Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension

NCT07218198 | Not Yet Recruiting

• 1 other identifier: V2.0 11Dec2025
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (1)

• Change in diastolic automated office blood pressure (AOBP)

  4 weeks

Other Outcomes (1)

• Safety of the CDS Tool

  4 weeks

Study Arms (2)

Standard of Care for Hypertension Management

ACTIVE COMPARATOR

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

Other: Standard medical treatment

Clinical Decision Support Tool

EXPERIMENTAL

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

Other: Clinical Decision Support Tool

Interventions

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

Also known as: hypertension, hypertension management

Clinical Decision Support Tool

Standard medical treatment OTHER

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

Also known as: hypertension, hypertension management

Standard of Care for Hypertension Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.

  PMID: 29133354 RESULT

• Mroz T, Griffin M, Cartabuke R, Laffin L, Russo-Alvarez G, Thomas G, Smedira N, Meese T, Shost M, Habboub G. Predicting hypertension control using machine learning. PLoS One. 2024 Mar 20;19(3):e0299932. doi: 10.1371/journal.pone.0299932. eCollection 2024.

  PMID: 38507433 RESULT

• Darricarrere C, Jacquot E, Bricout S, Louis C, Benard M, Poulter NR. Uncontrolled blood pressure and therapeutic inertia in treated hypertensive patients: A retrospective cohort study using a UK general practice database. J Clin Hypertens (Greenwich). 2023 Oct;25(10):895-904. doi: 10.1111/jch.14699. Epub 2023 Sep 22.

  PMID: 37740433 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luke Laffin, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie Melgaard, MS

CONTACT

216-318-9094; melgaac@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-03

Locations

US (1)