An interventional study of Standardized progress note in Polycythemia Vera, sponsored by Massachusetts General Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's planned enrollment of 32 is below the median of 52 across 204 interventional studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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- 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:
Standardized progress note templates with opt-in option for standard-of-care pharmacist support of ropeginterferon alfa-2b titration
Behavioral: Standardized 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.
Feasibility of intervention
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
Time frame: 12 months
Acceptibility of intervention
Acceptability measured by a single question on a 5-point Likert scale with score \>3 indicating higher acceptability.
Time frame: 12 months
Appropriateness of intervention
Appropriateness measured by a single question on a 5-point Likert scale with score \>3 indicating higher appropriateness.
Time frame: 12 months
Rate of progress note use
Rate of progress note use per total number of PV patient visits over 12 month study period.
Time frame: 12 months
Rate of symptoms documentation
Rate of symptom documentation per total number of PV patient visits
Time frame: 12 months
Rate of cytoreductive therapy change or initiation
Rate of cytoreductive therapy change or initiation by clinician per total number of PV patients who are eligible for a therapy change or initiation.
Time frame: 12 months
Rate of referrals or second opinion consultations with a leukemia specialist
Rate of referrals or second opinion consultations with a leukemia specialist per total number of PV patients evaluated over study period
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Undecided — There may be a plan in the future to make IPD available.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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