Human Influenza Vaccination in Healthcare WorkersNCT02758145
Promotion of Influenza Vaccination in Healthcare Workers During the Recruitment Visit
A study testing Flu vaccination information in 3 phases in people with Human Influenza Vaccination in Healthcare Workers, run by Service de Médecine Préventive Hospitalière.
Trial summary
The investigators will compare two groups, an intervention group with a control group. Each employee of the University Hospital of Lausanne (CHUV) and the University Medical Policlinic of Lausanne (PMU) who will do his recruitment visit at the occupational medicine unit of the CHUV between 04/29/16 (end of previous… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Influenza Vaccination in Healthcare Workers
- What is being tested?
- Flu vaccination information in 3 phases
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Employees of CHUV (University Hospital of Lausanne) or PMU (University Policlinic of Lausanne) who work regularly in contact with patients
- Employees who must do the recruitment visit at the occupational medicine unit of the CHUV
Who cannot join
- No exclusion criteria
About this study
The investigators will compare two groups, an intervention group with a control group. Each employee of the University Hospital of Lausanne (CHUV) and the University Medical Policlinic of Lausanne (PMU) who will do his recruitment visit at the occupational medicine unit of the CHUV between 04/29/16 (end of previous influenza epidemic) and 31/10/16 (the day before the start of the next influenza vaccination campaign) and exert a function in regular contact with patients will be eligible. Depending on his employee number (assigned by the human resources administration, independent of any parameter), he will be placed in the intervention group G1 (odd number) or in the control group G2 (even number). The information concerning the distribution of these two groups will be noted in the computerized medical records of the employee at the occupational medicine unit (Medipho4D software, secured database). Thereafter, the employee will be received by the nurse of the he occupational medicine unit for a recruitment visit according to the usual process. The nurse will perform the study intervention in addition to the usual procedure if it is stipulated ''intervention group'' on the employee's record in the database or only perform the usual steps if it is stipulated ''control group''. At the beginning of the next influenza vaccination campaign (mid-November 2016), employees in the intervention group will receive a letter reminding then about the intervention given during the recruitment visit and inviting them to get vaccinated. During the next influenza vaccination campaign (11.01.16) and until the end of the influenza epidemic that will follow (April 2017), each employee will have the opportunity to be vaccinated at the different vaccination stalls set up by the occupational medicine unit. For each employee vaccinated, the date of vaccination and vaccine name is entered in the electronic medical records of the occupational medicine unit (Medipho4D software) by a nurse or a secretary of the unit. At the end of the human influenza epidemic (April 2017), the data will be extracted from the database (Medipho4D software) and anonymized by an individual not implicated in the study. Data from two groups will be analyzed and compared to assess whether the intervention conducted among newly hired employees promotes influenza vaccination.
- Being tested
- Flu vaccination information in 3 phases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu vaccination information in 3 phasesOther
An oral information is given by the nurse during the recruitment visit at the occupational medicine unit. She initiates the discussion on flu and asks the employee if he usually receives the vaccine. Then she provides a brief standardized information on recommendations concerning flu vaccination, and the annual influenza vaccination campaign in CHUV and PMU. She responds to questions.
After the interview, she gives an informative document with key messages (information about the disease, benefits to be vaccinated, vaccine safety, etc.). The document includes frequently asked questions, website address, and the email address of the occupational medicine unit in case of questions.
The third phase consists of sending to the employee shortly after the start of the next campaign of flu vaccination (November 2016), a postal mail recalling the information provided during the recruitment examination and inviting them to get vaccinated.
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine information (G1) | Active comparator | During the recruitment visit at the occupational medicine unit between the 04/29/16 and the 10/31/16, the workers in this group (G1) in addition to their recruitment visit, will benefit from a short intervention given by the nurse concerning the flu, the advantages of the flu vaccination, and how they can be vaccinated in the institution. The nurse also transmits an information sheet concerning the benefits of the vaccination. 2 weeks after the beginning of the next flu vaccination campaign, they will receive a reminder letter to encourage vaccination. Receives: Other: Flu vaccination information in 3 phases |
| No information (G2) | No intervention | Workers in the control group (G2) receive no intervention, only recruitment visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Influenza Vaccination in Healthcare WorkersStudies of the same condition, open and under way.
- 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
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Service de Médecine Préventive Hospitalière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Currat Michael, Service de Médecine Préventive Hospitalière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758145
- Sponsor's protocol ID
- MDP-2016-00296-FLU
- Status last verified
- Sep 2018
- First submitted
- 26 Apr 2016
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Currat M, Lazor-Blanchet C, Zanetti G. Promotion of the influenza vaccination to hospital staff during pre-employment health check: a prospective, randomised, controlled trial. J Occup Med Toxicol. 2020 Nov 18;15(1):34. doi: 10.1186/s12995-020-00285-w.
