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Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study.
Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.
Full description
The study will be conducted over two phases.
In phase I (0-6 months), participants randomized to 'early' will receive the intervention at baseline through 6 months, while those randomized to 'late' will receive standard-of-care and represent a control arm over this period.
In phase II (6 to 12 months), those randomized to 'late' will receive the intervention at 6 months, while the 'early' group will continue in follow-up.
Multifaceted Intervention The intervention aims to increase the likelihood of effecting guideline-directed change in lipid lowering therapy through two key actors - both the patient and their clinician(s). The intervention is deliberately nested within routine clinical care to enhance the generalisability of the findings beyond a research environment and to reflect other elements of real world practice.
Standard of care Participants allocated to 'late' will receive standard-of-care for the first 6 months which involves the provision of the participant's lipid profile to their nominated primary care physician/general practitioner at 6 weeks, 3 months and 6 months.
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2,000 participants in 2 patient groups
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Central trial contact
Julie Butters, BHSc, MBA
Data sourced from clinicaltrials.gov
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