Opting In vs Opting Out
Primary Purpose
Influenza Vaccination
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opting Out
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Vaccination focused on measuring influenza vaccination rates
Eligibility Criteria
Inclusion Criteria:
- pregnant female age >17 years
- presenting for routine PNC at UT Houston or UT Galveston
- pregnant during influenza season
- pregnant when influenza vaccine available
Exclusion Criteria:
- influenza vaccine contraindication
Sites / Locations
- University of Texas Medical Branch, Women's Clinics
- University of Texas Health Science Center at Houston, Professional Building
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Opting in
Opting Out
Arm Description
Currently, pregnant women have to sign a consent stating that they want the influenza vaccine (at the clinics where the study is being conducted). Therefore, this group is the same as usual care. However, women will then be asked if they would like to take part in parts 2 and 3 of the study.
Women will sign a consent form only if they do not want to receive the flu vaccine.
Outcomes
Primary Outcome Measures
Vaccination rates
Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.
Secondary Outcome Measures
Full Information
NCT ID
NCT01233804
First Posted
October 27, 2010
Last Updated
May 29, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Gilstrap, Larry C, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01233804
Brief Title
Opting In vs Opting Out
Official Title
Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Gilstrap, Larry C, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare methods for consenting (opting in vs opting out) on influenza vaccine uptake rate in pregnant women. This study is designed to learn about the impact of influenza vaccination in pregnant women. This study will help gather knowledge about influenza vaccine side effects (if given) and whether the vaccine reduces the number of respiratory infection in mothers and their infants.
Detailed Description
Pregnant women who present for routine prenatal care when influenza vaccine is available would be eligible. Enrolled women would be randomized to either the Opting in (obtaining written consent to administer the vaccine) or Opting out (signing only to refuse the vaccine) study group (Part 1). Vaccine uptake rate and reason for refusal will be captured for enrollees. At the end of this clinic visit, enrollees will be asked if they are interested in participating in Part 2 and 3 of the study. If yes, consent will be obtained. Part 2 of the study, a random sample of 50 women will be called 2 days after enrollment to determine 1) vaccine side effects 2) recall of information provided in consent and 3) to confirm next followup visit with Obstetrician. During Part 3, at 6 weeks post EDD (estimated due date), data about episodes of respiratory illness in the mothers and their infants occuring between the time when influenza vaccine was offered (Part 1) and 6 weeks post-EDD will be abstracted using a standard form. Data will be collected retrospectively by research nurses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccination
Keywords
influenza vaccination rates
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opting in
Arm Type
No Intervention
Arm Description
Currently, pregnant women have to sign a consent stating that they want the influenza vaccine (at the clinics where the study is being conducted). Therefore, this group is the same as usual care. However, women will then be asked if they would like to take part in parts 2 and 3 of the study.
Arm Title
Opting Out
Arm Type
Experimental
Arm Description
Women will sign a consent form only if they do not want to receive the flu vaccine.
Intervention Type
Other
Intervention Name(s)
Opting Out
Intervention Description
Usual care is for pregnant women to sign a consent to get the influenza vaccine. The intervention is to offer a group of women the option to sign only when they refuse the influenza vaccine.
Primary Outcome Measure Information:
Title
Vaccination rates
Description
Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.
Time Frame
time 0 of part one study visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant female age >17 years
presenting for routine PNC at UT Houston or UT Galveston
pregnant during influenza season
pregnant when influenza vaccine available
Exclusion Criteria:
influenza vaccine contraindication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan H Wootton, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch, Women's Clinics
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Texas Health Science Center at Houston, Professional Building
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Opting In vs Opting Out
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