Clinical trial NCT04283565: Cost-utility Analysis, Cost-effectiveness Analysis, Budget Impact Analysis
Official title: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: detection
cost-utility analysis
cost-effectiveness analysis
blood pressure index measurement
motivational interviewing
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ
name: Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure
name: Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST
name: Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise
name: Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE
name: Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND
name: Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS
name: Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes
First posted: 2020-02-25
Enrollment: 960
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
timeFrame: 10 years
Secondary outcomes:
measure: ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
timeFrame: 10 years
measure: ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
timeFrame: 2 years
measure: Budget impact (in €) at 5 years
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: CRMG SAINT ETIENNE
name: Sebastien BRUEL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CRMG TOURS
name: Clarisse DIBAO DINA, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CRMG LYON
name: Thierry FARGE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CRMG BREST
name: Sophie LALANDE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CRMG LILLE
name: Michel CUNIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CRMG CLERMONT FERRAND
name: Philippe VORILHON, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CRMG NANTES
name: Delphine RUBÉ, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CRMG RENNES
name: Emmanuel ALLORY,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (42210 Montrond-les-Bains)
name: Florent CROUZET,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (42300 ROANNE)
name: Julien FAVIER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (42800 GENILAC)
name: Bastien LAVAL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (43 120 MONISTROL/LOIRE
name: Julien PEYRARD, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (42260 St Martin la sauveté)
name: Jean Philippe MELIZAN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (42230 ROCHE LA MOLIERE)
name: Catherine PLOTTON,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (69590 SAINT SYMPHORIEN SUR COISE)
name: Romain LAMOTTE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (42000 SAINT ETIENNE)
name: Hervé BONNEFOND, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (42300 ROANNE)
name: Alexandre BRULET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (43240 SAINT JUST MALMONT)
name: Olivier DURIEUX, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (43120 MONISTROL SUR LOIRE)
name: Claire CHARRAT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG SAINT ETIENNE (43210 BAS EN BASSET)
name: Morinne DUPIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (01430 ST MARTIN DU FRESNE)
name: Aurélien BARADEL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (38 280 VILLETTE D'ANTHON)
name: Myriam OLIVIA, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (69100 VILLEURBANNE)
name: Damien MONLOUBOU, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (01160 PONT D'AIN)
name: Ronan FOURE,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (01160 PONT D'AIN)
name: Nadia HASSAOUI,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (01160 PONT D'AIN)
name: Mélanie MICHEL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (01160 PONT D'AIN)
name: Pierre DE HAAS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (26750 CHATILLON ST JEAN)
name: Chloé FAYSSE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (26330 CHATEAUNEUF DE GALAURE)
name: Christophe PIGACHE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LYON (69007 LYON)
name: Gérard PETIT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29620 LANMEUR)
name: Emilie BECK ROBERT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29620 LANMEUR)
name: Hélène CRENN CORVEZ, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (22420 LE VIEUX MARCHE)
name: Etienne MELOT,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29190 PLEYBEN)
name: Lucas BEURTON- COURAUD,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29190 PLEYBEN)
name: Aldric LUCAS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29 000 QUIMPER)
name: Anton ROBIN YANN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29790 PONT CROIX)
name: Pierre- Marie BOSSER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29 400 LANDIVISIAU)
name: Roberto PITMAN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37210 VOUVRAY)
name: Patrick BIARD, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37400 AMBOISE)
name: Julie GROSSE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37000 TOURS)
name: Aude LINASSIER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37210 PARCAY MESLAY)
name: Anne- Catherine SCHLEGEL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37360 ROUZIERS DE TOURAINE)
name: Yann TEISSET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37000 TOURS)
name: Sylvie TIERCIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37300 JOUE LES TOURS)
name: Jean- Christophe TUROT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37240 LIGUEIL)
name: Maxime PAUTRAT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (37390 LA MEMBROLLE SUR CHOISILLE)
name: Olivier CUVILLIER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG TOURS (41 7000 CHEVERNY)
name: Ludivine BARBEAU, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59280 BOIS GRENIER)
name: Anita TILLY, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59190 HAZEBROUCK)
name: Ludovic WILLEMS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (62130 GAUCHIN VERLOINGT)
name: Laurent TURI, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59000 LILLE)
name: Nassir MESSAADI, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59287 GUESNAIN)
name: Marc BAYEN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59770 MARLY)
name: Axel DESCAMPS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59287 GUESNAIN)
name: Sabine BAYEN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59650 VILLENEUVE D'ASCQ)
name: Jonathan FAVRE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (62000 ARRAS)
name: Christian HULIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG LILLE (59150 WATTRELOS)
name: Jan BARAN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (03 800 GANNAT)
name: Benoît CAMBON, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (63 580 LE VERNET LA NARENNE)
name: Mathilde VICARD OLAGNE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (43 100 BRIOUDE)
name: Frédéric TESSIERES, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (63 230 PONTGIBAUD)
name: Thibault MENINI, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (63 500 ISSOIRE)
name: Yves NICOLLIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG BREST (29 520 CHATEAUNEUF DU FAVU)
name: Syndie CANN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (63 380 PONTAUMUR)
name: Gilles TANGUY, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (43410 LEMPDES)
name: Philippe MESTRE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (63190 LEZOUX)
name: PHILIPPE ZEGANADIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG CLERMONT FERRAND (6393 AUGEROLLES)
name: Véronique BERTRAND JARROUSSE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (44118 LA CHEVROLIERE)
name: Audrey MORICE RAMAT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (85000 LA ROCHE SUR YON)
name: Sylvain FOURE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (44160 PONTCHATEAU)
name: Chrystelle PEYRON, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (85340 OLONNE SUR MER)
name: Mariette RABAUD PELLETIER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (85430 LES CLOUZEAUX)
name: Elodie COSSET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (85000 LA ROCHE SUR YON)
name: Brigitte TREGOUET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (85430 LES CLOUZEAUX)
name: Cécile RABILLER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG NANTES (44000 NANTES)
name: Cédric RAT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (35000 RENNES)
name: Antoine DE GUIBERT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (22690 PLEUDIHEN SUR RANCE)
name: Mathilde GUERIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (56950 CRACH)
name: Isabelle EZANNO, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (35590 L'HERMITAGE)
name: Gilles TAPIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (35560 ANTRAIN)
name: jean- François RICONO, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (35160 BRETEIL)
name: Laure FIQUET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (56500 MOREAC)
name: Anne DONCIEUX, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (35200 RENNES)
name: Hervé LE NEEL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: MG RENNES (56240 PLOUAY)
name: Stephane DUQUENNE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: 35250 ST AUBIN D'AUBIGNE
name: Boris LAGOUTTE, Dr
role: PRINCIPAL_INVESTIGATOR
References: