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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early intervention | Active Comparator | Participants randomised to 'early' will receive the intervention at baseline through 6 months. while those randomised to 'late' will receive standard-of-care and represent a control arm over this period. |
|
| Late intervention | Other | Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Intervention | Behavioral | Participant and clinician lipid score card 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 Score Card documents four key fields to be completed by the participant, study team and participant's regular clinician including 1) 'current' LDL-C level, 2) participant's level of adherence to lipid-lowering therapy using modified Voil's criteria, 3) lipid-lowering management decisions made at the clinician's appointment and 4) currently prescribed lipid-lowering therapies. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving an LDL <1.4mmol/L | Proportion of patients achieving an LDL <1.4mmol/L at 6 months. This will be determined from values obtained through local laboratory testing. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who undergo intensification of lipid-lowering therapy | Proportion of patients who undergo intensification of lipid-lowering therapy in 6 months | 6 months |
| Proportion of patients prescribed high-intensity statin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Butters, BHSc, MBA | Contact | 61 434679018 | julie.butters@monash.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Nicholls, MBBS, PhD | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illawarra Shoalhaven Local Health District | Recruiting | Wollongong | New South Wales | 2500 | Australia |
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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.
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|
Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months
| 6 months |
| Proportion of patients prescribed high-intensity statin at 6 months | Proportion of patients prescribed a guideline-recommended high-intensity statin at 6 months | 6 months |
| Adherence to lipid lowering therapy | Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months | 6 months |
| Patient activation and engagement in care | Level of patient activation and engagement in their care at 6 months compared with baseline | 6 months |
| Proportion of patients achieving LDL<1.4mmol/L at 12 months | Proportion of patients achieving LDL<1.4mmol/L at 12 months | 12 months |
| Cairns & Hinterland Hospital & Health Service | Recruiting | Cairns | Queensland | 4870 | Australia |
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| Flinders Medical Centre | Not yet recruiting | Bedford Park | South Australia | 5042 | Australia |
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| Monash Health | Recruiting | Clayton | Victoria | 3800 | Australia |
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| Western Health | Recruiting | Melbourne | Victoria | 3011 | Australia |
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| Affiliated Zhongshan Hospital of Dalian University | Recruiting | Dalian | Liaoning | 116001 | China |
|
| All India Institute of Medical Sciences | Recruiting | New Delhi | 360110 | India |
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| Fukuoka University Hospital | Not yet recruiting | Fukuoka | Japan |
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| Kyorin University Hospital | Not yet recruiting | Mitaka | Japan |
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| National Cerebral and Cardiovascular Center | Recruiting | Osaka | Japan |
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| Osaka Medical and Pharmaceutical University Hospital | Not yet recruiting | Osaka | Japan |
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| University Teknologi MARA, Hospital UiTM, UiTM Medical Centre | Not yet recruiting | Shah Alam | Selangor | Malaysia |
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| National Heart Institute | Recruiting | Kuala Lumpur | 50400 | Malaysia |
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| University of Malaysia Medical Centre | Recruiting | Kuala Lumpur | 59100 | Malaysia |
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| National Heart Centre | Recruiting | Singapore | Singapore |
|
| National University Hospital Singapore (NUHS) | Not yet recruiting | Singapore | Singapore |
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| PyeongChon Hallym University Sacred Heart Hospital | Not yet recruiting | Pyeongchon | Gyeonggi Province | South Korea |
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| Kangnam Hallym University Sacred Heart Hospital | Not yet recruiting | Seoul | South Korea |
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| National Cheng Kung University Hospital | Recruiting | Tainan | 70403 | Taiwan |
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| Siriraj Hospital | Not yet recruiting | Bangkok | Thailand |
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| Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast | Not yet recruiting | Khon Kaen | Thailand |
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| Songklanagarind Hospital | Not yet recruiting | Songkhla | Thailand |
|
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D054058 | Acute Coronary Syndrome |
| D050197 | Atherosclerosis |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
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