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

Preventive Health Services (PREV HEALTH SERV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03885232
• Other study ID #: 17-1274
• Secondary ID: 1R01HD093628-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8620
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Preventive Health Services (PREV HEALTH SERV)

Intervention

Behavioral:
• Experimental: 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.

Other:
• Active Comparator: Control
Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (8)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child's Immunization Status	Immunization status will be obtained from either state's immunization registry or directly from the participating practices.	Child's immunization status at 19 months of age
Secondary	Parent Visit Experience Survey	To assess parent visit experience, we will administer surveys to all vaccine hesitant parents within 24-48 hours after the completion of their health supervision visit. (Update: Due to COVID-19 restrictions, we have extended the time frame to within 1 week after their health supervision visit)	Within 1 week after a health supervision visit
Secondary	Change in Provider Perception of Vaccine Discussion - Pre- Interim- and Post-Surveys	To assess provider perception of the vaccine discussion with parents, we will administer surveys to all study providers at baseline, interim and at study completion to establish changes in provider perception.	At Baseline (year 1), Interim (year 3) and Post-Intervention (years 4 and 5)