Influenza, HumanNCT03768596
Nudging for Vaccination : Efficacity and Acceptability Among Medical Students
A study testing Nudge and vaccination form in people with Influenza, Human and Vaccination; Sepsis, run by Adriaan Barbaroux at 1 site in France.
Trial summary
Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt, conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods have been studied for years in social psychology and are receiving renewed attention since the awarding of the Nobel Prize in economics to… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Vaccination; Sepsis
- What is being tested?
- Nudge and vaccination form
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2018to 20 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- medical students
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt, conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods have been studied for years in social psychology and are receiving renewed attention since the awarding of the Nobel Prize in economics to Richard Thaler for his work on the application of Nudge to the economy.
Health professionals are very inadequately vaccinated (25 to 45% of the population). Some studies have shown that a Nudge based on intent implementation can significantly increase vaccination coverage. However, few studies evaluate the acceptability of Nudge or its application to health professionals.
Read more
The investigators sought to apply a Nudge based on availability heuristics to health professionals, in order to evaluate its effectiveness and terms of behavior adoption (influenza vaccination) and its acceptability.
The investigator's hypothesis is that Nudging is both effective and acceptable and that people found nudging more acceptable if they have been exposed to a nudge.
Read the detailed description
The investigators asked residents in general medicine to pass a questionnaire including a Nudge. This Nudge was the influenza vaccine prescription form accompanied on the back of the telephone numbers of the occupational health centers of the hospitals where residents were on probation.
The interns of the group "Nudge" saw at the end of their questionnaire the following statement: "If you are not vaccinated against the flu so far, you can get the form stapled to this questionnaire, it will allow you to get the vaccine in pharmacy. On the back you will also find practical information about immunization services at your place of training. " A group will receive an implemented Nudge questionnaire, a group will receive a questionnaire without Nudge and a control group will not be asked. (Phase 1) The 3 groups will receive a month later a questionnaire evaluating the effectiveness in terms of immunization coverage, and the acceptability of the Nudge, for oneself and for others. (Phase 2) The control group will only receive the Phase 2 questionnaire to control the Hawthorne effect.
The difference between the 3 groups will consist exclusively in the exposure of the participants to:
- A questionnaire on their attitude (opinion) towards vaccination;
- The numbers of the occupational health vaccination centers of their places of training;
- The flu vaccine prescription form, to be signed and stamped by a doctor (also already freely available on the internet)
- Conditions
- Influenza, Human, Vaccination; Sepsis
- Being tested
- Nudge, vaccination form
- Keywords
- Nudge, acceptability
- Medical subject headings
- Influenza, Human, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
Influenza Vaccine Prescription Form accompanied on the back of telephone numbers of occupational health centers of different hospitals where interns are likely to be on probation.
vaccination formOther
a form about vaccination
| Study group | Role | What they receive |
|---|---|---|
| Nudge | Experimental | receiving nudge and form Receives: Behavioral: Nudge; Other: vaccination form |
| No nudge | Active comparator | receiving the same form without nudge (only questions about their opinion/attitudes about vaccination) Receives: Other: vaccination form |
| No intervention | No intervention | receiving no nudge nor form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency: vaccination rate
vaccination rate
Measured: 1 month
Secondary outcomes (1)
acceptability: scale
likert based acceptability form
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start7 Nov 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 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 Influenza, HumanStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group receives a form with the nudge, one group receives the same form without nudge and another group doesn't receive any form
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adriaan Barbaroux
- Collaborators
- Université de Nice Sophia Antipolis
- Responsible party
- Sponsor-investigator, Adriaan Barbaroux, Barbaroux, Adriaan, M.D.
- Investigators
- Isabelle MILHABET, MD, PhD, Study chair, LAPCOS-UCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768596
- Sponsor's protocol ID
- ABarbaroux
- Other IDs
- 2018-A02939-46
- Status last verified
- Jan 2019
- First submitted
- 5 Dec 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Barbaroux A, Benoit L, Raymondie RA, Milhabet I. Nudging health care workers towards a flu shot: reminders are accepted but not necessarily effective. A randomized controlled study among residents in general practice in France. Fam Pract. 2021 Jul 28;38(4):410-415. doi: 10.1093/fampra/cmab001.
