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NCT Number: NCT07218198

Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension

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.

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Key information

Conditions

Hypertension Blood Pressure Control Blood Pressure, High Cardiovascular Diseases Hypertension (HTN) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Standard Medical Treatment

Other

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

Other names: hypertension, hypertension management

Clinical Decision Support Tool

Other

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

Other names: hypertension, hypertension management

Primary outcomes

  1. Change in systolic automated office blood pressure (AOBP)

    Time frame: 4 weeks

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

Secondary outcomes

  1. Change in diastolic automated office blood pressure (AOBP)

    Time frame: 4 weeks

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

Other outcomes

  1. Safety of the CDS Tool

    Time frame: 4 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carrie Melgaard, MS

CONTACT

[email protected]

216-318-9094

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: AI-HTN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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