N/A
N=17,446
Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
Preventive Health Services (PREV HEALTH SERV)
Bottom Line
View on ClinicalTrials.gov: NCT03885232 ↗Enrolled (actual)
17,446
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) — 32; 24 percentage of days under-immunized — p=0.9
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental: PIVOT with MI (Behavioral); Active Comparator: Control (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) |
32; 24 | 0.9 |
| SECONDARY Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale |
96; 96 | <0.05 sig |
| SECONDARY Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys |
54; 39; 23; 20 | <0.05 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03885232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.