NCT00581347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,546

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 1, 2010

Completed
Last Updated

September 23, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

December 19, 2007

Results QC Date

August 12, 2010

Last Update Submit

August 17, 2016

Conditions

Adolescent ImmunizationsPreventive Care

Outcome Measures

Primary Outcomes (1)

  • Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)

    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.

    15 months

Secondary Outcomes (1)

  • Receipt of a Well Child Visit Within a 12 Month Period

    1 year

Study Arms (2)

Outreach

OTHER

Receives outreach services

Other: outreach services

Standard of Care

NO INTERVENTION

Receives standard medical care provided by primary care practice.

Interventions

outreach servicesOTHER

Tracking/reminder/recall/home visit strategy.

Outreach

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • receive medical care at one of the 9 pediatric or family medicine practices identified as study sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • 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.

    PMID: 21646588DERIVED

Results Point of Contact

Title
Peter Szilagyi
Organization
University of Rochester Medical Center
peter_szilagyi@urmc.rochester.edu
585-275-5798

Study Officials

  • Peter Szilagyi, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 27, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 23, 2016

Results First Posted

October 1, 2010

Record last verified: 2016-08

Locations

US(1)