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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study

NCT05030545

Primary Aldosteronism Hypertension

RECRUITING PHASE4

Multi-omics Studies of Primary Aldosteronism

NCT07111351

Primary Aldosteronism

RECRUITING

Prospective Phenotyping of Autonomous Aldosterone Secretion

NCT03484130

Aldosterone Disorder Adrenal Gland Disease Blood Pressure

ACTIVE_NOT_RECRUITING

Diagnosing Variable Primary Aldosteronism.

NCT05765786

Primary Aldosteronism High Blood Pressure

RECRUITING

Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone

NCT06047912

Hypertension Primary Aldosteronism Urine Aldosterone

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Aldosteronism Resistant Hypertension Secondary Hypertension Hyperaldosteronism Mineralocorticoid Excess Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Best Practice Advisory Computerized Alert

Intervention Type 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.

No Alert Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)