Vaccine Hesitancy Intervention--Provider (VHIP) (VHIP)

The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy.

Study Overview

• Status: Completed
• Conditions: Childhood Vaccination
• Intervention / Treatment: Behavioral: Academic Detailing

Detailed Description

The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy. The investigators will train primary care teams with an initial training followed by telephone coaching and follow-up visits, and assess the outcomes of parental vaccine hesitancy (primary) and physician self-efficacy (secondary) at baseline and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Study population:

• Eligible pediatric and family medicine practices in three counties in Washington State; King, Pierce and Snohomish Counties.
• Mothers whose infants will receive care in participating clinics.

Inclusion Clinics:

• Located in King, Snohomish, Pierce Counties, WA;
• Family practice clinics;
• Pediatric practice clinics;
• Order > 1000 doses of vaccine in 2009 from State of Washington Department of Health.

Exclusion Clinics: Not willing to be randomized.

Inclusion Mothers:

• Babies born at participating hospitals;
• Mother can be recruited before discharged post-birth;
• Mothers declare pediatric care at one of participating clinics;
• Singleton or twin pregnancies.

Exclusion Mothers:

• Babies born < 36 weeks gestational age;
• Known medical vaccine contraindications;
• Parental age < 18;
• NICU;
• Triplet or more;
• Maternal complications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Clinics; Providers in intervention clinics will receive a training followed by telephone coaching and follow-up visits for six months.	Behavioral: Academic Detailing; The intervention design is based on "academic detailing," an effective method of changing physician behavior. The aim of the training is effective communication with parents who are hesitant about childhood vaccinations.
No Intervention: Control Clinics; Control clinics will receive all intervention materials at the completion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Vaccine Hesitancy Measure	The investigators will contact mothers of newborns in study practices and conduct a telephone survey at two time points: baseline and 6 months. Surveys will assess parental hesitancy, parental trust in provider, and other covariates such as perceived social norms, other sources of information about vaccines, and demographic information.	Change from Baseline in Parental Hesitancy at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Self Efficacy Measure	Assessed via self-administered surveys of providers in all participating clinics at baseline and 6-months. The investigators will measure physician attitudes, perceived norms, intentions to change behavior, practice characteristics, and physician demographics.	Change from Baseline in Physician Attitudes at 6 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Seattle Children's Hospital; Washington State, Department of Health; WithinReach
• Investigators: Principal Investigator: David Grossman, MD, MPH, Kaiser Permanente

Publications and helpful links

General Publications

• Henrikson NB, Opel DJ, Grothaus L, Nelson J, Scrol A, Dunn J, Faubion T, Roberts M, Marcuse EK, Grossman DC. Physician Communication Training and Parental Vaccine Hesitancy: A Randomized Trial. Pediatrics. 2015 Jul;136(1):70-9. doi: 10.1542/peds.2014-3199. Epub 2015 Jun 1.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Parental Childhood Vaccine Hesitancy
• Other Study ID Numbers: 250147