Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vaccine Hesitancy Intervention--Provider (VHIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Seattle Children's Hospital
Washington State, Department of Health
WithinReach
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01667354
First received: March 6, 2012
Last updated: July 22, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Vaccine Hesitancy Intervention--Provider (VHIP)

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Parental Vaccine Hesitancy Measure [ Time Frame: Change from Baseline in Parental Hesitancy at 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: February 2012
Estimated Study Completion Date: April 2014
Estimated 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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667354

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

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01667354     History of Changes
Other Study ID Numbers: 250147
Study First Received: March 6, 2012
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Parental Childhood Vaccine Hesitancy

ClinicalTrials.gov processed this record on November 24, 2014