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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02546752
Other study ID # Merck - 20
Secondary ID
Status Completed
Phase Phase 0
First received September 9, 2015
Last updated May 24, 2016
Start date September 2015
Est. completion date May 2016

Study information

Verified date May 2016
Source Regenstrief Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1306
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 17 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Eskenazi Health Center Blackburn Indianapolis Indiana
United States Eskenazi Health Center Forest Manor Indianapolis Indiana
United States Eskenazi Health Outpatient Care Center Indianapolis Indiana
United States Eskenazi Health Pecar Indianapolis Indiana
United States Eskenazi Health West 38th Street Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Regenstrief Institute, Inc. Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (32)

Ali H, Donovan B, Wand H, Read TR, Regan DG, Grulich AE, Fairley CK, Guy RJ. Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ. 2013 Apr 18;346:f2032. doi: 10.1136/bmj.f2032. Erratum in: BMJ. 2013;346:F2942. — View Citation

Ali H, Guy RJ, Wand H, Read TR, Regan DG, Grulich AE, Fairley CK, Donovan B. Decline in in-patient treatments of genital warts among young Australians following the national HPV vaccination program. BMC Infect Dis. 2013 Mar 18;13:140. doi: 10.1186/1471-2334-13-140. — View Citation

Anand V, Carroll AE, Downs SM. Automated primary care screening in pediatric waiting rooms. Pediatrics. 2012 May;129(5):e1275-81. doi: 10.1542/peds.2011-2875. Epub 2012 Apr 16. — View Citation

Arnheim-Dahlström L, Pasternak B, Svanström H, Sparén P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013 Oct 9;347:f5906. doi: 10.1136/bmj.f5906. — View Citation

Baandrup L, Blomberg M, Dehlendorff C, Sand C, Andersen KK, Kjaer SK. Significant decrease in the incidence of genital warts in young Danish women after implementation of a national human papillomavirus vaccination program. Sex Transm Dis. 2013 Feb;40(2):130-5. doi: 10.1097/OLQ.0b013e31827bd66b. — View Citation

Biondich PG, Downs SM, Anand V, Carroll AE. Automating the recognition and prioritization of needed preventive services: early results from the CHICA system. AMIA Annu Symp Proc. 2005:51-5. — View Citation

Brewer NT, Gottlieb SL, Reiter PL, McRee AL, Liddon N, Markowitz L, Smith JS. Longitudinal predictors of human papillomavirus vaccine initiation among adolescent girls in a high-risk geographic area. Sex Transm Dis. 2011 Mar;38(3):197-204. doi: 10.1097/OLQ.0b013e3181f12dbf. — View Citation

Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for ADHD diagnosis: a randomized controlled trial. Pediatrics. 2013 Sep;132(3):e623-9. doi: 10.1542/peds.2013-0933. Epub 2013 Aug 19. — View Citation

Carroll AE, Biondich P, Anand V, Dugan TM, Downs SM. A randomized controlled trial of screening for maternal depression with a clinical decision support system. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):311-6. doi: 10.1136/amiajnl-2011-000682. Epub 2012 Jun 28. — View Citation

Carroll AE, Biondich PG, Anand V, Dugan TM, Sheley ME, Xu SZ, Downs SM. Targeted screening for pediatric conditions with the CHICA system. J Am Med Inform Assoc. 2011 Jul-Aug;18(4):485-90. doi: 10.1136/amiajnl-2011-000088. — View Citation

Chaturvedi AK. Beyond cervical cancer: burden of other HPV-related cancers among men and women. J Adolesc Health. 2010 Apr;46(4 Suppl):S20-6. doi: 10.1016/j.jadohealth.2010.01.016. — View Citation

Donahue KL, Stupiansky NW, Alexander AB, Zimet GD. Acceptability of the human papillomavirus vaccine and reasons for non-vaccination among parents of adolescent sons. Vaccine. 2014 Jun 30;32(31):3883-5. doi: 10.1016/j.vaccine.2014.05.035. Epub 2014 May 18. — View Citation

Downs SM, Uner H. Expected value prioritization of prompts and reminders. Proc AMIA Symp. 2002:215-9. — View Citation

Downs SM, Zhu V, Anand V, Biondich PG, Carroll AE. The CHICA smoking cessation system. AMIA Annu Symp Proc. 2008 Nov 6:166-70. — View Citation

