Guideline Oriented Approach to Lipid Lowering In Asia-Pacific (GOAL-ASIA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,928
- 试验地点
- 1
- 主要终点
- proportion of patients achieving LDL-Cholesterol less than 1.4 mmol/l at six months
研究概览
简要总结
Burden of disease
page9image47428400
Almost half of the global burden of cardiovascular disease arises from the Asia Pacific (Li, 2020). While many high income Asia-Pacific nations have enjoyed reductions in overall mortality through improved control of hypertension and implementation of smoking cessation programs, CVD and its atherosclerotic manifestations of heart attack, stroke and subsequent heart failure, remain the dominant cause of regional disability adjusted life years (DALYs)(Li, 2020). This burden of disease impacts not only patients, households and their families but also the public economy which sustains direct and indirect costs of rising acute and chronic care costs and the broader losses of early retirement and consequent reductions in domestic productivity. Once established, the risk of sustaining a further ASCVD complication such as a myocardial infarction, stroke, limb loss or cardiovascular death is at least 10% per year with overall mortality being 6-fold that of those without established disease (Morrow, 2010).
- 1.2. Gaps in care Despite these alarming statistics, control of modifiable risk factors remains suboptimal globally. In the most recent data from Europe and the US, less than 1/3 of patients with established atherosclerotic disease achieve a lipid target of <1.4mmol/L with barely 50% prescribed a guideline-recommended high intensity statin (Ray, 2021). These important gaps in statin use and residual cholesterol levels represent significant forfeiture of opportunity to modify risk for both patients and populations. Accordingly there is considerable interest in understanding barriers to guideline adoption and developing interventions to address this underuse. While statin intolerance renders achievement of LDL-C goals challenging for up to 15% of patients, studies evaluating clinician rationale for not intensifying therapy reveal a combination of knowledge gaps and clinical inertia in as many as 50% of cases (Langer, 2020).
- 1.3. Multifaceted intervention Studies evaluating predominantly provider-focused approaches (e.g. academic detailing, audit and feedback) or predominantly patient-focused approaches (e.g. motivational interviewing, direct outreach) have shown statin use can be increased by about 5-10% (30-50% relative increase) with each intervention. However, less is known about their use in other populations outside of the US and Europe and while several of these intensive, high-touch interventions have shown efficacy, there is a need to evaluate flexible, low-touch alternatives which can be scaled across regions and populations and are nested in pragmatic, real-world care environments.
- 1.4. The GOAL intervention Recently, a predominantly patient-focused intervention aimed at improving the use of guideline-directed medical therapy for heart failure increased the number of medication intensifications by 60% within a 12-month period compared to standard of care (Allen, 2021). This intervention involved the patient being counselled about the rationale for the medications and using this engagement in a flipped-classroom manner to drive adoption of guideline-based therapies with their treating clinician. GOAL will use a similar approach by providing patients with the knowledge and tools to generate a conversation about achieving their lipid-lowering goals using the ‘Cholesterol Score Card’.
A large body of evidence has shown that the most effective interventions aimed at improving care quality are multifaceted and involve both patient and physician components. In addition to the Score Card, the second component of the GOAL intervention will be the provision of a risk-based assessment to the patient’s nominated clinician (general practitioner, hospitalist, cardiologist) for ongoing care post discharge. This will involve the provision of a multivariable risk calculator percentage likelihood of a recurrent event in addition to a patient’s potential additional ‘genetic’ risk conveyed by their Lp(a) value. In the primary prevention setting, presentation of the risk-based information increases their acceptance and adherence to preventive therapies (Bengtsson, 2021; Naslund, 2019). It is hypothesised the provision of similar information in the GOAL intervention will encourage the clinician to intensify lipid lowering therapy and increase the likelihood of achieving LDL-C targets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients hospitalised with Type I Myocardial Infarction aged equal to or more than 18 years of age.
排除标准
- •LDL Cholesterol more than 1.4 mmol per litre at baseline.
- •unable to provide contact details of a nominated clinician.
- •Unable to provide written informed consent.
结局指标
主要结局
proportion of patients achieving LDL-Cholesterol less than 1.4 mmol/l at six months
时间窗: The primary outcome will be measured at 6 months from baseline
次要结局
- the proportion of patients who undergo intensification of lipid-lowering therapy at 6 months.(The proportion of patients prescribed a guideline- recommended high-intensity statin at any time during the first 6 months.)
研究者
Ragini Singh
All India Institute of Medical Sciences, Rajkot
