Overview

This trial is active, not recruiting.

Condition immunization status among obstetrics and gynecology patients
Treatment multimodal vaccine program
Sponsor University of Colorado, Denver
Collaborator Centers for Disease Control and Prevention
Start date September 2012
End date October 2015
Trial size 225000 participants
Trial identifier NCT01565135, 11-1149, U01IP000501

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, HPV, and influenza vaccines, than the usual care provided to patients in ob/gyn practices.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose health services research
Arm
(Experimental)
Intervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates.
multimodal vaccine program
Efforts will be made to collaborate with private ob/gyn offices to develop a multimodal intervention to improve patients'immunization rates. As part of the overall intervention, intervention practices will agree to 1) purchase, stock, and administer influenza, HPV, and Tdap vaccines, if not already doing so and 2) track patients' vaccination status. In addition, intervention strategies adopted by intervention settings to improve immunization rates may include: Patient education regarding the importance of vaccination, including encouragement of vaccination for family members Practice-based reminder/recall Seek to decrease missed opportunities for immunization by using either or both of the following: provider prompts and/or provider education and feedback
(No Intervention)
Control offices will offer usual health care related to immunizations throughout the duration of the study.

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.
time frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
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)
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)
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)

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.
time frame: 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
time frame: Feb/March 2013 & Feb/March 2014
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
time frame: Feb/March 2013 & Feb/March 2014

Eligibility Criteria

Female participants at least 15 years old.

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

Additional Information

Official title Immunization Delivery in Obstetrics and Gynecology Settings
Principal investigator Sean O'Leary, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.