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Trial registered on ANZCTR


Registration number
ACTRN12614001046695
Ethics application status
Approved
Date submitted
22/09/2014
Date registered
30/09/2014
Date last updated
15/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can e-Health improve post-marketing surveillance of drugs and vaccines? The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised controlled trial.
Scientific title
In individuals receiving routine vaccinations, can the use of e-health- by way of responding to SMS and internet surveys sent after vaccinations-improve the detection rate and timeliness of reporting of adverse events compared to the usual practice?
Secondary ID [1] 285231 0
None
Universal Trial Number (UTN)
U1111-1160-9119
Trial acronym
STARSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-marketing surveillance reporting of adverse events of vaccines
292860 0
E-health 292861 0
Condition category
Condition code
Public Health 293159 293159 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the current practice of adverse event reporting following immunisation, individuals can report any untoward symptoms to healthcare professionals (GP, hospital ED), Healthcare Direct phone helpline or the TGA.

In the STARSS study, consenting subjects receiving routine immunisations will be randomised to the 3 arms of the trial after the immunisation encounter, according to a double-blind protocol.

Two arms of the trial will evaluate two different SMS survey approaches to the follow-up of any medical events for up to 17 days following an immunisation. The third group will be the active control group, where the subjects will use the current usual practice of passive (voluntary) reporting of adverse events.
The SMS survey is interactive, with the subjects receiving a response SMS to their notification of a medical event. Such response will contain two different texts depending on the intervention arm the subject is enrolled into.
In the first intervention group, the SMS responders (eg the subjects reporting a medical event by return SMS) can report any untoward symptoms by visiting a healthcare professional, a hospital emergency department or by calling the Healthcare Direct helpline or the TGA for a health concern. In this intervention group, SMS responders confirming any contacts with a healthcare provider will be called by a nurse or a trained member of the study team within 24 hrs. These subjects will be administered a set questionnaire over the phone (CATI- "computer assisted telephone interview" group) to follow-up any medical events following the vaccination. Such follow-up will ascertain whether the symptoms for which medical attention was sought may be consistent with an adverse event.
In the second intervention group, the SMS follow-up of medical events will use the same set questionnaire, but rather than receiving a follow-up telephone call, the subjects will receive a return SMS containing a link to the survey. In this modality, the questionnaire is web-based (WBR- "web based report" group), and the reporting of the medical event will be carried out by the subjects themselves. In this scenario, the answers to the questionnaire will be scanned automatically and in real-time against a set of pre-determined keywords and conditions to generate "flags" for follow-up.

In both CATI and WBR groups, causality of any potential adverse events will be ascertained according the current WHO adverse event causality guidelines and reported as per common practice to the manufacturer, the TGA and the lead HREC .
Typologies of SMS: In the intervention groups, an enrolment SMS will be sent out on day 1 (when vaccination is received) to all the subjects enrolled in both the “CATI” and the “WBR” groups. Such SMS will thank participants for entering the study and remind them to answer ‘yes’ if they seek any medical attention at any time thereafter. Following the enrolment SMS, 3 further identical reminder SMS are sent for post-vaccination surveillance on days 2, 7 and 14 reminding the intervention subjects to answer ‘yes’ if they seek any medical attention. A final SMS to mark the close of survey will be sent on day 17.

20% of all subjects enrolled will also be administered an acceptability questionnaire 1 month post-vaccination to evaluate public perception, assess large-scale feasibility and estimate the health economics aspects of the STARSS e-health based reporting processes.
Intervention code [1] 290106 0
Early detection / Screening
Comparator / control treatment
The active control subjects will not receive any SMS messages following the immunisation encounter and will be treated as per usual practice: an information leaflet will be given at the immunisation encounter by the immunisation provider and reporting of any adverse events will be initiated by the subject.
Control group
Active

Outcomes
Primary outcome [1] 293018 0
The proportion of subjects in which an adverse event following a single immunisation episode is detected in the SMS intervention groups when compared with the active control group.

