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Primary Care and Adolescent Immunization for Rochester (PCAIR)

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.
ClinicalTrials.gov Identifier: NCT00581347
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : October 1, 2010
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):

December 19, 2007
December 27, 2007
August 12, 2010
October 1, 2010
September 23, 2016
October 2007
December 2008   (Final data collection date for primary outcome measure)
Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) [ Time Frame: 15 months ]
We compared the number of participants in the intervention group who received vaccinations for Tdap, Menactra, and (for girls only) HPV at the end of the study period versus those in the control group.
Adolescent immunization (Tdap, Menactra, HPV) [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00581347 on ClinicalTrials.gov Archive Site
Receipt of a Well Child Visit Within a 12 Month Period [ Time Frame: 1 year ]
We compared the number of participants in the intervention group who received a well child visit within a 12 month period versus those in the control group.
Well Child Visit [ Time Frame: 1 year ]
Not Provided
Not Provided
Primary Care and Adolescent Immunization for Rochester
Not Provided
This study will examine whether the implementation of an outreach program that employs a tracking/reminder/recall/home visiting strategy will have any impact on receipt of immunizations and preventive care among urban adolescents.

Outreach workers will be placed at 9 primary care pediatric and family medicine practices throughout one urban area. Adolescent patients at these 9 practices will be identified and then randomized into two groups; (1) those receiving outreach intervention during Year 1 of the study and (2) those receiving outreach intervention during Year 2 of the study. Randomization will be stratified by practice site, patient age, and patient gender.

After randomization, the list of Year 1 subjects will be distributed to the appropriate outreach worker. The outreach worker will track the immunization status of 11-15yo patients within their practice, identify patients who are eligible for but have not yet received immunizations recommended for their age group (MMR, Varicella, Hepatitis B, HPV, Meningococcal Conjugate, Tdap) and/or a well child visit within the past year, and then attempt to connect these patients with medical care through three levels of outreach activity. First level of outreach activity involves contacting the parent/guardian of the patient by telephone. Outreach workers will attempt to inform patient's parent/guardian of needed immunizations/preventive visit and facilitate the scheduling of a medical appointment. If unable to successfully complete the task through telephone contact, outreach workers will initiate the second level of outreach activity - contact by mail. If contact by mail is unsuccessful, the third and most intense level of outreach activity will be implemented. The outreach worker will attempt to notify the patient's parent/guardian of need for immunization/preventive appointment by visiting the patient's listed home address. During this visit, the outreach worker will attempt to inform the parent/guardian of recommended immunizations, provide information pertaining to these immunizations, facilitate appointment scheduling, and assist patient in compliance with scheduled medical appointment

Interventions directed towards the subjects of the Year 1 group will cease after 15 months of outreach activity. A chart review of intervention and control groups will be conducted to determine immunization and well child visit rates within the two groups. At this time, the tracking/reminder/recall/home visiting strategy employed with the Year 1 group will be repeated for Year 2 subjects.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Adolescent Immunizations
  • Preventive Care
Other: outreach services
Tracking/reminder/recall/home visit strategy.
  • Outreach
    Receives outreach services
    Intervention: Other: outreach services
  • No Intervention: Standard of Care
    Receives standard medical care provided by primary care practice.
Szilagyi PG, Humiston SG, Gallivan S, Albertin C, Sandler M, Blumkin A. Effectiveness of a citywide patient immunization navigator program on improving adolescent immunizations and preventive care visit rates. Arch Pediatr Adolesc Med. 2011 Jun;165(6):547-53. doi: 10.1001/archpediatrics.2011.73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 11-15 years of age
  • receive medical care at one of the 9 pediatric or family medicine practices identified as study sites
Sexes Eligible for Study: All
11 Years to 15 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Peter Szilagyi, MD University of Rochester
University of California, Los Angeles
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP