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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558803
• Other study ID #: Merck 21
• Status: Completed
• Phase: N/A
• First received: September 18, 2015
• Last updated: May 24, 2016
• Start date: February 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1305
• 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:

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

Study Design

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

Related Conditions & MeSH terms

• Cervical Cancer
• Communicable Diseases
• Genital Warts
• 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
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Papilloma
• Papillomavirus Infections
• Uterine Cervical Neoplasms
• Virus Diseases
• Warts

Intervention

Behavioral:
• Simple Reminder
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.

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 Center Pecar	Indianapolis	Indiana
United States	Eskenazi Health Outpatient Care Center	Indianapolis	Indiana
United States	Eskenazi Health West 38th Street	Indianapolis	Indiana

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Six Months	No
Secondary	Assessment of Physician Acceptance of the Prompts	The study team will compare changes in vaccination rates with qualitative feedback from providers.	Six Months	No