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Primary Care and Adolescent Immunization for Rochester (PCAIR)
This study is currently recruiting participants.
Verified by University of Rochester, September 2008
First Received: December 19, 2007   Last Updated: September 29, 2008   History of Changes
Sponsored by: University of Rochester
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00581347
  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: Health Services Research, Randomized, Open Label, Parallel Assignment

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Adolescent immunization (Tdap, Menactra, HPV) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Well Child Visit [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 7500
Study Start Date: October 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Receives outreach intervention.
Other: outreach services
Tracking/reminder/recall/home visit strategy.
2: No Intervention
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581347

Contacts
Contact: Sarah Gallivan 585-273-4089 sarah_gallivan@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Sub-Investigator: Sharon Humiston, MD            
Sub-Investigator: Mardy Sandler, MSW            
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Peter Szilagyi, MD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester ( Peter Szilagyi, MD, MPH/ Principal Investigator )
Study ID Numbers: PCAIR, OPP-P-2006-24
Study First Received: December 19, 2007
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00581347     History of Changes
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 02, 2009