Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension

NCT ID: NCT07218198

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2027-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of Care for Hypertension Management

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

Group Type ACTIVE_COMPARATOR

Standard medical treatment

Intervention Type OTHER

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

Clinical Decision Support Tool

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

Group Type EXPERIMENTAL

Clinical Decision Support Tool

Intervention Type OTHER

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

Interventions

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Standard medical treatment

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

Intervention Type OTHER

Clinical Decision Support Tool

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

Intervention Type OTHER

Other Intervention Names

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hypertension hypertension management hypertension hypertension management

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luke Laffin, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Jennifer Mitchell, MSN

Role: CONTACT

216-598-3488

Facility Contacts

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Barb Koehler

Role: primary

216-444-4249

Vivian Jeffers

Role: backup

216-636-9628

References

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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.

Reference Type RESULT
PMID: 29133354 (View on PubMed)

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.

Reference Type RESULT
PMID: 38507433 (View on PubMed)

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.

Reference Type RESULT
PMID: 37740433 (View on PubMed)

Other Identifiers

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V2.0 11Dec2025

Identifier Type: -

Identifier Source: org_study_id

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