Immunization Delivery in Obstetrics and Gynecology Settings - Full Text View

Purpose

The purpose of this study is to determine if a mulitmodal 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:

MedlinePlus related topics: Flu

U.S. FDA Resources

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 & two years after intervention at 1 year intervals (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 two years after the intervention at one year intervals. 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 & two years after intervention at 1 year intervals (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 two years after the intervention at one year intervals. 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 & two years after intervention at 1 year intervals (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 two years after the intervention at one year intervals. 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 & two years after intervention at 1 year intervals (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 two years after the intervention at one year intervals. 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 & two years after intervention at 1 year intervals (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 two years after the intervention at one year intervals. 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:	August 2014
Estimated Primary Completion Date:	August 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.

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:

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 two years 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

Contacts and Locations

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

Contacts

Contact: Jennifer Pyrzanowski, MSPH	303-724-0769	jennifer.pyrzanowski@ucdenver.edu
Contact: Sarah McCauley, MPA	3037246927	sarah.mccauley@ucdenver.edu

Locations

United States, Colorado
University of Colorado Denver	Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer L Pyrzanowski, MSPH 303-724-0769 jennifer.pyrzanowski@ucdenver.edu

Sponsors and Collaborators

University of Colorado, Denver

Centers for Disease Control and Prevention

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:	March 15, 2013
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013