Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-06-22
Brief Title:
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Electronic Alert-Based Computerized Decision Support to Improve Testing For Primary Aldosteronism in Patients With Hypertension ALERT-PA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALERT-PA
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 inclusionexclusion criteria for Primary Aldosteronism PA screening will comprise the study population with randomization of alertno alert occurring at the level of their treating clinician Attending Physician Nurse Practitioner or Physician Assistant to minimize spillovercontamination 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HL153004-03 | NIH | None | httpsreporternihgovquickSearch5R01HL153004-03 |