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

NCT07734272 | Not Yet Recruiting

• 1 other identifier: 26-263
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycythemia Vera

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• Acceptibility of intervention

  12 months

• Appropriateness of intervention

  12 months

Other Outcomes (4)

• Rate of progress note use

  12 months

• Rate of symptoms documentation

  12 months

• Rate of cytoreductive therapy change or initiation

  12 months

Study Arms (1)

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

Behavioral: Standardized progress note

Interventions

Standardized progress note BEHAVIORAL

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.

Standardized note with standard-of-care pharmacist support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Hematologists and medical oncologists within the Mass General Brigham network sites who treat at least one patient with PV in their outpatient clinic.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• PharmaEssentia: collaborator

MeSH Terms

Conditions

Polycythemia Vera

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Central Study Contacts

Michelle Lee, MD

CONTACT

617-882-6060; mlee37@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07