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Not yet recruiting NCT07218198

Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension

No phase Interventional Hypertension Hypertension (HTN) Blood Pressure, High Blood Pressure Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard medical treatment, Clinical Decision Support Tool.
Who it may be relevant to
Registry conditions: Hypertension, Hypertension (HTN), Blood Pressure, High, Blood Pressure Control. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Standard medical treatment
    Clinicians will use their own standard of care recommendations for combinations of medications.
  • 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

Primary outcome measures

  • Change in systolic automated office blood pressure (AOBP) [Time frame: 4 weeks]
Secondary outcome measures (1)
  • Change in diastolic automated office blood pressure (AOBP) [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Publications

  • 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 PMID 29133354
  • 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
  • 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

Identifiers

NCT: NCT07218198 · V2.0 11Dec2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