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Patient-directed strategies to assess the quality use of statins using a novel trial design.

Randomised Evaluation of a patient-direCted, Nudge-based letter EnCouraging patient-GP interaction to increase statin re-initiation (RECONNECT)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000221954
Acronym
Randomised Evaluation of a patient-direCted, Nudge-based letter EnCouraging patient-GP interaction
Enrollment
12000
Registered
2020-02-24
Start date
2020-03-09
Completion date
2020-03-13
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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:

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.

Sponsors

The George Institute for Global Health
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

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)

Exclusion criteria

Self-reported or recorded history of known contraindications to statins

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026