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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05925569

Collaborator

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

1,600

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism Resistant Hypertension Secondary Hypertension Hyperaldosteronism Mineralocorticoid Excess Hypertension	Other: Best Practice Advisory Computerized Alert	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
Frequency of "Positive" PA results [6 months]
Frequency of a "Positive" screening test result suggestive of PA among patients who are screened.

Other Outcome Measures

Change in Systolic Blood Pressure [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jenifer M. Brown, M.D., Associate Physician, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT05925569

Other Study ID Numbers:

2023P001435
5R01HL153004-03

First Posted:

Jun 29, 2023

Last Update Posted:

Jun 29, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jenifer M. Brown, M.D., Associate Physician, Brigham and Women's Hospital

Computer Decision Support

Primary Aldosteronism

Additional relevant MeSH terms:

Hypertension

Hyperaldosteronism

Study Results

No Results Posted as of Jun 29, 2023