Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension

ConditionsHypertension Hypertension (HTN)Blood Pressure, High Blood Pressure Control

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe Cleveland Clinic

About this trial

The goal of this clinical trial is to study whether having a clinical decision support (CDS) tool available to clinician use will more effectively lower BP 4 weeks after an outpatient visit compared with usual care. The main objective is to assess the impact of the CDS tool, that is embedded with the electronic medical record (EMR), that is available during outpatient clinical encounters, on blood pressure (BP) changes among participants with uncontrolled hypertension.

Participants will:

Visit the clinic 4 weeks, after their initial clinician visit, for a BP check.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women 18 years of age or older

Electronic Health Record (EHR) of hypertension AND prescribed at least one BP lowering medication

Office systolic BP of 130 mmHg or higher

Willing and able to comply with the study instructions AND attend a scheduled study visit

Disqualifiers

Women who are pregnant, plan to become pregnant, or are breast-feeding

Know heart failure with reduced ejection fraction and a left ventricular ejection fraction of less than 40%

End-stage kidney disease currently undergoing renal replacement therapy, or an eGFR < 15ml/min/1.73m2

In the opinion of the investigator, any other condition that will preclude participation in the study

Trial design

Design model

Parallel

Treatments tested in this trial

Standard medical treatment
Other intervention
Clinicians will use their own standard of care recommendations for combinations of medications.
Clinical Decision Support Tool
Other intervention
Clinical Decision Support Tool embedded into the Electronic Medical Record to help support clinicians to prescribe more effective combinations of medications

Treatment groups

168 Participants

are divided into 2 treatment groups

Group A: Standard of Care for Hypertension ManagementActive comparator 1 intervention

Group B: Clinical Decision Support ToolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in systolic automated office blood pressure (AOBP)

Clinical Decision Support (CDS) Tool is available, Change from baseline in systolic automated office blood pressure (AOBP) at 4 weeks.

Time frame

4 weeks

Secondary outcomes

Change in diastolic automated office blood pressure (AOBP)

Percentage of Participants with controlled BP (\<130mmHg), Change from baseline in diastolic automated office blood pressure (AOBP) at 4 weeks.

Time frame

4 weeks

Other outcomes

Safety of the CDS Tool

Number of participants with treatment related adverse events, Change from baseline at 4 weeks.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: