Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000114741
Ethics application status
Approved
Date submitted
23/11/2021
Date registered
24/01/2022
Date last updated
30/09/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Rebate for an Adolescent Health Assessment Trial (RAd Health Trial)
Scientific title
Rebate for an Adolescent Health Assessment Trial (RAd Health Trial). A cluster randomised controlled trial which aims to investigate whether a Medicare Benefits Schedule (MBS) rebate is effective at increasing the detection and management of risk behaviours and health conditions in young people aged 14-24 and is cost-effective.
Secondary ID [1] 305754 0
National Health and Medical Research Council (NHMRC) APP1184842
Universal Trial Number (UTN)
U1111-1271-3519
Trial acronym
RAd Health
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
mental health conditions 324250 0
sexually transmissible infections 324251 0
substance use / abuse 324252 0
unintended pregnancy 324253 0
weight issues 324254 0
nutritional issues 324255 0
physical inactivity 324256 0
Condition category
Condition code
Diet and Nutrition 321746 321746 0 0
Other diet and nutrition disorders
Mental Health 321747 321747 0 0
Depression
Mental Health 321748 321748 0 0
Anxiety
Reproductive Health and Childbirth 321749 321749 0 0
Contraception
Public Health 321750 321750 0 0
Health promotion/education
Diet and Nutrition 321751 321751 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GPs will be encouraged to undertake annual health assessments with adolescents aged 14-24 years. They will receive one rebate payment for each adolescent health assessment conducted per patient per year for a maximum of two years. It will be an annual rebate because the RACGP and the RACP recommend annual checks for young people. The rebate amount will be based on the MBS rebate for assessments such as the 45-49 and 75+ year checks. There is no minimum requirement for this health check; however, all GPs will be supplied with a comprehensive template for health assessment. The rebate claimed will be commensurate with time taken to undertake the assessment i.e. <30 mins (MBS item # 701) $59.35; 30-<45 minutes (MBS # 703) $137.90; 45-<60 mins (MBS # 705) $190.30 or 60 mins+ (MBS #707) $268.80.
This rebate will be administered by University of Melbourne and will mimic the process of Medicare whereby funds are transferred electronically to the clinic on a weekly basis.
Intervention code [1] 322158 0
Early detection / Screening
Intervention code [2] 322159 0
Prevention
Comparator / control treatment
GP in the control group will not receive the rebate and will be encouraged to do health assessments as per their usual practice.
Control group
Active

Outcomes
Primary outcome [1] 329503 0
The rate of risk behaviours detected and recorded in the patient medical record.
This includes alcohol and drug use, smoking, sexuality, sexual activity and risk of sexually transmissible infections, weight, nutrition & physical activity, immunisation update and mental health / emotional distress.
Timepoint [1] 329503 0
This will be assessed at the initial visit when the health check is conducted and at the conclusion of the trial after a 2 year intervention period, allowing for two health checks in two years.
Primary outcome [2] 329958 0
The rate of health conditions detected and recorded in the patient medical record. This includes sexually transmissible infections (such as Chlamydia) and blood borne viruses (such as Hepatitis B or HIV), pregnancies (planned or unplanned, obesity and mental health conditions.
Timepoint [2] 329958 0
This will be assessed at the initial visit when the health check is conducted and at the conclusion of the trial after a 2 year intervention period, allowing for two health checks in two years.
Secondary outcome [1] 402793 0
The rate of patient management activities conducted and recorded in the patient medical record.
This includes STI test undertaken, contraception and vaccine prescription, mental health care or care management plan initiated, anti-smoking medications prescribed, counselling provided or referrals.
Timepoint [1] 402793 0
This will be assessed at the conclusion of the trial after an up to 2 year intervention period.
Secondary outcome [2] 402794 0
An economic evaluation will compare the costs and outcomes of the RAd Health intervention with the costs and outcomes of the control group. Data from RAd Health trial will be used to estimate costs and efficacy in terms of risk behaviours and health conditions detected and quality of life.
Timepoint [2] 402794 0
This will be assessed at the conclusion of the trial.
Secondary outcome [3] 402795 0
Quality of life will be assessed using age appropriate, validated instruments (CHU-9D for school-aged children and AQOL-6D adolescent version for young people aged 18-24).
Timepoint [3] 402795 0
This will be assessed at time of recruitment and again at 12 months
Secondary outcome [4] 402796 0
Process outcome: Continuity of care (the proportion of 14 to 24 year-olds who attend the clinic 2+ times during the trial
Timepoint [4] 402796 0
Measured at conclusion of the trial; measured at baseline, 6 months after the initial visit and at the conclusion of the trial.
Secondary outcome [5] 404206 0
Safety of the intervention
Timepoint [5] 404206 0
During the process evaluation interviews (taken 6 months and 18 months after enrolment, the safety and fidelity of the intervention will be undertaken. This will include the impact of undertaking the health assessment on the resources / capacity of the GP practice, as well as any harms and acceptability identified by the participants, About 20 GPs, 20 nurses / practice managers and 20 young people will be interviewed and purposively sampled to ensure representation by age, gender and geographical location. Recruitment numbers will be dependent on reaching saturation of themes.
Secondary outcome [6] 404436 0
Process outcome: ii) Duration of consultation for each consultation during the trial
Timepoint [6] 404436 0
After initial visit using the data extraction tool, and up to 2 years after initial visit if the patient attends again in that time period.
Secondary outcome [7] 404437 0
Process outcome: Acceptability of the intervention among clinic staff and patients.
Timepoint [7] 404437 0
During the process evaluation interviews (taken 6 months and 18 months after enrolment, the acceptability of the intervention will be assessed with the process evaluation interviews. About 20 GPs, 20 nurses / practice managers and 20 young people will be interviewed and purposively sampled to ensure representation by age, gender and geographical location. Recruitment numbers will be dependent on reaching saturation of themes.


Eligibility
Key inclusion criteria
1) Clinics: a general practice will be eligible if they have (i) at least 600 consultations each year with 14-24 year-olds; (ii) use Medical Director or Best Practice for their electronic medical records software, as these are compatible with our data extraction tool GRHANITE.™

2) 14-24 year-olds: will be eligible for participating in the cohort study if they are aged 14 to 24 years, are attending the clinic for their own health during the trial and are able to give informed consent to participate.
Minimum age
14 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Clinics: If they refuse to allow GRHANITE data extraction tool to be installed on their clinic computer and extract patient consultation data.

2) 14-24 year olds: Unable to provide informed consent (eg: language or learning difficulties); 14-15 year olds whose legal guardians do not provide consent to participate; who do not have access to a computer to complete follow up surveys; who are severely unwell or distressed at the time of recruitment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation will be performed by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of the practices will take place after completion of the Induction program (Figure 2: CONSORT flow chart). Practices will be randomly allocated to the two trial arms in a 1:1 ratio, using a computer-generated allocation sequence set up by a statistician who is not involved in the recruitment of practices or data collection. Randomization will be stratified by the (i) the location of the practice (rural/regional versus metropolitan); and (ii) billing practice of the practice (bulk-billing, where doctors choose to accept only the Medicare fee paid directly from the Government with no-co-payment from the patient versus other, where the patient is required to make a co-payment in addition to the Medicare fee). Permuted blocks of random sizes will be used to ensure balance of the number of practices allocated to each arm. The permuted block sizes will not be released until practices have all been recruited ensure allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
Date of last participant enrolment
Anticipated
10/10/2024
Actual
Date of last data collection
Anticipated
27/06/2026
Actual
Sample size
Target
1000
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310113 0
Government body
Name [1] 310113 0
NHMRC
Country [1] 310113 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
1. Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health
Level 3, 207 Bouverie St, Carlton 3053 VICTORIA
2. Department of General Practice, 780 Elizabeth St, Melbourne VIC 3010 VICTORIA
Country
Australia
Secondary sponsor category [1] 311188 0
None
Name [1] 311188 0
Address [1] 311188 0
Country [1] 311188 0
Other collaborator category [1] 282065 0
Hospital
Name [1] 282065 0
Royal Children's Hospital
Address [1] 282065 0
Centre for Adolescent Health, 50 Flemington Rd, Parkville VIC 3052
Country [1] 282065 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309801 0
The Office of Research Ethics and Integrity (OREI), University of Melbourne
Ethics committee address [1] 309801 0
Office of Research Ethics and Integrity (OREI)
The University of Melbourne , Grattan St, Parkville, 3010, Victoria, AUSTRALIA 3010
Ethics committee country [1] 309801 0
Australia
Date submitted for ethics approval [1] 309801 0
30/06/2022
Approval date [1] 309801 0
01/07/2022
Ethics approval number [1] 309801 0
2022-23435-29990-3

