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Clinical Trials/NCT01565135
NCT01565135CompletedNot Applicable

Immunization Delivery in Obstetrics and Gynecology Settings

University of Colorado, Denver2 sites in 1 country97,087 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
97,087
Locations
2
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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 21 months 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

Arms & Interventions

Intervention Practices

Experimental

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

Intervention: Multimodal Vaccine Program (Behavioral)

Control Practices

No Intervention

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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