Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunization Delivery in Obstetrics and Gynecology Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565135
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE March 26, 2012
First Posted Date  ICMJE March 28, 2012
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
  • 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) & 3 months (survey data) prior to intervention & two years after intervention at 1 year intervals (administrative and survey data) ]
    The number and 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) & 3 months (survey data) prior to intervention & two years after intervention at 1 year intervals (administrative and survey data) ]
    The number and 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 number women who have initiated the HPV vaccine series (among eligible patients) in intervention settings compared to control settings. [ Time Frame: 1 year (administrative data) & 3 months (survey data) prior to intervention & two years after intervention at 1 year intervals (administrative and survey data) ]
    The number and 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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • 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) ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
Change in the number women who have completed the HPV vaccine series (among eligible patients) in intervention settings compared to control settings. [ Time Frame: 1 year (administrative data) & 3 months (survey data) prior to intervention & two years after intervention at 1 year intervals (administrative and survey data) ]
The number 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunization Delivery in Obstetrics and Gynecology Settings
Official Title  ICMJE Immunization Delivery in Obstetrics and Gynecology Settings
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Immunization Status Among Obstetrics and Gynecology Patients
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Intervention Practices
    Intervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates.
    Intervention: Behavioral: Multimodal Vaccine Program
  • No Intervention: Control Practices
    Control offices will offer usual health care related to immunizations throughout the duration of the study.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2019)
97087
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2012)
225000
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565135
Other Study ID Numbers  ICMJE 11-1149
U01IP000501 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
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
PRS Account University of Colorado, Denver
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP