- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04371887
Comparing Strategies for Implementing Primary HPV Screening
Comparing Strategies for Implementing Primary HPV Testing for Routine Cervical Cancer Screening
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures.
Limit: 32,000 characters.
Background and Significance: Strong evidence supports testing for the high risk human papillomavirus (HPV) infection, the etiology agent of cervical cancer, in routine cervical cancer screening. In 2014, the FDA approved the first test for primary HPV screening. Between 2015 and 2017, professional societies and national guideline bodies released practice recommendation for primary HPV screening. However, none of the large health care systems in the U.S. have systematically adopted this new screening strategy. Kaiser Permanente Southern California (KPSC) is preparing to transition to primary HPV screening in 2019, with considerable expected impact and barriers at multiple levels. There is a critical gap of knowledge on effective strategies to guide implementation of uptake of new evidence-based practice, especially around cancer screening where changes to clinical practice guidelines often created confusion among clinicians and patients. The overarching goals of this application is to generate insights and evidence regarding barriers and facilitators and effective strategies to achieve clinical practice substitution. Study Aims: SA1) Compare a local-tailored vs. a centralized approach for facilitating adoption of primary HPV testing for cervical cancer screening on (a) implementation outcomes including uptake of primary HPV screening, acceptability, appropriateness and feasibility; and (b) stakeholder-centered outcomes including knowledge, experience, behavior and satisfaction; SA2) Explain variations in implementation strategy effectiveness on study outcomes by multi-level factors; and SA3) Develop guidance for use of the effective implementation strategies in additional settings and for additional implementation problems. Study Descriptions: We will conduct a prospective, cluster randomized programmatic trial to compare and evaluate a local-tailored versus a centralized implementation approach. The local tailoring strategy will be guided by a structured process, using a menu of core functions and forms with evidence-based barrier assessment and intervention options. The centralized implementation will be based on the prevalent KPSC regional approach to new practice implementation, involving the design of a multi-component approach that is delivered in a relatively consistent manner. Twelve of the 14 KPSC medical centers will be randomized to receive one of the two implementation approaches, with two medical centers serving as pilot sites. The study subject will include screening age women, primary care and obstetrics & gynecology physicians, as well as clinic staff, administrators and operational leaders. The primary outcome of interest is uptake of primary HPV screening at the provider level. The secondary outcomes include stakeholder-centered outcomes such as knowledge and satisfaction, and additional implementation and system outcomes as well as implementation process evaluation. Data collection will be via electronic medical record extraction, patient and provider surveys, and semi-structured key-informant interviews. Multi-level models and generalized estimating equations will be used to evaluate the effect of the local-tailored approach on each outcomes of interest. Effect heterogeneity by multi-level factors will be examined by interaction terms. Content analysis will be used to evaluate qualitative data collected for Aims 1 and 3. We will use the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) to inform our overall study approach and provide rigor and structure to our analyses.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chunyi Hsu, MPH
- Número de teléfono: 626-564-3508
- Correo electrónico: chunyi.hsu@kp.org
Copia de seguridad de contactos de estudio
- Nombre: Nancy Cannizzaro, PhD
- Número de teléfono: 626-564-7663
- Correo electrónico: nancy.takahashi@kp.org
Ubicaciones de estudio
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California
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Pasadena, California, Estados Unidos, 91101
- Reclutamiento
- Kaiser Permanente Southern California
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Contacto:
- Chunyi Hsu, MPH
- Número de teléfono: 626-564-3508
- Correo electrónico: chunyi.hsu@kp.org
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Contacto:
- Nancy Cannizzaro, PhD
- Número de teléfono: 626-564-7663
- Correo electrónico: nancy.takahashi@kp.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
This is a cluster randomized trial. All KPSC's 12 service areas except Orange Country will be randomized and included in this study. All providers (physicians, nurses and medical assistants) and department administrator from the primary care departments (family medicine and internal medicine) and the department of obstetrics and gynecology at these 12 service areas randomized to this arm will be included in the study, as well as female patients at these service areas between age 30-65 who received cervical cancer screening during the data collection period.
