Adults 1 Day to 18 Months, any sex, with Preventive Health Services (PREV HEALTH SERV). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)Primary· Child's immunization status at 19 months of age
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 routin
Group
Value
95% CI
PIVOT With MI: Parent/Caregiver and Infant Dyad
32
± 38
Control: Parent/Caregiver and Infant Dyad
24
± 32
Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert ScaleSecondary· approximately 6 months post birth
To assess parental satisfaction with their clinician during a health supervision visit, we asked all vaccine hesitant parents (identified by a Parental Attitudes about Childhood Vaccines-Short Form (PAC-V SF) score of 2 or more) in both both intervention and control arms if they would complete an additional 15-question survey over the phone within 24-48 hours after the completion of a health supervision visit for their child around 6 months of age. Due to COVID-19 restrictions, we had to extend the time frame to within 1 week after a health supervision visit at 2, 4, or 6 months of age. Rating
Group
Value
95% CI
PIVOT With MI: Parent/Caregiver and Infant Dyad
96
Control: Parent/Caregiver and Infant Dyad
96
Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-SurveysSecondary· At Baseline and Post-Intervention (up to 2 years after baseline)
To assess changes in clinicians' perceived self-efficacy when discussing vaccines with parents/infant dyads with negative vaccine attitudes, a survey was administered to all participating clinicians at baseline and at study completion asking about vaccine recommendation behaviors and how they perceived their impact on parental decision making regarding vaccines. Self-efficacy was assessed with a 3-part question scored on a Likert Scale - Strongly Disagree, Somewhat Disagree, Somewhat Agree, Strongly Agree. Changes in perceived self-efficacy over time was assessed by comparing the number of cli
Baseline Survey Results
Group
Value
95% CI
PIVOT With MI: Clinicians
54
Control: Clinicians
39
Post-Study Survey Results
Group
Value
95% CI
PIVOT With MI: Clinicians
23
Control: Clinicians
20
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 30 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03885232.