Influenza Viral InfectionsGP-FluRecallNCT06123936
Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician
A study testing Reminder in people with Influenza Viral Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Influenza Viral Infections
- What is being tested?
- Reminder
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,400 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- Patients for which their attending physicians considers participating inappropriate (e.g. palliative care)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cabinet medical Lahire (01)
Paris, 75013
Laurent Rigal, Professor, 06 25 72 62 84 ext. (+33), laurent.rigal@universite-paris-saclay.fr
About this study
Official title: 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.
Read the 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
- Being tested
- Reminder
- Keywords
- Reminder, Vaccination campaign, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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 Receives: Other: Reminder |
| No intervention group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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...).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start30 Oct 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Viral InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent RIGAL, Professor, Principal investigator, Université de Paris-Saclay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123936
- Sponsor's protocol ID
- APHP220090
- Other IDs
- N° IDRCB: 2022-A00896-37
- Acronym
- GP-FluRecall
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician - a Cluster Randomized, Controlled and Pragmatic Trial
- ClinicalTrials.gov ID
- NCT06123936
- Acronym / sponsor ID
- GP-FluRecall / APHP220090
- Conditions
- Influenza Viral Infections
- Keywords
- Reminder, Vaccination campaign, Influenza
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: ReminderGPs 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 |
| No intervention group | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Patients for which their attending physicians considers participating inappropriate (e.g. palliative care)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReminderAt 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. | Other | Experimental group |
Primary outcome
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
Time frame: 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.
4 secondary outcomes
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent RIGAL, Professor principal investigator
Université de Paris-Saclay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder in people with Influenza Viral Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia MAKHLOUF (0145213010, sonia.makhlouf@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.