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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Indiana University | OTHER |
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Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.
The study team plans to conduct a randomized clinical trial with three arms: (1) usual care, (2) the simple reminder, and (3) the simple reminder plus the script. Randomization will be carried out at the physician level at each clinical site, to ensure that all three treatment arms are represented in each clinic. The primary outcome, HPV vaccine acceptance, will be assessed for each study participant.
This study will be implemented through the Child Health Improvement through Computer Automation system (CHICA). CHICA is a computer based clinical decision support system that has been operating in the Wishard/Eskenazi system since 2004. CHICA now operates in 5 clinics in the health system and has served well over 37,000 children. CHICA supports primary pediatric care, supporting screening, counseling, anticipatory guidance, vaccinations, and chronic disease diagnosis and management.
CHICA is unique in several respects. These include a unique tailored, scannable paper interface, a prioritization scheme that assures the highest priority reminders are given to physicians, and the ability to collect data directly from families in the waiting room. CHICA acts as a front end to the Regenstrief Medical Record System (RMRS), the electronic medical record for the Eskenazi health system. The RMRS and CHICA communicate using industry standard HL7 communication protocols.
When a patient checks into a CHICA clinic, CHICA receives an HL7 ADT (registration) message. In response CHICA requests a download of the patient's record from the RMRS. CHICA applies a set of Arden Syntax rules to the patient's data to select 20 yes/no questions that are printed. The family answers these questions by checking boxes. The nurse or medical assistant enters height, weight, etc. on the same form and the form is scanned. The data enter CHICA's database through optical mark recognition and optical character recognition. Recently we have begun converting from this scannable paper format to electronic tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | The clinical team will be left to identify the need for a follow-up HPV vaccine through existing mechanisms | |
| Simple Reminder | Experimental | A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple Reminder | Behavioral | A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients | To evaluate the rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients who have received 1 or 2 doses of vaccine. | Six Months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Physician Acceptance of the Prompts | The study team will compare changes in vaccination rates with qualitative feedback from providers. | Six Months |
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Inclusion Criteria:
Provider Criteria
Subject Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory D Zimet, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health Outpatient Care Center | Indianapolis | Indiana | 46202 | United States | ||
| Eskenazi Health Center Blackburn |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16949997 | Background | Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006 Aug 31;24 Suppl 3:S3/11-25. doi: 10.1016/j.vaccine.2006.05.111. | |
| 20138345 | Background | 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. |
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Individual provider data will not be made available.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 3, 2018 | |
| Reset | Nov 30, 2018 |
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| 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 Center Pecar | Indianapolis | Indiana | 46268 | United States |
| 20307840 | Background | 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. |
| 22018560 | Background | 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. |
| 24108159 | Background | Arnheim-Dahlstrom L, Pasternak B, Svanstrom H, Sparen 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. |
| 25562266 | Background | Scheller NM, Svanstrom H, Pasternak B, Arnheim-Dahlstrom L, Sundstrom 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. |
| 24013368 | Background | 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. |
| 23027469 | Background | 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. |
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| 17484215 | Background | 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. doi: 10.1097/01.inf.0000253970.29190.5a. |
| 23324976 | Background | 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. |
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| 25055186 | Background | 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. |
| 20838362 | Background | 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. |
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| 21924315 | Background | Vadaparampil ST, Kahn JA, Salmon D, Lee JH, Quinn GP, Roetzheim R, Bruder K, Malo TL, Proveaux T, Zhao X, Halsey N, Giuliano AR. Missed clinical opportunities: provider recommendations for HPV vaccination for 11-12 year old girls are limited. Vaccine. 2011 Nov 3;29(47):8634-41. doi: 10.1016/j.vaccine.2011.09.006. Epub 2011 Sep 14. |
| Background | 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. |
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| 23958768 | Background | 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. |
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| Background | Denzin, N.K. and Y.S. Lincoln, The Sage handbook of qualitative research. Vol. 4th. 2011, Thousand Oaks, CA: Sage. |
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| 31201057 | Derived | Wilkinson TA, Dixon BE, Xiao S, Tu W, Lindsay B, Sheley M, Dugan T, Church A, Downs SM, Zimet G. Physician clinical decision support system prompts and administration of subsequent doses of HPV vaccine: A randomized clinical trial. Vaccine. 2019 Jul 18;37(31):4414-4418. doi: 10.1016/j.vaccine.2019.05.004. Epub 2019 Jun 11. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 3, 2018 | Nov 30, 2018 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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