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
  Purpose

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 Intervention
Adolescent Immunizations
Preventive Care
Other: outreach services

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 7546
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Receives outreach services
Other: outreach services
Tracking/reminder/recall/home visit strategy.
No Intervention: 2
Receives standard medical care provided by primary care practice.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581347

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Peter Szilagyi, MD University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Szilagyi, MD, MPH/ Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00581347     History of Changes
Other Study ID Numbers: PCAIR, OPP-P-2006-24
Study First Received: December 19, 2007
Results First Received: August 12, 2010
Last Updated: September 14, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014