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

NCT03885232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17446

Last updated 2025-04-30

Study results available
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Summary

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.

Conditions

  • Preventive Health Services (PREV HEALTH SERV)

Interventions

BEHAVIORAL

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.

OTHER

Active Comparator: Control

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

Sponsors & Collaborators

  • University of Missouri, Kansas City

    collaborator OTHER
  • Portland State University

    collaborator OTHER
  • University of Washington

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • National Institutes of Health (NIH)

    collaborator NIH
  • Seattle Children's Hospital

    collaborator OTHER
  • Children's Mercy Hospital Kansas City

    collaborator OTHER
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Sean O'Leary, MD, MPH · University of Colorado, Denver

  • Douglas Opel, MD, MPH · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-05-17
Completion
2024-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03885232 on ClinicalTrials.gov