Clinical trial NCT02558803: HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3
Official title: HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Genital Warts
Oropharyngeal Cancer
Keywords: HPV Vaccinations
Quadrivalent Vaccine
Lead sponsor: Regenstrief Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Indiana University
First posted: 2015-09-24
Enrollment: 1305
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: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Six Months
Secondary outcomes:
measure: Assessment of Physician Acceptance of the Prompts
timeFrame: Six 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 Center Pecar
state: Indiana
Study officials:
affiliation: Indiana University
name: Gregory D Zimet, PhD
role: PRINCIPAL_INVESTIGATOR
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