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

Influenza Viral Infections Clinical Trial

— GP-FluRecall  

Official title:

Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician - a Cluster Randomized, Controlled and Pragmatic Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123936
• Other study ID #: APHP220090
• Secondary ID: N° IDRCB: 2022-A
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sonia MAKHLOUF
• Phone: 0145213010
• Email: sonia.makhlouf[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8400
• Est. completion date: February 28, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Influenza Viral Infections
• Influenza, Human
• Virus Diseases

Intervention

Other:
• Reminder
At mid-campaign, GPs in the interventional arm will recall their patients to be vaccinated via the reminder module Eo software This recall will be carried out as follows: patients whose medical records include a number likely to receive telephone text messages will be recalled by this means Two generic messages that doctors can choose will be proposed by the call-back module integrated into the Eo medical software In addition, the recall module will offer to send a postal letter with the same content as the text message to patients who do not have a mobile phone number in the business software but do have a postal address The recall module will also provide the doctor with a list of patients who have neither a mobile phone number or a postal address, so that he can recall them to be vaccinated orally by landline telephone or in consultation when they next visit. The type of recall and the date of it will be notified in the medical file of each patient.

Locations

Country	Name	City	State
France	Cabinet medical Lahire (01)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	1 year
Secondary	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
Secondary	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
Secondary	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