Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
2022年3月17日 更新者：Lyle J. Fagnan、Oregon Health and Science University
Increasing Human Papillomavirus (HPV) Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
The goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years.
研究概览
详细说明
The overarching goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years.
Using a step-wedge randomized controlled trial, we will design and test the effectiveness of multi-component primary care practice-based interventions on the completion of the HPV vaccine series and will explore implementation timing in high and low functioning practices to determine how specific characteristics affect the delivery of the full series.
Additionally, we will design and test the impact of a community organization-based intervention intended to educate the public about HPV and cancer risk and risk reduction via vaccination.
研究类型
介入性
注册 (实际的)
22000
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Oregon
-
Portland、Oregon、美国、97239
- ORPRN
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 89年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Oregon family medicine and pediatric clinics located in rural communities that see adequate numbers of patients in the age range we are studying (age 11-17 years).
Exclusion Criteria:
- We will not include neonates, decisionally impaired adults, and prisoners in this study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Practice Facilitation, Cluster 1
Intervention Cluster 1 is the first intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
|
|
实验性的：Practice Facilitation, Cluster 2
Intervention Cluster 2 is the second intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
|
|
实验性的：Practice Facilitation, Cluster 3
Intervention Cluster 3 is the third intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
|
|
实验性的：Practice Facilitation, Cluster 4
Intervention Cluster 4 is the fourth intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
|
|
实验性的：Practice Facilitation, Cluster 5
Intervention Cluster 5 is the final intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HPV vaccine series completion
大体时间：3 months
|
A primary outcome variable is the receipt rate of the full series of HPV vaccine among males and females aged 11-17 years.
Practices will be block randomized in five waves every six months.
Outcomes will be measured every three months in all clusters at every period, so that each cluster provides data points in both the control and intervention conditions.
Practices in each wave will be stratified based on designation of pediatric or family medicine clinic to balance pediatric/family medicine clinics at each wave.
Outcome data collection will be collected from Oregon's ALERT Immunization System beginning in quarter four and up to 17, for 14 longitudinal data collection points per practice.
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Lyle J Fagnan, MD、Oregon Health and Science University
- 首席研究员：Patty Carney, PhD、Oregon Health and Science University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
- Westfall JM, Mold J, Fagnan L. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403-6. doi: 10.1001/jama.297.4.403. No abstract available.
- Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. doi: 10.1016/s0749-3797(99)00118-x.
- Recommendations regarding interventions to improve vaccination coverage in children, adolescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):92-6. No abstract available.
- Munoz N, Castellsague X, Berrington de Gonzalez A, Gissmann L. Chapter 1: HPV in the etiology of human cancer. Vaccine. 2006 Aug 31;24 Suppl 3:S3/1-10. doi: 10.1016/j.vaccine.2006.05.115. Epub 2006 Jun 23.
- Lowy DR, Schiller JT. Reducing HPV-associated cancer globally. Cancer Prev Res (Phila). 2012 Jan;5(1):18-23. doi: 10.1158/1940-6207.CAPR-11-0542.
- Koutsky L. The epidemiology behind the HPV vaccine discovery. Ann Epidemiol. 2009 Apr;19(4):239-44. doi: 10.1016/j.annepidem.2009.01.023.
- Centers for Disease Control and Prevention (CDC). National and state vaccination coverage among adolescents aged 13-17 years--United States, 2011. MMWR Morb Mortal Wkly Rep. 2012 Aug 31;61(34):671-7. Erratum In: MMWR Morb Mortal Wkly Rep. 2012 Oct 19;61(41):844.
- Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD, Singleton JA, Curtis CR, MacNeil J, Markowitz LE, Stokley S. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years--United States, 2014. MMWR Morb Mortal Wkly Rep. 2015 Jul 31;64(29):784-92. doi: 10.15585/mmwr.mm6429a3.
- Oster NV, McPhillips-Tangum CA, Averhoff F, Howell K. Barriers to adolescent immunization: a survey of family physicians and pediatricians. J Am Board Fam Pract. 2005 Jan-Feb;18(1):13-9. doi: 10.3122/jabfm.18.1.13.
