Cervical Cancer Clinical Trial
Official title:
HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research
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