Opting In vs Opting Out

NCT ID: NCT01233804

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-08-31

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.

Conditions

Influenza Vaccination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Opting Out

Women will sign a consent form only if they do not want to receive the flu vaccine.

Group Type: EXPERIMENTAL

Opting Out

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gilstrap, Larry C, M.D.

INDIV

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Susan Wootton

Assitant Professor - Ctr For Clnc Rsrch & Evidnc MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan H Wootton, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Texas Medical Branch, Women's Clinics

Galveston, Texas, United States

University of Texas Health Science Center at Houston, Professional Building

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-10-0557

Identifier Type: -

Identifier Source: org_study_id