HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3
Condition: Human Papilloma Virus Infection Type 11; Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Human Papilloma Virus Infection Type 6; Cervical Cancer; Genital Warts; Oropharyngeal Cancer
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Condylomata Acuminata; Papillomavirus Infections; Papilloma; Oropharyngeal Neoplasms
Study type: Interventional

Summary: 
      Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care
      provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses
      of HPV vaccine for eligible male and female adolescents who have initiated vaccination.
    

Detailed description: 
      The study team plans to conduct a randomized clinical trial with three arms: (1) usual care,
      (2) the simple reminder, and (3) the simple reminder plus the script. Randomization will be
      carried out at the physician level at each clinical site, to ensure that all three treatment
      arms are represented in each clinic. The primary outcome, HPV vaccine acceptance, will be
      assessed for each study participant.

      This study will be implemented through the Child Health Improvement through Computer
      Automation system (CHICA). CHICA is a computer based clinical decision support system that
      has been operating in the Wishard/Eskenazi system since 2004. CHICA now operates in 5 clinics
      in the health system and has served well over 37,000 children. CHICA supports primary
      pediatric care, supporting screening, counseling, anticipatory guidance, vaccinations, and
      chronic disease diagnosis and management.

      CHICA is unique in several respects. These include a unique tailored, scannable paper
      interface, a prioritization scheme that assures the highest priority reminders are given to
      physicians, and the ability to collect data directly from families in the waiting room. CHICA
      acts as a front end to the Regenstrief Medical Record System (RMRS), the electronic medical
      record for the Eskenazi health system. The RMRS and CHICA communicate using industry standard
      HL7 communication protocols.

      When a patient checks into a CHICA clinic, CHICA receives an HL7 ADT (registration) message.
      In response CHICA requests a download of the patient's record from the RMRS. CHICA applies a
      set of Arden Syntax rules to the patient's data to select 20 yes/no questions that are
      printed. The family answers these questions by checking boxes. The nurse or medical assistant
      enters height, weight, etc. on the same form and the form is scanned. The data enter CHICA's
      database through optical mark recognition and optical character recognition. Recently we have
      begun converting from this scannable paper format to electronic tablets.
    

Intervention name(s): Simple Reminder
Intervention type(s): Behavioral
Intervention description(s): A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: HPV Vaccinations; Quadrivalent Vaccine