- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07734272
Standardized Documentation and Assessments for Polycythemia Vera: A Quality Improvement Initiative (STANDARDIZE-PV)
STANDARDIZEd Documentation and Assessments for Polycythemia Vera (STANDARDIZE-PV): A Quality Improvement Initiative
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) characterized by unregulated clonal expansion of myeloid cells that primarily manifests with elevated red blood cells. Transformation to more aggressive, and potentially fatal diagnoses such as myelofibrosis or acute myeloid leukemia is observed in 5-15% at 15 years. Compared to an age- and sex-matched general population, patients with PV have a 3- to 13-fold higher risk of arterial and venous thromboembolic (TE) complications, which are the leading causes of premature morbidity and mortality. Other manifestations include microvascular disturbances (blurry vision, problems with concentration, paresthesia, headaches, palpitations), pruritus, and erythromelalgia. These symptoms may present with severity that do not correspond to conventional risk and may be harbingers of disease progression. Palpable splenomegaly and associated weight loss is also present in a third of patients at the time of PV diagnosis.
Cytoreductive therapies are now available and recommended for low and high-risk PV patients. As an example, ropeginterferon alfa-2b is a Federal Drug Administration-approved and commercially available cytoreductive agent since 2021 that has been shown to improve symptoms, reduce thrombotic risk, reduce risk of disease transformation, and death. Consequently, it is important to be able to recognize who requires cytoreduction with a comprehensive assessment. Despite this, prior studies demonstrate assessments are rarely comprehensive, and despite the availability of cytoreductive therapies that may reduce risk of thromboses and improve symptoms and spleen, there are delays in adoption of such agents in the real-world clinical setting.
Numerous studies have shown that disease-specific standardized progress note templates can be an effective means to incorporate knowledge into a clinician's workflow and enhance care quality without increasing documentation burden. In addition, Mass General Brigham has recently implemented a pharmacist-led management of ropeginterferon alfa-2b for PV patients.
Hence, the researchers propose to assess the feasibility, acceptability, and appropriateness of a PV-specific, EMR-based progress note template, in addition to the pharmacist-led ropeginterferon alfa-2b titration pathway, for clinicians across the institution.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michelle Lee, MD
- Número de teléfono: 617-882-6060
- Correo electrónico: mlee37@mgb.org
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Hematologists and medical oncologists within the Mass General Brigham network sites who treat at least one patient with PV in their outpatient clinic.
Exclusion Criteria:
- Clinicians who do not have an outpatient hematology or medical oncology clinic within Mass General Brigham.
- Clinicians who do not utilize the EPIC electronic medical record (EMR) System as their method of patient progress note documentation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Standardized note with standard-of-care pharmacist support
Standardized progress note templates with opt-in option for standard-of-care pharmacist support of ropeginterferon alfa-2b titration
|
Pilot intervention will include a standardized progress note for PV patient visits in addition to a standard-of-care opt-in for pharmacist-led titration for patients on ropeginterferon alfa-2b.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of intervention
Periodo de tiempo: 12 months
|
Number of participants that are eligible who enroll in this initiative and rating of feasibility by a single question on a 5-point Likert scale with score >3 indicating higher feasibility
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptibility of intervention
Periodo de tiempo: 12 months
|
Acceptability measured by a single question on a 5-point Likert scale with score >3 indicating higher acceptability.
|
12 months
|
|
Appropriateness of intervention
Periodo de tiempo: 12 months
|
Appropriateness measured by a single question on a 5-point Likert scale with score >3 indicating higher appropriateness.
|
12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of progress note use
Periodo de tiempo: 12 months
|
Rate of progress note use per total number of PV patient visits over 12 month study period.
|
12 months
|
|
Rate of symptoms documentation
Periodo de tiempo: 12 months
|
Rate of symptom documentation per total number of PV patient visits
|
12 months
|
|
Rate of cytoreductive therapy change or initiation
Periodo de tiempo: 12 months
|
Rate of cytoreductive therapy change or initiation by clinician per total number of PV patients who are eligible for a therapy change or initiation.
|
12 months
|
|
Rate of referrals or second opinion consultations with a leukemia specialist
Periodo de tiempo: 12 months
|
Rate of referrals or second opinion consultations with a leukemia specialist per total number of PV patients evaluated over study period
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-263
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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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