Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03909126 |
| Other study ID # |
MSSS-PERT-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
May 30, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
St. Justine's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
