Hyperaldosteronism, Hypertension, Mineralocorticoid Excess, Primary Aldosteronism, Resistant Hypertension, Secondary Hypertension
Conditions
Keywords
Computer Decision Support, Primary Aldosteronism
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.
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.
Interventions
OTHERBest 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of PA testing orders by provider | 6 months | The primary outcome is the frequency of aldosterone/renin laboratory testing orders by providers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed