Pneumococcal InfectionsIMPROVEDNCT01899365
An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department
An observational study of Pneumococcal Infections, run by Centre Hospitalier Princesse Grace at 18 sites in 2 countries.
Trial summary
Background : Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the 6th cause of death. CAP also frequently associates with other disorders responsible for admission and death. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pneumococcal Infections
- Type of treatment
- Vaccines
- How many people
- 1,475 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Nov 2015to Oct 2017
- Phase
- Observational
- 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
Study population: patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies
Who may be able to join
- patients 65-year old and above,
- benefit from French or Monaco social security a social security.
Who cannot join
- refuse to participate,
- no possibility to receive SMS,
- impaired cognitive functions and mental status precluding understanding of the study,
- anticipated barriers precluding adequate follow-up (ex. homeless),
- previous APV,
- contraindication to APV,
- do not understand/read French.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
France17 sites
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63003
Centre Hospitalier Paul Ardier
Issoire, 63503
AP-HM - Hôpital Nord
Marseille, 13015
AP-HM - La Timone
Marseille, 13385
HIA Laveran
Marseille, 13915
Centre Hospitalier La Palmosa
Menton, 06507
Centre Hospitalier Universitaire de Nice
Nice, 06003
Centre Hospitalier Louis Giorgi
Orange, 84106
Hôpital Lariboisière
Paris, 75010
Hôpital Pitié-Salpêtrière
Paris, 75013
Hôpital Bichat-Claude Bernard
Paris, 75018
Hôpital Tenon
Paris, 75020
Hôpital Cochin
Paris, 75679
Centre hospitalier de Saint-Denis
Saint-Denis, 93200
Centre Hospitalier de Vaison-la-Romaine
Vaison-la-Romaine, 84110
Centre Hospitalier Jules Niel
Valréas, 84600
Centre Hospitalier Jacques Lacarin
Vichy, 03207
About this study
Official title: An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project
Background :
Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the 6th cause of death. CAP also frequently associates with other disorders responsible for admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major pathogen that is commonly involved and frequently leads to severe infection and admission. Categories at risk for this pathogen have been determined, and can be proposed anti-pneumococcal vaccination (APV) that efficiently and safely protects from this microorganism.
Read more
In the context of US health services, monocenter pilot experiences have reported improvement of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk were proposed vaccination at ED. To obtain these results, medical students were specifically trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when physicians were alerted for pneumococcal risk by the software they usually utilized at bedside. However these experiences remain sparse as additional dedicated resources are required or patients and attending ED physicians can be reluctant to proceed to vaccination at ED.
Mobile phone and derived communication modalities are current vectors to deliver information in several fields including education and medicine. Initially used in developing countries, short-message services (SMS) have improved behaviour of patients in various medical areas. In France, the investigators have observed that most patients above 50 years of age admitted after ED visit are equipped with mobile phone and can receive alerts by SMS.
These observations prompt us to propose a multifaceted procedure to improve APV after ED visit in at-risk patients, combining structured oral interview, written information and SMS as reminders.
Purpose : The investigators hypothesized that
- a multifaceted intervention to promote anti-pneumococcal vaccination combining a structured oral interview, a written information to patient and his/her general practitioner, and a series of 3 SMS,
- improves anti-pneumococcal vaccination at 6 months,
- in at-risk patients (65+ years) visiting the emergency department. In order to answer this question, the investigators designed an interventional prospective multicenter randomized study (cluster).
- Conditions
- Pneumococcal Infections
- Keywords
- anti-pneumococcal vaccination, information, emergency department
- Medical subject headings
- Pneumococcal Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted | * brief structured interview with the physician about pneumococcal risk and vaccination, * information sheet delivered to patients with explanation about risk and benefit of APV, * letter given to patient for his/her general practitioner stating that the patient is at-risk for pneumococcal infection and could benefit of APV, * 3 SMS every 2 weeks to remind patients talking of pneumococcal risk with general practitioner. | |
| Control | * information sheet delivered to patients with explanation about the aim of the study, * brief interview with the physician about study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a multifaceted procedure at ED visit on anti-pneumococcal vaccination. (APV) at 6-month. Evaluation criteria : Δ percentage (%) of APV vaccination at 6-month
Measured: 6 month
Secondary outcomes (5)
On Flu vaccination at 6-month Δ percentage (%)
number of patients receiving vaccination against flu at 6-month. This issue will be collected by phone (patient, relative or general practioner). This will be a declarative data
Measured: 6 month
On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)
number of patients who experienced respiratiory tract infection requiring antibiotics or admission. This issue will be collected by phone at 6-month (patient, relative or general practioner). This will be a declarative data
Measured: 6 month
On death at 6- and 12-month (absolute number of events)
Measured: 6 month
On death related to infection at 6- and 12-month (absolute number of events)
Measured: 6 month
Psychosocial evaluation of patients and acceptance / refusal of vaccination
The patient will fil a Psychosocial evaluation questionnaire during the ED visit. To achieve this issue, we will use the socio-economic indicators mobilized in investigations in social epidemiology: sex, age, education, occupation, housing, income and household size. This composite questionnaire will be used for qualitative analysis.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Scientifique de Monaco, Pfizer
- Responsible party
- Sponsor
- Investigators
- Yann-Erick CLAESSENS, MD-PHD, Study director, Centre Hospitalier Princesse GraceXavier DUVAL, MD-PHD, Study director, Groupe Hospitalier Bichat Claude-BernardJosé LABARERE, MD, Study director, University Hospital, GrenobleJocelyn RAUDE, PHD, Study director, Ecole des Hautes Etudes en Santé Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899365
- Sponsor's protocol ID
- 12-09
- Other IDs
- 2013-A00943-42
- Acronym
- IMPROVED
- Status last verified
- Oct 2017
- First submitted
- 4 Jul 2013
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project
- ClinicalTrials.gov ID
- NCT01899365
- Acronym / sponsor ID
- IMPROVED / 12-09
- Conditions
- Pneumococcal Infections
- Keywords
- anti-pneumococcal vaccination, information, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,475 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Collaborators
- Centre Scientifique de Monaco, Pfizer
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 15 Jul 2013 (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.
Background :
Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the 6th cause of death. CAP also frequently associates with other disorders responsible for admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major pathogen that is commonly involved and frequently leads to severe infection and admission. Categories at risk for this pathogen have been determined, and can be proposed anti-pneumococcal vaccination (APV) that efficiently and safely protects from this microorganism.
In the context of US health services, monocenter pilot experiences have reported improvement of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk were proposed vaccination at ED. To obtain these results, medical students were specifically trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when physicians were alerted for pneumococcal risk by the software they usually utilized at bedside. However these experiences remain sparse as additional dedicated resources are required or patients and attending ED physicians can be reluctant to proceed to vaccination at ED.
Mobile phone and derived communication modalities are current vectors to deliver information in several fields including education and medicine. Initially used in developing countries, short-message services (SMS) have improved behaviour of patients in various medical areas. In France, the investigators have observed that most patients above 50 years of age admitted after ED visit are equipped with mobile phone and can receive alerts by SMS.
These observations prompt us to propose a multifaceted procedure to improve APV after ED visit in at-risk patients, combining structured oral interview, written information and SMS as reminders.
Purpose : The investigators hypothesized that
- a multifaceted intervention to promote anti-pneumococcal vaccination combining a structured oral interview, a written information to patient and his/her general practitioner, and a series of 3 SMS,
- improves anti-pneumococcal vaccination at 6 months,
- in at-risk patients (65+ years) visiting the emergency department. In order to answer this question, the investigators designed an interventional prospective multicenter randomized study (cluster).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted | – | –* brief structured interview with the physician about pneumococcal risk and vaccination, * information sheet delivered to patients with explanation about risk and benefit of APV, * letter given to patient for his/her general practitioner stating that the patient is at-risk for pneumococcal infection and could benefit of APV, * 3 SMS every 2 weeks to remind patients talking of pneumococcal risk with general practitioner. |
| Control | – | –* information sheet delivered to patients with explanation about the aim of the study, * brief interview with the physician about study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies
Key inclusion criteria (2 listed)
- patients 65-year old and above,
- benefit from French or Monaco social security a social security.
Key exclusion criteria (7 listed)
- refuse to participate,
- no possibility to receive SMS,
- impaired cognitive functions and mental status precluding understanding of the study,
- anticipated barriers precluding adequate follow-up (ex. homeless),
- previous APV,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of a multifaceted procedure at ED visit on anti-pneumococcal vaccination. (APV) at 6-month. Evaluation criteria : Δ percentage (%) of APV vaccination at 6-month
Time frame: 6 month
5 secondary outcomes
On Flu vaccination at 6-month Δ percentage (%)
Time frame: 6 month
On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)
Time frame: 6 month
On death at 6- and 12-month (absolute number of events)
Time frame: 6 month
On death related to infection at 6- and 12-month (absolute number of events)
Time frame: 6 month
Psychosocial evaluation of patients and acceptance / refusal of vaccination
Time frame: 6 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 23 Jan 2020.
- 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.
Yann-Erick CLAESSENS, MD-PHD study director
Centre Hospitalier Princesse Grace
Xavier DUVAL, MD-PHD study director
Groupe Hospitalier Bichat Claude-Bernard
José LABARERE, MD study director
University Hospital, Grenoble
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections, run by Centre Hospitalier Princesse Grace at 18 sites in 2 countries.
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 2 inclusion and 7 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 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Monaco. 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?
Impact of a multifaceted procedure at ED visit on anti-pneumococcal vaccination. (APV) at 6-month. Evaluation criteria : Δ percentage (%) of APV vaccination at 6-month (time frame: 6 month). 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 23 Jan 2020.