Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000140752
Ethics application status
Approved
Date submitted
11/01/2022
Date registered
27/01/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
27/01/2022
Date results information initially provided
17/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
TEXT TO DETECT: Heart Health Check Recall Program in Australian general practice
Scientific title
Impact of a text-mediated, targeted cardiovascular screening program in Australian general practice.
Secondary ID [1] 306178 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 324886 0
Condition category
Condition code
Cardiovascular 322322 322322 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research Aim: The aim of this study is to explore the impact of general practice-initiated SMS recall messages (with and without an additional nudge message) on increasing attendance at GP clinics and increasing CVD risk assessment.

Research setting: The trial will be initiated via text mediated message sent by participating general practices across the country. Practices in one arm will be asked to send a second nudge message 2 weeks after the recall message is sent. CVD risk assessment and management will be undertaken within the practice and as part of the individual's routine medical care

Methodological approach:
The trial design will be a multiple-armed randomised control trial (RCT). The level of analysis will be general practice clinics.
Practices will be randomised into two intervention arms and 1 control arm. The intervention arms are as follows:
1. Active arm 1 (recall only message) will be provided with an information package (constituting a recall SMS with an embedded link to cardiovascular health promotion resources) to be sent to patients who are eligible for cardiovascular disease screening.
2. Active arm 2 (recall + nudge message) will be provided with an information package (constituting a recall SMS and an additional nudge SMS message, both with embedded link to cardiovascular health promotional resources to send to patients who are eligible for cardiovascular disease screening. There will be a two-week period between the sending of the recall and nudge message. The first recall SMS will be triggered manually via the GoShare Plus software followed by an automated nudge message 2 weeks later.

A 12 week observation period applies for both intervention arms, with a follow up three-month data report extracted at completion of observation period.

Recall text messages will be sent in bulk via GoShare Plus software (add on to clinical practice software) by relevant staff within the participating general practice e.g. GP, practice nurse or practice manager.

Both the recall and nudge message content will be between 200 - 230 characters long and broken into two sentences. We anticipate the reader will engage with the message for no longer than 1 minute. If the reader chooses to select the embedded link for more information, we anticipate the reader could spend between 3 to 5 minutes depending on the reader’s interest. The landing page content will include summary of information already available via the National Heart Foundation website, and includes:
• Summary information adapted from ‘Time to book a Heart Health Check’ webpage.
• Pre-existing animation, available on the ‘Time to book a Heart Health Check’ webpage’
• Two pre-exisiting patient stories, that has been used via National Heart Foundation consumer social media channels, campaigns and consumer facing e-newsletter. Both patient stories are selected from the ‘Heart Stories’ webpage
• Summary description and link to the consumer developed ‘Heart Age Calculator’

Recall and nudge message reach and content engagement with the content will be reported using a live dashboard developed by Healthily who have developed the GoShare Plus technology. The Dashboard will report on the number of SMS sent, the open rate per practice, the open rate of SMS landing page links per practice and the number of content views.
Intervention code [1] 322584 0
Prevention
Intervention code [2] 322585 0
Early detection / Screening
Intervention code [3] 322586 0
Behaviour
Comparator / control treatment
An active control group will consist of randomly allocated general practices who do not send out recall messages. The control arm will be asked to maintain care-as-usual for the 12 week observation period.

Following the 12 week observation period, the practices in the control arm will be provided with all materials and support provided to the active arm allowing them to provide identical information to their patients. At that point, control practices will be given the opportunity to choose if they want to send recall or recall + nudge as an intervention.
Control group
Active

Outcomes
Primary outcome [1] 330088 0
Number of patients who attend their general practice as a result of the recall SMS (with or without a nudge message) as assessed via visits and MBS billing recorded in clinical records (MBS items: 699, 177, 701, 703, 705, 707, 715)
Timepoint [1] 330088 0
at 3 months post intervention (recall message sent)
Primary outcome [2] 330089 0
Number of patients who have their CVD risk factors measured as a result of the recall SMS (with or without nudge message) as assessed via update of the following in clinical records: blood pressure, cholesterol, HbA1c/fasting glucose or smoking status
Timepoint [2] 330089 0
at 3 months post intervention (recall message sent)
Secondary outcome [1] 404851 0
Number of patients prescribed guideline-recommended blood pressure and/or lipid lowering pharmacotherapy as assessed by active medication listed in clinical records
Timepoint [1] 404851 0
at 3 months post intervention (recall message sent)

Eligibility
Key inclusion criteria
We will aim to recruit 200 general practices across Australia to participate in this trial. General practice inclusion criteria:
• General practices must have accreditation from one of the five Australian accreditation agencies recognised by the RACGP – AGPAL, Quality Practice Accreditation, Australian Council on Healthcare Standards, Global-Mark Pty Ltd or Institute for Healthy Communities Australia Certification Pty Ltd.
• Practices must be using CAT4 with Best Practice, Medical Director, Zedmed, Genie, Medtech, practiX, Communicare, MMEX or PCIS software.
• Practices must allow Healthily to enable GoShare Plus functionality in CAT4.

As part of the study, general practices in intervention arms 1 (recall only) and 2 (recall and nudge) will use GoShare Plus software to send Heart Health Check recall SMS to their eligible patients asking them to come in for cardiovascular screening. Eligible patients who will be identified via practice software:
• Aged 45 to 74 years
• No recorded diagnosis of existing CVD, and
• No health assessment or Heart Health Check in the last 24 months, and
• No recorded total cholesterol to HDL ratio (TC:HDL) in the last 24 months, and
• Active patient of the practice based on RACGP definition of active patient (at least 3 visits in the last 2 years)
Minimum age
45 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the patient has opted out of research projects and is included in the practice opt-out register.

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)
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
A power calculation was undertaken to estimate the minimum number of practices required to conduct a three-armed study observing changes in the number of CVD risk screening activities undertaken, as measured by Heart Health Checks (HHCs); MBS items 699 and 177.
Based on our prior study (RACGP ethics application #20-047), manuscript in preparation) the number of HHCs undertaken in a three-month period was nominated as 6.8 (s.d. 16.5). This was derived from the control population in this study. An impact of the SMS recall message was estimated at a 150% increase (IRR of 2.5). This is based on a large observed effect (IRR of 13) in the prior study. An impact of the nudge message was estimated to cause a 30% increase in the number of HHCs undertaken.
Based on these assumptions the total sample size required to detect a difference is 75 (25 practices x 3 arms). As the targeted recruitment is 200 this will allow substantial overhead for potential loss to follow up/dropout. If maximum recruitment is achieved, and there is limited dropout or loss to follow up, detection of effect sizes smaller than those assumed above will be possible.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/03/2022
Actual
4/08/2022
Date of last participant enrolment
Anticipated
30/07/2022
Actual
4/10/2022
Date of last data collection
Anticipated
30/03/2023
Actual
30/06/2023
Sample size
Target
200
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310521 0
Government body
Name [1] 310521 0
Commonwealth Department of Health, as part of the Public Health and Chronic Disease program
Country [1] 310521 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Heart Foundation of Australia
Address
National Heart Foundation of Australia
Level 3, 80 William Street, East Sydney ,
NSW 2011
Country
Australia
Secondary sponsor category [1] 311692 0
None
Name [1] 311692 0
Address [1] 311692 0
Country [1] 311692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310145 0
Royal Australian College of General Practitioners: National Research and Evaluation Ethics Committee (NREEC)
Ethics committee address [1] 310145 0
RACGP – NREEC
100 Wellington Parade, East Melbourne VIC 3002
Ethics committee country [1] 310145 0
Australia
Date submitted for ethics approval [1] 310145 0
24/01/2022
Approval date [1] 310145 0
19/05/2022
Ethics approval number [1] 310145 0
NREEC 22-122

Summary
Brief summary
This study will explore the impact of general practice-initiated SMS recall messages (with and without an additional nudge message) on increasing attendance at GP clinics and increasing CVD risk assessment.
The trial design will be a three-armed randomised control trial. The level of analysis will be general practice clinics. Practices in the two active arms will be provided with an information package (constituting a recall SMS with an embedded link to health promotion resources) to be sent to appropriate patients Active arm 2 will be provided with an additional nudge message (with embedded link to health promotion material) to be sent two weeks after the recall message is sent. The control arm practices will be asked to maintain care as usual for a three-month follow up period. Following the 3 month observation period, the practices in the control arm will be provided with all materials and support provided to the active arm allowing them to provide identical information to their patients. The practices will be randomised using a pseudo random number generator (RNG) to assign participating practices to one of three groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116638 0
Miss Natalie Raffoul
Address 116638 0
National Heart Foundation of Australia
Level 3, 80 William Street Woolloomooloo NSW 2011
Country 116638 0
Australia
Phone 116638 0
+61 431371584
Fax 116638 0
Email 116638 0
natalie.raffoul@heartfoundation.org.au
Contact person for public queries
Name 116639 0
Miss Natalie Raffoul
Address 116639 0
National Heart Foundation of Australia
Level 3, 80 William Street Woolloomooloo NSW 2011
Country 116639 0
Australia
Phone 116639 0
+61 431371584
Fax 116639 0
Email 116639 0
natalie.raffoul@heartfoundation.org.au
Contact person for scientific queries
Name 116640 0
Miss Natalie Raffoul
Address 116640 0
National Heart Foundation of Australia
Level 3, 80 William Street Woolloomooloo NSW 2011
Country 116640 0
Australia
Phone 116640 0
+61 431371584
Fax 116640 0
Email 116640 0
natalie.raffoul@heartfoundation.org.au

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.