Clinical Decision Support Tool for High Blood Pressure

(AI-HTN Trial)

CM
Overseen ByCarrie Melgaard, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
Must be taking: BP lowering
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool designed to help doctors manage high blood pressure (BP) during regular clinic visits. The research aims to determine if this Clinical Decision Support (CDS) tool can improve blood pressure control compared to usual care methods. Participants will be divided into two groups: one will receive standard treatment, while the other will have doctors using the CDS tool for their care. Ideal participants are adults diagnosed with high blood pressure, currently taking medication for it, and having a systolic BP of 130 mmHg or higher. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future hypertension management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must already be on at least one blood pressure medication, it seems likely you can continue your current treatment.

What prior data suggests that this clinical decision support tool is safe for use in managing high blood pressure?

Research has shown that clinical decision support tools (CDSTs) are generally safe in healthcare. These tools assist doctors in making better choices, such as selecting the right medication mix for high blood pressure, by using information from patient visits, like recent blood pressure readings.

Studies have found that CDSTs help doctors adhere to treatment guidelines more effectively and lower blood pressure. No direct evidence indicates that these tools cause harm, so they are considered safe. The primary focus is on how they aid doctors and patients in managing health conditions, rather than causing side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Clinical Decision Support Tool for high blood pressure because it integrates directly into Electronic Medical Records (EMR) to aid clinicians in prescribing more effective medication combinations. Unlike the standard approach, where doctors rely on their individual judgment and experience, this tool provides data-driven insights and personalized recommendations. This innovation could lead to more efficient hypertension management, potentially improving patient outcomes by optimizing treatment plans based on the latest research and patient-specific data.

What evidence suggests that this Clinical Decision Support Tool is effective for lowering high blood pressure?

Research has shown that tools designed to assist doctors in decision-making can effectively lower blood pressure in individuals with hypertension. A review of several studies found that these tools improved both systolic and diastolic blood pressure readings. One study found that these tools helped doctors adhere more closely to guidelines for managing high blood pressure. In this trial, some participants will receive care using the Clinical Decision Support Tool, embedded in the Electronic Medical Record, to aid clinicians in prescribing more effective medication combinations. Trials with patients demonstrated that these tools were more effective in controlling high blood pressure than standard care alone. Overall, the evidence suggests that these decision-support tools can be a valuable addition to treating high blood pressure.24678

Who Is on the Research Team?

LL

Luke Laffin, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with uncontrolled high blood pressure who are receiving standard medical treatment. They should be available for a follow-up clinic visit 4 weeks after their initial appointment to check their blood pressure.

Inclusion Criteria

I am 18 years old or older.
I have high blood pressure and am on medication for it.
I can follow the study rules and go to all planned visits.
See 1 more

Exclusion Criteria

In the opinion of the investigator, any other condition that will preclude participation in the study
Women who are pregnant, plan to become pregnant, or are breast-feeding
My heart's pumping ability is significantly reduced.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Clinical Decision Support Tool or standard care for hypertension management

4 weeks
1 visit (in-person) for BP check

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Clinical Decision Support Tool
Trial Overview The study is testing if using a Clinical Decision Support (CDS) tool, integrated with the electronic medical record system during outpatient visits, can more effectively lower patients' blood pressure compared to usual care without the CDS tool.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Clinical Decision Support ToolExperimental Treatment1 Intervention
Group II: Standard of Care for Hypertension ManagementActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Citations

study protocol for a pragmatic cluster-randomized controlled trialThe LIGHT trial will provide evidence on the effectiveness of a CDSS for improving guideline adherence for hypertension management in primary ...
Do clinical decision support tools improve quality of care ...Meta-analysis revealed CDSTs showed improvement in systolic (Mean Standardised Difference (MSD)=0.39, 95 %CI=-0.31, -1.10) and diastolic blood pressure ...
Results From a Cluster Randomized TrialWe performed a cluster randomized trial to test the effectiveness and cost‐effectiveness of a clinical DSS among Indian adult hypertensive patients.
Clinical Decision Support Systems Using Home Blood ...Objective: This study aimed to summarize existing studies on CDSSs that use HBP readings to manage patients with hypertension. Methods: We ...
Evaluation of a Computerized Clinical Decision Support ...This project analyzed the efficacy of using clinical decision support and performance feedback to improve the control of hypertension in patients treated in ...
Clinical Decision Support Systems Using Home Blood ...In the context of hypertension, a CDSS can detect elevated BP readings at clinic visits and support clinicians in diagnosing hypertension, ...
Implementation of an Integrated, Clinical Decision Support ...The intervention integrated structured clinical data, including recent BP readings, laboratory results, and visit dates, into the electronic ...
Effectiveness of a clinical decision support system for ... - TrialsThe LIGHT trial will provide evidence on the effectiveness of a CDSS for improving guideline adherence for hypertension management in primary care in China.
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