Health BehaviorProFluGPNCT03239795
Promoting Influenza Vaccination In General Practice Waiting Rooms
A study testing Advertisement in people with Health Behavior and Vaccination, run by Christophe Berkhout.
Trial summary
Most of family physicians (FPs) use advertising in their waiting rooms in order to educate patients. Our objective was to assess an advertising campaign for influenza vaccination using posters and pamphlets in FPs' waiting rooms. Registry based 2/1 cluster randomized controlled trial. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Vaccination, Influenza, Human
- What is being tested?
- Advertisement
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,597 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2014to 19 May 2017
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients aged 65 years and more
- Pregnant women
- Patients with a chronic long lasting disease needing yearly seasonal influenza immunization
- respiratory diseases: COPD, emphysema, asthma, silicosis, Bronchial dilatation, cystic fibrosis, other respiratory diseases at risk of influenza complications
- cardiovascular diseases: Congenital heart disease, heart failure, valvulopathy, rhythm disorder, coronary heart disease, stroke, infarction, coronary bypass
- neurologic diseases: Myopathy, multiple sclerosis, sequelae of stroke, dementia (Alzheimer or others), poliomyelitis, gravis, paraplegia or tetraplegia reaching the diaphragm
Show all 9Show fewer
- kidney and liver diseases: severe kidney failure, nephrotic syndrome, chronic hepatitis, cirrhosis
- metabolic disorders: diabetes, malignant obesity
- immunity disorders and blood diseases: cancer and other malignant diseases, organ and marrow transplantation, immune deficiency, Inflammatory and autoimmune diseases with immunosuppressive medication, HIV infection, sickle cell disease.
Who cannot join
- patients aged less than 16 years
About this study
Official title: Promoting Influenza Vaccination In General Practice Waiting Rooms By Posters And Pamphlets: A Registry Based Cluster Randomized Controlled Trial
Most of family physicians (FPs) use advertising in their waiting rooms in order to educate patients. Our objective was to assess an advertising campaign for influenza vaccination using posters and pamphlets in FPs' waiting rooms.
Registry based 2/1 cluster randomized controlled trial. Clusters gathered the listed patients over the age of 16 of 75 randomized FPs. The trial was conducted during the 2014-2015 influenza vaccination campaign. Intervention group, 25 FPs received and exposed in their waiting rooms pamphlets and one poster promoting the influenza vaccination campaign (added to the usual mandatory information). Control group (50 FPs), usual waiting room. The main outcome was the number of vaccination units delivered in pharmacies. Data were first extracted for 2013-2015 from the SIAM-ERASME claim database of the Health Insurance Fund of Lille-Douai (Northern France). The association between the intervention and the main outcome was assessed trough a generalized estimating equation.
Read the detailed description
Every autumn the French National Health Insurance conducts a seasonal influenza immunization campaign. Since 2009, in France like in many other countries, the seasonal influenza immunization uptake has been decreasing in people over 65 years of age and in people with diverse target chronic diseases or pregnancy. It has remained far under the national and European objective of 75%. For this reason, public advertising has been intensified (TV, newspapers and magazines) and the involvement of health professionals was stimulated, particularly by means of encounters with Health Insurance delegates, and posters and pamphlets to be exposed in FPs' waiting rooms. We conducted a preliminary systematic review (in press) to seek for publications assessing the effect of audio-visual aids in primary health waiting rooms. It appears that most articles about this topic have a low level of evidence and that the effect on patient health behaviour has only been assessed on surrogate outcomes. The existence of an effect on behaviour change is controversial, and if any, it is small sized, needing more than 10,000 subjects to be demonstrated.
Our aim is to evaluate the effect of the advertising campaign using posters and pamphlets in FPs' waiting rooms on patients behaviour measuring the number of influenza vaccination units delivered in community pharmacies.
We designed a single blinded 2/1 registry based cluster randomized controlled trial.
The outcome is the number of seasonal influenza vaccination sets released in community pharmacies. The target population are patients over the age of 65 or having a chronic disease requiring seasonal influenza immunization (like chronic obstructive pulmonary disease (COPD) or diabetes). Patients are informed about the anonymous use of their data and can refuse to participate at any time.