- Niccolai LM, Hansen CE. Practice- and Community-Based Interventions to Increase Human Papillomavirus Vaccine Coverage: A Systematic Review. JAMA Pediatr. 2015 Jul;169(7):686-92. doi: 10.1001/jamapediatrics.2015.0310.
- Smulian EA, Mitchell KR, Stokley S. Interventions to increase HPV vaccination coverage: A systematic review. Hum Vaccin Immunother. 2016 Jun 2;12(6):1566-88. doi: 10.1080/21645515.2015.1125055. Epub 2016 Feb 2.
- Petrosky E, Bocchini JA Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, Unger ER, Markowitz LE; Centers for Disease Control and Prevention (CDC). Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep. 2015 Mar 27;64(11):300-4.
- Meites E, Kempe A, Markowitz LE. Use of a 2-Dose Schedule for Human Papillomavirus Vaccination - Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2016 Dec 16;65(49):1405-1408. doi: 10.15585/mmwr.mm6549a5.
- Jacobson RM, Rogacki B, Thompson DM, Roberts JR, Margolis B, Darden PM. Vaccination Rates among Adolescents in Minnesota as Compared with the United States: Not "Above Average". Minn Med. 2015 Nov-Dec;98(11-12):38-43.
- Kepka D, Spigarelli MG, Warner EL, Yoneoka Y, McConnell N, Balch A. Statewide analysis of missed opportunities for human papillomavirus vaccination using vaccine registry data. Papillomavirus Res. 2016 Dec;2:128-132. doi: 10.1016/j.pvr.2016.06.002.
- Roberts JR, Naifeh M, Jacobson RM, Hinton E, O'Brien E, Rogacki B, Thompson D, Margolis B, Darden PM. Adolescent Vaccination Performance in South Carolina Compared to the United States. J S C Med Assoc. 2015 Dec-2016 Jan;111(4):117-21.
- Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.
- Marlow LA, Waller J, Wardle J. Parental attitudes to pre-pubertal HPV vaccination. Vaccine. 2007 Mar 1;25(11):1945-52. doi: 10.1016/j.vaccine.2007.01.059. Epub 2007 Jan 22.
- Roberts JR, Thompson D, Rogacki B, Hale JJ, Jacobson RM, Opel DJ, Darden PM. Vaccine hesitancy among parents of adolescents and its association with vaccine uptake. Vaccine. 2015 Mar 30;33(14):1748-55. doi: 10.1016/j.vaccine.2015.01.068. Epub 2015 Feb 7.
- Katz ML, Reiter PL, Heaner S, Ruffin MT, Post DM, Paskett ED. Acceptance of the HPV vaccine among women, parents, community leaders, and healthcare providers in Ohio Appalachia. Vaccine. 2009 Jun 19;27(30):3945-52. doi: 10.1016/j.vaccine.2009.04.040. Epub 2009 May 3.
- Coyne CA, Demian-Popescu C, Friend D. Social and cultural factors influencing health in southern West Virginia: a qualitative study. Prev Chronic Dis. 2006 Oct;3(4):A124. Epub 2006 Sep 15.
- Ferrer HB, Trotter C, Hickman M, Audrey S. Barriers and facilitators to HPV vaccination of young women in high-income countries: a qualitative systematic review and evidence synthesis. BMC Public Health. 2014 Jul 9;14:700. doi: 10.1186/1471-2458-14-700.
- Lyttle NL, Stadelman K. Assessing awareness and knowledge of breast and cervical cancer among Appalachian women. Prev Chronic Dis. 2006 Oct;3(4):A125. Epub 2006 Sep 15.
- Elnicki DM, Morris DK, Shockcor WT. Patient-perceived barriers to preventive health care among indigent, rural Appalachian patients. Arch Intern Med. 1995 Feb 27;155(4):421-4.
- Thomas T, Blumling A, Delaney A. The Influence of Religiosity and Spirituality on Rural Parents' Health Decision Making and Human Papillomavirus Vaccine Choices. ANS Adv Nurs Sci. 2015 Oct-Dec;38(4):E1-E12. doi: 10.1097/ANS.0000000000000094.
- Darden PM, Thompson DM, Roberts JR, Hale JJ, Pope C, Naifeh M, Jacobson RM. Reasons for not vaccinating adolescents: National Immunization Survey of Teens, 2008-2010. Pediatrics. 2013 Apr;131(4):645-51. doi: 10.1542/peds.2012-2384. Epub 2013 Mar 18.
