Opting In vs Opting Out

The University of Texas System (UT)

Status: Completed

Conditions: Influenza Vaccination

Treatments: Other: Opting Out

Study type: Interventional

Funder types: Other

Identifiers

NCT01233804

HSC-MS-10-0557

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Opting in

No Intervention group

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.

Opting Out

Experimental group

Description:

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

Treatment:

Other: Opting Out