NCT04302675: MI4MI

Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)

Completed NA Last updated 12 May 2023

What this trial tests

NA trial testing Prevention, Maternal Immunization in Maternal Immunization in 1,350 participants. Completed in 30 June 2022.

Timeline

27 May 2020

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	1,350
Start date	27 May 2020
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Prevention, Maternal Immunization

Conditions studied

• Maternal Immunization — all drugs for Maternal Immunization →

Sponsor

University of Colorado, Denver

Who can join

15 and older, female only, with Maternal Immunization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Motivational Interviewing for Maternal Immunisation (MI4MI) study: a protocol for an implementation study of a clinician vaccine communication intervention for prenatal care settings.
   Brewer SE, Cataldi JR, Fisher M, Glasgow RE, et al · · 2020 · cited 16× · PMID 33203635 · DOI 10.1136/bmjopen-2020-040226
2. Vaccine communication training using the Brief Motivational Interviewing for Maternal Immunization intervention: A PRISM implementation evaluation.
   Cataldi JR, Brewer SE, Perreira C, Fisher ME, et al · · 2024 · cited 3× · PMID 38493268 · DOI 10.1093/tbm/ibae012