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

Summary

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.

Conditions

• Peripheral Arterial Disease

Interventions

OTHER

Systematic screening of AOMI by BPI measurement.

The strategies will be associated according to a 2\*2 factorial design in order to obtain 4 arms

OTHER

Management of CVRF by a motivationnal interviewing.

The strategies will be associated according to a 2\*2 factorial design in order to obtain 4 arms

Sponsors & Collaborators

• Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ

  collaborator UNKNOWN

• Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure

  collaborator UNKNOWN

• Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST

  collaborator UNKNOWN

• Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise

  collaborator UNKNOWN

• Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE

  collaborator UNKNOWN

• Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND

  collaborator UNKNOWN

• Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS

  collaborator UNKNOWN

• Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes

  collaborator UNKNOWN

• University Hospital, Tours

  lead OTHER

Principal Investigators

• Sebastien BRUEL, Dr · CRMG SAINT ETIENNE

• Clarisse DIBAO DINA, Dr · CRMG TOURS

• Thierry FARGE, Pr · CRMG LYON

• Sophie LALANDE, Dr · CRMG BREST

• Michel CUNIN, Dr · CRMG LILLE

• Philippe VORILHON, Dr · CRMG CLERMONT FERRAND

• Delphine RUBÉ, Dr · CRMG NANTES

• Emmanuel ALLORY,, Dr · CRMG RENNES

• Florent CROUZET,, Dr · MG SAINT ETIENNE (42210 Montrond-les-Bains)

• Julien FAVIER, Dr · MG SAINT ETIENNE (42300 ROANNE)

• Bastien LAVAL, Dr · MG SAINT ETIENNE (42800 GENILAC)

• Julien PEYRARD, Dr · MG SAINT ETIENNE (43 120 MONISTROL/LOIRE

• Jean Philippe MELIZAN, Dr · MG SAINT ETIENNE (42260 St Martin la sauveté)

• Catherine PLOTTON,, Dr · MG SAINT ETIENNE (42230 ROCHE LA MOLIERE)

• Romain LAMOTTE, Dr · MG SAINT ETIENNE (69590 SAINT SYMPHORIEN SUR COISE)

• Hervé BONNEFOND, Dr · MG SAINT ETIENNE (42000 SAINT ETIENNE)

• Alexandre BRULET, Dr · MG SAINT ETIENNE (42300 ROANNE)

• Olivier DURIEUX, Dr · MG SAINT ETIENNE (43240 SAINT JUST MALMONT)

• Claire CHARRAT, Dr · MG SAINT ETIENNE (43120 MONISTROL SUR LOIRE)

• Morinne DUPIN, Dr · MG SAINT ETIENNE (43210 BAS EN BASSET)

• Aurélien BARADEL, Dr · MG LYON (01430 ST MARTIN DU FRESNE)

• Myriam OLIVIA, Dr · MG LYON (38 280 VILLETTE D'ANTHON)

• Damien MONLOUBOU, Dr · MG LYON (69100 VILLEURBANNE)

• Ronan FOURE,, Dr · MG LYON (01160 PONT D'AIN)

• Nadia HASSAOUI,, Dr · MG LYON (01160 PONT D'AIN)

• Mélanie MICHEL, Dr · MG LYON (01160 PONT D'AIN)

• Pierre DE HAAS, Dr · MG LYON (01160 PONT D'AIN)

• Chloé FAYSSE, Dr · MG LYON (26750 CHATILLON ST JEAN)

• Christophe PIGACHE, Dr · MG LYON (26330 CHATEAUNEUF DE GALAURE)

• Gérard PETIT, Dr · MG LYON (69007 LYON)

• Emilie BECK ROBERT, Dr · MG BREST (29620 LANMEUR)

• Hélène CRENN CORVEZ, Dr · MG BREST (29620 LANMEUR)

• Etienne MELOT,, Dr · MG BREST (22420 LE VIEUX MARCHE)

• Lucas BEURTON- COURAUD,, Dr · MG BREST (29190 PLEYBEN)

• Aldric LUCAS, Dr · MG BREST (29190 PLEYBEN)

• Anton ROBIN YANN, Dr · MG BREST (29 000 QUIMPER)

• Pierre- Marie BOSSER, Dr · MG BREST (29790 PONT CROIX)

• Roberto PITMAN, Dr · MG BREST (29 400 LANDIVISIAU)

• Patrick BIARD, Dr · MG TOURS (37210 VOUVRAY)

• Julie GROSSE, Dr · MG TOURS (37400 AMBOISE)

