Multi-tiered intervention to increase maternal immunization coverage: A randomized,controlled trial |
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| Institution: | 1. Yale Institute for Global Health, Yale University, New Haven, CT, United States;2. Department of Health Policy and Management, Yale School of Public Health, Yale University, New Haven, CT, United States;3. Department of Epidemiology of Microbial Diseases, Yale School of Public Health, Yale University, New Haven, CT, United States;4. Yale School of Nursing, Yale University, New Haven, CT, United States;5. Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado, Aurora, CO, United States;6. Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO, United States;7. Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States;8. Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States;9. Emory Vaccine Center, Emory University, Atlanta, GA, United States;10. Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States;11. Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States;12. Department of Health, Behavior and Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States;13. Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States;14. International Vaccine Access Center, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States;15. Department of Family Medicine, University of Colorado Anschutz Medical Campus, United States;p. Dean’s Office, Yale School of Public Health, New Haven, CT, United States;q. Department of Medicine, School of Medicine, Emory University, Atlanta, GA, United States;r. Department of Obstetrics and Gynecology, University of Kansas School of Medicine, Kansas City, KS, United States |
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| Abstract: | ObjectiveTo evaluate the impact of a multi-component intervention package of maternal immunization uptake in obstetric care clinics.MethodsIn a multi-level, cluster- and individually-randomized controlled trial we implemented an evidence-based intervention that targeted practice-, provider- and patient-level barriers to vaccine uptake. Obstetric practices were randomized to receive the practice and provider-level interventions or continue their normal standard of care. We enrolled pregnant women at practices in Georgia and Colorado and randomized women into patient-level intervention and control groups, resulting in four study arms. The primary outcomes were receipt of the influenza and tetanus, diphtheria and acellular pertussis (Tdap) vaccines during pregnancy. A sample size of 550 women per arm (2200 total) was planned and enrolled to compare the intervention between the four study arms.ResultsBetween June 2017 and July 2018, 4907 women were screened and 2200 women were randomized, 550 to each of the four study arms. We were unable to follow-up with 108 women, for a final sample size of 2092. Sample characteristics and sample size were similar among study arms. There was no significant increase in Tdap or influenza vaccine uptake overall. Among women who had no intention of or were unsure about receiving the influenza vaccine during pregnancy, those who received just the patient-level intervention were 61% more likely to receive the influenza vaccine than those in the control arm (Relative risk: 1.61; 95% Confidence Interval: 1.18–2.21). There was no significant difference in vaccine uptake for either influenza or tetanus, diphtheria and acellular pertussis between the four arms of the study.ConclusionsThis trial highlights the need for more targeted interventions to improve vaccine uptake. Future work should focus on clinics with low baseline vaccine uptake and the patient-level intervention should be expanded and targeted towards women with low vaccine confidence. |
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| Keywords: | Maternal immunization Quality improvement Vaccine delivery Vaccine uptake Influenza Pertussis |
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