NCT00715234

Brief Summary

A study team with extensive experience in immunization delivery research will evaluate the effectiveness of vaccination reminder/recall systems for adolescent patients in five types of clinical settings including: urban pediatric, urban family medicine and rural family medicine practices, public pediatric clinics, and school-based health centers. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site, with randomization at the level of the patient.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,807

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

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
9 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

July 10, 2008

Last Update Submit

June 21, 2013

Conditions

Keywords

adolescent reminder/recalladolescent vaccinesTdapMeningococcalHPVReminder cardsRecall messagesvaccineconjugate

Outcome Measures

Primary Outcomes (2)

  • 1) the percentage receiving any vaccine after the baseline time point

    6 months after intervention

  • The percentage of adolescents becoming up-to-date on all needed immunizations

    6 months post intervention

Study Arms (2)

Reminder/recall notices for vaccines

EXPERIMENTAL

This group will receive up to 4 recall messages (both letters and computer-generated phone messages) reminding them to get their vaccines. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients.

Other: Reminder/recall notices for vaccines

Usual Care

NO INTERVENTION

This group will receive usual care. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients.

Interventions

1. Receive a generic letter reminding them to make an appointment to get vaccines. 2. Receive a computer-generated telephone message at 1 week post initial letter. 3. Receive a computer-generated telephone message at 2 months post initial letter. 4. Receive a letter at 3 months post initial letter.

Reminder/recall notices for vaccines

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children ages 11-18
  • seen in practice in last 2 years
  • not up-to-date on any or all shots (Tdap, HPV, meningococcal)
  • parents agree to participate in Colorado Immunization and Information System registry

You may not qualify if:

  • up-to-date on all vaccines
  • under age 11 over age 18
  • patients who have moved or gone elsewhere at each practice setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Ziv A, Boulet JR, Slap GB. Utilization of physician offices by adolescents in the United States. Pediatrics. 1999 Jul;104(1 Pt 1):35-42. doi: 10.1542/peds.104.1.35.

    PMID: 10390257BACKGROUND
  • Schaffer SJ, Humiston SG, Shone LP, Averhoff FM, Szilagyi PG. Adolescent immunization practices: a national survey of US physicians. Arch Pediatr Adolesc Med. 2001 May;155(5):566-71. doi: 10.1001/archpedi.155.5.566.

    PMID: 11343499BACKGROUND
  • Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. doi: 10.1016/s0749-3797(99)00118-x.

    PMID: 10806982BACKGROUND
  • Humiston SG, Rosenthal SL. Challenges to vaccinating adolescents: vaccine implementation issues. Pediatr Infect Dis J. 2005 Jun;24(6 Suppl):S134-40. doi: 10.1097/01.inf.0000166161.12087.94.

    PMID: 15931141BACKGROUND
  • Szilagyi PG, Bordley C, Vann JC, Chelminski A, Kraus RM, Margolis PA, Rodewald LE. Effect of patient reminder/recall interventions on immunization rates: A review. JAMA. 2000 Oct 11;284(14):1820-7. doi: 10.1001/jama.284.14.1820.

    PMID: 11025835BACKGROUND
  • Kempe A, Lowery NE, Pearson KA, Renfrew BL, Jones JS, Steiner JF, Berman S. Immunization recall: effectiveness and barriers to success in an urban teaching clinic. J Pediatr. 2001 Nov;139(5):630-5. doi: 10.1067/mpd.2001.117069.

    PMID: 11713438BACKGROUND
  • Suh CA, Saville A, Daley MF, Glazner JE, Barrow J, Stokley S, Dong F, Beaty B, Dickinson LM, Kempe A. Effectiveness and net cost of reminder/recall for adolescent immunizations. Pediatrics. 2012 Jun;129(6):e1437-45. doi: 10.1542/peds.2011-1714. Epub 2012 May 7.

MeSH Terms

Conditions

Meningococcal InfectionsChickenpox

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Allison Kempe, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 15, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2009

Study Completion

September 1, 2010

Last Updated

June 25, 2013

Record last verified: 2013-06