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NCT04302675 · ClinicalTrials.gov registry record · NA

Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)

A NA study, sponsored by University of Colorado, Denver.

Completed
Registry status
NA
Development phase
1,350
Enrollment target

NCT04302675 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 1,350 participants.

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The verdict

NCT04302675, a NA study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
NA
Development phase
1,350 participants
Enrollment target

Study Summary

Vaccinating pregnant women affords a unique opportunity to protect both mother and child against influenza and pertussis, yet uptake of maternal immunizations remain far below national target goals. A significant barrier to vaccine uptake is the lack of evidence to guide provider communication with patients who have concerns about vaccines. This novel study will adapt motivational interviewing to the ob-gyn setting to provide information about how to improve provider communication and increase vaccine uptake among pregnant women. The investigators propose a pragmatic practice-based study in 5 ob-gyn practices in Colorado to develop the MI for maternal immunizations (MI4MI) intervention and assess fidelity, acceptability, and feasibility among patients and providers. Aim 1 will use an iterative process building upon existing knowledge of patient concerns about maternal immunizations and our prior experience training providers in Motivational Interviewing (MI) for childhood immunizations to develop the MI4MI training. During development, the study team will conduct focus groups to elicit provider input during. The MI4MI intervention will include a video-module, 2 asynchronous online trainings, provider reference sheets, and practice study champions. Aim 2 will include intervention implementation and assessment of intervention fidelity, acceptability, and feasibility. In Aim 2a, will conduct pre- and post-intervention chart reviews among participating practices to evaluate the impact of MI4MI on influenza and Tdap vaccine uptake among pregnant patients.

Interventions

  • BEHAVIORAL Prevention, Maternal Immunization

Trial Details

FieldValue
Enrollment Target 1,350 participants
Start Date 2020-05-27
Est. Completion 2022-06-30
Phase NA

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT04302675

The ClinicalTrials.gov registry entry for NCT04302675 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Prevention, Maternal Immunization is the first listed.

NCT04302675 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04302675 about?

NCT04302675 is a clinical study titled "Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)". Vaccinating pregnant women affords a unique opportunity to protect both mother and child against influenza and pertussis, yet uptake of maternal immunizations remain far below national target goals. A significant barrier to vaccine uptake is the lack of evidence to guide provider communication with ...

What is the current status of trial NCT04302675?

This trial is currently completed. It is a NA study. The enrollment target is 1,350 participants. The study started on 2020-05-27. Estimated completion is 2022-06-30.

What interventions are being tested in trial NCT04302675?

The interventions under investigation include: Prevention, Maternal Immunization (BEHAVIORAL).

Who is sponsoring clinical trial NCT04302675?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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