Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)

Study Overview
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Brief Summary
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The overall goal of this project is to determine whether a novel and innovative provider communication strategy is effective in improving vaccine acceptance among vaccine-hesitant parents (VHPs) and visit experience among VHPs and their health care providers.

Detailed Description
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The primary goal of this covariate constrained, cluster randomized controlled trial is to evaluate the effectiveness of an innovative provider communication strategy (PIVOT-MI) intervention in improving provider-parent vaccine discussions and increasing vaccine acceptance. Providers at intervention clinics will be trained to use the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents, followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Providers at control clinics will deliver care as usual. Specific aims are to evaluate the impact of PIVOT-MI, relative to control, on (1) child's immunization status; (2) parent-rated visit experience with their child's provider; and (3) change in provider experience of the vaccine discussion with vaccine-hesitant parents.

Official Title
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Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)

Conditions
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Preventive Health Services (PREV HEALTH SERV)

Intervention / Treatment
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* Behavioral: Experimental: PIVOT with MI
* Other: Active Comparator: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents: must be English or Spanish speaking, ≥18 years old, have an infant ≤18 months old, have legal guardianship of the infant, and is receiving pediatric care at an enrolled clinic Providers: All providers at participating study practices will be eligible to participate. Exclusion Criteria: Parents: not English or Spanish speaking, under 18 years old, have an infant older than 18 months, not the legal guardian of the infant, and/or having a child who is not receiving pediatric care at an enrolled clinic. Providers: Providers who are not at participating study practices.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIVOT with MI<br>Clinics with providers trained in the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing intervention (PIVOT with MI) | Behavioral: Experimental: PIVOT with MI<br>* Providers in participating intervention clinics will be trained in the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Parent participants will receive PIVOT-MI.<br>|
| Active Comparator: Control<br>Control-Care as usual | Other: Active Comparator: Control<br>* Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's Immunization Status | Immunization status will be obtained from either state's immunization registry or directly from the participating practices. | Child's immunization status at 19 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Visit Experience Survey | To assess parent visit experience, we will administer surveys to all vaccine hesitant parents within 24-48 hours after the completion of their health supervision visit. (Update: Due to COVID-19 restrictions, we have extended the time frame to within 1 week after their health supervision visit) | Within 1 week after a health supervision visit | 
| Change in Provider Perception of Vaccine Discussion - Pre- Interim- and Post-Surveys | To assess provider perception of the vaccine discussion with parents, we will administer surveys to all study providers at baseline, interim and at study completion to establish changes in provider perception. | At Baseline (year 1), Interim (year 3) and Post-Intervention (years 4 and 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Communication, Immunization