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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michelle Lee, MD
- 電話番号：617-882-6060
- メール：mlee37@mgb.org
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of intervention
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptibility of intervention
時間枠：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
時間枠：12 months
|
Appropriateness measured by a single question on a 5-point Likert scale with score >3 indicating higher appropriateness.
|
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of progress note use
時間枠：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
時間枠：12 months
|
Rate of symptom documentation per total number of PV patient visits
|
12 months
|
|
Rate of cytoreductive therapy change or initiation
時間枠：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
時間枠：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
|
協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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