Increasing Influenza and Tdap Vaccination of Pregnant Women

NCT04444518 | Completed Results

• 1 other identifier: STUDY00005115
• Study Type: interventional
• Target: 12,760
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

Conditions

Immunization; Infection; Pregnancy Related

Keywords

pertussis; influenza; vaccination; prenatal care

Outcome Measures

Primary Outcomes (2)

• Rate of Influenza Vaccination

  Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.

  10/1/2021-6/30/2022 (intervention flu season)

• Rate of Tdap Vaccination

  Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.

  7/1/2021 - 6/30/2022 (intervention period)

Study Arms (2)

VAX-MOM Intervention

EXPERIMENTAL

Behavioral: VAX-MOM Intervention

Standard of Care

ACTIVE COMPARATOR

Behavioral: Standard of Care

Interventions

VAX-MOM Intervention BEHAVIORAL

The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

VAX-MOM Intervention

Standard of Care BEHAVIORAL

Standard vaccine education and processes provided to patients by obstetric practices.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Patients
• Sex is female
• Pregnant
• identified as being eligible for influenza or Tdap vaccine
• Providers
• any provider, nurse or staff associated with the participating sites

You may not qualify if:

• Patients
• none
• Providers
• none

Sponsors & Collaborators

• University of Rochester: lead
• Centers for Disease Control and Prevention: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

University of Rochester Medical Center (URMC)

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Infections; Whooping Cough; Influenza, Human

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Cynthia Rand, PI
• Organization: University of Rochester

cynthia_rand@urmc.rochester.edu

5852759316

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: July 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 10, 2025
• Results First Posted: January 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)