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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667354
First Posted: August 17, 2012
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Seattle Children's Hospital
Washington State, Department of Health
WithinReach
Information provided by (Responsible Party):
Kaiser Permanente
  Purpose
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.

Condition Intervention
Childhood Vaccination Behavioral: Academic Detailing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Vaccine Hesitancy Intervention--Provider (VHIP)

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Parental Vaccine Hesitancy Measure [ Time Frame: Change from Baseline in Parental Hesitancy at 6 months ]
    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.


Secondary Outcome Measures:
  • Physician Self Efficacy Measure [ Time Frame: Change from Baseline in Physician Attitudes at 6 months ]
    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.


Enrollment: 491
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667354


Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
Seattle Children's Hospital
Washington State, Department of Health
WithinReach
Investigators
Principal Investigator: David Grossman, MD, MPH Kaiser Permanente
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01667354     History of Changes
Other Study ID Numbers: 250147
First Submitted: March 6, 2012
First Posted: August 17, 2012
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
Parental Childhood Vaccine Hesitancy

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs