Clinical trial NCT03909126: Pertussis Vaccination in Pregnant Women
Official title: Pertussis Vaccination in Pregnant Women: Implementation and Evaluation of Different Models of Vaccination Dispensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pertussis
Keywords: pertussis
immunization coverage
vaccination
pregnant women
Quebec
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Ministere de la Sante et des Services Sociaux
First posted: 2019-04-09
Enrollment: 946
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Brief Summary: The study compares four models of pertussis vaccination dispensation to pregnant women on the vaccine coverage obtained. In addition, the cost of the different models of vaccination will be evaluated.

Detailed description: This is a quasi-experimental study with a non-equivalent control group in pregnant women, taking place in 4 regions of Québec (Montréal, Montérégie, Capitale-Nationale, Mauricie). Four models of vaccine dispensation will be evaluated: one university hospital around gestational diabetes screening, local health and social services centres (CSLC) and a high volume clinic. 250 participants will be recruited in each of the four types of centres.

In addition, the study will also evaluate the costs incurred by all those involved in the pertussis vaccination program for pregnant women as well as the cost per woman vaccinated.

Health Professionals:

15 to 20 health professionals involved in providing immunization services to pregnant women: obsterician-gynaecologists, family doctors and nurses in participating clinics will be interviewed to evaluate their knowledge, attitudes and professional practises regarding pertussis vaccination during pregnancy.

Evaluating the Cost:

A detailed costing approach (micro-costing) will be used. Time and movement will be studied by direct observation using a grid on an electronic file in each of the 5 environments studied in order to identify the services and activities carried out as well as to determine the resources involved in the implementation of these services and activities. Three typical vaccination days will be chosen to make these observations, in each of the four study environments.

The main activities observed will be related to preparations for vaccination up to the vaccination itself (informed consent, injection, etc.), the capture of vaccination data the management of vaccines and equipment, clinical manifestations, etc. If necessary, the people observed can be interviewed directly to better understand the activities or services provided. Otherwise, some questions may be included in the interviews described above.

The major cost categories that will be evaluated for each of the delivery modalities are human resources and supplies. The cost components listed are: nursing time (immunization / training), coordination time, support staff time, office supplies, vaccine storage equipment, vaccine transportation equipment, vaccine transportation, health and safety equipment, emergency, single-use vaccination equipment and others.

With regard to the costs borne by women, the main categories of variables evaluated will be: the time spent making appointments and attending vaccination appointments, working time lost, if any, transportation, childcare and other expenses

Eligibility criteria: Inclusion Criteria:

* Pregnant women at least 18 years old who speak English or French
* Signed Informed Consent

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of pregnant women vaccinated against pertussis
timeFrame: 11 months, May 2019 o March 2020
measure: Proportion of pregnant women who consider pertussis as serious risk for infant
timeFrame: 12 months, May 2019 to April 2020
measure: Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe.
timeFrame: 12 months, May 2019 to April 2020
measure: Costs for each vaccinated woman
timeFrame: 12 months, January to December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Longueuil
country: Canada
facility: CLSC Montérégie
state: Quebec
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Québec
country: Canada
facility: CLSC Capitale Nationale
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Caroline Quach, MD
role: PRINCIPAL_INVESTIGATOR
References: