Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension (ALERT-PA)

Mass General Brigham

Status: Active, not recruiting

Conditions: Hypertension; Mineralocorticoid Excess; Resistant Hypertension; Primary Aldosteronism; Hyperaldosteronism; Secondary Hypertension

Treatments: Other: Best Practice Advisory Computerized Alert

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05925569

5R01HL153004-03 (U.S. NIH Grant/Contract)

2023P001435

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

12,501 participants in 2 patient groups

BPA Alert Intervention

Experimental group

Description:

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.

Treatment:

Other: Best Practice Advisory Computerized Alert

No Alert Intervention

No Intervention group

Description:

No electronic alert will be issued in the No Intervention group. Providers will continue standard of care with their patients.