Clinical trial NCT06123936: Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician
Official title: Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician - a Cluster Randomized, Controlled and Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Influenza Viral Infections
Keywords: Reminder
Vaccination campaign
Influenza
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 8400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Cabinet medical Lahire (01)
Study officials:
affiliation: Université de Paris-Saclay
name: Laurent RIGAL, Professor
role: PRINCIPAL_INVESTIGATOR
References: