Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)

NCT04302675 | Completed

• 2 other identifiers: 19-13121R21AI141822-01A1
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maternal Immunization

Keywords

Maternal Immunization; Immunization - Influenza; Immunization - Tdap; Tetanus; Diphtheria; Pertussis

Outcome Measures

Primary Outcomes (1)

• To develop the MI for maternal immunizations (MI4MI) provider training program

  Based on the success of our MI program for vaccine hesitancy among parents of adolescents, we will use an iterative process \[incorporating organizational perspectives and\] provider feedback through focus groups to develop a multifaceted provider training program for using MI to encourage maternal immunization acceptance among women with concerns about vaccines. We will build upon existing knowledge of patient concerns to develop training in MI techniques with specific strategies to apply to maternal immunizations. The training intervention will include an online explainer video, two virtual interactive training modules, and provider reference sheets that can be used as an additional communication tool during the MI sessions with patients.

  12-18 months

Secondary Outcomes (2)

• To assess [acceptability, adoption and implementation] the MI4MI provider training program

  12-18 months

• To evaluate the impact of the MI4MI intervention on vaccine acceptance among pregnant women

  12-18 months

Study Arms (1)

Prevention, Maternal Immunization

EXPERIMENTAL

Behavioral: Prevention, Maternal Immunization

Interventions

Prevention, Maternal Immunization BEHAVIORAL

This intervention will be focused on behavior change, both through providers gaining context, knowledge, confidence, and skills in talking to pregnant mothers about vaccination during pregnancy, but also with patients having increased knowledge about immunization issues, and decreased anxiety about getting vaccinated. There is only one intervention arm in this study, and this study is looking at prevention in a pre-post feasibility study.

Prevention, Maternal Immunization

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Participants must be currently pregnant, therefore anatomically female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending ob-gyn practice in Colorado that is participating in the MI4MI project (5 total practices)
• Patients attending a pre-natal clinic visit at a participating practice during the intervention period who are eligible for maternal immunizations
• Pregnant patients who are less than 18 but 15 or more years of age will also be eligible to participate

You may not qualify if:

• Patients with hypersensitivity to any component of one of the recommended vaccines
• No subjects will be excluded because of ethnicity or insurance status.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Colorado at Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Brewer SE, Cataldi JR, Fisher M, Glasgow RE, Garrett K, O'Leary ST. Motivational Interviewing for Maternal Immunisation (MI4MI) study: a protocol for an implementation study of a clinician vaccine communication intervention for prenatal care settings. BMJ Open. 2020 Nov 17;10(11):e040226. doi: 10.1136/bmjopen-2020-040226.

  PMID: 33203635 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Tetanus; Diphtheria; Whooping Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections

Study Officials

• Sean O'Leary, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post feasibility study

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 10, 2020
• Study Start: May 27, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)