Electronic Alert for Hypertension

(ALERT-PA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Mineralocorticoid antagonists

Disqualifiers: Primary aldosteronism

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new electronic alert system to help doctors identify patients who might have primary aldosteronism (PA), a condition that can cause high blood pressure and increase heart and kidney risks. The alert, called the Best Practice Advisory Computerized Alert, reminds doctors to screen for PA, which is often overlooked, and suggests specific tests. The trial compares two groups: one where doctors receive the alert and one where they do not. It seeks participants with high blood pressure who have either experienced blood pressure over 150/100 multiple times, take three or more blood pressure medications, have low potassium levels, or have a history of certain heart conditions like atrial fibrillation. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions that could improve diagnosis and treatment for many patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently prescribed a mineralocorticoid receptor antagonist, you may not be eligible to participate.

What prior data suggests that this computerized alert is safe for use in clinical settings?

Research has shown that Best Practice Advisory (BPA) alerts are generally well-received by users. These alerts help doctors manage blood pressure and diagnose high blood pressure effectively without harming patients. One study reported a significant improvement in blood pressure control, increasing from 82.3% to 92.3% in patients whose doctors used BPA alerts over six months. No reports have linked negative effects directly to these electronic alerts. This indicates that the BPA system is safe for patients and aids healthcare providers in making better decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electronic Alert for Hypertension trial because it introduces a proactive, tech-driven approach to managing hypertension. Unlike traditional treatments that rely on medication and lifestyle changes, this trial tests an electronic alert system that notifies clinicians to screen patients for Primary Aldosteronism, a condition that can contribute to hypertension. This method aims to streamline and enhance early detection and diagnosis, potentially leading to more personalized and effective treatment plans for patients. By integrating technology into routine care, this alert system could significantly improve clinical outcomes and efficiency.

What evidence suggests that this computerized alert is effective for increasing PA screening rates?

This trial will compare the effectiveness of a Best Practice Advisory (BPA) computerized alert with no alert intervention. Research has shown that BPA alerts can help manage blood pressure more effectively. One study found that using these alerts led to better control of high blood pressure in patients. Another study discovered that these alerts helped doctors diagnose high blood pressure more accurately during regular check-ups. While some studies noted fewer follow-up visits, patients who returned showed improved blood pressure results. Overall, BPA alerts appear promising in enhancing care for high blood pressure by encouraging necessary tests and treatments. ^{1 6 7 8 9}

Who Is on the Research Team?

Jenifer M Brown, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high blood pressure, seen at certain clinics in the last 2 years. They must have a history of very high blood pressure readings or be on multiple blood pressure medications, have low potassium levels, or a history of specific heart rhythm problems. People already diagnosed with Primary Aldosteronism or those recently treated with certain drugs for it cannot join.

Inclusion Criteria

I have a history of Atrial Fibrillation or Atrial Flutter.

I am currently taking three or more medications for high blood pressure.

I have a history of high blood pressure.

Exclusion Criteria

I have been prescribed an MRA in the last 3 months.

I have been diagnosed with Primary Aldosteronism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the Best Practice Advisory (BPA) alert to prompt screening for Primary Aldosteronism

6 months

Ongoing during outpatient clinical encounters

Follow-up

Participants are monitored for changes in systolic blood pressure and frequency of PA-related outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Best Practice Advisory Computerized Alert

Trial Overview The study tests if an electronic alert system helps doctors screen patients for Primary Aldosteronism—a commonly missed cause of high blood pressure—more effectively. It checks whether this alert increases screening rates and leads to better specialist referrals and treatment options.

How Is the Trial Designed?

Group I: BPA Alert Intervention Experimental Treatment 1 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 II: No Alert Intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study analyzing 1012 medication regimens in a nephrology clinic, more specific alerting strategies significantly reduced the number of alerts generated, with the most advanced strategy (D) resulting in alerts for only 7.81% of regimens compared to 87.5% with the least specific strategy (A).

