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

December 1, 2023 updated by: Jenifer M. Brown, M.D., Brigham and Women's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BPA Alert Intervention
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
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.
No Intervention: No Alert Intervention
No electronic alert will be issued in the No Intervention group. Providers will continue standard of care with their patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Jenifer M Brown, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P001435
  • 5R01HL153004-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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