Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546752
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : May 25, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Regenstrief Institute, Inc.

Tracking Information
First Submitted Date  ICMJE September 9, 2015
First Posted Date  ICMJE September 11, 2015
Last Update Posted Date May 25, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
Outcome Measure 1: Difference Between Average HPV Vaccine Series Initiation and Completion Rates [ Time Frame: Seven Months ]
Difference between average HPV vaccine series initiation and completion rates (as recorded in the CHIRP immunization registry) between sites using THEO integrated technology product compared to HPV Vaccination rates at Eskenazi sites not using THEO integrated technology product. Note that CHICA operates in 5 clinics in the Eskenazi Health Network. These clinics have been matched into two groups, each with 2 clinics, based on race and ethnicity of their patients. We will randomly assign one of these two groups to use THEO. The other group plus an additional CHICA clinic will continue to use CHICA without THEO.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
Outcome Measure 1: Relative Difference in Time of Appointment [ Time Frame: Seven Months ]
Relative differences in overall time of appointment for patient visits in which any dose of the HPV vaccine was given after using the integrated digital intervention, compared to overall time of appointment for patient visits in which any dose of the HPV vaccine was given after not using the integrated digital intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine
Official Title  ICMJE Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine
Brief Summary

This primary goal of this study is to assess whether patient whose parents watch a standardized digital video using the integrated digital approach during a routine office visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to those not completing the program. The study team anticipates eligible patients in the intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses) than patients in the usual care comparison clinics.

Additionally, the study team is interested in determining the impact of the integrated system on clinical workflow by measuring the number of minutes of each patient office visit when using the system compared to the number of minutes of each visit in offices where the system is not used.

Although this is a descriptive/exploratory aim, our expectation is that the THEO system will have minimal impact on patient flow.

Detailed Description

Brief Summary of Design: This is a 2-arm randomized study, with randomization occurring at the level of clinic. Five clinics will be included (2 implementing the THEO video; 3 providing usual care). All five clinics have been using the Child Health Improvement through Computer Automation System (CHICA) for several years. The evaluation phase of the study will last for approximately 6-7 months.

The CHICA System

The Child Health Improvement through Computer Automation system (CHICA) is a computer based decision support system that operates as a front end to the electronic medical record system (EMR). When a child is registered in the clinic, the registration system sends an HL7 ADT (registration) message to CHICA. In response, CHICA requests a download of the patient's record from the EMR. CHICA applies a rule base consisting of hundreds of Arden Syntax rules to the data in the record to select 20 yes/no questions that are displayed on an electronic tablet. The family answers the questions and returns the tablet to the medical assistant who enters the child's height, weight and other measurements onto another page on the tablet.

At the same time that CHICA produces the questions for family, it sends an HL7 request to CHIRP, the Indiana immunization registry. In response, CHICA receives a download of the child's immunization record. The download includes CHIRP's "forecast" of the immunizations for which the patient is due.

At the end of these processes, CHICA produces several paper documents. The first is the physician worksheet (PWS). The PWS includes up to six alerts and reminders for the physician. The reminders are selected by CHICA, using its Arden Syntax rule set based on the patient's EMR and answers provided on the tablet. Each alert has up to six check boxes with which the physician can document how s/he responded to the alert. The PWS, when completed, is scanned, the coded data corresponding to the check boxes are stored, and text is written into the physician's note in the medical record. CHICA may also produce any of a large number of handouts for helping the physician with assessment or patient education. CHICA also produces a summary of the patient's immunization history as well and advice on what shots the child is due to receive.

In an ongoing study of the Regenstrief-Merck collaboration, the investigators are studying the effect of providing physicians with a suggested "script" for recommending HPV vaccination to eligible patients' families. The study randomizes by physician whether the script is provided or whether the physician receives a simple reminder.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • 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
Intervention  ICMJE Other: THEO
THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). THEO is the intervention in this study.
Study Arms  ICMJE
  • Experimental: THEO Video Arm
    THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). Two programs have been developed. Parents/guardians of children who have not received the first HPV vaccine, will first assess whether the family has already decided in favor of the HPV vaccine or if they would like more information. The parent/guardian will be shown a video specific to where they are in the decision-making process. After completion, the THEO system will then ask the parent/guardian a series of Post Video questions. Parents/guardians of children who have received the first or second vaccine in the series, will emphasize the need to make the first vaccine "count". Pre and post video questions have been developed.
    Intervention: Other: THEO
  • No Intervention: Usual Care Arm
    This arm will receive usual care.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
1306
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2015)
598
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parents/legal guardians of 11-17 year old children.
  • Children receive their healthcare at one of the 5 CHICA clinics.
  • Parents are able to read either English or Spanish.
  • Children have received no more than 2 doses of HPV vaccine

Exclusion Criteria:

  • Parents will be excluded if their child is outside of the designated age range of 11-17 years, if the child has completed the 3-dose HPV vaccine series, or if the parent does not read either English or Spanish.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02546752
Other Study ID Numbers  ICMJE Merck - 20
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual provider data will not be shared.
Responsible Party Regenstrief Institute, Inc.
Study Sponsor  ICMJE Regenstrief Institute, Inc.
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Gregory D Zimet, PhD 317-274-8812
PRS Account Regenstrief Institute, Inc.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP