Immunization Delivery in Obstetrics and Gynecology Settings

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01565135
First received: March 26, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Immunization Status Among Obstetrics and Gynecology Patients
Behavioral: Multimodal Vaccine Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Immunization Delivery in Obstetrics and Gynecology Settings

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    The percent of eligible patients presenting for care who have completed the HPV vaccine series will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess for 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 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 ] [ Designated as safety issue: No ]
    The percent of patients who report one or more individuals who are/will be in frequent contact with their infant having received Tdap vaccine will be assessed during Feb/March 2013 and Feb/March 2014. These data will be collected in patients of both intervention and control settings via on-line survey and be administered to patients who volunteer to take the survey.

  • 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 ] [ Designated as safety issue: No ]
    The percent of patients who report one or more individuals who are/will be in frequent contact with their infant having received influenza vaccine will be assessed during Feb/March 2013 and Feb/March 2014. These data will be collected in patients of both intervention and control settings via on-line survey and be administered to patients who volunteer to take the survey.


Estimated Enrollment: 225000
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Practices
Intervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates.
Behavioral: 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 Practices
Control offices will offer usual health care related to immunizations throughout the duration of the study.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565135

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Sean O'Leary, MD, MPH University of Colorado Denver, Children's Hospital Colorado
Principal Investigator: Amanda Dempsey, MD, PhD, MPH University of Colorado, Children's Hospital Colorado
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01565135     History of Changes
Other Study ID Numbers: 11-1149, U01IP000501
Study First Received: March 26, 2012
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014