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

NCT05925569 | Active Not Recruiting

• 2 other identifiers: 2023P0014355R01HL153004-03
• Study Type: interventional
• Target: 12,501
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Computer Decision Support; Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• Frequency of PA testing orders by provider

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

  6 months

Secondary Outcomes (5)

• 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

• Frequency of "Positive" PA results

  6 months

Other Outcomes (1)

• Change in Systolic Blood Pressure

  6 months

Study Arms (2)

BPA Alert Intervention

EXPERIMENTAL

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.

Other: Best Practice Advisory Computerized Alert

No Alert Intervention

NO INTERVENTION

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

Interventions

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.

BPA Alert Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• 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.

  PMID: 35767459 BACKGROUND

• 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.

  PMID: 29129575 BACKGROUND

• 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.

  PMID: 32449886 BACKGROUND

• 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.

  PMID: 26934393 BACKGROUND

• 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.

  PMID: 33370170 BACKGROUND

• 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.

  PMID: 31228189 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jenifer M Brown, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: June 29, 2023
• Study Start: March 13, 2024
• Primary Completion: December 9, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)