• Aude LINASSIER, Dr · MG TOURS (37000 TOURS)

• Anne- Catherine SCHLEGEL, Dr · MG TOURS (37210 PARCAY MESLAY)

• Yann TEISSET, Dr · MG TOURS (37360 ROUZIERS DE TOURAINE)

• Sylvie TIERCIN, Dr · MG TOURS (37000 TOURS)

• Jean- Christophe TUROT, Dr · MG TOURS (37300 JOUE LES TOURS)

• Maxime PAUTRAT, Dr · MG TOURS (37240 LIGUEIL)

• Olivier CUVILLIER, Dr · MG TOURS (37390 LA MEMBROLLE SUR CHOISILLE)

• Ludivine BARBEAU, Dr · MG TOURS (41 7000 CHEVERNY)

• Anita TILLY, Dr · MG LILLE (59280 BOIS GRENIER)

• Ludovic WILLEMS, Dr · MG LILLE (59190 HAZEBROUCK)

• Laurent TURI, Dr · MG LILLE (62130 GAUCHIN VERLOINGT)

• Nassir MESSAADI, Dr · MG LILLE (59000 LILLE)

• Marc BAYEN, Dr · MG LILLE (59287 GUESNAIN)

• Axel DESCAMPS, Dr · MG LILLE (59770 MARLY)

• Sabine BAYEN, Dr · MG LILLE (59287 GUESNAIN)

• Jonathan FAVRE, Dr · MG LILLE (59650 VILLENEUVE D'ASCQ)

• Christian HULIN, Dr · MG LILLE (62000 ARRAS)

• Jan BARAN, Dr · MG LILLE (59150 WATTRELOS)

• Benoît CAMBON, Dr · MG CLERMONT FERRAND (03 800 GANNAT)

• Mathilde VICARD OLAGNE, Dr · MG CLERMONT FERRAND (63 580 LE VERNET LA NARENNE)

• Frédéric TESSIERES, Dr · MG CLERMONT FERRAND (43 100 BRIOUDE)

• Thibault MENINI, Dr · MG CLERMONT FERRAND (63 230 PONTGIBAUD)

• Yves NICOLLIN, Dr · MG CLERMONT FERRAND (63 500 ISSOIRE)

• Syndie CANN, Dr · MG BREST (29 520 CHATEAUNEUF DU FAVU)

• Gilles TANGUY, Dr · MG CLERMONT FERRAND (63 380 PONTAUMUR)

• Philippe MESTRE, Dr · MG CLERMONT FERRAND (43410 LEMPDES)

• PHILIPPE ZEGANADIN, Dr · MG CLERMONT FERRAND (63190 LEZOUX)

• Véronique BERTRAND JARROUSSE, Dr · MG CLERMONT FERRAND (6393 AUGEROLLES)

• Audrey MORICE RAMAT, Dr · MG NANTES (44118 LA CHEVROLIERE)

• Sylvain FOURE, Dr · MG NANTES (85000 LA ROCHE SUR YON)

• Chrystelle PEYRON, Dr · MG NANTES (44160 PONTCHATEAU)

• Mariette RABAUD PELLETIER, Dr · MG NANTES (85340 OLONNE SUR MER)

• Elodie COSSET, Dr · MG NANTES (85430 LES CLOUZEAUX)

• Brigitte TREGOUET, Dr · MG NANTES (85000 LA ROCHE SUR YON)

• Cécile RABILLER, Dr · MG NANTES (85430 LES CLOUZEAUX)

• Cédric RAT, Dr · MG NANTES (44000 NANTES)

• Antoine DE GUIBERT, Dr · MG RENNES (35000 RENNES)

• Mathilde GUERIN, Dr · MG RENNES (22690 PLEUDIHEN SUR RANCE)

• Isabelle EZANNO, Dr · MG RENNES (56950 CRACH)

• Gilles TAPIN, Dr · MG RENNES (35590 L'HERMITAGE)

• jean- François RICONO, Dr · MG RENNES (35560 ANTRAIN)

• Laure FIQUET, Dr · MG RENNES (35160 BRETEIL)

• Anne DONCIEUX, Dr · MG RENNES (56500 MOREAC)

• Hervé LE NEEL, Dr · MG RENNES (35200 RENNES)

• Stephane DUQUENNE, Dr · MG RENNES (56240 PLOUAY)

• Boris LAGOUTTE, Dr · 35250 ST AUBIN D'AUBIGNE

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-01

Primary Completion

2020-06-01

Completion

2022-06-01