Multi-tiered intervention to increase maternal immunization coverage: A randomized, controlled trial.

Objective: To evaluate the impact of a multi-component intervention package of maternal immunization uptake in obstetric care clinics.
Methods: In 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.
Results: Between 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.
Conclusions: This 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.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Saad B. Omer reports financial support was provided by National Institute of Allergy and Infectious Diseases. Matthew Z. Dudley reports a relationship with Walgreens that includes: funding grants. Allison T. Chamberlain reports a relationship with American College of Obstetricians and Gynecologists that includes: consulting or advisory. Walter Orenstein reports a relationship with Moderna that includes: board membership. Kevin Ault reports a relationship with Advisory Committee on Immunization Practices that includes: board membership. Kevin Ault reports a relationship with American College of Obstetricians and Gynecologists that includes: board membership. Neal Halsey reports a relationship with Merck & Co Inc that includes: board membership and consulting or advisory. Neal Halsey reports a relationship with Pfizer that includes: board membership and consulting or advisory. Neal Halsey reports a relationship with Valneva that includes: board membership and consulting or advisory. Neal Halsey reports a relationship with Takeda that includes: board membership and consulting or advisory. Neal Halsey reports a relationship with ILiAD Biotechnologies that includes: board membership and consulting or advisory. Daniel A. Salmon reports a relationship with Merck & Co Inc that includes: consulting or advisory. Daniel A. Salmon reports a relationship with Walgreens that includes: funding grants. Daniel A. Salmon reports a relationship with Pfizer that includes: consulting or advisory. During this study, P.F. had no conflicts or financial disclosures to report; at the time of publication, she is at Merck
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