Timepoint [1] 293018 0
17 days following immunisation
Secondary outcome [1] 310160 0
Determination of the MEFI (Medical Event Following Immunisation) rate in the 3 groups.
An MEFI indicates any medical symptoms experienced following the immunisation, which may or may not be related to the vaccine administration.
In the intervention groups, a return SMS confirming having sought medical attention will be considered to be an MEFI.
Timepoint [1] 310160 0
17 days following immunisation
Secondary outcome [2] 310611 0
Determination of the difference of the speed of detection of AEFI (Adverse Event Following Immunisation) in the 3 groups, calculated in days and hours.

An AEFI is a MEFI that causes concern and is
believed to be caused by the immunization. Examples of AEFI are local reactions such as swelling or redness at the site of injection, or systemic adverse reactions which include high fever, flu-like malaise, skin rash, myalgia or arthralgia.

In the treatment groups, this outcome is going to be assessed from both the CATI and WBR process and from patient medical records.
In the active control group: from the day of vaccination to the time of reporting to medical professional, healthcare direct by request to the TGA's records.
Timepoint [2] 310611 0
In the intervention groups: From the day of vaccination up to 17 days post immunisation.

Secondary outcome [3] 310612 0
Determination of the difference of the SAEFI (Serious Adverse Event Following Immunisation) detection in the 3 groups.

A SAEFI is defined by the WHO as an AEFI that ‘results in death, hospitalisation or prolongation of hospitalisation, persistent or significant disability/incapacity, or is life threatening.

In the treatment groups, this outcome is going to be assessed from both the CATI and WBR process and from patient medical records.
In the active control group: from the day of vaccination to the time of reporting to medical professional, healthcare direct by request to the TGA's records.
Timepoint [3] 310612 0
From the day of vaccination up to 17 days post immunisation
Secondary outcome [4] 310613 0
Determination of the difference of the NSAEFI (Non-Serious Adverse Event Following Immunisation) detection in the 3 groups.
A NSAEFI is an AEFI that does not require hospitalisation, or results in death or disability. Examples of a NSAEFI are redness, soreness or itchiness at the injection site, lymph node swelling and tenderness.

In the treatment groups, this outcome is going to be assessed from both the CATI and WBR process and from patient medical records.
In the active control group: from the day of vaccination to the time of reporting to medical professional, healthcare direct by request to the TGA's records.
Timepoint [4] 310613 0
From the day of vaccination up to 17 days post immunisation
Secondary outcome [5] 310614 0
Determination of the overall SMS response rates in the intervention groups (CATI and WBR) at day 2, 7 and 14.

This will be the total number of SMS responses (“YES” or NO) divided by the number of generated SMSs, on day 2, 7, and 14.
Timepoint [5] 310614 0
Day 2, 7 and 14.

Eligibility
Key inclusion criteria
1. Understanding of written and spoken English language;
2. Possession of a mobile phone (or guardian's possess in case of a young child);
3. Access to the internet.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All subjects who don't meet the inclusion criteria will be excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Patient Information Sheet will be given to subjects prior to their routine immunisation visit.
After immunisation, the rationale of the study will be discussed and subjects willing to enrol then provide written consent.
The enrolled subjects' demographic data will then be exported using an encryption protocol and transferred via the GRHANITE data extraction protocol to the study server. GRHANITE will also record and transfer data relating to the obtainment of subjects' consent.

The build and implementation of the downstream IT infrastructure for the SMS survey will be carried out by a contracted third party.

Enrolled subjects will be allocated to a treatment group using a computer generated randomisation schedule. Subjects will be randomised to one of three arms: SMS intervention + direct call computer assisted telephone interview (CATI), SMS intervention + web-based report (WBR, Web survey) or usual practice (active control) in a ratio of 1:1:1. Neither the participant nor their healthcare provider will be made aware of the treatment group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The automated, computer-generated random sequence will follow a simple sequence where every new subject entering the study database will be allocated sequentially to the 3 arms (CATI-WBR-Active-control) in the ratio 1:1:1 by using a computer generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 3010 0
Womens and Childrens Hospital - North Adelaide

