Evaluation of a Tdap-IPV (Tetanus, Diphteria, Pertussis and Inactivated Polio) Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older

Study Overview
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Brief Summary
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In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively. The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older. Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.

Official Title
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Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe

Conditions
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Vaccination

Intervention / Treatment
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* Biological: Remedial vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 65 years or older Patients capable of understanding and giving informed consent to participate in the study Valid social security coverage Exclusion Criteria: Patients under judicial safeguard measures Refusal to participate in the study Vaccination contra-indication Patient already included in the study

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center, prospective, cluster randomized trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination. | Biological: Remedial vaccination<br>* if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination.<br>|
| No Intervention: Standard care<br>if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date if the patients vaccinations are not up to date: the patient will be informed that a remedial vaccination is necessary and that he should contact his primary care provider after hospital discharge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older | Difference in the increase in vaccination coverage between the two arms, measured as a percentage | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunisation rate among patients 65 years of age or older in the Sarthe department of France | Pre-intervention vaccination coverage rate in both arms, measured as a percentage | two months | 
| Immunisation rate according to sex among patients 65 years or older | Sex of patients included in the study | two months | 
| Immunisation rate according to primary care coverage among patients 65 years of age or older | Primary care coverage is defined as having a regular primary care physician registered as such with French social security. | two months | 
| Immunisation rate according to socio professional category | Socio professional category defined according to the French national institute for statistics and economic studies (INSEE) | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination coverage