Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001055695
Ethics application status
Approved
Date submitted
4/09/2023
Date registered
29/09/2023
Date last updated
30/06/2024
Date data sharing statement initially provided
29/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Bridge to Better Health: Capacity Building in Intellectual Disability Health for General Practice
Scientific title
Bridge to Better Health: A Cluster Randomised Controlled Trial for Capacity Building in Intellectual Disability Health for General Practice
Secondary ID [1] 310513 0
2015740 - NHMRC Grant ID Number
Universal Trial Number (UTN)
U1111-1297-3388
Trial acronym
B2BH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intellectual Disability Health Care 331345 0
Condition category
Condition code
Public Health 328073 328073 0 0
Health service research
Mental Health 328175 328175 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Bridge to Better Health Intervention is made up of 3 arms. This intervention is targeted at Practice Nurses who are supporting patients with intellectual disability.
Arm 1: Access to a specialised intellectual disability nurse
- The specialist intellectual disability nurse will have received training and/or detailed experience supporting people with intellectual disability prior to their involvement in their study.
- The specialist disability nurse will provide direct support to the practice nurses through monthly check-ins via phone or video call (approximately 15-30 minutes depending on the practice nurses needs). In addition to the monthly check ins, the specialist intellectual disability nurse will also be available to provide advice as needed and where required, will travel within a 150km radius of the Mater Hospital to provide additional support.

Arm 2: Online Education
- The education content/modules are being specifically designed for this study, with members of the project having recently designed similar education as part of the EASY health project.
- Examples of topics include; health risks of patients with intellectual disability, barriers to accessing healthcare, reasonable adjustments and a CHAP health assessment information video.
- The education will be designed in modules, with short videos, written text and infographics. It will be available through a secure web portal and receive a log in to do so. This will not be available to the general public.
- We aim to have a maximum of six modules that can be completed in one sitting (as to ensure the completion of them) and run for roughly 1 hour in total.

Arm 3: Online Resources
- Online resources will be available in a secure web portal and not open to the general public. They will be specifically designed for this project and include things such as; instructions on completing health assessments, access to previous research completed by the MIDAS team etc.

Response to all arms of the intervention:
- Participants will be given access to all three arms of the intervention.
- The overall duration of the intervention will be 6 months post-enrolment and be active for 12 months.
- All online resources/education will be hosted on a secure web portal that which we will have access to the analytics. We will be able to monitor which participants have completed and send automated reminders if they have not. The specialist intellectual disability nurse will keep a diary of participants they have seen and at what date/time etc.

Intervention code [1] 326922 0
Prevention
Comparator / control treatment
The control group is usual care, where participants who are not receiving the intervention will have no change in their normal practice. Practice staff will have access to the online education and resources at the completion of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 335962 0
The determine whether practice nurses who are supported by a specialised intellectual disability health nurse to complete health assessments will change the number preventative health actions assessed through hearing tests (Whisper test, Webber test, Renne test or Rub test).

