Polycythemia VeraSTANDARDIZE-PVNCT07734272
Standardized Documentation and Assessments for Polycythemia Vera: A Quality Improvement Initiative
A study testing Standardized progress note in people with Polycythemia Vera, run by Massachusetts General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- Standardized progress note
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Hematologists and medical oncologists within the Mass General Brigham network sites who treat at least one patient with PV in their outpatient clinic.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: STANDARDIZEd Documentation and Assessments for Polycythemia Vera (STANDARDIZE-PV): A Quality Improvement Initiative
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.
Read the 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.
- Conditions
- Polycythemia Vera
- Being tested
- Standardized progress note
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized progress noteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized note with standard-of-care pharmacist support | Experimental | Standardized progress note templates with opt-in option for standard-of-care pharmacist support of ropeginterferon alfa-2b titration Receives: Behavioral: Standardized progress note |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Acceptibility of intervention
Acceptability measured by a single question on a 5-point Likert scale with score >3 indicating higher acceptability.
Measured: 12 months
Appropriateness of intervention
Appropriateness measured by a single question on a 5-point Likert scale with score >3 indicating higher appropriateness.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start5 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaEssentia
- Responsible party
- Principal investigator, Michelle Lee, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734272
- Sponsor's protocol ID
- 26-263
- Acronym
- STANDARDIZE-PV
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There may be a plan in the future to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STANDARDIZEd Documentation and Assessments for Polycythemia Vera (STANDARDIZE-PV): A Quality Improvement Initiative
- ClinicalTrials.gov ID
- NCT07734272
- Acronym / sponsor ID
- STANDARDIZE-PV / 26-263
- Conditions
- Polycythemia Vera
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- PharmaEssentia
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized note with standard-of-care pharmacist support | Experimental | Behavioral: Standardized progress noteStandardized progress note templates with opt-in option for standard-of-care pharmacist support of ropeginterferon alfa-2b titration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hematologists and medical oncologists within the Mass General Brigham network sites who treat at least one patient with PV in their outpatient clinic.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized progress notePilot 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. | Behavioural | Standardized note with standard-of-care pharmacist support |
Primary outcome
Feasibility of intervention
Time frame: 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
2 secondary outcomes
Acceptibility of intervention
Time frame: 12 months
Appropriateness of intervention
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided. There may be a plan in the future to make IPD available.
Related trials for Polycythemia Vera
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Polycythemia Vera (PV)
RecruitingPhase 1
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
RecruitingPhase 1
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Polycythemia Vera (PV), Myelofibrosis (MF)
Recruiting
Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes
Myeloproliferative Neoplasm, Polycythemia Vera
RecruitingPhase 3
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Polycythemia Vera
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized progress note in people with Polycythemia Vera, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Lee, MD (617-882-6060, mlee37@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.