跳至主要内容
临床试验/NCT05925569
NCT05925569进行中(未招募)不适用

Electronic Alert-Based Computerized Decision Support to Improve Testing For Primary Aldosteronism in Patients With Hypertension: ALERT-PA

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 12,501 人开始时间: 2024年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
12,501
试验地点
2
主要终点
Frequency of PA testing orders by provider

研究概览

简要总结

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.

详细描述

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. 1600 patients meeting inclusion/exclusion criteria for Primary Aldosteronism (PA) screening 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • History of Primary Aldosteronism (ICD Code)
  • Prescription for a Mineralocorticoid Receptor Antagonist (MRA) within the last 3 months

结局指标

主要结局

Frequency of PA testing orders by provider

时间窗: 6 months

The primary outcome is the frequency of aldosterone/renin laboratory testing orders by providers.

次要结局

  • Frequency of "Positive" PA results(6 months)
  • Frequency of PA-related Specialty Referral(6 months)
  • Frequency of Empiric Mineralocorticoid Receptor Antagonist (MRA) Prescription(6 months)
  • Frequency of new PA-related diagnoses(6 months)
  • Frequency of E-Consult order by provider(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenifer M. Brown, M.D.

Associate Physician

Brigham and Women's Hospital

研究点 (2)

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