Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001465448
Ethics application status
Approved
Date submitted
18/10/2016
Date registered
20/10/2016
Date last updated
20/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
SMS reminders promoting influenza vaccines in general practice
Scientific title
A randomised controlled trial to evaluate the effectiveness of SMS immunisation reminders in general practice
Secondary ID [1] 290347 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza vaccination 300628 0
Condition category
Condition code
Public Health 300475 300475 0 0
Epidemiology
Public Health 300476 300476 0 0
Health promotion/education
Infection 300477 300477 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients at 10 participating general practices in the Perth metropolitan area will be sent a short message service (SMS) reminding them to schedule an appointment for influenza vaccination. The message will be sent only once between 10 May and 26 May 2016 (approximately 8 weeks following the availability of influenza vaccine). The message will only be sent to patients who have not yet received an annual influenza vaccine. The message will be sent directly from the general practice to the patient and will read:

"Our records show that [you/your child] is eligible for free seasonal influenza vaccine. Please contact [Practice name] at [Practice number] to schedule an appointment for vaccination."
Intervention code [1] 296164 0
Prevention
Comparator / control treatment
No SMS will be sent to the control group
Control group
Active

Outcomes
Primary outcome [1] 299908 0
Ten to thirteen weeks following transmission of the SMS reminder, vaccination information, including any vaccine administered in 2016 and the date of vaccination, will be extracted from electronic medical records at participating practices. The percent of patients immunised against influenza will be compared between those who received a SMS reminder and those who didn't.
Timepoint [1] 299908 0
Ten to thirteen weeks following the SMS transmission (26 July to 15 August 2016)
Secondary outcome [1] 328485 0
Based on vaccination information extracted from patients' electronic medical record at the general practice, timeliness of vaccination following the transmission of a SMS reminder will be assessed.
Timepoint [1] 328485 0
Between May and August 2016

Eligibility
Key inclusion criteria
1. Active patients at a participating general practice.
2. Are eligible for the influenza vaccine under the National Immunisation Programme or state-funded programme (e.g., adults >=65 years of age, adults with chronic medical conditions [including chronic heart and lung conditions], pregnant women, Aboriginal and Torres Strait Islander individuals >=15 years, pregnant women, parents of children<15 years)
3. Have not received this year's influenza vaccine at the time of the trial.
4. Have a mobile phone number on record with the general practice
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have not visited the practice in the last three years
2. Are not eligible for free influenza vaccine under the National Immunisation Programme or state-funded programme.
3. Have a record of receiving this year's influenza vaccine prior to the trial start.
4. Have no mobile phone number on record at the general practice.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/05/2016
Date of last participant enrolment
Anticipated
Actual
26/05/2016
Date of last data collection
Anticipated
Actual
15/08/2016
Sample size
Target
10150
Accrual to date
Final
12355
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294730 0
Government body
Name [1] 294730 0
Communicable Disease Control Directorate, Department of Health Western Australia
Country [1] 294730 0
Australia
Primary sponsor type
Government body
Name
Department of Health Western Australia
Address
PO Box 8172
Perth Business Centre
Western Australia 6849 Australia
Country
Australia
Secondary sponsor category [1] 293576 0
None
Name [1] 293576 0
N/A
Address [1] 293576 0
N/A
Country [1] 293576 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296148 0
Department of Health Western Australia Human Research Ethics Committee
Ethics committee address [1] 296148 0
Executive Officer
DOHWA HREC
Level 1, C Block
189 Royal Street
East Perth WA 6004
Ethics committee country [1] 296148 0
Australia
Date submitted for ethics approval [1] 296148 0
23/03/2016
Approval date [1] 296148 0
29/04/2016
Ethics approval number [1] 296148 0
RA#2016/18

Summary
Brief summary
Immunisations are an important public health intervention for reducing the morbidity and mortality caused by vaccine-preventable diseases in the community. Certain individuals are at higher risk of serious complications following influenza infection, and unfortunately, influenza vaccine has the lowest uptake of any routine vaccination program in Australia. Studies from overseas have shown the use of text message reminders (also called short message service [SMS] reminders) can be an effective method of promoting vaccines to priority groups. The Western Australia Department of Health (WA Health) is interested in creating a program for general practitioners to use during the influenza vaccination season to remind patients they are eligible for government-funded influenza vaccine. To assess whether this activity is an effective and efficient use of resources, WA health intends to evaluate the impact of a prototypic reminder system in a subset of practices.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69754 0
Dr Annette Regan
Address 69754 0
Communicable Disease Control Directorate
Department of Health Western Australia
Level 1, Grace Vaughan House
227 Stubbs Terrace
Shenton Park WA 6008
Country 69754 0
Australia
Phone 69754 0
+61893884876
Fax 69754 0
Email 69754 0
[email protected]
Contact person for public queries
Name 69755 0
Dr Annette Regan
Address 69755 0
Communicable Disease Control Directorate
Department of Health Western Australia
Level 1, Grace Vaughan House
227 Stubbs Terrace
Shenton Park WA 6008
Country 69755 0
Australia
Phone 69755 0
+61893884876
Fax 69755 0
Email 69755 0
[email protected]
Contact person for scientific queries
Name 69756 0
Dr Annette Regan
Address 69756 0
Communicable Disease Control Directorate
Department of Health Western Australia
Level 1, Grace Vaughan House
227 Stubbs Terrace
Shenton Park WA 6008
Country 69756 0
Australia
Phone 69756 0
+61893884876
Fax 69756 0
Email 69756 0
[email protected]

No information has been provided regarding IPD availability


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.