Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician

Not Applicable

Recruiting

• Conditions: Influenza Viral Infections
• Interventions: Other: Reminder

• Registration Number: NCT06123936
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-10-16
• Study Start: 2023-10-30
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-10-30
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8400

Inclusion Criteria

The inclusion criteria for physicians are:

• To be a GPs
• To be based in Ile-de-France (Paris region, France)
• To be a user of the Eo medical software

The patients inclusion criteria are:

• belonging to the list of attending physicians of the participating GPs
• being 65 years of age or older
• having a medical file in the GP's Eo medical software
• having been selected at random if the number of patients aged 65 or over exceeds 210 patients (for 44 participating GPs).

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Exclusion Criteria

• Patients for which their attending physicians considers participating inappropriate (e.g. palliative care)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Reminder	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

Primary Outcome Measures

Name	Time	Method
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	12 months	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.

Secondary Outcome Measures

Name	Time	Method
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	1 year	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.
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.	1 year	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.
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.	1 year	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.
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.	1 year	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...).

Trial Locations

Locations (1)

Cabinet medical Lahire (01); 🇫🇷 Paris, France