Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000221954
Ethics application status
Approved
Date submitted
14/01/2020
Date registered
24/02/2020
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-directed strategies to assess the quality use of statins using a novel trial design.
Scientific title
Randomised Evaluation of a patient-direCted, Nudge-based letter EnCouraging patient-GP interaction to increase statin re-initiation (RECONNECT)
Secondary ID [1] 300200 0
None
Universal Trial Number (UTN)
U1111-1246-1386
Trial acronym
Randomised Evaluation of a patient-direCted, Nudge-based letter EnCouraging patient-GP interaction to increase statin re-initiation (RECONNECT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 315755 0
Condition category
Condition code
Public Health 314047 314047 0 0
Health promotion/education
Cardiovascular 314585 314585 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RECONNECT is a randomised controlled trials that will be embedded within the 45 and Up study using the trials within cohort (TwiC) approach, a type of platform trial design.
A random selection of eligible participants will receive the intervention (one of four variations of a patient-directed letter described below) and be compared to those who do not. The patient-directed letter aims to promote a discussion with the patient’s GP about their medicine use. RECONNECT will assess 2 comparisons:
1. Statin use in participants who receive a letter vs. those who do not:
- Letter arm: A pre-defined proportion of eligible participants will be randomly selected to receive a patient-directed letter empowering them to have a conversation with their general practitioner (GP) about their statin use. In keeping with Choosing Wisely (a national and international initiative that focuses on bringing together patients and health care providers to identify ways to improve the quality use of treatments, tests and procedures) the emphasis will be on beginning a conversation with the prescriber (i.e. GP); all letters will be mailed to the eligible participants simultaneously
- No letter arm: Eligible non-selected participants will form the control (standard care) group.

2. In the intervention arm, participants will receive one of four letters (see letters A-D below) with a combination of different message and messenger options:
- Message options: educational content only vs. educational content + social nudges. The educational content + social nudge letter will be based on highlighting social norms.
- Messenger options: academic group only (The George Institute for Global Health) vs. academic group + professional society or organisation (e.g. Heart Foundation). The academic group +/- professional society's logos will be used to signify endorsement of the letters. This will test the impact of the source of the letter by comparing academic group alone vs. addition of professional medical societies.

Letter A: (Educational content) + (Academic institution endorsement)
Letter B: (Educational content + social nudge) + (Academic institution endorsement)
Letter C: (Educational content) + (Academic institution + professional society endorsement)
Letter D: (Educational content + social nudge) + (Academic institution + professional society endorsement)

The letters will emphasie the importance of ongoing statin use with some information on possible side effects. They will include social nudges such as information on how many people who do experience a side effect to their medication may continue at a lower dose or tolerate a different type of statin. While the aim of the letter is to encourage the participant to speak to their doctor about statin use, making an appointment to see their doctor is not a requirement for this intervention.
Intervention code [1] 316476 0
Prevention
Intervention code [2] 316898 0
Treatment: Other
Comparator / control treatment
Eligible non-selected participants will form the control (standard care) group. This group will not receive the intervention letter or any other form of intervention or treatment specifically as part of this study.
Control group
Active

Outcomes
Primary outcome [1] 322444 0
Statin re-initiation in the first 6 months after the letter is sent
Study outcomes will be ascertained using existing data linkage to administrative data sources including Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) data.
Timepoint [1] 322444 0
In the first 6 months after the letter is sent
Secondary outcome [1] 378571 0
Proportion of patients with 1 or more GP visit within first 6 months after the letter is sent. This outcome will be assessed using Medicare Benefits Schedule linked data.
Timepoint [1] 378571 0
Over 6 months after the letter is sent

Eligibility
Key inclusion criteria
• Had 1 or more statin (defined as atorvastatin, fluvastatin, pravastatin, simvastatin or rosuvastatin) dispensed (ascertained based on PBS data) on or after the time of 45 and Up study recruitment and

• Discontinued statin use (defined as no statin dispensed for 3 or more months prior to the end date of the PBS data available within the 45 and Up study)
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Self-reported or recorded history of known contraindications to statins

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)
Computer generated randomisation of participant project numbers will be provided to the Sax Institute. Letters will be sent by the Sax Institute to intervention group.
All analyses will be programmed and finalised while masked to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Estimated eligible population size:
• 12,000 statin users who have discontinued statin therapy
• A total of 6,000 of the eligible population will be selected at random to receive an intervention letter and compared to 6,000 who do not receive a letter
Power estimation:
• 90% power (2p=0.05) to detect a 1.3% absolute and 34% relative increase (from 3.8% to 5.1%) in the primary outcome for letter vs. no letter, assuming a 6-month re-initiation rate in the no letter group of 3.8%

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/03/2020
Actual
Date of last participant enrolment
Anticipated
13/03/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
12000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28971 0
2007 - Ultimo

Funding & Sponsors
Funding source category [1] 304631 0
Government body
Name [1] 304631 0
NHMRC
Country [1] 304631 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 5, 1 King St
Newtown
NSW 2042
Country
Australia
Secondary sponsor category [1] 304940 0
None
Name [1] 304940 0
Address [1] 304940 0
Country [1] 304940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305051 0
Royal Prince Alfred Ethics Review Committee
Ethics committee address [1] 305051 0
Research ETHICS AND GOVERNANCE Office
Royal Prince Alfred Hospital
CAMPERDOWN NSW 2050
Ethics committee country [1] 305051 0
Australia
Date submitted for ethics approval [1] 305051 0
30/09/2019
Approval date [1] 305051 0
30/10/2019
Ethics approval number [1] 305051 0
Ethics committee name [2] 305062 0
NSW population and health services research ethics committee
Ethics committee address [2] 305062 0
Level 9, 8 Central Avenue, Australian Technology Park, Eveleigh NSW 2015
Ethics committee country [2] 305062 0
Australia
Date submitted for ethics approval [2] 305062 0
02/03/2020
Approval date [2] 305062 0
Ethics approval number [2] 305062 0

Summary
Brief summary
Objective: to determine the impact of a letter encouraging patients to visit their GP on
increasing appropriate statin re-initiation
Hypothesis: the letter will significantly increase statin re-initiation over 6 months compared to no letter among individuals who have previously discontinued statin therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99102 0
A/Prof Min Jun
Address 99102 0
The George Institute for Global Health
Level 5, 1 King St | Newtown NSW 2042 Australia
Country 99102 0
Australia
Phone 99102 0
+61 2 8052 4403
Fax 99102 0
Email 99102 0
[email protected]
Contact person for public queries
Name 99103 0
A/Prof Min Jun
Address 99103 0
The George Institute for Global Health
Level 5, 1 King St | Newtown NSW 2042 Australia
Country 99103 0
Australia
Phone 99103 0
+61 2 8052 4403
Fax 99103 0
Email 99103 0
[email protected]
Contact person for scientific queries
Name 99104 0
A/Prof Min Jun
Address 99104 0
The George Institute for Global Health
Level 5, 1 King St | Newtown NSW 2042 Australia
Country 99104 0
Australia
Phone 99104 0
+61 2 8052 4403
Fax 99104 0
Email 99104 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6423Ethical approval  [email protected]



Results publications and other study-related documents

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