Maternal ImmunizationMI4MINCT04302675
Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)
A study testing Prevention, Maternal Immunization in people with Maternal Immunization, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Immunization
- What is being tested?
- Prevention, Maternal Immunization
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with hypersensitivity to any component of one of the recommended vaccines
- No subjects will be excluded because of ethnicity or insurance status.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Maternal Immunization
- Being tested
- Prevention, Maternal Immunization
- Keywords
- Maternal Immunization, Immunization - Influenza, Immunization - Tdap, Tetanus, Diphtheria, Pertussis
- Medical subject headings
- Influenza, Human, Tetanus, Diphtheria, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention, Maternal ImmunizationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prevention, Maternal Immunization | Experimental | Not described Receives: Behavioral: Prevention, Maternal Immunization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-18 months
Secondary outcomes (2)
To assess [acceptability, adoption and implementation] the MI4MI provider training program
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.
Measured: 12-18 months
To evaluate the impact of the MI4MI intervention on vaccine acceptance among pregnant women
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.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start27 May 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal ImmunizationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post feasibility study
- Masking
- None (open label)
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean O'Leary, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302675
- Sponsor's protocol ID
- 19-1312
- Other IDs
- 1R21AI141822-01A1
- Acronym
- MI4MI
- Status last verified
- May 2023
- First submitted
- 25 Feb 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No - We do not plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 33203635
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)
- ClinicalTrials.gov ID
- NCT04302675
- Acronym / sponsor ID
- MI4MI / 19-1312
- Conditions
- Maternal Immunization
- Keywords
- Maternal Immunization, Immunization - Influenza, Immunization - Tdap, Tetanus, Diphtheria, Pertussis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 27 May 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post feasibility study
| Arm | Type | Receives |
|---|---|---|
| Prevention, Maternal Immunization | Experimental | Behavioral: Prevention, Maternal Immunization |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with hypersensitivity to any component of one of the recommended vaccines
- No subjects will be excluded because of ethnicity or insurance status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention, Maternal ImmunizationThis 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. | Behavioural | Prevention, Maternal Immunization |
Primary outcome
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.
2 secondary outcomes
To assess [acceptability, adoption and implementation] the MI4MI provider training program
Time frame: 12-18 months
To evaluate the impact of the MI4MI intervention on vaccine acceptance among pregnant women
Time frame: 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 33203635Brewer 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.
- Individual participant dataSharing planned: No. No - We do not plan to make individual participant data (IPD) available to other researchers.
Related trials for Maternal Immunization
RecruitingObservational study
Preparing for Maternal GBS Vaccine Trials in Africa
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Not yet recruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean O'Leary, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention, Maternal Immunization in people with Maternal Immunization, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop the MI for maternal immunizations (MI4MI) provider training program (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023; AzTrials last refreshed its copy on 29 Oct 2026.