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Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

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ClinicalTrials.gov Identifier: NCT00715234
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : June 25, 2013
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE July 10, 2008
First Posted Date  ICMJE July 15, 2008
Last Update Posted Date June 25, 2013
Study Start Date  ICMJE October 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2013)
  • 1) the percentage receiving any vaccine after the baseline time point [ Time Frame: 6 months after intervention ]
  • The percentage of adolescents becoming up-to-date on all needed immunizations [ Time Frame: 6 months post intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
  • 1) the percentage receiving any vaccine after the baseline time point [ Time Frame: 6 months after intervention ]
  • 2) the percentage receiving one or more of each of the following vaccinations: for male adolescents-Tdap, meningococcal conjugate vaccine; for female adolescents-Tdap, meningococcal conjugate vaccine, HPV (1st dose) [ Time Frame: 6 months after intervention ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
  • 1) the percentage of male and female adolescents in intervention and control groups receiving a second varicella dose, if eligible for vaccine (no history of chickenpox and previous receipt of zero or one dose of varicella) [ Time Frame: 6 months post intervention ]
  • 2) the percentage of female adolescents in intervention and control groups receiving three doses of HPV [ Time Frame: 12 months post-intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
Official Title  ICMJE Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
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.
Detailed Description

Although patient reminder/recall systems have been shown to be effective at improving vaccination coverage levels for infants and younger children, little is known about the effectiveness of such systems for increasing immunization rates in adolescent populations. The process of reminder/recall in adolescents, and vaccination of adolescents overall, presents particular challenges. Adolescents are less likely to routinely access health care compared to younger children and adults. In addition, other obstacles such as lack of health insurance, missed opportunities for vaccination during health care visits, and the scattering of immunization records across multiple providers have posed major challenges in the vaccination of adolescents. Issues of parental consent for vaccination can also be problematic, given that adolescents may present for care without their parents accompanying them. These and other barriers to immunization may reduce the effectiveness of reminder/recall for adolescents. In the current research study, a study team with extensive experience in immunization delivery research will investigate the ability of pediatricians and family physicians in a number of different practice settings to implement a reminder/recall system for their adolescent patient populations. In addition, we will be able to examine the effectiveness of reminder/recall originating at public school-based health centers, an innovative strategy that has not previously been reported. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site. The study team will track important process measures during reminder/recall including the percentage of the eligible population who actually received intervention; percentage with incorrect addresses; percentage with incorrect or disconnected phones; percentage actually up-to-date but incorrectly recalled; missed vaccination opportunities; and invalid doses of vaccines administered. In this way, we will be able to not only determine the degree to which reminder/recall was successful for adolescents, but also identify impediments to success, which will provide a foundation for future efforts. Our study will also investigate the cost of establishing and operating a reminder/recall system for adolescents in each type of clinical setting.

Major Hypotheses

  1. Reminder/recall of adolescents will result in an increased rate of receipt of immunizations in private settings of approximately 10 percentage points
  2. Reminder/recall will result in a greater rate of receipt of immunizations when patients in public settings have access to a school-based health center (SBHC) compared to when they do not have access to a SBHC
  3. Reminder/recall originating at SBHC sites will result in the highest efficacy of reminder/recall among all the types of clinical sites
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Human Papilloma Virus (HPV)
  • Tetanus-diphtheria-acellular Pertussis (Tdap)
  • Meningococcal Infection
  • Varicella
Intervention  ICMJE Other: Reminder/recall notices for vaccines
  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.
Study Arms  ICMJE
  • Experimental: Reminder/recall notices for vaccines
    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.
    Intervention: Other: Reminder/recall notices for vaccines
  • No Intervention: Usual Care
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2013)
4807
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2008)
13784
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • up-to-date on all vaccines
  • under age 11 over age 18
  • patients who have moved or gone elsewhere at each practice setting
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00715234
Other Study ID Numbers  ICMJE 07-0763
U01IP000129 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Allison Kempe, MD, MPH University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP