ANZCTR - Registration

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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]

National Health and Medical Research Council (NHMRC) APP1184842

Universal Trial Number (UTN)

U1111-1271-3519

Trial acronym

RAd Health

Linked study record

Health condition

Health condition(s) or problem(s) studied:

mental health conditions

sexually transmissible infections

substance use / abuse

unintended pregnancy

weight issues

nutritional issues

physical inactivity

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Mental Health

Depression

Mental Health

Anxiety

Reproductive Health and Childbirth

Contraception

Public Health

Health promotion/education

Diet and Nutrition

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]

Early detection / Screening

Intervention code [2]

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]

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]

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]

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]

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]

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]

This will be assessed at the conclusion of the trial after an up to 2 year intervention period.

Secondary outcome [2]

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]

This will be assessed at the conclusion of the trial.

Secondary outcome [3]

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]

This will be assessed at time of recruitment and again at 12 months

Secondary outcome [4]

Process outcome: Continuity of care (the proportion of 14 to 24 year-olds who attend the clinic 2+ times during the trial

Timepoint [4]

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]

Safety of the intervention

Timepoint [5]

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]

Process outcome: ii) Duration of consultation for each consultation during the trial

Timepoint [6]

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]

Process outcome: Acceptability of the intervention among clinic staff and patients.

Timepoint [7]

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Royal Children's Hospital

Address [1]

Centre for Adolescent Health, 50 Flemington Rd, Parkville VIC 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Office of Research Ethics and Integrity (OREI), University of Melbourne

Ethics committee address [1]

Office of Research Ethics and Integrity (OREI)
The University of Melbourne , Grattan St, Parkville, 3010, Victoria, AUSTRALIA 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2022

Approval date [1]

01/07/2022

Ethics approval number [1]

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

Prof Jane S Hocking

Address

Melbourne School of Population and Global Health, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Vic, Australia

Country

Australia

Phone

+61 03 8344 0762

Fax

jhocking@unimelb.edu.au

Contact person for public queries

Name

Jane S Hocking

Address

Melbourne School of Population and Global Health, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Vic, Australia

Country

Australia

Phone

+61 03 8344 0762

Fax

jhocking@unimelb.edu.au

Contact person for scientific queries

Name

Jane S Hocking

Address

Melbourne School of Population and Global Health, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Vic, Australia

Country

Australia

Phone

+61 03 8344 0762

Fax

jhocking@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Current supporting documents:

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

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14029	Study protocol	Hocking JS, Watson C, Chondros P, et al. Will a feefor-service payment for a young people’s health assessment in general practice increase the detection of health risk behaviours and health conditions? Protocol for a cluster randomised controlled trial (RAd Health Trial). BMJ Open 2023;13:e074154. doi:10.1136/ bmjopen-2023-074154	https://bmjopen.bmj.com/content/bmjopen/13/8/e074154.full.pdf	j.hocking@unimelb.edu.au	Study protocol will be located on RAd Health websi... [More Details]	383095-(Uploaded-04-12-2024-14-53-02)-Final published RAd BMJ Open.pdf
14030	[Marked for deletion] Statistical analysis plan				Statistical analysis plan will be located on RAd ... [More Details]
14032	[Marked for deletion] Clinical study report				Clinical study report will be located on RAd Healt... [More Details]
14033	[Marked for deletion] Ethical approval	2022	Not available		Ethics approval is located on RAd Health website a... [More Details]	383095-(Uploaded-04-12-2024-14-53-02)-Approval letter_01072022.pdf

Results publications and other study-related documents

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