Trial Outcomes & Findings for Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI) (NCT NCT03885232)

Last Updated: 2025-04-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

17446 participants

Primary outcome timeframe

Child's immunization status at 19 months of age

Results posted on

2025-04-30

Participant Flow

Unit of analysis: clinics

Participant milestones

Participant milestones
Measure	PIVOT With MI Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy was implemented.	Control Clinics delivered standard care.
Overall Study STARTED	9905 12	7541 12
Overall Study Participants Are Clinicians	127 12	85 12
Overall Study Participants Are Parents Within the Parent/Infant Dyads	4889 12	3728 12
Overall Study Participants Are Infants Within the Parent/Infant Dyads	4889 12	3728 12
Overall Study COMPLETED	9799 12	7486 12
Overall Study NOT COMPLETED	106 0	55 0

Reasons for withdrawal

Reasons for withdrawal
Measure	PIVOT With MI Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy was implemented.	Control Clinics delivered standard care.
Overall Study Lost to Follow-up	74	32
Overall Study Staff turnover at enrolled clinics	32	23

Baseline Characteristics

Data was collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants. Age was not a measure collected for clinicians.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Child's immunization status at 19 months of age

Population: Infants of parents/caregivers who had negative vaccine attitudes (Parental Attitudes about Childhood Vaccines short form (PACV-SF) score of 2 or higher)

Outcome measures

Outcome measures
Measure	PIVOT With MI: Parent/Caregiver and Infant Dyad n=586 Participants Parent/Caregiver and Infant dyads at participating clinics trained to use the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy.	Control: Parent/Caregiver and Infant Dyad n=351 Participants Parent/Caregiver and Infant dyads at participating clinics in the control arm who received care as usual.
Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)	32 percentage of days under-immunized Standard Deviation 38	24 percentage of days under-immunized Standard Deviation 32

SECONDARY outcome

Timeframe: approximately 6 months post birth

Population: A subset of parent/infant dyads in both intervention and control clinics who were identified as vaccine hesitant (score of 2 or more on the Parental Attitudes about Childhood Vaccines short form (PACV-SF)) and who completed the post-healthcare visit satisfaction survey.

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. Ratings were on a 7-point Likert scale - Very Poor (1), Poor (2), Fair (3), Good (4), Very Good (5), Excellent (6), Outstanding (7). Overall experience with a rating of "Good (4)" or higher was considered to be a satisfactory visit.

Outcome measures

Outcome measures
Measure	PIVOT With MI: Parent/Caregiver and Infant Dyad n=73 Participants Parent/Caregiver and Infant dyads at participating clinics trained to use the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy.	Control: Parent/Caregiver and Infant Dyad n=46 Participants Parent/Caregiver and Infant dyads at participating clinics in the control arm who received care as usual.
Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale	96 % of participants scoring 4 or higher	96 % of participants scoring 4 or higher

SECONDARY outcome

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

Population: Clinicians enrolled across n=24 clinics (n=12 intervention clinics; n=12 control clinics)

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 clinicians who answered "Strongly Agree" or "Somewhat Agree" to the statement "When parents wish to delay or refuse childhood vaccines for their child, there is not much I can say to change their minds" at baseline and at post-study. Note that fewer clinicians completed the post-study survey due to such factors as retirement and staff turnover.

Outcome measures

Outcome measures
Measure	PIVOT With MI: Parent/Caregiver and Infant Dyad n=127 Participants Parent/Caregiver and Infant dyads at participating clinics trained to use the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy.	Control: Parent/Caregiver and Infant Dyad n=85 Participants Parent/Caregiver and Infant dyads at participating clinics in the control arm who received care as usual.
Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys Baseline Survey Results	54 Participants	39 Participants
Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys Post-Study Survey Results	23 Participants	20 Participants

Adverse Events

PIVOT With MI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sean O'Leary, MD, MPH - Principal Investigator

University of Colorado at Anschutz Medical Campus

Phone: (303)724-1582

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place