
Ethics approval number [1] 312164 0
2023-25885-28972-4

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

Contacts
Principal investigator
Name 123698 0
Prof Lena Sanci
Address 123698 0
Department of General Practice, Melbourne Medical School
Faculty of Medicine, Dentistry & Health Sciences
The University of Melbourne
780 Elizabeth Street
Melbourne VIC 3000
Country 123698 0
Australia
Phone 123698 0
+61 3 8344 6152
Fax 123698 0
+61 3 9347 6136
Email 123698 0
[email protected]
Contact person for public queries
Name 123699 0
Sonia Khano
Address 123699 0
Honorary, University of Melbourne
Murdoch Children's Research Institute
The Royal Children's Hospital,
50 Flemington Road
Parkville, Victoria 3052
Country 123699 0
Australia
Phone 123699 0
+61 4 22 087 114
Fax 123699 0
Email 123699 0
[email protected]
Contact person for scientific queries
Name 123700 0
Lena Sanci
Address 123700 0
Department of General Practice, Melbourne Medical School
Faculty of Medicine, Dentistry & Health Sciences
The University of Melbourne
780 Elizabeth Street
Melbourne VIC 3000
Country 123700 0
Australia
Phone 123700 0
+61 3 8344 6152
Fax 123700 0
Email 123700 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
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
18181Ethical approval    385160-(Uploaded-19-04-2023-16-48-16)-Study-related document.pdf



Results publications and other study-related documents

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