HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3

Regenstrief Institute

Status: Completed

Conditions: Oropharyngeal Cancer; Human Papilloma Virus Infection Type 18; Genital Warts; Human Papilloma Virus Infection Type 6; Human Papilloma Virus Infection Type 16; Cervical Cancer; Human Papilloma Virus Infection Type 11

Treatments: Behavioral: Simple Reminder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02558803

Merck 21

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,305 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Provider Criteria

• All pediatricians and nurse practitioners who provide health care at the 5 CHICA clinics will be included in this study

Subject Criteria

• Patients will be 11-17 year old
• Males and females
• A visit to at least one of the five CHICA clinics
• Eligible for the 2nd or 3rd dose of HPV vaccine

Exclusion criteria

• Patients in the eligible age range who have not started or have completed the HPV vaccine series will be excluded

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,305 participants in 2 patient groups

Usual Care

No Intervention group

Description:

The clinical team will be left to identify the need for a follow-up HPV vaccine through existing mechanisms

Simple Reminder

Experimental group

Description:

A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine.

Treatment:

Behavioral: Simple Reminder