Exclusion Criteria:
- Patients who are younger than 30 years old
- Providers working for departments other than Ob/Gyn, family or internal medicine
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Local Tailoring
The intervention arm will consist of six KPSC service areas randomly assigned to the intervention arm.
Immediately after primary HPV screening opens at KPSC, the intervention arm will receive the local tailoring interventions.
All providers (physicians, nurses and medical assistants) and department administrator from the primary care departments (family medicine and internal medicine) and the department of obstetrics and gynecology at these six service areas randomized to this arm will be included in the study, as well as female patients at these service areas between age 30-65 who received cervical cancer screening during the data collection period.
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The "guided local tailoring" approach will employ a standard structured process, including (1) convening a project team, (2) conducting a local diagnostic process to identify likely barriers using provider/patient survey and interviews with providers/administrators, (3) selecting from a pre-developed menu of implementation strategies categorized by core function (form and function menu), and (4) deploying the selected strategies in collaboration with local implementation and improvement consultants.
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Sin intervención: Hybrid Usual Care
The hybrid-usual care arm will consist of six KPSC service areas randomly assigned to this arm.
The hybrid usual care arm will receive regional educational activities for the transition (as will the intervention arm) before the roll out of primary HPV testing.
However, they will not receive any research-led intervention or adaptation guidance after primary HPV screening opens at KPSC.
All providers (physicians, nurses and medical assistants) and department administrator from the primary care departments (family medicine and internal medicine) and the department of obstetrics and gynecology at these six service areas randomized to this arm will be included in the study, as well as female patients at these service areas between age 30-65 who received cervical cancer screening during the data collection period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Uptake of primary HPV testing
Periodo de tiempo: Within the 3 months after the end of the 2 months intervention window
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Proportion of primary HPV testing of all cervical cancer screening performed for women age 30-65 at the provider level.
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Within the 3 months after the end of the 2 months intervention window
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Provider-centered outcomes
Periodo de tiempo: Within the 3 months after the end of the 2 months intervention window
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Knowledge about the efficacy of the new test.
We will assess provider knowledge via provider surveys which elicits information on provider knowledge and practice on cervical cancer screening.
Provider delivery of education during patient screening visit will be measured in provider survey, including whether education is delivered and average time spent on patient education/counseling. Provider/staff satisfaction of the transition process and provider resistance to the new screening modality will be ascertained via survey questions.
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Within the 3 months after the end of the 2 months intervention window
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Patient-centered outcomes
Periodo de tiempo: Within the 3 months after the end of the 2 months intervention window
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Knowledge about the new test and why the change is made.
To measure this outcome, we will use and modify validated survey questions on HPV test knowledge.
Emotional reactions (stigma and shame) of a positive HPV test result will be measured using survey questions developed by Waller et al.
Patient satisfaction during the transition may be measured with survey questions such as "Were you able to discuss all your concerns/questions about the new screening approach with your provider?"
"Where these concerns/questions adequately addressed?"
"Did you get your test result back in a timely manner?"
"Did someone explain to you what the test result mean?" and "How satisfy are you with the screening experience?"
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Within the 3 months after the end of the 2 months intervention window
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Time to colposcopy after a positive test result
Periodo de tiempo: Within the 6 months after the end of the 2 months intervention window
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Time to colposcopy after a positive test result represents the combination of correct and timely referral, patient compliance, and availability of colposcopy appointments and will be measured using laboratory and utilization data collected in KPSC's electronic medical records.
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Within the 6 months after the end of the 2 months intervention window
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chun R Chao, PhD, KPSC Department of Research and Evaluation
- Investigador principal: Devansu Tewari, MD, KPSC Orange County Medical Center Department of Obstetrics and Gynecology
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR-2018C1-10987
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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