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

Primary Purpose

Primary Aldosteronism, Resistant Hypertension, Secondary Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice Advisory Computerized Alert
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Primary Aldosteronism focused on measuring Computer Decision Support, Primary Aldosteronism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BPA Alert Intervention

No Alert Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Frequency of PA testing orders by provider
The primary outcome is the frequency of aldosterone/renin laboratory testing orders by providers.

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2023
Last Updated
June 22, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05925569
Brief Title
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Acronym
ALERT-PA
Official Title
Electronic Alert-Based Computerized Decision Support to Improve Testing For Primary Aldosteronism in Patients With Hypertension: ALERT-PA
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism, Resistant Hypertension, Secondary Hypertension, Hyperaldosteronism, Mineralocorticoid Excess, Hypertension
Keywords
Computer Decision Support, Primary Aldosteronism

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BPA Alert Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No Alert Intervention
Arm Type
No Intervention
Arm Description
No electronic alert will be issued in the No Intervention group. Providers will continue standard of care with their patients.
Intervention Type
Other
Intervention Name(s)
Best Practice Advisory Computerized Alert
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of PA testing orders by provider
Description
The primary outcome is the frequency of aldosterone/renin laboratory testing orders by providers.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Frequency of PA-related Specialty Referral
Description
Frequency of referral to PA specialists, particularly in endocrinology and cardiology
Time Frame
6 months
Title
Frequency of Empiric Mineralocorticoid Receptor Antagonist (MRA) Prescription
Description
Frequency of prescription of empiric MRA such as spironolactone, eplerenone, or finerenone
Time Frame
6 months
Title
Frequency of new PA-related diagnoses
Description
Frequency of new ICD Diagnostic Code for PA, Secondary Hypertension, or Endocrine Hypertension
Time Frame
6 months
Title
Frequency of E-Consult order by provider
Description
Frequency of provider ordering an E-Consult with a PA-specialist
Time Frame
6 months
Title
Frequency of "Positive" PA results
Description
Frequency of a "Positive" screening test result suggestive of PA among patients who are screened.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in Systolic Blood Pressure
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenifer M Brown, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35767459
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.
Results Reference
background
PubMed Identifier
29129575
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.
Results Reference
background
PubMed Identifier
32449886
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.
Results Reference
background
PubMed Identifier
26934393
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.
Results Reference
background
PubMed Identifier
33370170
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.
Results Reference
background
PubMed Identifier
31228189
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.
Results Reference
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Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension

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