Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine
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
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Papillomavirus Infections; Papilloma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This primary goal of this study is to assess whether patient whose parents watch a
      standardized digital video using the integrated digital approach during a routine office
      visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to
      those not completing the program. The study team anticipates eligible patients in the
      intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses)
      than patients in the usual care comparison clinics.

      Additionally, the study team is interested in determining the impact of the integrated system
      on clinical workflow by measuring the number of minutes of each patient office visit when
      using the system compared to the number of minutes of each visit in offices where the system
      is not used.

      Although this is a descriptive/exploratory aim, our expectation is that the THEO system will
      have minimal impact on patient flow.
    

Detailed description: 
      Brief Summary of Design: This is a 2-arm randomized study, with randomization occurring at
      the level of clinic. Five clinics will be included (2 implementing the THEO video; 3
      providing usual care). All five clinics have been using the Child Health Improvement through
      Computer Automation System (CHICA) for several years. The evaluation phase of the study will
      last for approximately 6-7 months.

      The CHICA System

      The Child Health Improvement through Computer Automation system (CHICA) is a computer based
      decision support system that operates as a front end to the electronic medical record system
      (EMR). When a child is registered in the clinic, the registration system sends an HL7 ADT
      (registration) message to CHICA. In response, CHICA requests a download of the patient's
      record from the EMR. CHICA applies a rule base consisting of hundreds of Arden Syntax rules
      to the data in the record to select 20 yes/no questions that are displayed on an electronic
      tablet. The family answers the questions and returns the tablet to the medical assistant who
      enters the child's height, weight and other measurements onto another page on the tablet.

      At the same time that CHICA produces the questions for family, it sends an HL7 request to
      CHIRP, the Indiana immunization registry. In response, CHICA receives a download of the
      child's immunization record. The download includes CHIRP's "forecast" of the immunizations
      for which the patient is due.

      At the end of these processes, CHICA produces several paper documents. The first is the
      physician worksheet (PWS). The PWS includes up to six alerts and reminders for the physician.
      The reminders are selected by CHICA, using its Arden Syntax rule set based on the patient's
      EMR and answers provided on the tablet. Each alert has up to six check boxes with which the
      physician can document how s/he responded to the alert. The PWS, when completed, is scanned,
      the coded data corresponding to the check boxes are stored, and text is written into the
      physician's note in the medical record. CHICA may also produce any of a large number of
      handouts for helping the physician with assessment or patient education. CHICA also produces
      a summary of the patient's immunization history as well and advice on what shots the child is
      due to receive.

      In an ongoing study of the Regenstrief-Merck collaboration, the investigators are studying
      the effect of providing physicians with a suggested "script" for recommending HPV vaccination
      to eligible patients' families. The study randomizes by physician whether the script is
      provided or whether the physician receives a simple reminder.
    

Intervention name(s): THEO
Intervention type(s): Other
Intervention description(s): THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). THEO is the intervention in this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research