Clinical trial NCT05925569: Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Official title: Electronic Alert-Based Computerized Decision Support to Improve Testing For Primary Aldosteronism in Patients With Hypertension: ALERT-PA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Aldosteronism
Resistant Hypertension
Secondary Hypertension
Hyperaldosteronism
Mineralocorticoid Excess
Hypertension
Keywords: Computer Decision Support
Primary Aldosteronism
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-06-29
Enrollment: 12501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of PA testing orders by provider
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of PA-related Specialty Referral
timeFrame: 6 months
measure: Frequency of Empiric Mineralocorticoid Receptor Antagonist (MRA) Prescription
timeFrame: 6 months
measure: Frequency of new PA-related diagnoses
timeFrame: 6 months
measure: Frequency of E-Consult order by provider
timeFrame: 6 months
measure: Frequency of "Positive" PA results
timeFrame: 6 months
Other outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jenifer M Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.