- Darden PM, Taylor JA, Brooks DA, Hendricks JW, Massoudi M, Stevenson JM, Bocian AB. How should immunization rates be measured in the office setting? A study from PROS and NMA PedsNet. Clin Pediatr (Phila). 2008 Apr;47(3):252-60. doi: 10.1177/0009922807308743. Epub 2007 Dec 5.
- Slora EJ, Steffes JM, Harris D, Clegg HW, Norton D, Darden PM, Sullivan SA, Wasserman RC. Improving pediatric practice immunization rates through distance-based quality improvement: a feasibility trial from PROS. Clin Pediatr (Phila). 2008 Jan;47(1):25-36. doi: 10.1177/0009922807304597. Epub 2007 Aug 10.
- McElligott JT, Darden PM. Are patient-held vaccination records associated with improved vaccination coverage rates? Pediatrics. 2010 Mar;125(3):e467-72. doi: 10.1542/peds.2009-0835. Epub 2010 Feb 15.
- Mennito SH, Darden PM. Impact of practice policies on pediatric immunization rates. J Pediatr. 2010 Apr;156(4):618-22. doi: 10.1016/j.jpeds.2009.10.046. Epub 2010 Jan 13.
- Darden PM, Gustafson KK, Nietert PJ, Jacobson RM. Extra-immunization as a clinical indicator for fragmentation of care. Public Health Rep. 2011 Jul-Aug;126 Suppl 2(Suppl 2):48-59. doi: 10.1177/00333549111260S207.
- Fagnan LJ, Dorr DA, Davis M, McGinnis P, Mahler J, King MM, Michaels L. Turning on the care coordination switch in rural primary care: voices from the practices--clinician champions, clinician partners, administrators, and nurse care managers. J Ambul Care Manage. 2011 Jul-Sep;34(3):304-18. doi: 10.1097/JAC.0b013e31821c63ee.
- Carney PA, Cook AJ, Miglioretti DL, Feig SA, Bowles EA, Geller BM, Kerlikowske K, Kettler M, Onega T, Elmore JG. Use of clinical history affects accuracy of interpretive performance of screening mammography. J Clin Epidemiol. 2012 Feb;65(2):219-30. doi: 10.1016/j.jclinepi.2011.06.010. Epub 2011 Oct 15.
- Fagnan LJ, Morris C, Shipman SA, Holub J, King A, Angier H. Characterizing a practice-based research network: Oregon Rural Practice-Based Research Network (ORPRN) survey tools. J Am Board Fam Med. 2007 Mar-Apr;20(2):204-19. doi: 10.3122/jabfm.2007.02.060140.
- Dietrich AJ, Carney PA, Winchell CW, Sox CH, Reed SC. An office systems approach to cancer prevention in primary care. Cancer Pract. 1997 Nov-Dec;5(6):375-81.
- Dietrich AJ, Woodruff CB, Carney PA. Changing office routines to enhance preventive care. The preventive GAPS approach. Arch Fam Med. 1994 Feb;3(2):176-83. doi: 10.1001/archfami.3.2.176.
- Dietrich AJ, O'Connor GT, Keller A, Carney PA, Levy D, Whaley FS. Cancer: improving early detection and prevention. A community practice randomised trial. BMJ. 1992 Mar 14;304(6828):687-91. doi: 10.1136/bmj.304.6828.687.
- Carney PA, Dietrich AJ, Keller A, Landgraf J, O'Connor GT. Tools, teamwork, and tenacity: an office system for cancer prevention. J Fam Pract. 1992 Oct;35(4):388-94.
- Cates JR, Diehl SJ, Crandell JL, Coyne-Beasley T. Intervention effects from a social marketing campaign to promote HPV vaccination in preteen boys. Vaccine. 2014 Jul 16;32(33):4171-8. doi: 10.1016/j.vaccine.2014.05.044. Epub 2014 Jun 2.
- Cates JR, Shafer A, Diehl SJ, Deal AM. Evaluating a County-Sponsored Social Marketing Campaign to Increase Mothers' Initiation of HPV Vaccine for their Pre-teen Daughters in a Primarily Rural Area. Soc Mar Q. 2011 Spring;17(1):4-26. doi: 10.1080/15245004.2010.546943.
