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Primary Care and Adolescent Immunization for Rochester (PCAIR)

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00581347
First received: December 19, 2007
Last updated: September 14, 2010
Last verified: September 2008

December 19, 2007
September 14, 2010
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Adolescent Immunizations
  • Preventive Care
Other: outreach services
Tracking/reminder/recall/home visit strategy.
  • 1
    Receives outreach services
    Intervention: Other: outreach services
  • No Intervention: 2
    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.
 
Completed
7546
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
Both
11 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581347
PCAIR, OPP-P-2006-24
Not Provided
Peter Szilagyi, MD, MPH/ Principal Investigator, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Peter Szilagyi, MD University of Rochester
University of Rochester
September 2008

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