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Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

Primary Purpose

Human Papilloma Virus (HPV), Tetanus-diphtheria-acellular Pertussis (Tdap), Meningococcal Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reminder/recall notices for vaccines
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus (HPV) focused on measuring adolescent reminder/recall, adolescent vaccines, Tdap, Meningococcal, HPV, Reminder cards, Recall messages, vaccine, conjugate

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Reminder/recall notices for vaccines

    Usual Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    1) the percentage receiving any vaccine after the baseline time point
    The percentage of adolescents becoming up-to-date on all needed immunizations

    Secondary Outcome Measures

    Full Information

    First Posted
    July 10, 2008
    Last Updated
    June 21, 2013
    Sponsor
    University of Colorado, Denver
    Collaborators
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00715234
    Brief Title
    Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
    Official Title
    Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Centers for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 Reminder/recall of adolescents will result in an increased rate of receipt of immunizations in private settings of approximately 10 percentage points 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 Reminder/recall originating at SBHC sites will result in the highest efficacy of reminder/recall among all the types of clinical sites

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Papilloma Virus (HPV), Tetanus-diphtheria-acellular Pertussis (Tdap), Meningococcal Infection, Varicella
    Keywords
    adolescent reminder/recall, adolescent vaccines, Tdap, Meningococcal, HPV, Reminder cards, Recall messages, vaccine, conjugate

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    4807 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Reminder/recall notices for vaccines
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Reminder/recall notices for vaccines
    Intervention Description
    Receive a generic letter reminding them to make an appointment to get vaccines. Receive a computer-generated telephone message at 1 week post initial letter. Receive a computer-generated telephone message at 2 months post initial letter. Receive a letter at 3 months post initial letter.
    Primary Outcome Measure Information:
    Title
    1) the percentage receiving any vaccine after the baseline time point
    Time Frame
    6 months after intervention
    Title
    The percentage of adolescents becoming up-to-date on all needed immunizations
    Time Frame
    6 months post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allison Kempe, MD, MPH
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10390257
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11343499
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10806982
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15931141
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11025835
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11713438
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22566415
    Citation
    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.
    Results Reference
    derived

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    Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

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