Clinical trial NCT03885232: Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
Official title: Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Health Services (PREV HEALTH SERV)
Keywords: Communication
Immunization
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Missouri, Kansas City
name: Portland State University
name: University of Washington
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institutes of Health (NIH)
name: Seattle Children's Hospital
name: Children's Mercy Hospital Kansas City
First posted: 2019-03-21
Enrollment: 17446
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)
timeFrame: Child's immunization status at 19 months of age
Secondary outcomes:
measure: Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale
timeFrame: approximately 6 months post birth
measure: Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys
timeFrame: At Baseline and Post-Intervention (up to 2 years after baseline)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Colorado, Denver
name: Sean O'Leary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Douglas Opel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.