- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01565135
Immunization Delivery in Obstetrics and Gynecology Settings
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Practices
Control offices will offer usual health care related to immunizations throughout the duration of the study.
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Experimental: Intervention Practices
Intervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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.
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1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
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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)
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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.
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1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
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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.
|
1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
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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
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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.
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Feb/March 2013 & Feb/March 2014
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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
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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.
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Feb/March 2013 & Feb/March 2014
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda Dempsey, MD, PhD, MPH, University of Colorado, Children's Hospital Colorado
- Principal Investigator: Sean O'Leary, MD, MPH, University of Colorado Denver, Children's Hospital Colorado
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11-1149
- U01IP000501 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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