Health-economic Evaluation of the Care Pathway in General Medicine for High Cardiovascular Risk Patients Based on the Detection of Asymptomatic Lower Limb Peripherial Arterial Disease (AOMI) by the Blood Pressure Index (BPI).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
研究概览
简要总结
Cardiovascular pathologies (CV), the second leading cause of death just behind tumors, are particularly frequent in France and strongly mobilize the resources of the healthcare system (ambulatory and health facility). The French High Authority for Health (HAS) has defined major cardio-vascular risk factors (CVRF): smoking, high blood pressure (hypertension), elevated total cholesterol (TC) or LDL, decreased HDL cholesterol, type II diabetes and age, and predisposing CVRF or discussed: obesity, sedentary lifestyle, menopause, elevation of triglycerides and genetic factors.
Lower-linb peripherial arterial disease (AOMI), even if asymptomatic, involves systemic atherial disease, responsible for mortality irrespective of the presence of CVRF. The prevalence of asymptomatic AOMI is 10 to 20% beyond 55 years old, and the associated mortality is 18 to 30% at 5 years.
Individual screening is achievable by well-conducted clinical evaluation and systematic measurement of the simple, non-invasive Blood Pressure Index (BPI) in all subjects at risk. A BPI<0.9 indicates an event risk close to that of the symptomatic patient. However, if this strategy is recommended by the HAS, it is not carried out systematically in current practice. Therapeutic means available for the management of an asymptomatic AOMI are the identification and support for controllable CVRF such as smoking and nutrition (diet and physical activity) in the context of secondary prevention of atherosclerosis. Thus, the generalization of a systematique screening strategy of AOMI, allowing faster handling of CVRF by advices and Motivational Interviewing (MI), could have a significant impact, both clinically and economically.
Patients could also benefit from this support in terms of quality of life both on the physiological dimension (effect of weight loss, correction of disorders of cardiac function, etc.), that on the psychic dimension (well-being of patients, management of disorders anxious). However, few studies have evaluated the benefit of such a strategy in terms of quality-adjusted life years (QALYs),none did it on a cost recovery basis. No such studies have been conducted in France.
The feasibility of this project is based on the success of a pilot study conducted in Centre-Val de Loire region (France) in 2013. It showed that the implementation of a strategy of systematic screening of the asymptomatic AOMI based on the measurement of the BPI in high cardiovascular risk patients is feasible in current practice by general practitioners, and could be more efficient than interventions performed in current practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The investigators will include the patients before knowing their randomization arm. This procedure is essential to avoid selection bias by having an effect on the level of recruitment and the profile of the people included in the study.
The initial randomization unit is the CRMG. Eight CRMG will be included in the investigator's study. Four CRMGs will be randomly assigned to the group "systematic AOMI screening by IPS measurement", four CRMG to the "no systematic screening" group. Then, each group thus obtained will be randomly divided into two CRMGs with "advice and EM" and two without CRMG.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRITERIA FOR INCLUDING PERSONS LENDING TO RESEARCH
- •Man over 50 years old and under 80 years old or woman over 60 years old and under 90 years old with at least 2 FRCV including at least 1 major FRCV:
- •Major LIFs:
- •Active or withdrawn smoking for less than 1 year
- •Type 2 diabetes, treated or not
- •Other FRCV:
- •Family history: MI, coronary revascularization or sudden death before age 50 with a 1st degree parent
- •Dyslipidemia: LDL-cholesterol> 1.3 g / l and / or HDL-cholesterol <0.4 g / l
- •hypertension (≥ 140/90 mmHg) for at least 6 months, balanced or not
- •Sedentary lifestyle
- •Ability to benefit from an EM and to complete a quality of life questionnaire (mastery and understanding of the French language)
- •Patient affiliated or beneficiary of a social security scheme
- •Patient who has expressed informed consent
- •CRITERIA FOR NON-INCLUSION OF PERSONS LENDING TO RESEARCH
- •History of cardiovascular event (symptomatic PADI, acute coronary syndrome, stroke, transient ischemic attack, etc.), therefore patient already in tertiary prevention
- •Patient participating in another interventional study.
- •Known asymptomatic PADI
排除标准
- •History of cardiovascular event (symptomatic AOMI, acute coronary syndrome, stroke, transient ischemic attack ...), therefore patient already in tertiary prevention
- •Patient included in another interventional study
研究组 & 干预措施
Strategy 2: Motivationnal interviewing
No systematic screening of asymptomatic AOMI and management of CVRF by a motivationnal interviewing.
干预措施: Management of CVRF by a motivationnal interviewing. (Other)
Strategy 3: Systematic screening of AOMI by BPI measurement
Systematic screening of AOMI by BPI measurement and routine management of FRCV.
干预措施: Systematic screening of AOMI by BPI measurement. (Other)
Strategy 4: Both strategies
Systematic screening of AOMI by BPI measurement and management of CVRF by a motivationnal interviewing.
干预措施: Systematic screening of AOMI by BPI measurement. (Other)
Strategy 4: Both strategies
Systematic screening of AOMI by BPI measurement and management of CVRF by a motivationnal interviewing.
干预措施: Management of CVRF by a motivationnal interviewing. (Other)
Strategy 1: Usual practice
No systematic screening of asymptomatic AOMI and routine management of FRCV.
结局指标
主要结局
ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
时间窗: 10 years
Incremental Cost-Utility Ratio (ICUR): Cost per QALY gained at 10 years from the collective and health insurance viewpoint. The quality of life data needed to calculate QALYs will be obtained from the EQ-5D questionnaire and extrapolated to 10 years based on the risk of CV event (SCORE) and prescribed treatments. The costs will be collected by a CRF.
次要结局
- ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.(2 years)
- Budget impact (in €) at 5 years(5 years)