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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2024-07-31

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.

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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.

Conditions

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Preventive Health Services (PREV HEALTH SERV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Data Analysis study team members and parent participants will be masked to study assignment.

Study Groups

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PIVOT with MI

Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented.

Group Type EXPERIMENTAL

Experimental: PIVOT with MI

Intervention Type BEHAVIORAL

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.

Control

Clinics delivered standard care.

Group Type ACTIVE_COMPARATOR

Active Comparator: Control

Intervention Type OTHER

Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.

Interventions

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Experimental: PIVOT with MI

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.

Intervention Type BEHAVIORAL

Active Comparator: Control

Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.

Intervention Type OTHER

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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No