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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

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.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus (HPV) Tetanus-diphtheria-acellular Pertussis (Tdap) Meningococcal Infection Varicella Other: Reminder/recall notices for vaccines Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4807 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
Study Start Date : October 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2010


Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 1) the percentage receiving any vaccine after the baseline time point [ Time Frame: 6 months after intervention ]
  2. The percentage of adolescents becoming up-to-date on all needed immunizations [ Time Frame: 6 months post intervention ]


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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715234


Sponsors and Collaborators
University of Colorado, Denver
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Allison Kempe, MD, MPH University of Colorado, Denver
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00715234    
Other Study ID Numbers: 07-0763
U01IP000129 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013
Keywords provided by University of Colorado, Denver:
adolescent reminder/recall
adolescent vaccines
Tdap
Meningococcal
HPV
Reminder cards
Recall messages
vaccine
conjugate
Additional relevant MeSH terms:
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Diphtheria
Meningococcal Infections
Papilloma
Gram-Negative Bacterial Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Corynebacterium Infections
Actinomycetales Infections
Neisseriaceae Infections