Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)

Sponsor

University of Colorado, Denver (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04302675

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

1,500

Enrollment

Location

Arm

25.1

Anticipated Duration (Months)

59.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Immunization	Behavioral: Prevention, Maternal Immunization	N/A

Detailed Description

Pertussis and influenza are the most poorly controlled vaccine preventable diseases in the United States. Pregnant women have increased risk of severe disease from influenza and newborns have increased risk of severe disease from influenza and pertussis. The Advisory Committee on Immunization Practices and American College of Obstetricians and Gynecologists recommend women receive influenza and pertussis (Tdap) vaccine during each pregnancy, yet only about half of pregnant women receive these vaccines. Among identified barriers to maternal immunization are patient concerns about vaccine safety and effectiveness and lack of evidence for how ob-gyn providers can best communicate vaccine recommendations. Interventions to address these barriers and increase uptake of maternal immunizations are urgently needed. Motivational interviewing (MI) is a communication technique that has proven effective for changing health behaviors including increasing adolescent vaccination rates. MI is both time-effective and acceptable to providers. The long-term goal of this project is to adapt MI to the ob-gyn setting to improve influenza and Tdap vaccine uptake in pregnancy. There is evidence to support use of MI for childhood immunizations; however it is unknown if MI is feasible and acceptable among ob-gyn providers and pregnant women. The investigators propose a pragmatic practice-based study in 5 Colorado ob-gyn practices to develop the MI for maternal immunizations (MI4MI) intervention and assess acceptability, adoption and implementation 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 MI for childhood immunizations to develop the MI4MI training. During development, the investigators will conduct focus groups for provider input and [organizational context. 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 MI4MI acceptability, adoption, and implementation. The study team will utilize patient "card study" surveys to assess the patient perspective of intervention acceptability. Patient surveys will be given to each pregnant patient seen for a prenatal visit during a 2-week period. We will interview up to 8 patient per practice after they fill out their card study to learn more about their interactions with providers and conversations around maternal immunizations. The investigators will conduct post-intervention provider focus groups to assess acceptability and adoption of the MI training intervention. The study team will also conduct pre-, interim-, and post-intervention surveys among providers to assess time spent and self-efficacy in vaccine communication. Providers will receive Maintenance of Certification or Continuing Medical Education credit for participation. In Aim 2a, investigators will conduct pre- and post-intervention chart reviews in study practices to evaluate the impact of MI4MI on influenza and Tdap vaccine uptake in pregnant patients. This study will provide data for a larger implementation study with rigorous assessment of the effectiveness of MI4MI in increasing maternal immunization uptake in the future.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre-post feasibility studyPre-post feasibility study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)

Actual Study Start Date :

May 27, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prevention, Maternal Immunization	Behavioral: Prevention, Maternal Immunization 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.

Arm

Intervention/Treatment

Experimental: Prevention, Maternal Immunization

Behavioral: Prevention, Maternal Immunization

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.

Outcome Measures

Primary Outcome Measures

To develop the MI for maternal immunizations (MI4MI) provider training program [12-18 months]
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.

Secondary Outcome Measures

To assess [acceptability, adoption and implementation] the MI4MI provider training program [12-18 months]
We will conduct a pragmatic pilot study implementing the intervention in 5 Colorado ob-gyn practices. We will survey patients on their vaccine conversations with providers and interview up to 8 patients per practice to assess fidelity and adaptation of the intervention. These surveys will be conducted using a method known as a card study. Information gathered in the patient survey and subsequent interview will assess the acceptability of the intervention among patients who accept and refuse vaccines. We will conduct post-intervention focus groups among providers to assess the acceptability [and adoption] of the MI training intervention.
To evaluate the impact of the MI4MI intervention on vaccine acceptance among pregnant women [12-18 months]
To assess [effectiveness], we will conduct chart reviews of study practices to compare Tdap and influenza vaccination rates in pregnant women pre- and post-intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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