- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302675
Adapting Motivational Interviewing for Maternal Immunizations (MI4MI) (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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado at Denver and Health Sciences Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To develop the MI for maternal immunizations (MI4MI) provider training program
Time Frame: 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.
|
12-18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess [acceptability, adoption and implementation] the MI4MI provider training program
Time Frame: 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.
|
12-18 months
|
To evaluate the impact of the MI4MI intervention on vaccine acceptance among pregnant women
Time Frame: 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.
|
12-18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sean O'Leary, MD, MPH, University of Colorado, Denver
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19-1312
- 1R21AI141822-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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