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| ID | Type | Description | Link |
|---|---|---|---|
| N° IDRCB: 2022-A00896-37 | Other Identifier | ANSM |
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This study is a clinical trial designed to assess the impact on influenza vaccination rates among people aged over 65 of a telephone text message recalling them to be vaccinated by their GP. Twenty-two GPs will be randomly selected in each arm (recall versus usual care, 1:1). Each GP will include a maximum of 210 patients by random selection from their patient list. A difference of 4 percentage points is expected between the two arms at the end vaccination campaign in the vaccination rate.
This is an open-label trial with 2 arms: an interventional or "recall" arm and a "usual care" or control arm. Cluster randomization at the physician level was chosen to avoid contamination within the same patients group. Physicians will be randomized at the start of the vaccination campaign in one of the two arms (1:1), and all patients eligible (with a maximum of 210 per doctor) to be vaccinated will be recalled or not, depending on their GPs arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | GPs selected at random in the intervention arm "Recall" will recall their patients to be vaccinated via the recall module integrated into their Eo medical software |
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| No intervention group | No Intervention | GPs in the ""usual care"" or ""control"" arm will not recall their patients to be vaccinated. GPs with their medical software. They will worked as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reminder | Other | At mid-campaign, GPs in the interventional arm will recall their patients to be vaccinated via the reminder module Eo software
The type of recall and the date of it will be notified in the medical file of each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| The influenza vaccination rate will be calculated as the ratio between the number of patients vaccinated (those who will report having been vaccinated in the questionnaire send at the end of the campaign) and the number of patients aged 65 years and over | The influenza vaccination rate will be calculated as the ratio between the number of patients vaccinated (i.e., those who will report having been vaccinated during the vaccination campaign in the questionnaire send at the end of the campaign) and the number of patients aged 65 years and over. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 1/ Social inequalities related to the intervention, based on individual and ecological indicators (social deprivation index for example) will be estimated via absolute indicators (SII: slope of the inequality index) and relative (RII: relative inequality | At the end of the vaccination campaign, the GPs will send patients a postal mail containing: an accompanying explanatory letter, the patient questionnaire, and a pre-addressed and prepaid envelope for the return of the completed questionnaire to their attending physician. |
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Inclusion Criteria:
The inclusion criteria for physicians are:
The patients inclusion criteria are:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia MAKHLOUF | Contact | 0145213010 | sonia.makhlouf@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent RIGAL, Professor | Université de Paris-Saclay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet medical Lahire (01) | Recruiting | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 1 year |
| 2/ Acceptability of reminders (in the intervention arm only) based on the description of the patients answers to the related question in the questionnaires. This outcome is assessed by questionnaire. | At the end of the vaccination campaign, the GPs will send patients a postal mail containing: an accompanying explanatory letter, the patient questionnaire, and a pre-addressed and prepaid envelope for the return of the completed questionnaire to their attending physician. | 1 year |
| 3/ Reasons for non-vaccination will be described (stratified by trial arm) based on the description of the patients answers to the related question in the questionnaires.This outcome is assessed by questionnaire. | Reasons for non-vaccination will be described (stratified by trial arm) based on the description of the patients answers to the related question in the questionnaires. | 1 year |
| 4/ Characteristics of participating GPs based on the description of the physicians answers to the related question in the questionnaires. These outcomes are assessed by the physician questionnaire. | At the beginning of the study, participating GPs will answer a short questionnaire about their main characteristics (Sex, Date of birth, Size of the patients list...). | 1 year |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |