Clinical trial NCT04302675: Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)
Official title: Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Immunization
Keywords: Maternal Immunization
Immunization - Influenza
Immunization - Tdap
Tetanus
Diphtheria
Pertussis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-03-10
Enrollment: 1350
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post feasibility study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To develop the MI for maternal immunizations (MI4MI) provider training program
timeFrame: 12-18 months
Secondary outcomes:
measure: To assess [acceptability, adoption and implementation] the MI4MI provider training program
timeFrame: 12-18 months
measure: To evaluate the impact of the MI4MI intervention on vaccine acceptance among pregnant women
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sean O'Leary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.