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
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Adolescent Immunizations
Preventive Care
Intervention: Other: outreach services

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The target population was teens with birthdates between 7/1/92 & 6/30/97 at 8 practices in Rochester, NY. 2 methods were used to identify eligible adolescents;(1)2 insurance plans in the region provided a list of all their pts at these practices. (2)2 practices added to the list all teens who made a visit within 2 years of the study start date.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We preformed a stratified random sample, allocating all adolescents to either an intervention or standard of care group (using SAS 9.1). We stratified by practice, age and gender. For families with 2 or more eligible siblings, we assigned all siblings to the same group. Healthcare providers were unaware of group assignment.

Reporting Groups
  Description
Outreach

The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.

Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.

Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.

Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.

Standard of Care Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.

Participant Flow:   Overall Study
    Outreach     Standard of Care  
STARTED     3839     3707  
COMPLETED     3839     3707  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Outreach

The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.

Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.

Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.

Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.

Standard of Care Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
Total Total of all reporting groups

Baseline Measures
    Outreach     Standard of Care     Total  
Number of Participants  
[units: participants]
  3839     3707     7546  
Age, Customized  
[units: participants]
     
11 years old     784     757     1541  
12 years old     743     701     1444  
13 years old     714     686     1400  
14 years old     781     758     1539  
15 years old     817     805     1622  
Gender  
[units: participants]
     
Female     1903     1849     3752  
Male     1936     1858     3794  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)   [ Time Frame: 15 months ]

2.  Secondary:   Receipt of a Well Child Visit Within a 12 Month Period   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Szilagyi
Organization: University of Rochester Medical Center
phone: 585-275-5798
e-mail: peter_szilagyi@urmc.rochester.edu


No publications provided by University of Rochester

Publications automatically indexed to this study:

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