Summary
Brief summary
Adolescence and young adulthood (‘young people’) is a time when health-compromising (‘risk’) behaviours such as substance use emerge and sexual activity commences – 1 in 4 will have a mental health condition. The Royal Australian College of General Practitioners Guidelines recommend evidence-based health checks for young people to detect risk behaviours such as substance use, unsafe sexual practices, assess weight and diet, and identify mental health conditions early enough to reduce morbidity and prevent escalation of behaviours. GPs can intervene by counselling, STI screening, referring to dieticians, prescribing contraception and initiating mental health plans. Yet, general practice is failing young people: only 15% have an annual chlamydia test; only 6% are prescribed the most effective contraception, and; only one third of the those with a mental health condition have a mental health plan initiated. Consultation time is the key obstacle. To address this, there are calls for a Medicare rebate to fund a longer consult so that the assessment can done. However, without RCT evidence that such a rebate would be ‘value for the patient’ and ‘value for the health system’, a rebate is unlikely to be recommended. We will conduct a cluster RCT to determine whether a rebated health assessment for patients aged 14 to 24 years in general practice is cost-effective. A total of 42 clinics will participate and be randomised to receive a rebate payment the same as is available for the 45-49 year check. The primary outcome is detection of risks and health conditions because this is the first step required to get GPs to initiate an action to improve patient outcomes whether this be testing (e.g. STI screening), prescribing (e.g. contraception), managing (e.g. common mental condition), referral (e.g. mental health, dietetics) or education/counselling (e.g. alcohol).We will recruit a cohort of 1,000 14 to 24 year old patients from the clinics to collect information about the impact of the health assessment on their quality of life. This information will inform our economic modelling which will investigate the impact of rebates on downstream health outcomes.
Trial website
https://mspgh.unimelb.edu.au/research-groups/centre-for-epidemiology-and-biostatistics-research/sexual-health/rebate-adolescent-health-rad-health
Trial related presentations / publications
Public notes
The two joint Chief Investigators are located at two different Departments at University of Melbourne.
1. Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health
Level 3, 207 Bouverie St, Carlton 3053 VICTORIA
2. Department of General Practice, 780 Elizabeth St, Melbourne VIC 3010 VICTORIA

Contacts
Principal investigator
Name 115438 0
Prof Jane S Hocking
Address 115438 0
Melbourne School of Population and Global Health, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Vic, Australia
Country 115438 0
Australia
Phone 115438 0
+61 03 8344 0762
Fax 115438 0
Email 115438 0
jhocking@unimelb.edu.au
Contact person for public queries
Name 115439 0
Prof Jane S Hocking
Address 115439 0
Melbourne School of Population and Global Health, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Vic, Australia
Country 115439 0
Australia
Phone 115439 0
+61 03 8344 0762
Fax 115439 0
Email 115439 0
jhocking@unimelb.edu.au
Contact person for scientific queries
Name 115440 0
Prof Jane S Hocking
Address 115440 0
Melbourne School of Population and Global Health, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Vic, Australia
Country 115440 0
Australia
Phone 115440 0
+61 03 8344 0762
Fax 115440 0
Email 115440 0
jhocking@unimelb.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
Data dictionaries will be available. It will not be possible to provide individual participant data.
Data from progress notes and further investigations (e.g., pathology test results) will be de-identified by GRHANITE® before extraction, using the methods currently used by Data for Decisions. This means that just like the data fields currently extracted, the progress notes and pathology test results will also have patient identifying information removed before it leaves each GP practice.

Given progress notes can contain other potentially identifying information, an additional layer of privacy protection will be provided by using an Natural Language Processing (NLP)-based de-identification tool designed to locate and scrub all patient, provider, and practice details within the data management system 'Patron' before approved researchers are given access to the records.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14029Study protocol    Study protocol will be located on RAd Health websi... [More Details]
14030Statistical analysis plan    Statistical analysis plan will be located on RAd ... [More Details]
14032Clinical study report    Clinical study report will be located on RAd Healt... [More Details]
14033Ethical approval    Ethics approval is located on RAd Health website a... [More Details]



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.