Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension

A Stepped Wedged, Cluster Randomized Clinical Trial to Evaluate the Efficacy of a Clinical Decision Support Tool in the Treatment of Uncontrolled Hypertension

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07218198

Acronym

AI-HTN

Enrollment

168

Registered

2025-10-20

Start date

2026-05-01

Completion date

2027-10-01

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Uncontrolled Hypertension, Hypertension, Blood Pressure, High Blood Pressure, Artificial Intelligence, AI

Brief summary

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.

Interventions

OTHERStandard medical treatment

Clinicians will use their own standard of care recommendations for combinations of medications.

OTHERClinical Decision Support Tool

Clinical Decision Support Tool embedded into the Electronic Medical Record to help support clinicians to prescribe more effective combinations of medications

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

The study is a stepped wedge cluster randomized trial. All participating clinicians will receive access to the CDS tool, but clinicians will have different start dates for the tool.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Men and women 18 years of age or older 2. Electronic Health Record (EHR) of hypertension AND prescribed at least one BP lowering medication 3. Office systolic BP of 130 mmHg or higher 4. Willing and able to comply with the study instructions AND attend a scheduled study visit

Exclusion criteria

1. Women who are pregnant, plan to become pregnant, or are breast-feeding 2. Know heart failure with reduced ejection fraction and a left ventricular ejection fraction of less than 40% 3. End-stage kidney disease currently undergoing renal replacement therapy, or an eGFR \< 15ml/min/1.73m2 4. In the opinion of the investigator, any other condition that will preclude participation in the study

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTJennifer Mitchell, MSN

mitchej3@ccf.org216-598-3488

PRINCIPAL_INVESTIGATORLuke Laffin, MD

The Cleveland Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026