Funding & Sponsors
Funding source category [1] 289844 0
Government body
Name [1] 289844 0
WA Health
Address [1] 289844 0
Department of Health
189 Royal Street
East Perth WA 6004
Australia
Country [1] 289844 0
Australia
Funding source category [2] 289846 0
Other
Name [2] 289846 0
Murdoch Children's Research Institute
Address [2] 289846 0
The Royal Children's Hospital
Flemington Road Parkville
Victoria 3052 Australia
Country [2] 289846 0
Australia
Funding source category [3] 289848 0
Commercial sector/Industry
Name [3] 289848 0
Glaxo-Smith Kline Australia Pty Ltd
Address [3] 289848 0
GSK
Level 4, 436 Johnston Street, Abbotsford, Victoria, 3067, Australia
PO Box 18095, Melbourne, Victoria, 8003, Australia
Country [3] 289848 0
Australia
Funding source category [4] 289849 0
Commercial sector/Industry
Name [4] 289849 0
Sanofi Aventis Australia Pty Ltd trading as Sanofi Pasteur
Address [4] 289849 0
Building D 12/24 Talavera Rd
Macquarie Park
NSW 2113
Country [4] 289849 0
Australia
Funding source category [5] 290017 0
Government body
Name [5] 290017 0
National Health and Medical Research Council
Address [5] 290017 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [5] 290017 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 288705 0
None
Name [1] 288705 0
Address [1] 288705 0
Country [1] 288705 0
Other collaborator category [1] 278140 0
Government body
Name [1] 278140 0
SA Health
Address [1] 278140 0
Citi Centre Building
11 Hindmarsh Square
Adelaide
South Australia 5000
Country [1] 278140 0
Australia
Other collaborator category [2] 278141 0
Hospital
Name [2] 278141 0
The Children’s Hospital at Westmead
Address [2] 278141 0
Kerry Packer Building
Cnr Hawkesbury Rd and Hainsworth St
Westmead
NSW 2145
Country [2] 278141 0
Australia
Other collaborator category [3] 278142 0
University
Name [3] 278142 0
Rural Health Academic Centre, Melbourne Medical School
University of Melbourne
Address [3] 278142 0
49 Graham Street, Shepparton
Victoria 3630 Australia
PO Box 6500, Shepparton Vic 3632
Country [3] 278142 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291575 0
Women's & Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 291575 0
Research Secretariat
2nd Floor,
Samuel Way Bldg
72 King William Road
NORTH ADELAIDE
SA 5006
Ethics committee country [1] 291575 0
Australia
Date submitted for ethics approval [1] 291575 0
Approval date [1] 291575 0
27/02/2014
Ethics approval number [1] 291575 0
EC00197

Summary
Brief summary
Vaccines used in Australian clinical practice have been tested for safety in clinical trials and are then registered for use by the Therapeutic Goods Administration. Safety monitoring of vaccines (as for all licensed medicines) is an ongoing process.
This is usually done in Australia by “passive” or voluntary reporting of any reactions known as ‘adverse events’ that may occur after a drug or vaccine is used. The purpose of the Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) study is to evaluate a new way of monitoring the safety of vaccines. This system is a way of involving the consumer in reporting immunisation adverse events and will give “real time” information about vaccine safety. This will be achieved by sending a short message service (SMS) mobile phone text similar to what one often gets to remind you to attend a doctor’s appointment. The potential benefit of such a study is that vaccine and drug safety could be evaluated in a large number of consumers and any potential issues (these would be unlikely) can be identified very soon.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50962 0
A/Prof Michael Gold
Address 50962 0
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
AUSTRALIA
Country 50962 0
Australia
Phone 50962 0
+61 (8) 8161-7030
Fax 50962 0
Email 50962 0
michael.gold@adelaide.edu.au
Contact person for public queries
Name 50963 0
Dr Gabriella Lincoln
Address 50963 0
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
AUSTRALIA
Country 50963 0
Australia
Phone 50963 0
+61 (8) 8161 7030
Fax 50963 0
Email 50963 0
gabriella.lincoln@adelaide.edu.au
Contact person for scientific queries
Name 50964 0
A/Prof Michael Gold
Address 50964 0
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
AUSTRALIA
Country 50964 0
Australia
Phone 50964 0
+61 (8) 8161 7030
Fax 50964 0
Email 50964 0
michael.gold@adelaide.edu.au

No data has been provided for results reporting
Summary results
Not applicable