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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care for Hypertension Management | Active Comparator | Clinicians will use their own standard of care recommendations for combinations of medications. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard medical treatment | Other | Clinicians will use their own standard of care recommendations for combinations of medications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diastolic automated office blood pressure (AOBP) | Percentage of Participants with controlled BP (<130mmHg), Change from baseline in diastolic automated office blood pressure (AOBP) at 4 weeks. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the CDS Tool | Number of participants with treatment related adverse events, Change from baseline at 4 weeks. | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carrie Melgaard, MS | Contact | 216-318-9094 | melgaac@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Luke Laffin, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29133354 | Result | 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. | |
| 38507433 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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|
| 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 |
|
|
| 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. |
| 37740433 | 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. |