NCT01667354

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

March 6, 2012

Last Update Submit

October 11, 2017

Conditions

Keywords

Parental Childhood Vaccine Hesitancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Physician Self Efficacy Measure

    Change from Baseline in Physician Attitudes at 6 months

Study Arms (2)

Intervention Clinics

EXPERIMENTAL

Providers in intervention clinics will receive a training followed by telephone coaching and follow-up visits for six months.

Behavioral: Academic Detailing

Control Clinics

NO INTERVENTION

Control clinics will receive all intervention materials at the completion of the study.

Interventions

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.

Intervention Clinics

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • 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 Officials

  • David Grossman, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

August 17, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

April 1, 2014

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations