Immunization Delivery in Obstetrics and Gynecology Settings

NCT ID: NCT01565135

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97087 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Immunization Status Among Obstetrics and Gynecology Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Practices

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

Group Type EXPERIMENTAL

Multimodal Vaccine Program

Intervention Type 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

Control Practices

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean O'Leary, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver, Children's Hospital Colorado

Amanda Dempsey, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Children's Hospital Colorado

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31103367 (View on PubMed)

Other Identifiers

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U01IP000501

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-1149

Identifier Type: -

Identifier Source: org_study_id

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