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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01667354
Other study ID # 250147
Secondary ID
Status Completed
Phase N/A
First received March 6, 2012
Last updated October 11, 2017
Start date February 2012
Est. completion date April 2014

Study information

Verified date October 2017
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 491
Est. completion date April 2014
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Group Health Research Institute Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
Kaiser Permanente Seattle Children's Hospital, Washington State, Department of Health, WithinReach

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT01770496 - Age-Specific Strategies for Immunization Reminders and Recalls N/A
Completed NCT05425823 - Intervention to Promote Childhood Vaccinations and Influence Vaccination Attitudes N/A