The findings suggest that using patient and drug-specific information in alert systems can effectively minimize alert fatigue among physicians, potentially improving the safety of prescribing medications to patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring of alerts substantially reduces the alert burden in computerized clinical decision support for drugs that should be avoided in patients with renal disease. Czock, D., Konias, M., Seidling, HM., et al.[2017]

In a study involving 264 participants aged 35 to 74 with hypertension, e-counseling significantly reduced systolic blood pressure by an average of 10.1 mm Hg compared to 6.0 mm Hg in the control group after 12 months, indicating its efficacy in hypertension management.

E-counseling also led to improvements in pulse pressure and cardiovascular risk, demonstrating that combining technology with structured behavioral counseling can enhance the effectiveness of standard medical treatments for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of E-Counseling for Hypertension: REACH. Nolan, RP., Feldman, R., Dawes, M., et al.[2019]

A workplace intervention program that included self-monitoring of daily salt excretion and personalized e-mail advice led to significant reductions in blood pressure among 41 hypertensive male workers over 4 weeks.

The intervention group showed greater decreases in both daily salt excretion and home blood pressure compared to the control group, indicating the program's effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of salt reduction intervention program using an electronic salt sensor and cellular phone on blood pressure among hypertensive workers. Morikawa, N., Yamasue, K., Tochikubo, O., et al.[2017]

In a study of elderly diabetes patients (65 or older) with HbA1C levels of 6.5 or higher, clinicians' acknowledgment of Clinical Best Practice Advisories (BPA) alerts led to improved management of HbA1C levels.

Patients whose BPA alerts were ignored did not experience any significant negative effects on their HbA1C management, suggesting that while acknowledgment is beneficial, ignoring alerts does not worsen patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Physicians' Acknowledgement of Clinical Decision Support Systems Generated Alerts on Patient Diabetes Management in a Primary Care Setting. Faysel, MA., Miller, T., Singer, J., et al.[2023]

Automated alerts and reminders for patients can significantly improve adherence to healthcare regimens, as shown in a review of 51 studies, indicating their effectiveness in fostering shared accountability for health outcomes.

These reminders can be personalized and are effective across various age groups, suggesting that as technology advances, their use will likely expand, leading to better patient management and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated alerts and reminders targeting patients: A review of the literature. Perri-Moore, S., Kapsandoy, S., Doyon, K., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30346480/

Effectiveness of a Best Practice Alerts at Improving ... Conclusions: BPA activation was associated with worse patient follow-up but improved BP control. Some subgroups had significantly different ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S294991272300034X

Interacting with best practice advisory (BPA) notifications in ... We reviewed all patients who triggered a BPA alert for AAA screening from December 2018 to December 2021 in a single tertiary academic setting.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6118864/

Primary care provider adherence to an alert for ... CONCLUSION. We achieved relatively high specificity in a BPA alert for the intensification of blood pressure medications for primary care ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833283

Integrating a High Blood Pressure Advisory Across ... This quality improvement study of an EMR high BP advisory intervention found significantly improved primary care hypertension control and diagnosis.

5. researchgate.net researchgate.net/publication/328462984_Effectiveness_of_a_Best_Practice_Advisory_at_Improving_Hypertension_Control

Effectiveness of a Best Practice Advisory at Improving ... For those who did follow up, BPA activation was associated with improved BP control. Conclusions: BPA activation was associated with worse patient follow-up but ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10393867/

Optimizing Best Practice Advisory alerts in electronic ... There was a significant reduction of 59.6% in the total number of interruptive BPA alerts, despite an increase in the number of unique BPAs from ...

7. patientcareonline.com patientcareonline.com/view/high-blood-pressure-advisory-in-ehr-improves-hypertension-diagnosis-control-across-a-primary-care-network

High Blood Pressure Advisory in EHR Improves ... Over the 6-month interval, modeled hypertension control improved from 82.3% to 92.3% in the intervention cohort, while it declined slightly from ...

8. thieme-connect.com thieme-connect.com/products/ejournals/pdf/10.1055/a-2554-3969.pdf

User Actions within a Clinical Decision Support Alert for the ... Abstract. Objective This study aimed to examine user actions within a clinical decision support. (CDS) alert addressing hypertension (HTN) ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02436421

Impact of Best Practice Alerts in Cardiology Outpatient Clinics Hypertension BPA. The alert will notify providers when patients have elevated blood pressure. Intervention/Treatment, Other : Best Practice Alert based in the ...