高血圧患者の原発性アルドステロン症の検査を改善するための電子アラート (ALERT-PA)
高血圧患者における原発性アルドステロン症の検査を改善する電子アラートベースのコンピューター化された意思決定支援: ALERT-PA
Primary aldosteronism (PA) is common but rarely recognized cause of hypertension that carries excess cardiovascular and renal risk and has approved targeted treatments. Despite current clinical guidelines that recommend screening in a defined set of high-risk populations, less than 5% of eligible patients are ever screened for PA. This study aims to evaluate the impact of a computer decision support Best Practice Advisory (BPA) alert on rates of screening for PA in guideline-eligible patients, referral to specialist PA care, and treatment with mineralocorticoid receptor antagonists.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The study protocol is a single-center Quality Improvement initiative performed as a cluster-randomized controlled trial designed to evaluate the impact of an EPIC electronic health record Best Practice Advisory (BPA) alert on rates of screening for PA in guideline-eligible patients. All patients meeting inclusion/exclusion criteria for Primary Aldosteronism (PA) screening seen over the 12-week enrollment period will comprise the study population, with randomization of alert/no alert occurring at the level of their treating clinician (Attending Physician, Nurse Practitioner, or Physician Assistant) to minimize spillover/contamination effects of the BPA onto other patients treated by the same clinician. Treating clinicians within primary care and relevant specialties including endocrinology, nephrology, and cardiology will be randomized 1:1 to receive or not receive a BPA prompting screening for PA with laboratory testing of plasma aldosterone, plasma renin activity, and a basic metabolic panel, as well as an order for an e-consult to provide guidance on interpretation of results, for eligible patients. Outcomes will be ascertained by electronic health record review at 6 months.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Adults 18+
-
Seen by clinician at one of the intervention practices at least once in the prior 2 years
-
History of Hypertension (ICD Code) PLUS ≥1 of the below:
- Outpatient BP >150/100 on 2 or more occasions
- Three or more current antihypertensive medication prescriptions
- Potassium level <3.5mEq/L or potassium supplement prescription in the last 5 years
- History of Atrial Fibrillation or Atrial Flutter (ICD Code)
Exclusion Criteria:
- History of Primary Aldosteronism (ICD Code)
- Prescription for a Mineralocorticoid Receptor Antagonist (MRA) within the last 3 months
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:ふるい分け
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:BPA Alert Intervention
An on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the clinician that their patient should be screened for Primary Aldosteronism and provides an order set for the corresponding laboratory evaluation. Details of the electronic alert are provided in the Intervention description. |
For patients randomly assigned to the BPA Alert Group, an on-screen electronic alert will be issued during the outpatient clinical encounter than notifies the clinician that their patient should be screened for PA. The clinician will be provided with on-screen details of which patient-specific risk factors qualified them for PA screening and with an option to order a plasma renin activity, aldosterone, and basic metabolic panel. If screening labs are ordered, the clinician will also receive an option to order an eConsult for expert guidance on interpretation of the test results. If the clinician does not order the PA screening labs, they will be able to continue with clinical EHR documentation but will need to select a reason they opted not to follow the alert's evidence-based clinical practice recommendation. |
|
介入なし:No Alert Intervention
No electronic alert will be issued in the No Intervention group. Providers will continue standard of care with their patients. |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of PA Testing Orders by Provider
時間枠:6 months
|
The primary outcome is the frequency of aldosterone/renin laboratory testing orders placed by providers. |
6 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of PA-related Specialty Referral
時間枠:6 months
|
Frequency of referral to specialist who may treat PA (endocrinology, cardiology, or nephrology) |
6 months
|
|
Frequency of Empiric Mineralocorticoid Receptor Antagonist (MRA) Prescription
時間枠:6 months
|
Frequency of prescription of empiric MRA such as spironolactone, eplerenone, or finerenone |
6 months
|
|
Frequency of New PA-related Diagnoses
時間枠:6 months
|
Frequency of new ICD Diagnostic Code for PA, Secondary Hypertension, or Endocrine Hypertension |
6 months
|
|
Frequency of E-Consult Order by Provider
時間枠:6 months
|
Frequency of provider ordering an E-Consult with a PA-specialist |
6 months
|
|
Frequency of "Positive" PA Results
時間枠:6 months
|
Frequency of a suppressed plasma renin activity <=1 and aldosterone >=7.5 among patients who are screened. |
6 months
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Jenifer M Brown, MD、Brigham and Women's Hospital
出版物と役立つリンク
一般刊行物
- Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
- Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9.
- Vaidya A, Hundemer GL, Nanba K, Parksook WW, Brown JM. Primary Aldosteronism: State-of-the-Art Review. Am J Hypertens. 2022 Dec 8;35(12):967-988. doi: 10.1093/ajh/hpac079.
- Brown JM, Siddiqui M, Calhoun DA, Carey RM, Hopkins PN, Williams GH, Vaidya A. The Unrecognized Prevalence of Primary Aldosteronism: A Cross-sectional Study. Ann Intern Med. 2020 Jul 7;173(1):10-20. doi: 10.7326/M20-0065. Epub 2020 May 26.
- Cohen JB, Cohen DL, Herman DS, Leppert JT, Byrd JB, Bhalla V. Testing for Primary Aldosteronism and Mineralocorticoid Receptor Antagonist Use Among U.S. Veterans : A Retrospective Cohort Study. Ann Intern Med. 2021 Mar;174(3):289-297. doi: 10.7326/M20-4873. Epub 2020 Dec 29.
- Piazza G, Hurwitz S, Galvin CE, Harrigan L, Baklla S, Hohlfelder B, Carroll B, Landman AB, Emani S, Goldhaber SZ. Alert-based computerized decision support for high-risk hospitalized patients with atrial fibrillation not prescribed anticoagulation: a randomized, controlled trial (AF-ALERT). Eur Heart J. 2020 Mar 7;41(10):1086-1096. doi: 10.1093/eurheartj/ehz385.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 2023P001435
- 5R01HL153004-03 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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