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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
1   Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas
,
Sean C. Blackwell
2   Department of Obstetrics, Gynecology and Reproductive Services, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas
,
George Saade
3   Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Pamela D. Berens
2   Department of Obstetrics, Gynecology and Reproductive Services, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas
,
Maria Hutchinson
2   Department 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
4   Center 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
5   Research Compliance, Education and Support Services, The University of Texas Health Science Center at Houston, Houston, Texas
,
Kara M. Elam
4   Center 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
4   Center 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
Funding Source All phases of this trial were supported by a KL2 CCTS Supplement Award #3KL2RR024149–05S1, a CTSA Award #UL1RR024148 and the Larry C. Gilstrap Center for Perinatal and Women's Health Research, University of Texas Health Science Center at Houston, Houston, TX.
Further Information

Publication History

10 January 2018

29 June 2018

Publication Date:
28 August 2018 (online)

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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