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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546752
• Other study ID #: Merck - 20
• Status: Completed
• Phase: Phase 0
• First received: September 9, 2015
• Last updated: May 24, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Regenstrief Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1306
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cervical Cancer
• Communicable Diseases
• Human Papilloma Virus Infection Type 11
• Human Papilloma Virus Infection Type 16
• Human Papilloma Virus Infection Type 18
• Human Papilloma Virus Infection Type 6
• Infection
• Papilloma
• Papillomavirus Infections
• Uterine Cervical Neoplasms
• Virus Diseases
• Warts

Intervention

Other:
• THEO
THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). THEO is the intervention in this study.

Locations

Country	Name	City	State
United States	Eskenazi Health Center Blackburn	Indianapolis	Indiana
United States	Eskenazi Health Center Forest Manor	Indianapolis	Indiana
United States	Eskenazi Health Outpatient Care Center	Indianapolis	Indiana
United States	Eskenazi Health Pecar	Indianapolis	Indiana
United States	Eskenazi Health West 38th Street	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Regenstrief Institute, Inc.	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure 1: Difference Between Average HPV Vaccine Series Initiation and Completion Rates	Difference between average HPV vaccine series initiation and completion rates (as recorded in the CHIRP immunization registry) between sites using THEO integrated technology product compared to HPV Vaccination rates at Eskenazi sites not using THEO integrated technology product. Note that CHICA operates in 5 clinics in the Eskenazi Health Network. These clinics have been matched into two groups, each with 2 clinics, based on race and ethnicity of their patients. We will randomly assign one of these two groups to use THEO. The other group plus an additional CHICA clinic will continue to use CHICA without THEO.	Seven Months	No
Secondary	Outcome Measure 1: Relative Difference in Time of Appointment	Relative differences in overall time of appointment for patient visits in which any dose of the HPV vaccine was given after using the integrated digital intervention, compared to overall time of appointment for patient visits in which any dose of the HPV vaccine was given after not using the integrated digital intervention	Seven Months	No