PubMed 33506858
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging for Vaccination : Efficacity and Acceptability Among Medical Students
- ClinicalTrials.gov ID
- NCT03768596
- Acronym / sponsor ID
- ABarbaroux
- Conditions
- Influenza, Human, Vaccination; Sepsis
- Keywords
- Nudge, acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Adriaan Barbaroux
- Collaborators
- Université de Nice Sophia Antipolis
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 7 Dec 2018 (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.
Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt, conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods have been studied for years in social psychology and are receiving renewed attention since the awarding of the Nobel Prize in economics to Richard Thaler for his work on the application of Nudge to the economy.
Health professionals are very inadequately vaccinated (25 to 45% of the population). Some studies have shown that a Nudge based on intent implementation can significantly increase vaccination coverage. However, few studies evaluate the acceptability of Nudge or its application to health professionals.
The investigators sought to apply a Nudge based on availability heuristics to health professionals, in order to evaluate its effectiveness and terms of behavior adoption (influenza vaccination) and its acceptability.
The investigator's hypothesis is that Nudging is both effective and acceptable and that people found nudging more acceptable if they have been exposed to a nudge.
Detailed description
The investigators asked residents in general medicine to pass a questionnaire including a Nudge. This Nudge was the influenza vaccine prescription form accompanied on the back of the telephone numbers of the occupational health centers of the hospitals where residents were on probation.
The interns of the group "Nudge" saw at the end of their questionnaire the following statement: "If you are not vaccinated against the flu so far, you can get the form stapled to this questionnaire, it will allow you to get the vaccine in pharmacy. On the back you will also find practical information about immunization services at your place of training. " A group will receive an implemented Nudge questionnaire, a group will receive a questionnaire without Nudge and a control group will not be asked. (Phase 1) The 3 groups will receive a month later a questionnaire evaluating the effectiveness in terms of immunization coverage, and the acceptability of the Nudge, for oneself and for others. (Phase 2) The control group will only receive the Phase 2 questionnaire to control the Hawthorne effect.
The difference between the 3 groups will consist exclusively in the exposure of the participants to:
- A questionnaire on their attitude (opinion) towards vaccination;
- The numbers of the occupational health vaccination centers of their places of training;
- The flu vaccine prescription form, to be signed and stamped by a doctor (also already freely available on the internet)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- one group receives a form with the nudge, one group receives the same form without nudge and another group doesn't receive any form
| Arm | Type | Receives |
|---|---|---|
| Nudge | Experimental | Behavioral: Nudge, Other: vaccination formreceiving nudge and form |
| No nudge | Active comparator | Other: vaccination formreceiving the same form without nudge (only questions about their opinion/attitudes about vaccination) |
| No intervention | No intervention | –receiving no nudge nor form |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- medical students
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| NudgeInfluenza Vaccine Prescription Form accompanied on the back of telephone numbers of occupational health centers of different hospitals where interns are likely to be on probation. | Behavioural | Nudge |
| vaccination forma form about vaccination | Other | No nudge, Nudge |
Primary outcome
Efficiency: vaccination rate
Time frame: 1 month
vaccination rate
1 secondary outcome
acceptability: scale
Time frame: One month
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 10 Jan 2019.
- Derived from this study: PubMed 33506858Barbaroux A, Benoit L, Raymondie RA, Milhabet I. Nudging health care workers towards a flu shot: reminders are accepted but not necessarily effective. A randomized controlled study among residents in general practice in France. Fam Pract. 2021 Jul 28;38(4):410-415. doi: 10.1093/fampra/cmab001.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Isabelle MILHABET, MD, PhD study chair
LAPCOS-UCA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge and vaccination form in people with Influenza, Human and Vaccination; Sepsis, run by Adriaan Barbaroux 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 1 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 10 Jan 2019. 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?
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?
Efficiency: vaccination rate (time frame: 1 month). 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 NCT03768596, 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 10 Jan 2019.