Cost-utility Analysis, Cost-effectiveness Analysis, Budget Impact Analysis

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Systematic screening of AOMI by BPI measurement.
* Other: Management of CVRF by a motivationnal interviewing.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man over 50 and under 80 or woman over 60 and under 90 with at least 2 CVRF including at least 1 major CVRF (Major CVRF: Active or stopped smoking for less than 3 years; Type II treated or not treated Diabetes; Other CVRF: Family history: myocardial infarction, sudden death <55 years (male first degree relative) or <65 years (female first degree relative) or Cerebrovascular Stroke (CVA) < 45 years old; Dyslipidemia: LDL-cholesterol> 1.6 g/L and / or HDL-cholesterol <0.4 g/L; HTA (≥ 140/90 mmHg) for at least 6 months, balanced or not) Ability to benefit of an Motivational interviewing and to complete a quality of life questionnaire (fluent in french) Social insured patient Informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Two strategies are studied in this study: Screening for asymptomatic AOMI by measuring IPS Management of the FRCV by advices and motivational interviewing The strategies will be associated according to a factorial plan 2 * 2 in order to obtain 4 groups: Strategy 1: Routine testing for asymptomatic AOMI and management of FRCV. Strategy 2: Routine practice of asymptomatic AOMI screening and management of FRCVs by councils and a MA. Strategy 3: Systematic Screening of asymptomatic AOMI by measurement of SPI and routine management of FRCV. Strategy 4: Systematic screening of asymptomatic AOMI by measuring SPI and taking care of FRCVs by councils and a ME.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Strategy 1: Usual practice<br>No systematic screening of asymptomatic AOMI and routine management of FRCV. | |
| Experimental: Strategy 2: Motivationnal interviewing<br>No systematic screening of asymptomatic AOMI and management of CVRF by a motivationnal interviewing. | Other: Management of CVRF by a motivationnal interviewing.<br>* The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms<br>|
| Experimental: Strategy 3: Systematic screening of AOMI by BPI measurement<br>Systematic screening of AOMI by BPI measurement and routine management of FRCV. | Other: Systematic screening of AOMI by BPI measurement.<br>* The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms<br>|
| Experimental: Strategy 4: Both strategies<br>Systematic screening of AOMI by BPI measurement and management of CVRF by a motivationnal interviewing. | Other: Systematic screening of AOMI by BPI measurement.<br>* The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms<br>Other: Management of CVRF by a motivationnal interviewing.<br>* The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. | 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. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. | Incremental Cost-Effectiveness Ratio (ICER): Cost per prevented cardio-vascular event at 10 years from the collective and health insurance viewpoint. CV events at 10 years will be compute from the SCORE calculation at 2 years. The cost will be collected by a CRF. | 10 years | 
| ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. | ICER: Cost per SCORE point less at 2 years from the collective and health insurance viewpoint. The cost will be collected by a CRF. | 2 years | 
| Budget impact (in €) at 5 years | Budget impact at 5 years from the collective and health insurance viewpoint of the dissemination of the most efficient strategy. The cost will be collected by a CRF. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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detection, cost-utility analysis, cost-effectiveness analysis, blood pressure index measurement, motivational interviewing