Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension

Not Applicable

Active, not recruiting

• Conditions: Secondary Hypertension; Mineralocorticoid Excess; Hypertension; Hyperaldosteronism; Primary Aldosteronism; Resistant Hypertension
• Interventions: Other: Best Practice Advisory Computerized Alert

• Registration Number: NCT05925569
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-29
• Study Start: 2024-03-13
• Primary Completion: 2024-12-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12501

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPA Alert Intervention	Best Practice Advisory Computerized Alert	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.

Primary Outcome Measures

Name	Time	Method
Frequency of PA testing orders by provider	6 months	The primary outcome is the frequency of aldosterone/renin laboratory testing orders by providers.

Secondary Outcome Measures

Name	Time	Method
Frequency of "Positive" PA results	6 months	Frequency of a "Positive" screening test result suggestive of PA among patients who are screened.
Frequency of PA-related Specialty Referral	6 months	Frequency of referral to PA specialists, particularly in endocrinology and cardiology
Frequency of Empiric Mineralocorticoid Receptor Antagonist (MRA) Prescription	6 months	Frequency of prescription of empiric MRA such as spironolactone, eplerenone, or finerenone
Frequency of new PA-related diagnoses	6 months	Frequency of new ICD Diagnostic Code for PA, Secondary Hypertension, or Endocrine Hypertension
Frequency of E-Consult order by provider	6 months	Frequency of provider ordering an E-Consult with a PA-specialist

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States