NCT02546752|CompletedEarly Phase 1
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Sponsor study identifier
interventional
1,306
1 country
5
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 9, 2015
Actual (reported)September 11, 2015
Actual (reported)May 2016
Actual (reported)May 2016
Actual (reported)Outcome Measure 1: Difference Between Average HPV Vaccine Series Initiation and Completion Rates
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.
Seven Months
Outcome Measure 1: Relative Difference in Time of Appointment
Seven Months
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.
This arm will receive usual care.
THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). THEO is the intervention in this study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eskenazi Health Outpatient Care Center
Indianapolis, Indiana, 46202, United States
Eskenazi Health Center Blackburn
Indianapolis, Indiana, 46208, United States
Eskenazi Health Center Forest Manor
Indianapolis, Indiana, 46226, United States
Eskenazi Health West 38th Street
Indianapolis, Indiana, 46254, United States
Eskenazi Health Pecar
Indianapolis, Indiana, 46268, United States
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Gregory D Zimet, PhD
317-274-8812
1,306 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2015
First Posted
September 11, 2015
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Contact the study team to confirm eligibility.
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Primary Completion
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Last Updated
May 25, 2016
Record last verified: 2016-05
Individual provider data will not be shared.
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