Skip to content

Standardized Documentation and Assessments for Polycythemia Vera: A Quality Improvement Initiative

STANDARDIZEd Documentation and Assessments for Polycythemia Vera (STANDARDIZE-PV): A Quality Improvement Initiative

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07734272
Acronym
STANDARDIZE-PV
Enrollment
32
Registered
2026-07-29
Start date
2026-08-05
Completion date
2028-03-31
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera

Brief summary

The purpose of this quality improvement initiative is to explore whether an electronic medical records-based templated progress note for polycythemia vera (PV) in addition to a standard-of-care pharmacist-collaborative ropeginterferon alfa-2b titration service is feasible, acceptable, and appropriate for clinicians who manage PV.

Detailed description

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.

Interventions

BEHAVIORALStandardized progress note

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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
PharmaEssentia
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of intervention12 monthsNumber 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

Secondary

MeasureTime frameDescription
Acceptibility of intervention12 monthsAcceptability measured by a single question on a 5-point Likert scale with score \>3 indicating higher acceptability.
Appropriateness of intervention12 monthsAppropriateness measured by a single question on a 5-point Likert scale with score \>3 indicating higher appropriateness.

Contacts

CONTACTMichelle Lee, MD
mlee37@mgb.org617-882-6060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026