Opting In vs Opting Out

This study has been completed.
Sponsor:
Collaborator:
Gilstrap, Larry C, M.D.
Information provided by (Responsible Party):
Susan Wootton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01233804
First received: October 27, 2010
Last updated: June 26, 2013
Last verified: June 2013

October 27, 2010
June 26, 2013
November 2010
March 2011   (final data collection date for primary outcome measure)
Vaccination rates [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.
Vaccination rates [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.
Complete list of historical versions of study NCT01233804 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Opting In vs Opting Out
Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza Vaccination
Other: Opting Out
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.
  • No Intervention: Opting in
    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.
  • Experimental: Opting Out
    Women will sign a consent form only if they do not want to receive the flu vaccine.
    Intervention: Other: Opting Out
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
August 2011
March 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01233804
HSC-MS-10-0557
No
Susan Wootton, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Gilstrap, Larry C, M.D.
Principal Investigator: Susan H Wootton, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP