Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study
Background: Streptococcus pneumoniae causes infections especially in patients with immunodeficiency or specific comorbidities. Most could be avoided through pneumococcal vaccination (PV), but PV coverage is only 20 % in France. Many studies assess methods on vaccination coverage improvement, but non...
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Elsevier
2025-04-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000365 |
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| author | Florent Dubois Emilie Champiot-Bayard Bogdan Cireașă Paul Loubet Jérôme Vallat Julie Bonnet Valérie Jacob Pauline Puyo Ioana Pînzar Sarah Théret Emmanuelle Dubois Elisabeth Peus Laurent Giraudon Clarisse Roux-Marson Pascale Fabbro-Peray Géraldine Leguelinel-Blache Jean-Marie Kinowski |
| author_facet | Florent Dubois Emilie Champiot-Bayard Bogdan Cireașă Paul Loubet Jérôme Vallat Julie Bonnet Valérie Jacob Pauline Puyo Ioana Pînzar Sarah Théret Emmanuelle Dubois Elisabeth Peus Laurent Giraudon Clarisse Roux-Marson Pascale Fabbro-Peray Géraldine Leguelinel-Blache Jean-Marie Kinowski |
| author_sort | Florent Dubois |
| collection | DOAJ |
| description | Background: Streptococcus pneumoniae causes infections especially in patients with immunodeficiency or specific comorbidities. Most could be avoided through pneumococcal vaccination (PV), but PV coverage is only 20 % in France. Many studies assess methods on vaccination coverage improvement, but none evaluates pharmacist-physician collaboration in hospital on PV coverage of inpatients at-risk of invasive pneumococcal disease (IPD). Methods: This study is a multicentric stepped-wedged randomized trial involving 12 units in 9 French hospitals (3 university and 6 local) during 4 periods of 90 days each. Three clusters will be made, each composed randomly of clinical and surgical units from one university hospital and clinical and surgical units of 2 local hospitals. For each period, one unit will have to include 16 non-vaccinated inpatients at risk of IPD. Patients in the control phase will receive usual care. During the interventional phase, the pharmacist will inform the physician on PV necessity, who will report recommendation and prescribe it at discharge. The pharmacist will perform a consultation and send a discharge letter to the patient's community pharmacist. The primary outcome will assess the impact of intervention on PV coverage after 6 months. Secondary outcomes will evaluate vaccines dispensing, uncompleted protocol rate and intervention process. A subgroup analysis between university and local hospitals and clinical and surgical units, respectively will be made. Discussion: This study will assess the impact of medico-pharmaceutical collaboration in hospital on PV coverage in inpatients at risk of IPD. Hospitalization could be a way to promote vaccination and enhance healthcare system performance. Trial registration: Clinicaltrials.gov, NCT05060146. Registered on September 16th, 2021. |
| format | Article |
| id | doaj-art-bdf39d71e0d14f438b181d5d0a83d51a |
| institution | DOAJ |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-bdf39d71e0d14f438b181d5d0a83d51a2025-08-20T02:50:45ZengElsevierContemporary Clinical Trials Communications2451-86542025-04-014410146210.1016/j.conctc.2025.101462Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge studyFlorent Dubois0Emilie Champiot-Bayard1Bogdan Cireașă2Paul Loubet3Jérôme Vallat4Julie Bonnet5Valérie Jacob6Pauline Puyo7Ioana Pînzar8Sarah Théret9Emmanuelle Dubois10Elisabeth Peus11Laurent Giraudon12Clarisse Roux-Marson13Pascale Fabbro-Peray14Géraldine Leguelinel-Blache15Jean-Marie Kinowski16Department of Pharmacy, Nimes University Hospital, Univ Montpellier, Nimes, France; Desbrest Institute of Epidemiology and Public Health (IDESP), Univ Montpellier, INSERM, Montpellier, France; Corresponding author. Pharmacy Department, CHU de Nîmes, Prof. Robert Debré square, Nîmes Cedex 9, 30029, France.Department of Pharmacy, Nimes University Hospital, Univ Montpellier, Nimes, FranceDepartment of Pharmacy, Nimes University Hospital, Univ Montpellier, Nimes, FranceDepartment of Infectious and Tropical Diseases, Nimes University Hospital, Univ Montpellier, Nimes, France; VBIC, INSERM U1047, University of Montpellier, Nimes, FranceDepartment of Pharmacy, Montauban Hospital, Montauban, FranceDepartment of Pharmacy, Saint-Gaudens Hospital, Saint-Gaudens, FranceDepartment of Pharmacy, Alès Hospital, Alès, FranceDepartment of Pharmacy, Toulouse