The number of participants completing hearing tests including a Whisper test, Webber test, Renne test and/or Rub test will be assessed as a composite primary outcome. The number of participants completing the tests will be determined through practice medical records and access to health data.
Timepoint [1] 335962 0
The efficacy of the primary outcome will be determined one year post intervention, after researchers have accessed health data a year post intervention.
Primary outcome [2] 335963 0
To determine the number of potentially preventable hospitalisations according to the set of clinical indicators identified by the advisory group. Hospitalisation data will be collected from Queensland Health Admitted Patient Data Collection and Emergency Data Collection and assessed against the set of clinical indicators identified by the advisory group including Pneumonia, Urinary Tract Infections, Dental conditions and more.
Timepoint [2] 335963 0
The efficacy of the primary outcome will be determined one year post intervention, after researchers have accessed health data a year post intervention.
Primary outcome [3] 335964 0
An economic evaluation from the health sector perspective will be undertaken to determine the value for money of Bridge to Better Health versus usual care. Incremental cost per quality adjusted life year gained. Cost data will be collected from the Medicare Benefits Scheme database accessed through ABS DataLab.
Timepoint [3] 335964 0
The efficacy of the primary outcome will be determined one year post intervention, after researchers have accessed health data a year post intervention.
Secondary outcome [1] 426275 0
Any change in the uptake of preventative health actions including vaccination, smoking cessation, and cancer screening will be assessed. Uptake of any preventative health action will be assessed as a composite secondary outcome. The uptake of preventative health actions will be determined through an audit of general practice records and access to MBS/PBS data.
Timepoint [1] 426275 0
The efficacy of this secondary outcome will be determined one year post intervention, after researchers have accessed health data a year post intervention.
Secondary outcome [2] 426276 0
Hospitalisation data will be collected from Queensland Health Admitted Patient Data Collection and Queensland Health Non-Admitted Patient Data Collection, Emergency Data Collection and assessed against a previously developed list of non-impactable hospital admissions from disease management programs (Falster & Jorm, 2017; Health Quality & Safety Commission New Zealand, 2016)
Timepoint [2] 426276 0
The efficacy of this secondary outcome will be determined one year post intervention, after researchers have accessed health data a year post intervention.
Secondary outcome [3] 426277 0
To determine the impact of specialised disability support nurses on general practice nurses’ ability to provide healthcare to people with intellectual disabilities. This will be determined by semi-structured telephone or video call interviews with a member of the research team.
Timepoint [3] 426277 0
Interviews will be conducted within 6 months of the intervention ending
Secondary outcome [4] 426711 0
Outcome is primary:
To determine the difference in general nurses self-perceived knowledge, confidence and attitudes in providing healthcare to people with intellectual disability pre and post intervention measured using the TCS-ID & MCPS-ID questionnaires. These will be assessed as a composite secondary outcome.
Timepoint [4] 426711 0
This outcome will be explored after the completion of the education and online resources (within six months of the education being completed).
Secondary outcome [5] 427115 0
To determine the impact of the intervention on the healthcare experiences of patients with intellectual disability. This will be determined by semi-structured telephone or video call interviews with a member of the research team.
Timepoint [5] 427115 0
Interviews will be conducted within 6 months of the intervention ending

Eligibility
Key inclusion criteria
General practices in the Greater Brisbane area, including the catchments of Brisbane North, Brisbane South and Darling Downs and West Moreton PHNs (approx. 750 practices), will be eligible to participate in screening for the RCT. Individual practices will be eligible for study inclusion if they
i. employ at least one practice nurse who consents to be part of the project
ii. the practice provides services to at least 5 patients with intellectual disability.

Individuals with intellectual disability will be eligible to participate if they:
i. have intellectual disability (self-identify or confirmed by GP),
ii. are aged 15 years and above
iii. provide informed consent or if required, have a substitute decision-maker to provide informed consent.

Support people of individuals with intellectual disability will be eligible to participate if they:
i. support a person aged 15 years and above with intellectual disability (support person reported or confirmed by GP),
ii. are aged 18 years and above,
iii. provide informed consent

Practice nurses, GPs and other practice staff will be eligible to participate if they:
i. are aged 18 years and above,
ii. provide informed consent.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent or assent
Under the age of 15 for participants with intellectual disability
Under the age of 18 for practice staff and support people

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)
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). Randomisation will be provided by the Griffith University Randomisation Service.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2024
Actual
Date of last participant enrolment
Anticipated
6/03/2025
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314716 0
Government body
Name [1] 314716 0
National Health and Medical Research Council
Country [1] 314716 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland, St Lucia, 4072, QLD
Country
Australia
Secondary sponsor category [1] 316686 0
Hospital
Name [1] 316686 0
Mater Hospital
Address [1] 316686 0
Raymond Terrace, South Brisbane, QLD, 4101
Country [1] 316686 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313726 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 313726 0
Ethics committee country [1] 313726 0
Australia
Date submitted for ethics approval [1] 313726 0
22/08/2023
Approval date [1] 313726 0
31/08/2023
Ethics approval number [1] 313726 0

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

Contacts
Principal investigator
Name 129154 0
Dr Katie Brooker
Address 129154 0
Mater Research, Level 3, Aubigny Place, Raymond Terrace, South Brisbane
Country 129154 0
Australia
Phone 129154 0
+61 7 3163 1983
Fax 129154 0
+61 7 3163 2445
Email 129154 0
[email protected]
Contact person for public queries
Name 129155 0
Katie Brooker
Address 129155 0
Mater Research, Level 3, Aubigny Place, Raymond Terrace, South Brisbane
Country 129155 0
Australia
Phone 129155 0
+61 7 3163 1983
Fax 129155 0
+61 7 3163 2445
Email 129155 0
[email protected]
Contact person for scientific queries
Name 129156 0
Catherine Franklin
Address 129156 0
Mater Research, Level 3, Aubigny Place, Raymond Terrace, South Brisbane
Country 129156 0
Australia
Phone 129156 0
+61 7 3163 1625
Fax 129156 0
Email 129156 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


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.