Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05925569

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Mineralocorticoid Excess Resistant Hypertension Secondary Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice Advisory Computerized Alert

Other

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.

Primary outcomes

  1. Frequency of PA testing orders by provider

    Time frame: 6 months

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

Secondary outcomes

  1. Frequency of PA-related Specialty Referral

    Time frame: 6 months

    Frequency of referral to PA specialists, particularly in endocrinology and cardiology

  2. Frequency of Empiric Mineralocorticoid Receptor Antagonist (MRA) Prescription

    Time frame: 6 months

    Frequency of prescription of empiric MRA such as spironolactone, eplerenone, or finerenone

  3. Frequency of new PA-related diagnoses

    Time frame: 6 months

    Frequency of new ICD Diagnostic Code for PA, Secondary Hypertension, or Endocrine Hypertension

  4. Frequency of E-Consult order by provider

    Time frame: 6 months

    Frequency of provider ordering an E-Consult with a PA-specialist

  5. Frequency of "Positive" PA results

    Time frame: 6 months

    Frequency of a "Positive" screening test result suggestive of PA among patients who are screened.

Other outcomes

  1. Change in Systolic Blood Pressure

    Time frame: 6 months

    Difference between average of last 3 outpatient systolic blood pressure readings prior to study initiation vs. average of first 3 outpatient readings after study completion (Exploratory)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: ALERT-PA

Important dates

Study start
2024
Primary completion
2024
Study completion
2029
First posted
Jun 29, 2023
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.