Multi-tiered intervention to increase maternal immunization coverage: A randomized, controlled trial.
Autor: | Omer SB; Yale Institute for Global Health, Yale University, New Haven, CT, United States; Department of Health Policy and Management, Yale School of Public Health, Yale University, New Haven, CT, United States; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, Yale University, New Haven, CT, United States; Yale School of Nursing, Yale University, New Haven, CT, United States., O'Leary ST; 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; Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO, United States., Bednarczyk RA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States; Emory Vaccine Center, Emory University, Atlanta, GA, United States., Ellingson MK; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, Yale University, New Haven, CT, United States. Electronic address: mallory.ellingson@yale.edu., Spina CI; 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., Dudley MZ; Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States., Chamberlain AT; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States., Limaye RJ; Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Department of Health, Behavior and Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; International Vaccine Access Center, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States., Brewer SE; 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; Department of Family Medicine, University of Colorado Anschutz Medical Campus, United States., Frew PM; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States; Department of Medicine, School of Medicine, Emory University, Atlanta, GA, United States., Malik FA; Department of Health Policy and Management, Yale School of Public Health, Yale University, New Haven, CT, United States; Dean's Office, Yale School of Public Health, New Haven, CT, United States., Orenstein W; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States; Emory Vaccine Center, Emory University, Atlanta, GA, United States; Department of Medicine, School of Medicine, Emory University, Atlanta, GA, United States., Halsey N; Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States., Ault K; Department of Obstetrics and Gynecology, University of Kansas School of Medicine, Kansas City, KS, United States., Salmon DA; Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Department of Health, Behavior and Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States. |
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Jazyk: | angličtina |
Zdroj: | Vaccine [Vaccine] 2022 Aug 12; Vol. 40 (34), pp. 4955-4963. Date of Electronic Publication: 2022 Jul 08. |
DOI: | 10.1016/j.vaccine.2022.06.055 |
Abstrakt: | 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 (Copyright © 2022 Elsevier Ltd. All rights reserved.) |
Databáze: | MEDLINE |
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