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

12501 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Best Practice Advisory Computerized Alert for hypertension?

Research shows that when doctors acknowledge and follow alerts from Clinical Best Practice Advisories, it can lead to better management of chronic conditions like diabetes. This suggests that similar alerts for hypertension could also help improve patient outcomes by encouraging timely and appropriate care. ^{1 2 3 4 5}

Is the Electronic Alert for Hypertension safe for humans?

There is no specific safety data available for the Electronic Alert for Hypertension, but studies on similar alert systems suggest that usability issues can impact safety. Improving the design of these systems is important to ensure they are safe and effective for clinical use. ^{1 6 7 8 9}

How does the Electronic Alert for Hypertension treatment differ from other treatments for high blood pressure?

The Electronic Alert for Hypertension treatment is unique because it uses electronic tools to remind healthcare providers about cardiovascular risk assessments and drug contraindications, which can help in better managing high blood pressure compared to traditional methods. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Jenifer M Brown, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical inertia: a common barrier to changing provider prescribing behavior. [2019]

2. Netherlands 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Primary care provider adherence to an alert for intensification of diabetes blood pressure medications before and after the addition of a "chart closure" hard stop. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Automated alerts and reminders targeting patients: A review of the literature. [2022]

5. England 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. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Risk management, or just a different risk? [2018]

7. England pubmed.ncbi.nlm.nih.gov

Drug safety alert generation and overriding in a large Dutch university medical centre. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Overriding of drug safety alerts in computerized physician order entry. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Evidence-based usability design principles for medication alerting systems. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to evidence-based blood pressure control in community practice. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Lifestyle modifications to lower or control high blood pressure: is advice associated with action? The behavioral risk factor surveillance survey. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of E-Counseling for Hypertension: REACH. [2019]

13. England 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. [2017]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Development of electronic form of the 1999 WHO/ISH hypertension guidelines. [2007]