A cluster is defined as the patients over the age of 16, who are registered by the Health Insurance on the participating FPs' patients' lists. A computerized random draw is used to allocate FPs in each group. In the intervention group, FPs will receive and expose in their waiting rooms 135 pamphlets and one poster (added to the usual mandatory information) withdrawing all the other posters. In the control group, waiting rooms are kept in their usual state. To evaluate the number of FPs needed for the trial, we set an interclass correlation coefficient of 0.02, for α = 5% and β = 20%. With a predicted rate of influenza vaccination delivery of 0.65 in the intervention group and 0.60 in the control group, and a target size by FP of 400 patients, 75 FPs have to be enrolled (50 in the control group and 25 in the intervention group).
Baseline is defined as the 2013-2014 vaccination campaign. Data are extracted between October 15, 2014 and February 28, 2015 from the SIAM-ERASME claim database of the Lille-Douai district Health Insurance Fund on patient level. To assess the association between the vaccination status (dependent variable) and the group intervention/control, because of the hierarchical structure of the data and the high incidence rate of the main outcome, we will use a generalized estimating equation (GEE) Poisson regression clustering by GP; an exchangeable working correlation matrix will be used. The analysis will be carried out using R software (version 3.3.1) and the package Geepack.
- Conditions
- Health Behavior, Vaccination, Influenza, Human
- Being tested
- Advertisement
- Keywords
- Posters, Pamphlets, Primary Health Care, Health Facilities
- Medical subject headings
- Health Behavior, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvertisementOther
Also called Advertising, poster, pamphlets
Advertisement by means of a poster and pamphlets in FP waiting rooms, removing all the other posters and pamphlets (except mandatory information, like opening hours, fees, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Family physicians' patients exposed to advertisement in waiting rooms consisting in a poster and pamphlets promoting seasonal influenza vaccination (+ usual mandatory information) Receives: Other: Advertisement |
| Control group | No intervention | Family physicians' patients exposed to usual laying out of waiting rooms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seasonal influenza vaccination sets released in community pharmacies
The number of seasonal influenza vaccination sets released in community pharmacies and the date of release are extracted from the SIAM-ERASME claim database of the Lille-Douai district Health Insurance Fund on patient level.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start15 Oct 2014
- Primary completion28 Feb 2015
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Model description
- Registry based cluster randomized trial. The population was the patients aged over 16 of 75 FPs, with an indication for seasonal influenza immunization (pregnancy, long lasting disease, age over 65). The main outcome is the proportion of vaccinated patients, based on the number of vaccination units dispensed in community pharmacies. This number is retrieved from the SIAM-ERASME claim database of the Lille-Douai Health Insurance Fund.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10,597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christophe Berkhout
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor-investigator, Christophe Berkhout, Berkhout, Christophe
- Investigators
- Christophe Berkhout, MD, Study director, Lille Univ. UDSL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239795
- Sponsor's protocol ID
- 001
- Other IDs
- HP 14/51, 1783641 v 0
- Acronym
- ProFluGP
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD have been anonymized and will be available after full publication of the results
Publications
Tuppin P, Choukroun S, Samson S, Weill A, Ricordeau P, Allemand H. [Vaccination against seasonal influenza in France in 2010 and 2011: decrease of coverage rates and associated factors]. Presse Med. 2012 Nov;41(11):e568-76. doi: 10.1016/j.lpm.2012.05.017. Epub 2012 Jul 15. French.
PubMed 22795870Bohmer MM, Walter D, Falkenhorst G, Muters S, Krause G, Wichmann O. Barriers to pandemic influenza vaccination and uptake of seasonal influenza vaccine in the post-pandemic season in Germany. BMC Public Health. 2012 Oct 31;12:938. doi: 10.1186/1471-2458-12-938.
PubMed 23113995Wicke DM, Lorge RE, Coppin RJ, Jones KP. The effectiveness of waiting room notice-boards as a vehicle for health education. Fam Pract. 1994 Sep;11(3):292-5. doi: 10.1093/fampra/11.3.292.
PubMed 7843520Ward K, Hawthorne K. Do patients read health promotion posters in the waiting room? A study in one general practice. Br J Gen Pract. 1994 Dec;44(389):583-5.
PubMed 7748670Gignon M, Idris H, Manaouil C, Ganry O. The waiting room: vector for health education? The general practitioner's point of view. BMC Res Notes. 2012 Sep 18;5:511. doi: 10.1186/1756-0500-5-511.
