Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study
Introduction The ongoing ageing population is associated with an increase in the number of patients suffering a stroke, transient ischaemic attack (TIA) or myocardial infarction (MI). In these patients, implementing secondary prevention is a critical challenge and new strategies need to be developed...
Saved in:
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-04-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e070197.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850062499006644224 |
|---|---|
| author | Yannick Béjot Marc Bardou Mathieu Boulin Yves Cottin Maurice Giroud Anne-Laure Soilly Gauthier Duloquin Thibaut Pommier Gabriel Laurent Lucie Vadot Héloïse Adam |
| author_facet | Yannick Béjot Marc Bardou Mathieu Boulin Yves Cottin Maurice Giroud Anne-Laure Soilly Gauthier Duloquin Thibaut Pommier Gabriel Laurent Lucie Vadot Héloïse Adam |
| author_sort | Yannick Béjot |
| collection | DOAJ |
| description | Introduction The ongoing ageing population is associated with an increase in the number of patients suffering a stroke, transient ischaemic attack (TIA) or myocardial infarction (MI). In these patients, implementing secondary prevention is a critical challenge and new strategies need to be developed to close the gap between clinical practice and evidence-based recommendations. We describe the protocol of a randomised clinical trial that aims to evaluate the efficiency and effectiveness of an intensive multidisciplinary follow-up of patients compared with standard care.Methods and analysis The DiVa study is a randomised, prospective, controlled, multicentre trial including patients >18 years old with a first or recurrent stroke (ischaemic or haemorrhagic) or TIA, or a type I or II MI, managed in one of the participating hospitals of the study area, with a survival expectancy >12 months. Patients will be randomised with an allocation ratio of 1:1 in two parallel groups: one group assigned to a multidisciplinary, nurse-based and pharmacist-based 2-year follow-up in association with general practitioners, neurologists and cardiologists versus one group with usual follow-up. In each group for each disease (stroke/TIA or MI), 430 patients will be enrolled (total of 1720 patients) over 3 years. The primary outcome will be the incremental cost–utility ratio at 24 months between intensive and standard follow-up in a society perspective. Secondary outcomes will include the incremental cost–utility ratio at 6 and 12 months, the incremental cost-effectiveness ratio at 24 months, reduction at 6, 12 and 24 months of the rates of death, unscheduled rehospitalisation and iatrogenic complications, changes in quality of life, net budgetary impact at 5 years of the intensive follow-up on the national health insurance perspective and analysis of factors having positive or negative effects on the implementation of the project in the study area.Ethics and dissemination Ethical approval was obtained and all patients receive information about the study and give their consent to participate before randomisation. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal.Trial registration number ClinicalTrials.gov Identifier: NCT04188457. Registered on 6 December 2019. |
| format | Article |
| id | doaj-art-7588983f10c5404096d7347300eabeea |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-7588983f10c5404096d7347300eabeea2025-08-20T02:49:53ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-070197Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) studyYannick Béjot0Marc Bardou1Mathieu Boulin2Yves Cottin3Maurice Giroud4Anne-Laure Soilly5Gauthier Duloquin6Thibaut Pommier7Gabriel Laurent8Lucie Vadot9Héloïse Adam105 Dijon Stroke Registry, EA7460, Pathophysiology and Epidemiology of Cerebro-Cardiovascular Diseases (PEC2), University of Burgundy and Franche-Comté, Dijon, Burgundy, FranceCIC-P INSERM 1432, Institut national de la santé et de la recherche médicale, Paris, France4 Department of Pharmacy, University Hospital Centre Dijon, Dijon, FranceCardiology, University Hospital Centre Dijon Bourgogne, Dijon, FranceNeurology, University Hospital Centre Dijon Bourgogne, Dijon, FranceDepartment of Clinical Research and Innovation, Clinical Research Unit-Methodological Support Network (USMR), University Hospital Centre Dijon Bourgogne, Dijon, FranceDijon Stroke Registry, Department of Neurology, University Hospital Centre Dijon, Dijon, France1 Cardiology, CHU Dijon Bourgogne, Dijon, FranceCardiology, CHU Dijon Bourgogne, Dijon, FrancePharmacy, University Hospital Centre Dijon Bourgogne, Dijon, FrancePharmacy, University Hospital Centre Dijon Bourgogne, Dijon, FranceIntroduction The ongoing ageing population is associated with an increase in the number of patients suffering a stroke, transient ischaemic attack (TIA) or myocardial infarction (MI). In these patients, implementing secondary prevention is a critical challenge and new strategies need to be developed to close the gap between clinical practice and evidence-based recommendations. We describe the protocol of a randomised clinical trial that aims to evaluate the efficiency and effectiveness of an intensive multidisciplinary follow-up of patients compared with standard care.Methods and analysis The DiVa study is a randomised, prospective, controlled, multicentre trial including patients >18 years old with a first or recurrent stroke (ischaemic or haemorrhagic) or TIA, or a type I or II MI, managed in one of the participating hospitals of the study area, with a survival expectancy >12 months. Patients will be randomised with an allocation ratio of 1:1 in two parallel groups: one group assigned to a multidisciplinary, nurse-based and pharmacist-based 2-year follow-up in association with general practitioners, neurologists and cardiologists versus one group with usual follow-up. In each group for each disease (stroke/TIA or MI), 430 patients will be enrolled (total of 1720 patients) over 3 years. The primary outcome will be the incremental cost–utility ratio at 24 months between intensive and standard follow-up in a society perspective. Secondary outcomes will include the incremental cost–utility ratio at 6 and 12 months, the incremental cost-effectiveness ratio at 24 months, reduction at 6, 12 and 24 months of the rates of death, unscheduled rehospitalisation and iatrogenic complications, changes in quality of life, net budgetary impact at 5 years of the intensive follow-up on the national health insurance perspective and analysis of factors having positive or negative effects on the implementation of the project in the study area.Ethics and dissemination Ethical approval was obtained and all patients receive information about the study and give their consent to participate before randomisation. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal.Trial registration number ClinicalTrials.gov Identifier: NCT04188457. Registered on 6 December 2019.https://bmjopen.bmj.com/content/13/4/e070197.full |
| spellingShingle | Yannick Béjot Marc Bardou Mathieu Boulin Yves Cottin Maurice Giroud Anne-Laure Soilly Gauthier Duloquin Thibaut Pommier Gabriel Laurent Lucie Vadot Héloïse Adam Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study BMJ Open |
| title | Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study |
| title_full | Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study |
| title_fullStr | Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study |
| title_full_unstemmed | Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study |
| title_short | Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study |
| title_sort | efficiency and effectiveness of intensive multidisciplinary follow up of patients with stroke tia or myocardial infarction compared to usual monitoring protocol of a pragmatic randomised clinical trial diva dijon vascular study |
| url | https://bmjopen.bmj.com/content/13/4/e070197.full |
| work_keys_str_mv | AT yannickbejot efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT marcbardou efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT mathieuboulin efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT yvescottin efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT mauricegiroud efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT annelauresoilly efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT gauthierduloquin efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT thibautpommier efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT gabriellaurent efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT lucievadot efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy AT heloiseadam efficiencyandeffectivenessofintensivemultidisciplinaryfollowupofpatientswithstroketiaormyocardialinfarctioncomparedtousualmonitoringprotocolofapragmaticrandomisedclinicaltrialdivadijonvascularstudy |