Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
17 de marzo de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
22000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- ORPRN
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 89 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
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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.
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|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
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Experimental: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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HPV vaccine series completion
Periodo de tiempo: 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.
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3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Lyle J Fagnan, MD, Oregon Health and Science University
- Investigador principal: Patty Carney, PhD, Oregon Health and Science University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- 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.
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- 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.
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- 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.
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- 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.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2019
Finalización primaria (Anticipado)
1 de diciembre de 2022
Finalización del estudio (Anticipado)
1 de junio de 2023
Fechas de registro del estudio
Enviado por primera vez
11 de julio de 2018
Primero enviado que cumplió con los criterios de control de calidad
19 de julio de 2018
Publicado por primera vez (Actual)
27 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
17 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 18660
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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