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.

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Key information

Conditions

Human Papilloma Virus Infection Type 11 Cervical Cancer Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genital Warts Head and Neck Neoplasms Human Papilloma Virus Infection Type 16 Human Papilloma Virus Infection Type 18 Human Papilloma Virus Infection Type 6 Infections Neoplasms Neoplasms by Site Oropharyngeal Cancer Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases Warts

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health Center Blackburn, Indianapolis, Indiana, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simple Reminder

Behavioral

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.

Primary outcomes

Rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients

Time frame: Six Months

To evaluate the rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients who have received 1 or 2 doses of vaccine.

Secondary outcomes

Assessment of Physician Acceptance of the Prompts

Time frame: Six Months

The study team will compare changes in vaccination rates with qualitative feedback from providers.

Sponsors and collaborators

Lead sponsor

Regenstrief Institute, Inc.

Other

Collaborators

Indiana University
Merck Sharp & Dohme LLC

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 24, 2015
Registry last updated: May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed