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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
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adolescent Immunizations Preventive Care Other: outreach services Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : October 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Outreach
Receives outreach services
 Other: outreach services
Tracking/reminder/recall/home visit strategy.
No Intervention: Standard of Care
Receives standard medical care provided by primary care practice.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 11-15 years of age
  • receive medical care at one of the 9 pediatric or family medicine practices identified as study sites
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581347


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Peter Szilagyi, MD University of Rochester
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00581347    
Other Study ID Numbers: PCAIR
OPP-P-2006-24
First Posted: December 27, 2007    Key Record Dates
Results First Posted: October 1, 2010
Last Update Posted: September 23, 2016
Last Verified: August 2016