An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department
NCT01899365
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- patients 65-year old and above,
- benefit from French or Monaco social security a social security.
- 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.
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Descriptive Information | |||||||||||||
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Brief Title | An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department | ||||||||||||
Official Title | An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project | ||||||||||||
Brief 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. 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
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Detailed Description | Not Provided | ||||||||||||
Study Type | Observational | ||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||||||||
Target Follow-Up Duration | Not Provided | ||||||||||||
Biospecimen | Not Provided | ||||||||||||
Sampling Method | Probability Sample | ||||||||||||
Study Population | patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies | ||||||||||||
Condition | Pneumococcal Infections | ||||||||||||
Intervention | Not Provided | ||||||||||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status | Completed | ||||||||||||
Actual Enrollment | 1475 | ||||||||||||
Original Estimated Enrollment | 1800 | ||||||||||||
Actual Study Completion Date | October 2017 | ||||||||||||
Actual Primary Completion Date | October 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 65 Years and older (Older Adult) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries | France, Monaco | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT01899365 | ||||||||||||
Other Study ID Numbers | 12-09 2013-A00943-42 ( Other Identifier: ANSM ) | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement |
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Responsible Party | Centre Hospitalier Princesse Grace | ||||||||||||
Study Sponsor | Centre Hospitalier Princesse Grace | ||||||||||||
Collaborators |
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Investigators |
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PRS Account | Centre Hospitalier Princesse Grace | ||||||||||||
Verification Date | October 2017 |