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CompletedNCT01667354VHIPUpdated Oct 13, 2017

Vaccine Hesitancy Intervention--Provider (VHIP)

An interventional study of Academic Detailing in Childhood Vaccination, sponsored by Kaiser Permanente. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-10-13.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
491
Allocation
Randomized
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Childhood Vaccination

Keywords

  • Parental Childhood Vaccine Hesitancy
03

In context

Lead sponsor

Kaiser Permanente is the lead sponsor of 392 studies on the registry; 42 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
491 participants (actual)

Study arms

  • 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

  • No intervention
    Control Clinics

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

Interventions

  • BehavioralAcademic 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.

06

What researchers measure

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.

    Time frame: Change from Baseline in Parental Hesitancy at 6 months

Secondary outcomes

  1. 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.

    Time frame: Change from Baseline in Physician Attitudes at 6 months

07

Study locations

1 site
  • Group Health Research Institute
    Seattle, Washington 98101, United States
08

References and documents

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. PubMed 26034240 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Oct 2013 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2012
First posted
Aug 17, 2012
Start
Feb 2012
Primary completionActual
Oct 2013
CompletionActual
Apr 2014
Last update
Oct 13, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01667354
Lead sponsor
Kaiser Permanente
Collaborators
Seattle Children's Hospital, Washington State, Department of Health, WithinReach
Responsible party
Sponsor
First posted
Aug 17, 2012
Start date
Feb 2012
Primary completion
Oct 2013
Completion
Apr 2014
Last update
Oct 13, 2017

Study contacts

David Grossman, MD, MPH
principal investigator · Kaiser Permanente

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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