Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine



Status:Completed
Conditions:Cervical Cancer, Cervical Cancer, Cancer, Infectious Disease, Infectious Disease, Women's Studies, Women's Studies, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:11 - 17
Updated:5/26/2016
Start Date:September 2015
End Date:May 2016

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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.

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.

Inclusion Criteria:

- Parents/legal guardians of 11-17 year old children.

- Children receive their healthcare at one of the 5 CHICA clinics.

- Parents are able to read either English or Spanish.

- Children have received no more than 2 doses of HPV vaccine

Exclusion Criteria:

- Parents will be excluded if their child is outside of the designated age range of
11-17 years, if the child has completed the 3-dose HPV vaccine series, or if the
parent does not read either English or Spanish.
We found this trial at
5
sites
Indianapolis, Indiana 46226
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710 Eskenazi Avenue
Indianapolis, Indiana 46202
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Indianapolis, Indiana 46208
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Indianapolis, Indiana 46254
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Indianapolis, IN
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Indianapolis, Indiana 46268
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Indianapolis, IN
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