Immunization Delivery in Obstetrics and Gynecology Settings

NCT01565135 | Completed

• 2 other identifiers: 11-1149U01IP000501
• Study Type: interventional
• Target: 97,087
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunization Status Among Obstetrics and Gynecology Patients

Outcome Measures

Primary Outcomes (4)

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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (3)

• 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

• 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

Study Arms (2)

Intervention Practices

EXPERIMENTAL

Intervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates.

Behavioral: Multimodal Vaccine Program

Control Practices

NO INTERVENTION

Control offices will offer usual health care related to immunizations throughout the duration of the study.

Interventions

Multimodal Vaccine Program BEHAVIORAL

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

Intervention Practices

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 31103367 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

US (1)