Elam-Evans LD, Yankey D, Jeyarajah J, Singleton JA, Curtis RC, MacNeil J, Hariri S; Immunization Services Division, National Center for Immunization and Respiratory Diseases; Centers for Disease Control and Prevention (CDC). National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years--United States, 2013. MMWR Morb Mortal Wkly Rep. 2014 Jul 25;63(29):625-33. — View Citation

Fu LY, Bonhomme LA, Cooper SC, Joseph JG, Zimet GD. Educational interventions to increase HPV vaccination acceptance: a systematic review. Vaccine. 2014 Apr 7;32(17):1901-20. doi: 10.1016/j.vaccine.2014.01.091. Epub 2014 Feb 14. Review. — View Citation

Gerend MA, Shepherd MA, Lustria ML. Increasing human papillomavirus vaccine acceptability by tailoring messages to young adult women's perceived barriers. Sex Transm Dis. 2013 May;40(5):401-5. doi: 10.1097/OLQ.0b013e318283c8a8. — View Citation

Giuliano AR, Anic G, Nyitray AG. Epidemiology and pathology of HPV disease in males. Gynecol Oncol. 2010 May;117(2 Suppl):S15-9. doi: 10.1016/j.ygyno.2010.01.026. Epub 2010 Feb 6. Review. — View Citation

Guerry SL, De Rosa CJ, Markowitz LE, Walker S, Liddon N, Kerndt PR, Gottlieb SL. Human papillomavirus vaccine initiation among adolescent girls in high-risk communities. Vaccine. 2011 Mar 9;29(12):2235-41. doi: 10.1016/j.vaccine.2011.01.052. Epub 2011 Feb 1. — View Citation

Haupt RM, Sings HL. The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil. J Adolesc Health. 2011 Nov;49(5):467-75. doi: 10.1016/j.jadohealth.2011.07.003. Epub 2011 Sep 9. — View Citation

Holman DM, Benard V, Roland KB, Watson M, Liddon N, Stokley S. Barriers to human papillomavirus vaccination among US adolescents: a systematic review of the literature. JAMA Pediatr. 2014 Jan;168(1):76-82. doi: 10.1001/jamapediatrics.2013.2752. Review. — View Citation

Kester LM, Zimet GD, Fortenberry JD, Kahn JA, Shew ML. A national study of HPV vaccination of adolescent girls: rates, predictors, and reasons for non-vaccination. Matern Child Health J. 2013 Jul;17(5):879-85. doi: 10.1007/s10995-012-1066-z. — View Citation

Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451. — View Citation

Kreuter MW, Strecher VJ, Glassman B. One size does not fit all: the case for tailoring print materials. Ann Behav Med. 1999 Fall;21(4):276-83. Review. — View Citation

Lustria ML, Noar SM, Cortese J, Van Stee SK, Glueckauf RL, Lee J. A meta-analysis of web-delivered tailored health behavior change interventions. J Health Commun. 2013;18(9):1039-69. doi: 10.1080/10810730.2013.768727. Epub 2013 Jun 10. Erratum in: J Health Commun. 2013;18(11):1397. — View Citation

Noar SM, Benac CN, Harris MS. Does tailoring matter? Meta-analytic review of tailored print health behavior change interventions. Psychol Bull. 2007 Jul;133(4):673-93. — View Citation

Ojha RP, Jackson BE, Tota JE, Offutt-Powell TN, Singh KP, Bae S. Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States. Hum Vaccin Immunother. 2014;10(1):232-7. doi: 10.4161/hv.26292. Epub 2013 Sep 6. — View Citation

Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006 Aug 31;24 Suppl 3:S3/11-25. Review. — View Citation

Pedersen C, Petaja T, Strauss G, Rumke HC, Poder A, Richardus JH, Spiessens B, Descamps D, Hardt K, Lehtinen M, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health. 2007 Jun;40(6):564-71. — View Citation

Petty RE, Wegener DT, Fabrigar LR. Attitudes and attitude change. Annu Rev Psychol. 1997;48:609-47. Review. — View Citation

Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9. — View Citation

Scheller NM, Svanström H, Pasternak B, Arnheim-Dahlström L, Sundström K, Fink K, Hviid A. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system. JAMA. 2015 Jan 6;313(1):54-61. doi: 10.1001/jama.2014.16946. — View Citation

* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Outcome Measure 1: Relative Difference in Time of Appointment 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 Seven Months No
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