Regional University Hospital, Univ Toulouse, Toulouse, FranceDepartment of Pharmacy, Nimes University Hospital, Univ Montpellier, Nimes, FranceDepartment of Pharmacy, Montpellier Regional University Hospital, Univ Montpellier, Montpellier, FranceDepartment of Pharmacy, Bagnols-sur-Ceze Hospital, Bagnols-sur-Ceze, FranceDepartment of Pharmacy, Perpignan Hospital, Perpignan, FranceDepartment of Pharmacy, Sète Hospital, Sète, FranceDepartment of Pharmacy, Nimes University Hospital, Univ Montpellier, Nimes, France; Desbrest Institute of Epidemiology and Public Health (IDESP), Univ Montpellier, INSERM, Montpellier, FranceDesbrest Institute of Epidemiology and Public Health (IDESP), Univ Montpellier, INSERM, Montpellier, France; Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology, Nimes University Hospital, Nimes, FranceDepartment of Pharmacy, Nimes University Hospital, Univ Montpellier, Nimes, France; Desbrest Institute of Epidemiology and Public Health (IDESP), Univ Montpellier, INSERM, Montpellier, France; Department of Law and Health Economics, Univ Montpellier, Montpellier, FranceDepartment of Pharmacy, Nimes University Hospital, Univ Montpellier, Nimes, France; Desbrest Institute of Epidemiology and Public Health (IDESP), Univ Montpellier, INSERM, Montpellier, FranceBackground: Streptococcus pneumoniae causes infections especially in patients with immunodeficiency or specific comorbidities. Most could be avoided through pneumococcal vaccination (PV), but PV coverage is only 20 % in France. Many studies assess methods on vaccination coverage improvement, but none evaluates pharmacist-physician collaboration in hospital on PV coverage of inpatients at-risk of invasive pneumococcal disease (IPD). Methods: This study is a multicentric stepped-wedged randomized trial involving 12 units in 9 French hospitals (3 university and 6 local) during 4 periods of 90 days each. Three clusters will be made, each composed randomly of clinical and surgical units from one university hospital and clinical and surgical units of 2 local hospitals. For each period, one unit will have to include 16 non-vaccinated inpatients at risk of IPD. Patients in the control phase will receive usual care. During the interventional phase, the pharmacist will inform the physician on PV necessity, who will report recommendation and prescribe it at discharge. The pharmacist will perform a consultation and send a discharge letter to the patient's community pharmacist. The primary outcome will assess the impact of intervention on PV coverage after 6 months. Secondary outcomes will evaluate vaccines dispensing, uncompleted protocol rate and intervention process. A subgroup analysis between university and local hospitals and clinical and surgical units, respectively will be made. Discussion: This study will assess the impact of medico-pharmaceutical collaboration in hospital on PV coverage in inpatients at risk of IPD. Hospitalization could be a way to promote vaccination and enhance healthcare system performance. Trial registration: Clinicaltrials.gov, NCT05060146. Registered on September 16th, 2021.http://www.sciencedirect.com/science/article/pii/S2451865425000365InfectiologyPneumococcal infectionsVaccinationHospital pharmacy |
| spellingShingle | Florent Dubois Emilie Champiot-Bayard Bogdan Cireașă Paul Loubet Jérôme Vallat Julie Bonnet Valérie Jacob Pauline Puyo Ioana Pînzar Sarah Théret Emmanuelle Dubois Elisabeth Peus Laurent Giraudon Clarisse Roux-Marson Pascale Fabbro-Peray Géraldine Leguelinel-Blache Jean-Marie Kinowski Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study Contemporary Clinical Trials Communications Infectiology Pneumococcal infections Vaccination Hospital pharmacy |
| title | Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study |
| title_full | Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study |
| title_fullStr | Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study |
| title_full_unstemmed | Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study |
| title_short | Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study |
| title_sort | prevention of pneumococcal infections impact of structured medico pharmaceutical collaborative management to improve vaccination coverage of at risk patients optivacc study protocol for a multicenter randomized stepped wedge study |
| topic | Infectiology Pneumococcal infections Vaccination Hospital pharmacy |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000365 |
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