Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03885232
Enrollment
17446
Registered
2019-03-21
Start date
2019-09-01
Completion date
2024-07-31
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preventive Health Services (PREV HEALTH SERV)

Keywords

Communication, Immunization

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.

Detailed description

The primary goal of this covariate constrained, cluster randomized controlled trial is to evaluate the effectiveness of an innovative provider communication strategy (PIVOT-MI) intervention in improving provider-parent vaccine discussions and increasing vaccine acceptance. Providers at intervention clinics will be trained to use 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. Providers at control clinics will deliver care as usual. Specific aims are to evaluate the impact of PIVOT-MI, relative to control, on (1) child's immunization status; (2) parent-rated visit experience with their child's provider; and (3) change in provider experience of the vaccine discussion with vaccine-hesitant parents.

Interventions

BEHAVIORALExperimental: 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.

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Data Analysis study team members and parent participants will be masked to study assignment.

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)Child's immunization status at 19 months of ageImmunization 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.

Secondary

MeasureTime frameDescription
Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scaleapproximately 6 months post birthTo 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.
Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-SurveysAt 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 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
PIVOT With MI
Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented.
9,905
Control
Care delivered as usual.
7,541
Total17,446

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up7432
Overall StudyStaff turnover at enrolled clinics3223

Baseline characteristics

CharacteristicPIVOT With MIControlTotal
Age, Categorical
Parent/Infant Dyads
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Parent/Infant Dyads
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Parent/Infant Dyads
Between 18 and 65 years
4889 Participants3728 Participants8617 Participants
Ethnicity (NIH/OMB)
Clinicians
Hispanic or Latino
3 Participants5 Participants8 Participants
Ethnicity (NIH/OMB)
Clinicians
Not Hispanic or Latino
123 Participants79 Participants202 Participants
Ethnicity (NIH/OMB)
Clinicians
Unknown or Not Reported
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Parent/Infant Dyads
Hispanic or Latino
551 Participants460 Participants1011 Participants
Ethnicity (NIH/OMB)
Parent/Infant Dyads
Not Hispanic or Latino
4,162 Participants3158 Participants7320 Participants
Ethnicity (NIH/OMB)
Parent/Infant Dyads
Unknown or Not Reported
176 Participants110 Participants286 Participants
Race (NIH/OMB)
Clinicians
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Clinicians
Asian
13 Participants8 Participants21 Participants
Race (NIH/OMB)
Clinicians
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Clinicians
More than one race
6 Participants2 Participants8 Participants
Race (NIH/OMB)
Clinicians
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Clinicians
Unknown or Not Reported
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Clinicians
White
106 Participants74 Participants180 Participants
Race (NIH/OMB)
Parent/Infant Dyads
American Indian or Alaska Native
62 Participants28 Participants90 Participants
Race (NIH/OMB)
Parent/Infant Dyads
Asian
228 Participants358 Participants586 Participants
Race (NIH/OMB)
Parent/Infant Dyads
Black or African American
85 Participants63 Participants148 Participants
Race (NIH/OMB)
Parent/Infant Dyads
More than one race
188 Participants142 Participants330 Participants
Race (NIH/OMB)
Parent/Infant Dyads
Native Hawaiian or Other Pacific Islander
14 Participants19 Participants33 Participants
Race (NIH/OMB)
Parent/Infant Dyads
Unknown or Not Reported
315 Participants187 Participants502 Participants
Race (NIH/OMB)
Parent/Infant Dyads
White
3997 Participants2931 Participants6928 Participants
Region of Enrollment
United States
9905 participants7541 participants17446 participants
Sex/Gender, Customized
Clinicians
Female
88 Participants61 Participants149 Participants
Sex/Gender, Customized
Clinicians
Male
39 Participants24 Participants63 Participants
Sex/Gender, Customized
Clinicians
Unknown
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Parent/Infant Dyads
Female
4138 Participants3200 Participants7338 Participants
Sex/Gender, Customized
Parent/Infant Dyads
Male
567 Participants425 Participants992 Participants
Sex/Gender, Customized
Parent/Infant Dyads
Unknown
184 Participants103 Participants287 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 5,0160 / 3,813
other
Total, other adverse events
0 / 5,0160 / 3,813
serious
Total, serious adverse events
0 / 5,0160 / 3,813

Outcome results

Primary

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.

Time frame: 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)

ArmMeasureValue (MEAN)Dispersion
PIVOT With MI: Parent/Caregiver and Infant DyadChild Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)32 percentage of days under-immunizedStandard Deviation 38
Control: Parent/Caregiver and Infant DyadChild Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)24 percentage of days under-immunizedStandard Deviation 32
p-value: 0.995% CI: [0.68, 1.6]Generalized linear mixed effects regress
Secondary

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

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.

Time frame: 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)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PIVOT With MI: Parent/Caregiver and Infant DyadChange in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-SurveysBaseline Survey Results54 Participants
PIVOT With MI: Parent/Caregiver and Infant DyadChange in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-SurveysPost-Study Survey Results23 Participants
Control: Parent/Caregiver and Infant DyadChange in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-SurveysBaseline Survey Results39 Participants
Control: Parent/Caregiver and Infant DyadChange in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-SurveysPost-Study Survey Results20 Participants
Comparison: 1. Ho: No difference in the proportion of clinicians using presumptive and Motivational Interviewing techniques between intervention and control.~2. Ho: No difference in the proportion of clinicians time spent talking to vaccine hesitant parents between intervention and control.p-value: <0.0595% CI: [0.66, 5.64]Generalized linear mixed effects regress
Secondary

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

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
PIVOT With MI: Parent/Caregiver and Infant DyadPost-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale96 % of participants scoring 4 or higher
Control: Parent/Caregiver and Infant DyadPost-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale96 % of participants scoring 4 or higher
Comparison: Calculated individual survey means for vaccine hesitant parents who participated in the survey. Survey consisted of 15 questions with a 7-point Likert scale. We then created a dichotomous variable where 1 = mean \> or equal to 6; 0 = mean \< 6.p-value: <0.05Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026