- Moss JL, Gilkey MB, Rimer BK, Brewer NT. Disparities in collaborative patient-provider communication about human papillomavirus (HPV) vaccination. Hum Vaccin Immunother. 2016 Jun 2;12(6):1476-83. doi: 10.1080/21645515.2015.1128601. Epub 2016 Jan 19.
- Keating KM, Brewer NT, Gottlieb SL, Liddon N, Ludema C, Smith JS. Potential barriers to HPV vaccine provision among medical practices in an area with high rates of cervical cancer. J Adolesc Health. 2008 Oct;43(4 Suppl):S61-7. doi: 10.1016/j.jadohealth.2008.06.015.
- Hughes CC, Jones AL, Feemster KA, Fiks AG. HPV vaccine decision making in pediatric primary care: a semi-structured interview study. BMC Pediatr. 2011 Aug 30;11:74. doi: 10.1186/1471-2431-11-74.
- Pope CA, Escobar-Gomez M, Davis BH, Roberts JR, O'Brien ES, Hinton E, Darden PM. The challenge of tetradic relationships in medically interpreted pediatric primary care visits: A descriptive study of communication practices. Patient Educ Couns. 2016 Apr;99(4):542-548. doi: 10.1016/j.pec.2015.10.032. Epub 2015 Dec 8.
- Stone EG, Morton SC, Hulscher ME, Maglione MA, Roth EA, Grimshaw JM, Mittman BS, Rubenstein LV, Rubenstein LZ, Shekelle PG. Interventions that increase use of adult immunization and cancer screening services: a meta-analysis. Ann Intern Med. 2002 May 7;136(9):641-51. doi: 10.7326/0003-4819-136-9-200205070-00006.
- Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.
- McPhee SJ, Detmer WM. Office-based interventions to improve delivery of cancer prevention services by primary care physicians. Cancer. 1993 Aug 1;72(3 Suppl):1100-12. doi: 10.1002/1097-0142(19930801)72:3+3.0.co;2-n.
- Carney PA, O'Malley J, Buckley DI, Mori M, Lieberman DA, Fagnan LJ, Wallace J, Liu B, Morris C. Influence of health insurance coverage on breast, cervical, and colorectal cancer screening in rural primary care settings. Cancer. 2012 Dec 15;118(24):6217-25. doi: 10.1002/cncr.27635. Epub 2012 May 30.
- Fagnan LJ, Shipman SA, Gaudino JA, Mahler J, Sussman AL, Holub J. To give or not to give: Approaches to early childhood immunization delivery in Oregon rural primary care practices. J Rural Health. 2011 Winter;27(4):385-93. doi: 10.1111/j.1748-0361.2010.00356.x. Epub 2011 Jan 11.
- Solberg LI, Kottke TE, Brekke ML, Magnan S, Davidson G, Calomeni CA, Conn SA, Amundson GM, Nelson AF. Failure of a continuous quality improvement intervention to increase the delivery of preventive services. A randomized trial. Eff Clin Pract. 2000 May-Jun;3(3):105-15.
- Miller WL, Crabtree BF, McDaniel R, Stange KC. Understanding change in primary care practice using complexity theory. J Fam Pract. 1998 May;46(5):369-76.
- Carney PA, Hatch B, Stock I, Dickinson C, Davis M, Larsen R, Valenzuela S, Marino M, Darden PM, Gunn R, Ferrara L, Fagnan LJ. A stepped-wedge cluster randomized trial designed to improve completion of HPV vaccine series and reduce missed opportunities to vaccinate in rural primary care practices. Implement Sci. 2019 Mar 14;14(1):30. doi: 10.1186/s13012-019-0871-9.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月1日
初级完成 (预期的)
2022年12月1日
研究完成 (预期的)
2023年6月1日
研究注册日期
首次提交
2018年7月11日
首先提交符合 QC 标准的
2018年7月19日
首次发布 (实际的)
2018年7月27日
研究记录更新
最后更新发布 (实际的)
2022年3月31日
上次提交的符合 QC 标准的更新
2022年3月17日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.