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

Sponsor

University Hospital, Tours (Other)

Overall Status

Unknown status

CT.gov ID

NCT04283565

Collaborator

Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ (Other), Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure (Other), Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST (Other), Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise (Other), Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE (Other), Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND (Other), Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS (Other), Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes (Other)

960

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Other: Systematic screening of AOMI by BPI measurement. Other: Management of CVRF by a motivationnal interviewing.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

960 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

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.Two strategies are studied in this study:Screening for asymptomatic AOMI by measuring IPS Management of the FRCV by advices and motivational interviewingThe 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)

Masking Description:

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.

Primary Purpose:

Prevention

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).

Anticipated Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Strategy 1: Usual practice No systematic screening of asymptomatic AOMI and routine management of FRCV.
Experimental: Strategy 2: Motivationnal interviewing No systematic screening of asymptomatic AOMI and management of CVRF by a motivationnal interviewing.	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
Experimental: Strategy 3: Systematic screening of AOMI by BPI measurement Systematic screening of AOMI by BPI measurement and routine management of FRCV.	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
Experimental: Strategy 4: Both strategies Systematic screening of AOMI by BPI measurement and management of CVRF by a motivationnal interviewing.	Other: Systematic screening of AOMI by BPI measurement. The strategies will be associated according to a 22 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

Outcome Measures

Primary Outcome Measures

ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. [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.

Secondary Outcome Measures

ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. [10 years]
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.
ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. [2 years]
ICER: Cost per SCORE point less at 2 years from the collective and health insurance viewpoint. The cost will be collected by a CRF.
Budget impact (in €) at 5 years [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Tours
Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ
Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure
Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST
Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise
Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE
Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND
Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS
Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes

Investigators

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