Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician (GP-FluRecall)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza Viral Infections
• Intervention / Treatment: Other: Reminder

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 Type: Interventional
• Enrollment (Estimated): 8400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonia MAKHLOUF; Phone Number: 0145213010; Email: sonia.makhlouf@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Cabinet medical Lahire (01)
    • Contact: Laurent Rigal, Professor; Phone Number: (+33) 06 25 72 62 84; Email: laurent.rigal@universite-paris-saclay.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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	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.
No Intervention: No intervention group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Laurent RIGAL, Professor, Université de Paris-Saclay

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Influenza; Reminder; Vaccination campaign
• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Virus Diseases; Influenza, Human
• Other Study ID Numbers: APHP220090; N° IDRCB: 2022-A00896-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No