Randomized Quality Improvement Trial of Opting-In Versus Opting-Out to Increase Influenza Vaccination Rates during Pregnancy

Susan H. Wootton; Sean C. Blackwell; George Saade; Pamela D. Berens; Maria Hutchinson; Charles E. Green; Sujatha Sridhar; Kara M. Elam; Jon E. Tyson

doi:10.1055/s-0038-1668566

American Journal of Perinatology Reports, Table of Contents

CC BY-NC-ND 4.0 · AJP Rep 2018; 08(03): e161-e167
DOI: 10.1055/s-0038-1668566

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Randomized Quality Improvement Trial of Opting-In Versus Opting-Out to Increase Influenza Vaccination Rates during Pregnancy

Susan H. Wootton

¹Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas

,

Sean C. Blackwell

²Department of Obstetrics, Gynecology and Reproductive Services, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas

,

George Saade

³Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas

,

Pamela D. Berens

²Department of Obstetrics, Gynecology and Reproductive Services, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas

,

Maria Hutchinson

²Department of Obstetrics, Gynecology and Reproductive Services, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas

,

Charles E. Green

⁴Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas

,

Sujatha Sridhar

⁵Research Compliance, Education and Support Services, The University of Texas Health Science Center at Houston, Houston, Texas

,

Kara M. Elam

⁴Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas

,

Jon E. Tyson

⁴Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas

› Author Affiliations

Abstract

Introduction Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were vaccinated against influenza during the 2009 pandemic. We tested whether an opting-out approach would improve vaccine uptake.

Methods We conducted a randomized quality improvement (QI) trial to compare opting-out with conventional opting-in consent for influenza immunization. Women age ≥ 18 years attending the University of Texas Health Science Center at Houston (UTHealth) or UT-Medical Branch (UTMB) prenatal clinics during the 2010–2011 influenza season, were eligible.

Results We enrolled 280 women (140 UTHealth, 140 UTMB). Both groups had similar mean age (26.0 ± 5.5 years), mean gestational age (19.4 ± 9.5 weeks), and percent with underlying health conditions (20.7%). Vaccination rates with opting-in and opting-out were similar among all (83 vs. 84%), UTHealth (87 vs. 93%), and UTMB patients (79 vs.76%) (p > 0.05). In subsamples of patients assessed, consent strategy did not significantly affect maternal recall of information provided.

Conclusion While prenatal influenza vaccination uptake doubled from the 2009–2010 influenza season, opting-out did not perform better than opting-in, a conclusion opposite that we would have reached had this been a nonconcurrent trial. Vaccination rates dropped posttrial; hence, continued research is needed to increase the prenatal influenza immunizations.

Keywords

pregnancy - influenza vaccines - vaccines - immunization - consent forms

Full Text

References

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