Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001221145
Ethics application status
Approved
Date submitted
13/08/2019
Date registered
4/09/2019
Date last updated
25/03/2022
Date data sharing statement initially provided
4/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Influenza, pneumococcus, and herpes zoster vaccination among patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and inflammatory bowel disease, and the effect of reminders on vaccination rates in Australian general practice
Scientific title
Coverage of influenza, pneumococcus, and herpes zoster immunisation amongst patients with immune-mediated inflammatory conditions and the effect of reminders on vaccination rates in Australian general practice
Secondary ID [1] 299001 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 314009 0
Pneumococcus 314010 0
Herpes Zoster 314011 0
Rheumatoid arthritis 314116 0
Inflammatory bowel disease 314117 0
Psoriatic arthritis 314118 0
Ankylosing spondylitis 314119 0
Crohn's Disease 314120 0
Condition category
Condition code
Public Health 312399 312399 0 0
Health promotion/education
Inflammatory and Immune System 312494 312494 0 0
Rheumatoid arthritis
Inflammatory and Immune System 312495 312495 0 0
Autoimmune diseases
Inflammatory and Immune System 312496 312496 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 312497 312497 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 312498 312498 0 0
Crohn's disease
Infection 312499 312499 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In participant practices, when any patient book an appointment the Doctor Control Panel (DCP), as part of its standard preventative health communication with clinical software, compares demographic and clinical data in the patient’s electronic clinical record with authoritative guidelines for preventive services including immunisations. If the DCP identifies that the patients meets the follow conditions:
• Any of the target diagnoses (IMID) are identified in the patient’s list of health problems,
AND
• no record of refusal of the relevant vaccine is documented,
AND
• there is no record of contraindication to the relevant vaccine,
AND
• if the visit is in the influenza vaccine season (April to July in Australia) and there is no record of the administration of that season’s influenza vaccine,
OR
• the recommended number of doses of pneumococcus vaccine is not recorded,
OR
• a herpes zoster vaccination is not recorded,
and the practice is already able to contact the patient by SMS, the DCP will automatically send a brief and generic immunisation reminder SMS upon the patient booking an appointment, and another brief generic reminder SMS on the day of the appointment. When they arrive for an in-clinic consultation they will also receive from the receptionist a reminder letter printed automatically by the DCP. The reminder explains why each outstanding preventive service is recommended and encourages the patient to ask about those services during the current consultation with the GP. Patients who cannot be contacted by the practice via SMS, but who do come to the clinic for their consultation, will receive one printed immunisation reminder.
The same software will also be used to remind GPs electronically about the immunisation status of these patients during the subsequent consultation. The DCP will open a window on the computer screen including a list of recommended preventive activities, either they are due or not, with links to current guidelines and easy access to the corresponding fields in the patient’s health record.

Before the introduction of reminders, GPs and nurses from participant practices will have an educational activity for up to one hour about the immunisation needs of patients with IMID.

In the end of two influenza seasons, i.e. 18 months from the beginning of the study, the researchers will receive from the practices aggregated tabulated results, in the form of total numbers: number of patients in the practice; by sex; five year age groups, type of medical condition, number of patients eligible for the study (i.e. those who have a relevant condition but haven’t received the relevant vaccination); the number of patients who received the reminder; and the number of eligible patients who received the vaccination. The same aggregated results, except those numbers related to reminders, will be received from control practices, and from all practices for years 2013-2018 to provide a baseline for comparison.
We will then analyse influenza, pneumococcus and herpes zoster vaccination coverage among patients with IMID before and after the introduction of reminders. 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. All results will be non-identifiable.
Results will be analysed 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.

Data on GPs and registered nurses confidence in vaccination recommendations for patients with immune-mediated inflammatory conditions will be collected in the beginning of the study (before the use of reminders), soon after the educational activities, and in the end of the study (18 months from the beginning of the study).

The SMS for patients at booking is presented below:

Dear [Patient Name], I look forward to talking with you at [time] on [day and date]. Our records indicate that your [influenza and/or pneumococcal and/or herpes zoster] vaccination is due. Please ask me about this when you attend at your appointment if you wish to discuss immunisation. Kind regards, [Dr. GP Name]
...............................................................................................................................

The SMS for patients on the day of appointment:

Dear [Patient Name], Just a reminder of your appointment today at [time]. Our records indicate that your [influenza and/or pneumococcal and/or herpes zoster] vaccination is due. Please ask me about this when you attend at your appointment if you wish to discuss immunisation. Kind regards, [Dr. GP Name]
...............................................................................................................................

Two examples of patient printed reminders (that will be given to the patient in the waiting room) are presented below.

Example 1 of patient reminder:

Important information about immunisations for Ms. Test Patient

Dear Test, 09/07/2018

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.

We have diagnosed you 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), which can put you out of action for several weeks, and invasive pneumococcal infection, which can cause pneumonia and septicaemia (infection of the blood stream).

You are also at higher than average risk of developing shingles (herpes zoster).

The good news is that we can help you to decrease your risk of these serious illnesses by immunising you against these infections.

We have no record of pneumococcal vaccine, influenza vaccine or herpes zoster vaccine for you.

Influenza vaccine is available for you free of charge and we should give it to you every year. The best time to receive it is in May.

We have to prescribe pneumococcal vaccine for you, and it costs about $40, or if you have a Heath Care or pension card $6.40, from pharmacies.

Please ask me whether your condition and its treatments allow you to receive the vaccine to prevent shingles.

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

Dr. XXX

..................................................................................................


Example 2 of patient reminder:

Important information about immunisations for Ms. Test Patient

Dear Test, 09/07/2018

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.

We have diagnosed you with ulcerative colitis.

Ulcerative colitis 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), which can put you out of action for several weeks, and invasive pneumococcal infection, which can cause pneumonia and septicaemia (infection of the blood stream).

You are also at higher than average risk of developing shingles (herpes zoster).

The good news is that we can help you to decrease your risk of these serious illnesses by immunising you against these infections.

Influenza vaccine is available for you free of charge and we should give it to you every year. The best time to receive it is in May. You received the influenza vaccine on 24/5/2017. We should give you this year’s influenza vaccine today.

You received a first dose of pneumococcal vaccine on 15/03/2015. We should give you the second dose today or at your next visit. We have to prescribe pneumococcal vaccine for you, and it costs about $40 from pharmacies.

We have no record of shingles (herpes zoster) vaccine for you. Please ask me whether your condition and its treatments allow you to receive the vaccine to prevent shingles

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

Dr. XXX
Intervention code [1] 315270 0
Prevention
Comparator / control treatment
No intervention (no reminders).
For each practice that agrees to be part of the intervention, one practice with similar characteristics in regards of location and number of full time equivalent (FTE) GPs will be selected.
Control group
Active

Outcomes
Primary outcome [1] 321038 0
Change in influenza immunisation status according to electronic medical records
Timepoint [1] 321038 0
18 months from the beginning of the study
Primary outcome [2] 321039 0
Change in pneumococcus immunisation according to electronic medical records
Timepoint [2] 321039 0
18 months from the beginning of the study
Primary outcome [3] 321040 0
Change in herpes zoster immunisation status according to electronic medical records
Timepoint [3] 321040 0
18 months from the beginning of the study
Secondary outcome [1] 373763 0
Change in GPs and registered nurses confidence in vaccination recommendations for patients with immune-mediated inflammatory conditions through educational activities, which will be evaluated through interviews and/or focus groups, using a semi-structured questionnaire designed specifically for this study.
Timepoint [1] 373763 0
First questionnaire/interview will happen in the beginning of the study (before the use of reminders), the second one soon after the educational activity, and the last one in the end of the study (18 months form the beginning of the study).

Eligibility
Key inclusion criteria
All patients with immune-mediated inflammatory diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease) from Australian general practices using the DCP software that agreed to be part of this study. All GPs and registered nurses from participant practices will be invited to a training session about appropriate vaccinations for patients with immune-mediated inflammatory diseases.
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have already received the immunisations of interest, patients with contraindication to the relevant vaccine. All GPs and registered nurses who do not accept to participate in the educational activities.

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
Active, not recruiting
Date of first participant enrolment
Anticipated
4/06/2020
Actual
4/06/2020
Date of last participant enrolment
Anticipated
Actual
12/10/2021
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
1036
Accrual to date
Final
1903
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303537 0
Commercial sector/Industry
Name [1] 303537 0
Pfizer Independent Grants Program
Country [1] 303537 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace Campus, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 303617 0
None
Name [1] 303617 0
Address [1] 303617 0
Country [1] 303617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304064 0
Human Research Ethics Commitee of the University of Adelaide
Ethics committee address [1] 304064 0
Ethics committee country [1] 304064 0
Australia
Date submitted for ethics approval [1] 304064 0
04/03/2019
Approval date [1] 304064 0
06/08/2019
Ethics approval number [1] 304064 0
H-2019-138

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

Contacts
Principal investigator
Name 95698 0
Prof Nigel Stocks
Address 95698 0
The University of Adelaide. Frome Rd, Helen Maio North Building, Level 1, Room N115, Adelaide, SA 5000
Country 95698 0
Australia
Phone 95698 0
+61 0883133462
Fax 95698 0
Email 95698 0
[email protected]
Contact person for public queries
Name 95699 0
David Gonzalez-Chica
Address 95699 0
The University of Adelaide. Frome Rd, Helen Maio North Building, Level 1, Room N113.03, Adelaide, SA 5000
Country 95699 0
Australia
Phone 95699 0
+61 0883131631
Fax 95699 0
Email 95699 0
[email protected]
Contact person for scientific queries
Name 95700 0
David Gonzalez-Chica
Address 95700 0
The University of Adelaide. Frome Rd, Helen Maio North Building, Level 1, Room N113.03, Adelaide, SA 5000
Country 95700 0
Australia
Phone 95700 0
+61 0883131631
Fax 95700 0
Email 95700 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
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
4033Ethical approval    378160-(Uploaded-12-06-2020-08-51-24)-Study-related document.pdf
4034Informed consent form    378160-(Uploaded-13-08-2019-15-06-10)-Study-related document.docx
10981Ethical approval    378160-(Uploaded-12-06-2020-08-54-51)-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.