Clinical trial NCT02546752: Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine
Official title: Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: 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
Lead sponsor: Regenstrief Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-09-11
Enrollment: 1306
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Outcome Measure 1: Difference Between Average HPV Vaccine Series Initiation and Completion Rates
timeFrame: Seven Months
Secondary outcomes:
measure: Outcome Measure 1: Relative Difference in Time of Appointment
timeFrame: Seven Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health Outpatient Care Center
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health Center Blackburn
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health Center Forest Manor
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health West 38th Street
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health Pecar
state: Indiana
Study officials:
affiliation: 317-274-8812
name: Gregory D Zimet, PhD
role: PRINCIPAL_INVESTIGATOR
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