- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michelle Lee, MD
- Telefonnummer: 617-882-6060
- E-post: mlee37@mgb.org
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of intervention
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptibility of intervention
Tidsramme: 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
Tidsramme: 12 months
|
Appropriateness measured by a single question on a 5-point Likert scale with score >3 indicating higher appropriateness.
|
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of progress note use
Tidsramme: 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
Tidsramme: 12 months
|
Rate of symptom documentation per total number of PV patient visits
|
12 months
|
|
Rate of cytoreductive therapy change or initiation
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-263
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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