VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

Sponsor
University of Rochester (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05570630
Collaborator
Centers for Disease Control and Prevention (U.S. Fed), University of California, Los Angeles (Other)
8,000
26
2
8.3
307.7
37

Study Details

Study Description

Brief Summary

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VAX-MOM COVID-19 Intervention
  • Other: Standard of Care
N/A

Detailed Description

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID-19 vaccination rates for pregnant people overall.

Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve COVID-19 vaccination rates for pregnant people. To address this, the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM COVID-19 intervention and the other half to standard of care. The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
Actual Study Start Date :
Oct 21, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: VAX-MOM COVID-19 Intervention

Behavioral: VAX-MOM COVID-19 Intervention
The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Active Comparator: Standard of Care

Other: Standard of Care
Standard vaccine education and processes provided to patients by obstetric practices.

Outcome Measures

Primary Outcome Measures

  1. Change in the rate of COVID-19 vaccination [6 month baseline compared to 6 month intervention]

    Average rate of COVID-19 vaccination over 6 months during baseline will be compared with average rate of COVID-19 vaccination over 6 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Patient criteria:
  • Sex is female

  • Pregnant

  • Identified as being eligible for COVID-19 vaccine

Practice personnel criteria:

*Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites

Exclusion Criteria:

*None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ronald Reagan Los Angeles California United States 90095
2 Pasadena Pasadena California United States 91105
3 Porter Ranch Porter Ranch California United States 91326
4 Santa Monica Santa Monica California United States 90404
5 South Bay: Torrance Torrance California United States 90503
6 Westlake/Thousand Oaks Westlake Village California United States 91361
7 Unity OB/GYN at Brockport Brockport New York United States 14420
8 Clifton Springs Hospital & Clinic Clifton Springs New York United States 14432
9 Finger Lakes Geneva Geneva New York United States 14456
10 TWC Newark Newark New York United States 14513
11 TWC Clinton Rochester New York United States 14605
12 TWC at Alexander Park Rochester New York United States 14607
13 Community OB (COB) Rochester New York United States 14609
14 URMC Midwifery at Culver Rochester New York United States 14609
15 UMG OBGYN St Marys Rochester New York United States 14611
16 Parkway OBGYN Rochester New York United States 14612
17 UMG OBGYN Clinton Crossings Rochester New York United States 14618
18 Gender Wellness Obstetrics & Gynecology (GOG) Rochester New York United States 14620
19 Highland Women's Health (HWH) (POB) Rochester New York United States 14620
20 University OB/GYN (UOG) Rochester New York United States 14620
21 URMC Midwifery at Lattimore Rochester New York United States 14620
22 TWC at RGH (Portland) Rochester New York United States 14621
23 Strong Perinatal Associates (SPA) Rochester New York United States 14623
24 Park Ridge OBGYN Rochester New York United States 14626
25 Unity OB/GYN at Ridgeway Rochester New York United States 14626
26 Bay Creek Midwifery Webster New York United States 14580

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cynthia Rand, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT05570630
Other Study ID Numbers:
  • STUDY00007624
First Posted:
Oct 6, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cynthia Rand, Associate Professor, University of Rochester
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022