PubMed 33292400
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Influenza Vaccination in Healthcare Workers During the Recruitment Visit
- ClinicalTrials.gov ID
- NCT02758145
- Acronym / sponsor ID
- MDP-2016-00296-FLU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Service de Médecine Préventive HospitalièreUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
The investigators will compare two groups, an intervention group with a control group. Each employee of the University Hospital of Lausanne (CHUV) and the University Medical Policlinic of Lausanne (PMU) who will do his recruitment visit at the occupational medicine unit of the CHUV between 04/29/16 (end of previous influenza epidemic) and 31/10/16 (the day before the start of the next influenza vaccination campaign) and exert a function in regular contact with patients will be eligible. Depending on his employee number (assigned by the human resources administration, independent of any parameter), he will be placed in the intervention group G1 (odd number) or in the control group G2 (even number). The information concerning the distribution of these two groups will be noted in the computerized medical records of the employee at the occupational medicine unit (Medipho4D software, secured database). Thereafter, the employee will be received by the nurse of the he occupational medicine unit for a recruitment visit according to the usual process. The nurse will perform the study intervention in addition to the usual procedure if it is stipulated ''intervention group'' on the employee's record in the database or only perform the usual steps if it is stipulated ''control group''. At the beginning of the next influenza vaccination campaign (mid-November 2016), employees in the intervention group will receive a letter reminding then about the intervention given during the recruitment visit and inviting them to get vaccinated. During the next influenza vaccination campaign (11.01.16) and until the end of the influenza epidemic that will follow (April 2017), each employee will have the opportunity to be vaccinated at the different vaccination stalls set up by the occupational medicine unit. For each employee vaccinated, the date of vaccination and vaccine name is entered in the electronic medical records of the occupational medicine unit (Medipho4D software) by a nurse or a secretary of the unit. At the end of the human influenza epidemic (April 2017), the data will be extracted from the database (Medipho4D software) and anonymized by an individual not implicated in the study. Data from two groups will be analyzed and compared to assess whether the intervention conducted among newly hired employees promotes influenza vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine information (G1) | Active comparator | Other: Flu vaccination information in 3 phasesDuring the recruitment visit at the occupational medicine unit between the 04/29/16 and the 10/31/16, the workers in this group (G1) in addition to their recruitment visit, will benefit from a short intervention given by the nurse concerning the flu, the advantages of the flu vaccination, and how they can be vaccinated in the institution. The nurse also transmits an information sheet concerning the benefits of the vaccination. 2 weeks after the beginning of the next flu vaccination campaign, they will receive a reminder letter to encourage vaccination. |
| No information (G2) | No intervention | –Workers in the control group (G2) receive no intervention, only recruitment visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Employees of CHUV (University Hospital of Lausanne) or PMU (University Policlinic of Lausanne) who work regularly in contact with patients
- Employees who must do the recruitment visit at the occupational medicine unit of the CHUV
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Flu vaccination information in 3 phasesAn oral information is given by the nurse during the recruitment visit at the occupational medicine unit. She initiates the discussion on flu and asks the employee if he usually receives the vaccine. Then she provides a brief standardized information on recommendations concerning flu vaccination, and the annual influenza vaccination campaign in CHUV and PMU. She responds to questions. After the interview, she gives an informative document with key messages (information about the disease, benefits to be vaccinated, vaccine safety, etc.). The document includes frequently asked questions, website address, and the email address of the occupational medicine unit in case of questions. The third phase consists of sending to the employee shortly after the start of the next campaign of flu vaccination (November 2016), a postal mail recalling the information provided during the recruitment examination and inviting them to get vaccinated. | Other | Influenza vaccine information (G1) |
Primary outcome
Influenza vaccination rate
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 33292400Currat M, Lazor-Blanchet C, Zanetti G. Promotion of the influenza vaccination to hospital staff during pre-employment health check: a prospective, randomised, controlled trial. J Occup Med Toxicol. 2020 Nov 18;15(1):34. doi: 10.1186/s12995-020-00285-w.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flu vaccination information in 3 phases in people with Human Influenza Vaccination in Healthcare Workers, run by Service de Médecine Préventive Hospitalière.
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 3 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: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza vaccination rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758145, which also lists 1 linked publication.
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 28 Sep 2018.