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

NCT03885232 | Completed Results

• 2 other identifiers: 17-12741R01HD093628-01A1
• Study Type: interventional
• Target: 17,446
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Communication; Immunization

Outcome Measures

Primary Outcomes (1)

• Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)

  Immunization status was obtained from WA or CO state immunization registry or directly from participating practices. At enrollment, parent/infant dyads completed the Parental Attitudes about Childhood Vaccines short version (PACV-SF), a validated survey scored from 0 to 4. A score of 2 or more represented parent/infant dyad with negative vaccine attitudes. Among parent/infant dyads with negative vaccine attitudes, the child's immunization status at 19 months was calculated based on recommended ages and intervals between doses provided by ACIP for summing late days for each dose of the 8 routine vaccines recommended by 19 months (HepB, rotavirus, DTaP, Hib, pneumococcal conjugate, inactivated polio virus, MMR, and varicella). There was a max of 23 recommended doses for the 8 vaccines - doses varied depending on brand. Total max DUI was a sum of total possible days late for each dose through 19mo(2830 days).Percent DUI was calculated by dividing child's DUI by the total maximum DUI.

  Child's immunization status at 19 months of age

Secondary Outcomes (2)

• Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale

  approximately 6 months post birth

• Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys

  At Baseline and Post-Intervention (up to 2 years after baseline)

Study Arms (2)

PIVOT with MI

EXPERIMENTAL

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

Behavioral: Experimental: PIVOT with MI

Control

ACTIVE COMPARATOR

Clinics delivered standard care.

Other: Active Comparator: Control

Interventions

Experimental: PIVOT with MI 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.

PIVOT with MI

Active Comparator: Control OTHER

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

Control

Eligibility Criteria

• Age: 1 Day - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Missouri, Kansas City: collaborator
• Portland State University: collaborator
• University of Washington: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institutes of Health (NIH): collaborator
• Seattle Children's Hospital: collaborator
• Children's Mercy Hospital Kansas City: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• Opel DJ, Robinson JD, Zhou C, Colborn K, Spielvogle H, Furniss A, Spina C, Perreira C, O'Leary ST. Tiered Clinician Vaccine Communication Strategy to Improve Childhood Vaccine Uptake: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257814. doi: 10.1001/jamanetworkopen.2025.7814.

  PMID: 40305020 DERIVED

• Opel DJ, Robinson JD, Spielvogle H, Spina C, Garrett K, Dempsey AF, Perreira C, Dickinson M, Zhou C, Pahud B, Taylor JA, O'Leary ST. 'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention. BMJ Open. 2020 Aug 11;10(8):e039299. doi: 10.1136/bmjopen-2020-039299.

  PMID: 32784263 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Sean O'Leary, MD, MPH - Principal Investigator
• Organization: University of Colorado at Anschutz Medical Campus

sean.oleary@cuanschutz.edu

(303)724-1582

Study Officials

• Sean O'Leary, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Douglas Opel, MD, MPH

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data Analysis study team members and parent participants will be masked to study assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 21, 2019
• Study Start: September 1, 2019
• Primary Completion: May 17, 2023
• Study Completion: July 31, 2024
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)