HPV Vaccination: An Investigation of Physician Reminders and Recommendation Scripts

NCT02551887 | Completed Results

• 1 other identifier: Merck - 14
• Study Type: interventional
• Target: 647
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary, Secondary, and Exploratory Objective(s): Primary objective: To evaluate the effect of interventions on 1st dose uptake of HPV vaccine.

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

Outcome Measures

Primary Outcomes (1)

• First Dose HPV Vaccine Uptake

  The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.

  Nine Months

Secondary Outcomes (1)

• Second Dose HPV Vaccine Uptake

  Nine Months

Study Arms (3)

Usual Care

NO INTERVENTION

Usual Care Only

Automated Reminder

ACTIVE COMPARATOR

Reminder

Behavioral: Automated Reminder

Automated Reminder Plus Script

EXPERIMENTAL

Provider sees both reminder and script.

Behavioral: Automated Reminder Plus Script

Interventions

Automated Reminder BEHAVIORAL

Automated reminder shown to provider

Automated Reminder

Automated Reminder Plus Script BEHAVIORAL

Provider sees both reminder and script.

Automated Reminder Plus Script

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regenstrief Institute, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator
• Indiana University: collaborator

Related Publications (45)

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MeSH Terms

Conditions

Uterine Cervical Neoplasms; Condylomata Acuminata; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Gregory Zimet
• Organization: Indiana University

gzimet@iu.edu

317-274-8812

Study Officials

• Gregory D Zimet, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 16, 2015
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 11, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share