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
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 - 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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