Clinical trial NCT01565135: Immunization Delivery in Obstetrics and Gynecology Settings
Official title: Immunization Delivery in Obstetrics and Gynecology Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization Status Among Obstetrics and Gynecology Patients
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2012-03-28
Enrollment: 97087
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if a multimodal immunization program carried out in obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn patients' immunization rates, specifically for Tdap (Tetanus, Diphtheria, Pertussis), HPV (Human papilloma virus), and influenza vaccines, than the usual care provided to patients in ob/gyn practices.


Eligibility criteria: Inclusion Criteria:

1. 15 years of age or older when presenting for care
2. Patients who present for care one year prior to the start of the intervention and up to 21 months after the start of the intervention

Exclusion Criteria:

1. less than 15 years of age when presenting for care
2. patient is not eligible for any immunizations

Primary outcomes:
measure: Change in the percent of women vaccinated with one or more Tdap vaccines (among eligible patients) in intervention settings compared to control settings.
timeFrame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
measure: Change in the percent of women vaccinated with influenza vaccine (among eligible patients) in intervention settings compared to control settings.
timeFrame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
measure: Change in the percent of women who have initiated the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.
timeFrame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
measure: Change in the percent of women who have received one or more needed vaccines (eligible patients who receive HPV, influenza, and/or Tdap vaccines) in intervention settings compared to control settings.
timeFrame: 1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
Secondary outcomes:
measure: Change in the percent of women who have completed the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.
timeFrame: 1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
measure: Change in the percent of women who report Tdap vaccine uptake among individuals in frequent contact with their infant in intervention offices compared to control offices
timeFrame: Feb/March 2013 & Feb/March 2014
measure: Change in the percent of women who report influenza vaccine uptake among individuals in frequent contact with their infant in intervention offices. compared to control offices
timeFrame: Feb/March 2013 & Feb/March 2014
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado Denver, Children's Hospital Colorado
name: Sean O'Leary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Children's Hospital Colorado
name: Amanda Dempsey, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Leary ST, Pyrzanowski J, Brewer SE, Sevick C, Miriam Dickinson L, Dempsey AF. Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings. Vaccine. 2019 Jun 6;37(26):3409-3418. doi: 10.1016/j.vaccine.2019.05.034. Epub 2019 May 15.