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

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ClinicalTrials.gov Identifier: NCT02558803
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : May 25, 2016
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Indiana University
Information provided by (Responsible Party):
Regenstrief Institute, Inc.

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Simple Reminder Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3
Study Start Date : February 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
No Intervention: Usual Care
The clinical team will be left to identify the need for a follow-up HPV vaccine through existing mechanisms
Experimental: 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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558803


Locations
United States, Indiana
Eskenazi Health Outpatient Care Center
Indianapolis, Indiana, United States, 46202
Eskenazi Health Center Blackburn
Indianapolis, Indiana, United States, 46208
Eskenazi Health Center Forest Manor
Indianapolis, Indiana, United States, 46226
Eskenazi Health West 38th Street
Indianapolis, Indiana, United States, 46254
Eskenazi Health Center Pecar
Indianapolis, Indiana, United States, 46268
Sponsors and Collaborators
Regenstrief Institute, Inc.
Merck Sharp & Dohme Corp.
Indiana University
Investigators
Principal Investigator: Gregory D Zimet, PhD Indiana University

Publications:
Evans, G. and A. Bostrom, The evolution of vaccine risk communication in the United States: 1982-2002, in Jordan report 20th anniversary: Accelerated development of vaccines 2002, A. National Institute of and D. Infectious, Editors. 2002, U.S. Department of Health and Human Services, National Institute of Allergy and Infectious Diseases: Washington, D.C. p. 58-71.
Bauer, N.S., et al., Computer Decision Support to Improve Autism Screening and Care in Community Pediatric Clinics. Infants & Young Children, 2013. 26(4): p. 306-317.
Denzin, N.K. and Y.S. Lincoln, The Sage handbook of qualitative research. Vol. 4th. 2011, Thousand Oaks, CA: Sage.
Braun, V. and V. Clarke, Using thematic analysis in psychology. Qualitative Research in Psychology, 2006. 3: p. 77-101.

Responsible Party: Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier: NCT02558803     History of Changes
Other Study ID Numbers: Merck 21
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual provider data will not be made available.

Keywords provided by Regenstrief Institute, Inc.:
HPV Vaccinations
Quadrivalent Vaccine

Additional relevant MeSH terms:
Infection
Communicable Diseases
Uterine Cervical Neoplasms
Virus Diseases
Papilloma
Oropharyngeal Neoplasms
Condylomata Acuminata
Papillomavirus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Warts
DNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral