title: Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season.
abstract: BACKGROUND
  Evidence-based interventions to improve influenza vaccine coverage among pregnant women are needed, particularly among those who remain unvaccinated late into the influenza season. Improving rates of antenatal tetanus, diphtheria and acellular pertussis (Tdap) vaccination is also needed.
  
  
  OBJECTIVE
  To test the effectiveness of a practice-, provider-, and patient-focused influenza and Tdap vaccine promotion package on improving antenatal influenza and Tdap vaccination in the obstetric setting.
  
  
  METHODS
  A cluster-randomized trial among 11 obstetric practices in Georgia was conducted in 2012-2013. Intervention practices adopted the intervention package that included identification of a vaccine champion, provider-to-patient talking points, educational brochures, posters, lapel buttons, and iPads loaded with a patient-centered tutorial. Participants were recruited from December 2012-April 2013 and included 325 unvaccinated pregnant women in Georgia. Random effects regression models were used to evaluate primary and secondary outcomes.
  
  
  RESULTS
  Data on antenatal influenza and Tdap vaccine receipt were obtained for 300 (92.3%) and 291 (89.5%) women, respectively. Although antenatal influenza and Tdap vaccination rates were higher in the intervention group than the control group, improvements were not significant (For influenza: risk difference (RD)=3.6%, 95% confidence interval (CI): -4.0%, 11.2%; for Tdap: RD=1.3%, 95% CI: -10.7%, 13.2%). While the majority of intervention package components were positively associated with antenatal vaccine receipt, a provider's recommendation was the factor most strongly associated with actual receipt, regardless of study group or vaccine.
  
  
  CONCLUSIONS
  The intervention package did not significantly improve antenatal influenza or Tdap vaccine coverage. More research is needed to determine what motivates women remaining unvaccinated against influenza late into the influenza season to get vaccinated. Future research should quantify the extent to which clinical interventions can bolster a provider's recommendation for vaccination. This study is registered with clinicaltrials.gov, study ID NCT01761799.
authors.affiliation: Department of Epidemiology, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, CNR Room 3040Z, Atlanta, GA 30322, USA. Electronic address: allison.chamberlain@emory.edu.
authors.forename: A T
authors.initials: AT
authors.lastname: Chamberlain
authors.affiliation: Division of Infectious Diseases, School of Medicine, Emory University, 1462 Clifton Rd. NE, Room 446, Atlanta, GA 30322, USA. Electronic address: kseib@emory.edu.
authors.forename: K
authors.initials: K
authors.lastname: Seib
authors.affiliation: Department of Gynecology and Obstetrics, School of Medicine, Emory University, 1365 Clifton Road, Building A, 4th Floor, Atlanta, GA 30322, USA. Electronic address: kault2@kumc.edu.
authors.forename: K A
authors.initials: KA
authors.lastname: Ault
authors.affiliation: Department of Epidemiology, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, GCR Room 472, Atlanta, GA 30322, USA. Electronic address: esrose2@emory.edu.
authors.forename: E S
authors.initials: ES
authors.lastname: Rosenberg
authors.affiliation: Department of Medicine, Division of Infectious Diseases, 500 Irvin Court, Decatur, GA 30030, USA. Electronic address: pfrew@emory.edu.
authors.forename: P M
authors.initials: PM
authors.lastname: Frew
authors.affiliation: Hubert Department of Global Health, Rollins School of Public Health, 1518 Clifton Road NE, Atlanta, GA 30322, USA. Electronic address: marielysse@aol.com.
authors.forename: M
authors.initials: M
authors.lastname: Cortés
authors.affiliation: Department of Epidemiology, Rollins School of Public Health, 1518 Clifton Rd. NE, CNR Room 3047, Atlanta, GA 30322, USA. Electronic address: ewhitn2@emory.edu.
authors.forename: E A S
authors.initials: EA
authors.lastname: Whitney
authors.affiliation: Department of Epidemiology, Rollins School of Public Health, 1518 Clifton Road NE, CNR Room 3045, Atlanta, GA 30322, USA. Electronic address: rberkel@emory.edu.
authors.forename: R L
authors.initials: RL
authors.lastname: Berkelman
authors.affiliation: Division of Infectious Diseases, School of Medicine, Emory University, 1462 Clifton Rd. NE, Room 446, Atlanta, GA 30322, USA. Electronic address: worenst@emory.edu.
authors.forename: W A
authors.initials: WA
authors.lastname: Orenstein
authors.affiliation: Hubert Department of Global Health, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, CNR Room 7017, Atlanta, GA 30322, USA. Electronic address: somer@emory.edu.
authors.forename: S B
authors.initials: SB
authors.lastname: Omer
mesh_terms: D000293:Adolescent; D000328:Adult; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D005845:Georgia; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008875:Middle Aged; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D014611:Vaccination / Q000379:methods* / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D007252:Influenza Vaccines
keywords: Antenatal immunization; Influenza; Maternal immunization; Randomized clinical trial; Tdap