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Clinical Trials/NCT01565135
NCT01565135
Completed
Not Applicable

Immunization Delivery in Obstetrics and Gynecology Settings

University of Colorado, Denver1 site in 1 country97,087 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immunization Status Among Obstetrics and Gynecology Patients
Sponsor
University of Colorado, Denver
Enrollment
97087
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
October 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 15 years of age or older when presenting for care
  • 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

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

Outcomes

Primary Outcomes

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.

Time Frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)

The percent of eligible patients presenting for care who have received one or more needed vaccines (HPV, Tdap, and/or influenza vaccines) will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.

Change in the percent of women vaccinated with one or more Tdap vaccines (among eligible patients) in intervention settings compared to control settings.

Time Frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)

The percent of eligible patients presenting for care who receive Tdap vaccine will be assessed one year prior to the intervention and 12 and 21 months after the intervention. This assessment will occur in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.

Change in the percent of women vaccinated with influenza vaccine (among eligible patients) in intervention settings compared to control settings.

Time Frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)

The percent of eligible patients presenting for care who receive influenza vaccine will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This will be assessed in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.

Change in the percent of women who have initiated the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.

Time Frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)

The percent of eligible patients presenting for care who have received one or more HPV vaccines will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.

Secondary Outcomes

  • 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(Feb/March 2013 & Feb/March 2014)
  • Change in the percent of women who have completed the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.(1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data))
  • 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(Feb/March 2013 & Feb/March 2014)

Study Sites (1)

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