PubMed 22988947Austin PC. A comparison of the statistical power of different methods for the analysis of cluster randomization trials with binary outcomes. Stat Med. 2007 Aug 30;26(19):3550-65. doi: 10.1002/sim.2813.
PubMed 17238238Eubelen C, Brendel F, Belche JL, Freyens A, Vanbelle S, Giet D. Effect of an audiovisual message for tetanus booster vaccination broadcast in the waiting room. BMC Fam Pract. 2011 Sep 28;12:104. doi: 10.1186/1471-2296-12-104.
PubMed 21955570
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Influenza Vaccination In General Practice Waiting Rooms By Posters And Pamphlets: A Registry Based Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03239795
- Acronym / sponsor ID
- ProFluGP / 001
- Conditions
- Health Behavior, Vaccination, Influenza, Human
- Keywords
- Posters, Pamphlets, Primary Health Care, Health Facilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,597 participants (actual)
- Lead sponsor
- Christophe Berkhout
- Collaborators
- University Hospital, Lille
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 4 Aug 2017 (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.
Most of family physicians (FPs) use advertising in their waiting rooms in order to educate patients. Our objective was to assess an advertising campaign for influenza vaccination using posters and pamphlets in FPs' waiting rooms.
Registry based 2/1 cluster randomized controlled trial. Clusters gathered the listed patients over the age of 16 of 75 randomized FPs. The trial was conducted during the 2014-2015 influenza vaccination campaign. Intervention group, 25 FPs received and exposed in their waiting rooms pamphlets and one poster promoting the influenza vaccination campaign (added to the usual mandatory information). Control group (50 FPs), usual waiting room. The main outcome was the number of vaccination units delivered in pharmacies. Data were first extracted for 2013-2015 from the SIAM-ERASME claim database of the Health Insurance Fund of Lille-Douai (Northern France). The association between the intervention and the main outcome was assessed trough a generalized estimating equation.
Detailed description
Every autumn the French National Health Insurance conducts a seasonal influenza immunization campaign. Since 2009, in France like in many other countries, the seasonal influenza immunization uptake has been decreasing in people over 65 years of age and in people with diverse target chronic diseases or pregnancy. It has remained far under the national and European objective of 75%. For this reason, public advertising has been intensified (TV, newspapers and magazines) and the involvement of health professionals was stimulated, particularly by means of encounters with Health Insurance delegates, and posters and pamphlets to be exposed in FPs' waiting rooms. We conducted a preliminary systematic review (in press) to seek for publications assessing the effect of audio-visual aids in primary health waiting rooms. It appears that most articles about this topic have a low level of evidence and that the effect on patient health behaviour has only been assessed on surrogate outcomes. The existence of an effect on behaviour change is controversial, and if any, it is small sized, needing more than 10,000 subjects to be demonstrated.
Our aim is to evaluate the effect of the advertising campaign using posters and pamphlets in FPs' waiting rooms on patients behaviour measuring the number of influenza vaccination units delivered in community pharmacies.
We designed a single blinded 2/1 registry based cluster randomized controlled trial.
The outcome is the number of seasonal influenza vaccination sets released in community pharmacies. The target population are patients over the age of 65 or having a chronic disease requiring seasonal influenza immunization (like chronic obstructive pulmonary disease (COPD) or diabetes). Patients are informed about the anonymous use of their data and can refuse to participate at any time.
A cluster is defined as the patients over the age of 16, who are registered by the Health Insurance on the participating FPs' patients' lists. A computerized random draw is used to allocate FPs in each group. In the intervention group, FPs will receive and expose in their waiting rooms 135 pamphlets and one poster (added to the usual mandatory information) withdrawing all the other posters. In the control group, waiting rooms are kept in their usual state. To evaluate the number of FPs needed for the trial, we set an interclass correlation coefficient of 0.02, for α = 5% and β = 20%. With a predicted rate of influenza vaccination delivery of 0.65 in the intervention group and 0.60 in the control group, and a target size by FP of 400 patients, 75 FPs have to be enrolled (50 in the control group and 25 in the intervention group).
Baseline is defined as the 2013-2014 vaccination campaign. Data are extracted between October 15, 2014 and February 28, 2015 from the SIAM-ERASME claim database of the Lille-Douai district Health Insurance Fund on patient level. To assess the association between the vaccination status (dependent variable) and the group intervention/control, because of the hierarchical structure of the data and the high incidence rate of the main outcome, we will use a generalized estimating equation (GEE) Poisson regression clustering by GP; an exchangeable working correlation matrix will be used. The analysis will be carried out using R software (version 3.3.1) and the package Geepack.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Registry based cluster randomized trial. The population was the patients aged over 16 of 75 FPs, with an indication for seasonal influenza immunization (pregnancy, long lasting disease, age over 65). The main outcome is the proportion of vaccinated patients, based on the number of vaccination units dispensed in community pharmacies. This number is retrieved from the SIAM-ERASME claim database of the Lille-Douai Health Insurance Fund.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: AdvertisementFamily physicians' patients exposed to advertisement in waiting rooms consisting in a poster and pamphlets promoting seasonal influenza vaccination (+ usual mandatory information) |
| Control group | No intervention | –Family physicians' patients exposed to usual laying out of waiting rooms |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- All patients aged 65 years and more
- Pregnant women
- Patients with a chronic long lasting disease needing yearly seasonal influenza immunization
Key exclusion criteria (1 listed)
- patients aged less than 16 years
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 |
|---|---|---|
| AdvertisementAlso: Advertising, poster, pamphletsAdvertisement by means of a poster and pamphlets in FP waiting rooms, removing all the other posters and pamphlets (except mandatory information, like opening hours, fees, etc.) | Other | Intervention group |
Primary outcome
Number of seasonal influenza vaccination sets released in community pharmacies
Time frame: 20 weeks
The number of seasonal influenza vaccination sets released in community pharmacies and the date of release are extracted from the SIAM-ERASME claim database of the Lille-Douai district Health Insurance Fund on patient level.
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 4 Aug 2017.
- Results publication: PubMed 22795870Tuppin P, Choukroun S, Samson S, Weill A, Ricordeau P, Allemand H. [Vaccination against seasonal influenza in France in 2010 and 2011: decrease of coverage rates and associated factors]. Presse Med. 2012 Nov;41(11):e568-76. doi: 10.1016/j.lpm.2012.05.017. Epub 2012 Jul 15. French.
- Results publication: PubMed 23113995Bohmer MM, Walter D, Falkenhorst G, Muters S, Krause G, Wichmann O. Barriers to pandemic influenza vaccination and uptake of seasonal influenza vaccine in the post-pandemic season in Germany. BMC Public Health. 2012 Oct 31;12:938. doi: 10.1186/1471-2458-12-938.
- Results publication: PubMed 7843520Wicke DM, Lorge RE, Coppin RJ, Jones KP. The effectiveness of waiting room notice-boards as a vehicle for health education. Fam Pract. 1994 Sep;11(3):292-5. doi: 10.1093/fampra/11.3.292.
- Results publication: PubMed 7748670Ward K, Hawthorne K. Do patients read health promotion posters in the waiting room? A study in one general practice. Br J Gen Pract. 1994 Dec;44(389):583-5.
- Results publication: PubMed 22988947Gignon M, Idris H, Manaouil C, Ganry O. The waiting room: vector for health education? The general practitioner's point of view. BMC Res Notes. 2012 Sep 18;5:511. doi: 10.1186/1756-0500-5-511.
- Results publication: PubMed 17238238Austin PC. A comparison of the statistical power of different methods for the analysis of cluster randomization trials with binary outcomes. Stat Med. 2007 Aug 30;26(19):3550-65. doi: 10.1002/sim.2813.
- Results publication: PubMed 21955570Eubelen C, Brendel F, Belche JL, Freyens A, Vanbelle S, Giet D. Effect of an audiovisual message for tetanus booster vaccination broadcast in the waiting room. BMC Fam Pract. 2011 Sep 28;12:104. doi: 10.1186/1471-2296-12-104.
- Individual participant dataSharing planned: Undecided. IPD have been anonymized and will be available after full publication of the results
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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.
Christophe Berkhout, MD study director
Lille Univ. UDSL
Questions about this trial
What is this clinical trial studying?
A study testing Advertisement in people with Health Behavior and Vaccination, run by Christophe Berkhout.
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: finished, as of the sponsor's last update on 4 Aug 2017. 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?
Number of seasonal influenza vaccination sets released in community pharmacies (time frame: 20 weeks). 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 NCT03239795, which also lists 7 linked publications.
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 4 Aug 2017.