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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01984125
Other study ID # IP000312
Secondary ID
Status Completed
Phase N/A
First received November 7, 2013
Last updated April 28, 2017
Start date April 2011
Est. completion date December 2013

Study information

Verified date April 2017
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although most US adolescents visit their primary care doctor, their immunization rates are low. Primary care practices from two networks, one in upstate New York as well as a national network of pediatric clinics were surveyed to ask what they thought was the best strategy to increase immunization rates. Point-of-care prompts (either by an electronic health record message or by a nurse) when an adolescent patient comes in for any type of visit and is due for a vaccine was chosen. This study will determine if these prompts will increase immunization rates after a 12-month intervention period.


Recruitment information / eligibility

Status Completed
Enrollment 7040
Est. completion date December 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria:

- Adolescents aged 11 - 18 who had a visit to their primary care provider during the 12 month intervention period

Exclusion Criteria:

- Adolescent is pregnant during intervention time period

Study Design


Intervention

Other:
Point-of-Care Prompt


Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Boston Children's Boston Massachusetts
United States Oak Orchard Community Health Center Brockport New York
United States Children's Memorial Hospital - Northwestern University Chicago Illinois
United States Nationwide Children's Hospital Columbus Ohio
United States University of Florida Gainesville Florida
United States Honeoye Falls Family Medicine Honeoye Falls New York
United States Baylor College of Medicine, Texas Children's Hospital Houston Texas
United States University of Texas - Houston Houston Texas
United States University of Iowa Hospital Iowa City Iowa
United States University of Arkansas - Arkansas Children's Hospital Little Rock Arkansas
United States Mendon Pediatrics Mendon New York
United States 12 Corner Pediatrics Rochester New York
United States English Road Pediatrics Rochester New York
United States Goodman Pediatrics Rochester New York
United States Long Pond Pediatrics Rochester New York
United States Parkway Pediatrics Rochester New York
United States Ridgewood Med-Peds Rochester New York
United States Westside Pediatrics Rochester New York
United States St. Louis University - School of Medicine Saint Louis Missouri
United States University of Washington Medical Center Seattle Washington
United States Wilmington Hospital Health Center Wilmington Delaware

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

Szilagyi PG, Serwint JR, Humiston SG, Rand CM, Schaffer S, Vincelli P, Dhepyasuwan N, Blumkin A, Albertin C, Curtis CR. Effect of provider prompts on adolescent immunization rates: a randomized trial. Acad Pediatr. 2015 Mar-Apr;15(2):149-57. doi: 10.1016/ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adolescent Immunization Rates Bivariate analysis will measure the overall change between the control and intervention groups. Vaccination rates will be summarized using descriptive statistics. As appropriate, two sample t-test or chi-square tests will be used to summarize patient level data. Odds ratio with associated 95% confidence interval will be reported within each of the 2 networks. One Year
Secondary Missed Opportunities A hierarchical logistic regression model will evaluate the intervention effect on rates of missed opportunities. One Year
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