Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000614998
Ethics application status
Approved
Date submitted
23/04/2020
Date registered
26/05/2020
Date last updated
31/10/2022
Date data sharing statement initially provided
26/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing immunisation in general practice against invasive pneumococcal disease and influenza in people under 70 years old whose chronic conditions put them at higher risk of and from these infections.
Scientific title
Using opportunistic targeted reminders to increase immunisation in general practice against invasive pneumococcal disease and influenza in people under 70 years old whose chronic conditions put them at higher risk of and from these infections.
Secondary ID [1] 300612 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infection 317179 0
Influenza 317180 0
Condition category
Condition code
Public Health 314630 314630 0 0
Health service research
Respiratory 315505 315505 0 0
Other respiratory disorders / diseases
Infection 315506 315506 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In intervention practices, when all eligible patients (those aged <70 years with chronic conditions) book an appointment and prior to attendance at an in-person or telehealth consultation at their general practice, they will receive information about their immunisation status and advice that either pneumococcal or influenza immunisations are recommended for them. The advice will encourage them to ask their GP or practice nurse about this in the imminent consultation. The information and advice will be generated automatically by the practice's clinical software Doctors Control Panel (DCP) software (www.doctorscontrolpanel.com.au).

As the patient books, and then again when they arrive for a consultation, the software searches the patient’s electronic clinical record seeking history of the target conditions and immunisations against pneumococcal infection or influenza. If the patient has any of the target conditions and is not fully immunised, DCP will automatically send an SMS to the patient with a prompt to discuss immunisations at the impending appointment. On arrival for the appointment, DCP will automatically print a letter with vaccination information and advice for the patient to read while waiting.

In both intervention and control practices, during the consultation the GP or practice nurse that the patient is seeing will receive a small reminder prompt on their computer screen that links to more information. Patients, GPs and practice nurses will be free to act on or to ignore the reminders as they see fit. However, reminders for patients will only be generated in the intervention arm and not the control arm.

The intervention will run for approximately 18 months from November 2020, incorporating two influenza immunisation seasons.

Aggregated, non-identifiable tabular results about pneumococcal and influenza vaccination and characteristics of patients will be received from the practices who will use the DCP software to generate the required tables. No individual data will be collected in any part of the study. We will analyse the proportion of each practice’s eligible patients who had been immunised at baseline and the proportion who have been immunised by the end of the study, after the use of reminders. We will examine aggregated results according to characteristics of patients and practices.

Reminder letters (shown below) that will be generated by the DCP have been specifically designed for the study.

As the reminder function is automated via the clinical software DCP, researchers will be able to assess or monitor fidelity to the intervention in real time via a DCP dashboard, which will show aggregate, non-identifiable rates of SMS and printed letter generation for intervention practices. A research support officer will also be in contact with participating practices to ensure they are enacting interventions and addressing concerns when they arise. From all GPS that agreed to be part of the study, we will receive information of the number of eligible patients each GP has seen, whether the patients received the reminder and whether they were vaccinated or not, for the whole period of study. If the GP decides to withdraw the from study, his/her patients will not receive the reminders and we will have this information in the aggregated tables.

An equal number of intervention and control practices with similar characteristics (location, number of full-time equivalent GPs) will be recruited into the study, and allocated into intervention and control arms. All eligible patients in intervention practices will receive automatically-generated reminders. Patients from control practices will not receive the reminders. All GPs in intervention and control practices will receive on-screen reminders. Aggregated data from control practices will be collected for comparison.

Recruitment into intervention and control arms will be pseudorandomised. During the initial recruitment phase, prioritisation will be given to allocation into the intervention arm. However, once at least four urban practices and at least two rural practices have been recruited, researchers will allocate practices into control or intervention arms to ensure that the study ultimately has equal numbers of practices with similar characteristics in each arm. From this point, where possible, practices will be allocated into intervention and control in alternating order.


****Example of automatically-generated reminder letter****

[Practice Name
Address
Contact
Date]

Important information about immunisations

Dear [Patient First Name]

We want to help you to stay well.The advice below is based on the information that we have in your record.If any of it is incorrect, please tell me.

Our records indicate that you have been diagnosed with rheumatoid arthritis. Rheumatoid arthritis and some of the medicines that are commonly used to help to treat it increase your risk of becoming seriously unwell from infections. These infections include influenza (the flu), and pneumococcal infection, which can cause pneumonia. Immunisations for these infections help decrease the risk of contracting these infections.

Our practice has no record of pneumococcal vaccine or influenza vaccine for you.

National guidelines recommend that you receive a single dose of Prevenar pneumococcal vaccine now.

National guidelines recommend that you also receive a total of two doses of Pneumovax 23 pneumococcal vaccine. Our records indicate that you have had fewer than two doses of Pneumovax 23.

You should receive a dose of Pneumovax 23 vaccine two months after you have received the Prevenar vaccine.

You should receive influenza vaccination now.

Please ask me about these immunisations when we meet in a few minutes.

Dr. [name of GP]
Intervention code [1] 316924 0
Prevention
Comparator / control treatment
No intervention (no reminder).
Control group
Active

Outcomes
Primary outcome [1] 323078 0
Change in influenza immunisation status according to electronic medical records
Timepoint [1] 323078 0
18 months from the beginning of the study.
Primary outcome [2] 323079 0
Change in pneumococcus immunisation status according to electronic medical records
Timepoint [2] 323079 0
18 months from the beginning of the study
Secondary outcome [1] 382311 0
Nil
Timepoint [1] 382311 0
Nil

Eligibility
Key inclusion criteria
All patients with chronic conditions recommended for pneumococcal and influenza vaccination under Australian Immunisation Handbook guidelines, who attend a consultation at a participating practice, and who have not received an influenza or pneumococcal vaccine.
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and patients aged 70 years or older

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
We will analyse the proportion of each practice’s eligible patients who had been immunised at baseline and the proportion who have been immunised by the end of the study after the use of reminders. We will examine aggregated results according to characteristics of patients and practices using descriptive statistics and McNemar paired test for binary outcomes. Comparisons between intervention and control practices will be performed using Qui-square test. Statistical analysis will be performed using the software Stata 15.0.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2020
Actual
4/06/2020
Date of last participant enrolment
Anticipated
Actual
26/03/2021
Date of last data collection
Anticipated
31/07/2022
Actual
27/10/2022
Sample size
Target
6000
Accrual to date
Final
10488
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 305031 0
Charities/Societies/Foundations
Name [1] 305031 0
RACGP Foundation
Country [1] 305031 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace Campus, Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 305483 0
None
Name [1] 305483 0
Address [1] 305483 0
Country [1] 305483 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305427 0
Human Research Ethics Commitee of the University of Adelaide
Ethics committee address [1] 305427 0
Ethics committee country [1] 305427 0
Australia
Date submitted for ethics approval [1] 305427 0
28/02/2020
Approval date [1] 305427 0
15/04/2020
Ethics approval number [1] 305427 0
H-2020-044

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

Contacts
Principal investigator
Name 100342 0
Dr Oliver Frank
Address 100342 0
Discipline of General Practice
Room N113, Level 1 Helen Mayo North
The University of Adelaide
Frome Road
Adelaide SA 5005
Country 100342 0
Australia
Phone 100342 0
+61 08 83133455
Fax 100342 0
Email 100342 0
oliver.frank@adelaide.edu.au
Contact person for public queries
Name 100343 0
Oliver Frank
Address 100343 0
Discipline of General Practice
Room N113, Level 1 Helen Mayo North
The University of Adelaide
Frome Road
Adelaide SA 5005
Country 100343 0
Australia
Phone 100343 0
+61 08 83133455
Fax 100343 0
Email 100343 0
oliver.frank@adelaide.edu.au
Contact person for scientific queries
Name 100344 0
Oliver Frank
Address 100344 0
Discipline of General Practice
Room N113, Level 1 Helen Mayo North
The University of Adelaide
Frome Road
Adelaide SA 5005
Country 100344 0
Australia
Phone 100344 0
+61 08 83133455
Fax 100344 0
Email 100344 0
oliver.frank@adelaide.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 was obtained from a third party (Doctors Control Panel) for this specific project and will not be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7746Ethical approval    379321-(Uploaded-23-04-2020-13-20-47)-Study-related document.pdf



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.