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

NCT ID: NCT06123936

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2025-02-28

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.

Conditions

Influenza Viral Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Reminder

Intervention Type: OTHER

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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent RIGAL, Professor

Role: PRINCIPAL_INVESTIGATOR

Université de Paris-Saclay

Locations

Cabinet medical Lahire (01)

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sonia MAKHLOUF

Role: CONTACT

sonia.makhlouf@aphp.fr

0145213010

Facility Contacts

Laurent Rigal, Professor

Role: primary

laurent.rigal@universite-paris-saclay.fr

06 25 72 62 84 ext. (+33)

Other Identifiers

N° IDRCB: 2022-A00896-37

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220090

Identifier Type: -

Identifier Source: org_study_id