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HPV Vaccination: An Investigation of Physician Reminders and Recommendation Scripts

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ClinicalTrials.gov Identifier: NCT02551887
Recruitment Status : Completed
First Posted : September 16, 2015
Results First Posted : February 4, 2016
Last Update Posted : March 11, 2016
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Indiana University
Information provided by (Responsible Party):
Regenstrief Institute, Inc.

Brief Summary:

Primary, Secondary, and Exploratory Objective(s):

Primary objective: To evaluate the effect of interventions on 1st dose uptake of HPV vaccine.


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: Automated Reminder Behavioral: Automated Reminder Plus Script Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 647 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: HPV Vaccination: An Investigation of Physician Reminders and Recommendation Scripts
Study Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
No Intervention: Usual Care
Usual Care Only
Active Comparator: Automated Reminder
Reminder
Behavioral: Automated Reminder
Automated reminder shown to provider

Experimental: Automated Reminder Plus Script
Provider sees both reminder and script.
Behavioral: Automated Reminder Plus Script
Provider sees both reminder and script.




Primary Outcome Measures :
  1. First Dose HPV Vaccine Uptake [ Time Frame: Nine Months ]
    The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.


Secondary Outcome Measures :
  1. Second Dose HPV Vaccine Uptake [ Time Frame: Nine Months ]
    The rate of second dose of HPV vaccine uptake, is recorded as the number of patients who receive the second dose of HPV vaccine.



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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible Providers

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

Eligible Patients

  • Males and females
  • 11-14 years of age with no prior HPV vaccine doses administered
  • Eligible for Tdap and/or MCV4 vaccination at the visit.

Exclusion Criteria:

  • Patients in the eligible age range who have already received one or more of the adolescent platform vaccines

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): NCT02551887


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.
Glanzer, M. and A.R. Cunitz, Two storage mechanisms in free recall. Journal of Verbal Learning and Verbal Behavior, 1966. 5(4): p. 351-360.
Rogers, E.M., Diffusion of innovations. Vol. 4th 1995, New York: Free Press.
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(2): p. 77-101.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier: NCT02551887     History of Changes
Other Study ID Numbers: Merck - 14
First Posted: September 16, 2015    Key Record Dates
Results First Posted: February 4, 2016
Last Update Posted: March 11, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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