Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy

NCT05713916 | Completed

• 1 other identifier: 2022P002383
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

Brief Summary

The electronic health record contains vast amounts of cardiovascular data, including potential clues that an individual may have unrecognized cardiac conditions. One important example is the finding of thickened heart muscle -- known as left ventricular hypertrophy (LVH) -- on echocardiograms (heart ultrasounds). If the underlying cause of LVH is untreated, individuals are at an increased risk of developing more severe pathology. As the most common cause of LVH, hypertension and its downstream consequences account for more cardiovascular deaths than any other modifiable risk factor. Critically, many individuals have signs of cardiac damage from hypertension before it is diagnosed or treated. Despite this evidence, there are often gaps in healthcare delivery that contribute to substandard recognition and treatment. Thus, there is an urgent need to validate alternative cost-effective screening and intervention strategies. Echocardiograms are ordered by many specialties and for numerous indications. Even when LVH is reported, the finding may be underappreciated and not prompt further evaluation. Whether data from prior echocardiograms can be harnessed to improve patient care through a centralized intervention is unknown. Accordingly, the goal of this randomized pragmatic clinical trial is to study the impact of a centralized clinical support pathway on the diagnosis and treatment of hypertension and the recognition of LVH-associated diseases in individuals with evidence of thickened heart muscle on previously performed echocardiograms.

Conditions

Hypertrophy, Left Ventricular; Hypertension; Cardiomyopathies

Keywords

Left ventricular hypertrophy; Pragmatic clinical trial

Outcome Measures

Primary Outcomes (1)

• Number of participants who are initiated on an antihypertensive medication

  Collected from electronic health record data based on electronic prescribing data

  12 months from the start of follow-up

Secondary Outcomes (2)

• Number of participants who receive new diagnoses of hypertension

  12 months from the start of follow-up

• Number of participants who are diagnosed with alternate causes of LVH (e.g., infiltrative cardiomyopathy, hypertrophic cardiomyopathy, etc.) that were not previously identified

  12 months from the start of follow-up

Study Arms (2)

Intervention: Population Health Coordinator

EXPERIMENTAL

For subject randomized to the intervention arm, population health coordinators will notify the established longitudinal specialty clinician (cardiologist or nephrologist) or the primary care provider (PCP) that their patient has a recent echocardiogram demonstrating left ventricular hypertrophy (LVH). The outpatient clinician will be notified via the electronic health record (EHR) messaging system that the finding of LVH -- in the absence of significant valvular heart disease or a previously diagnosed cardiomyopathy -- may reflect undiagnosed or untreated hypertension.

Other: Intervention: Population Health Coordinator

Observation: Usual Care

NO INTERVENTION

Those subjects randomized to the observation arm will receive usual care and their clinicians will not be notified about the finding of LVH on a prior echocardiogram until after study completion.

Interventions

Intervention: Population Health Coordinator OTHER

After being notified of the finding of LVH in their patient, the population health coordinator will offer to schedule a dedicated visit for the provider and their patient to discuss this finding through a structured correspondence. Additionally, the population health coordinator will offer to coordinate 24-hour ambulatory blood pressure monitoring before or after the patient visit as part of the evaluation of LVH. Finally, for patients without established cardiovascular care and whose etiology of LVH remains undetermined, the population health coordinator will offer to coordinate a visit with a cardiologist to discuss the finding of LVH.

Intervention: Population Health Coordinator

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-75 years
• Transthoracic echocardiogram as of 1/1/2019
• LVH on echocardiogram
• Mass General Brigham PCP affiliation with at least 1 PCP practice visit within the last 24 months

You may not qualify if:

• Current or previous outpatient blood pressure medication prescription
• Moderate or severe aortic stenosis
• Severe concentric LVH
• Asymmetric LVH
• History of prosthetic heart valve
• Bicuspid aortic valve
• Known cardiomyopathy (or had an outpatient visit diagnosis for a cardiomyopathy)
• Autonomic dysfunction
• History of heart or lung transplantation
• Active cancer treatment plan
• Active pregnancy
• Dementia
• Individuals whose primary address is in a nursing home or long-term care facility

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• Cheng S, Claggett B, Correia AW, Shah AM, Gupta DK, Skali H, Ni H, Rosamond WD, Heiss G, Folsom AR, Coresh J, Solomon SD. Temporal trends in the population attributable risk for cardiovascular disease: the Atherosclerosis Risk in Communities Study. Circulation. 2014 Sep 2;130(10):820-8. doi: 10.1161/CIRCULATIONAHA.113.008506. Epub 2014 Aug 11.

  PMID: 25210095 BACKGROUND

• Sakhuja S, Colvin CL, Akinyelure OP, Jaeger BC, Foti K, Oparil S, Hardy ST, Muntner P. Reasons for Uncontrolled Blood Pressure Among US Adults: Data From the US National Health and Nutrition Examination Survey. Hypertension. 2021 Nov;78(5):1567-1576. doi: 10.1161/HYPERTENSIONAHA.121.17590. Epub 2021 Oct 13.

  PMID: 34644171 BACKGROUND

• Washington AE, Coye MJ, Boulware LE. Academic Health Systems' Third Curve: Population Health Improvement. JAMA. 2016 Feb 2;315(5):459-60. doi: 10.1001/jama.2015.18550. No abstract available.

  PMID: 26836726 BACKGROUND

• Scirica BM, Cannon CP, Fisher NDL, Gaziano TA, Zelle D, Chaney K, Miller A, Nichols H, Matta L, Gordon WJ, Murphy S, Wagholikar KB, Plutzky J, MacRae CA. Digital Care Transformation: Interim Report From the First 5000 Patients Enrolled in a Remote Algorithm-Based Cardiovascular Risk Management Program to Improve Lipid and Hypertension Control. Circulation. 2021 Feb 2;143(5):507-509. doi: 10.1161/CIRCULATIONAHA.120.051913. Epub 2020 Nov 17. No abstract available.

  PMID: 33201729 BACKGROUND

• 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: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e484-e594. doi: 10.1161/CIR.0000000000000596. No abstract available.

  PMID: 30354654 BACKGROUND

• Berman AN, Ginder C, Sporn ZA, Tanguturi V, Hidrue MK, Shirkey LB, Zhao Y, Blankstein R, Turchin A, Wasfy JH. Natural Language Processing for the Ascertainment and Phenotyping of Left Ventricular Hypertrophy and Hypertrophic Cardiomyopathy on Echocardiogram Reports. Am J Cardiol. 2023 Nov 1;206:247-253. doi: 10.1016/j.amjcard.2023.08.109. Epub 2023 Sep 13.

  PMID: 37714095 BACKGROUND

• Berman AN, Ginder C, Wang XS, Borden L, Hidrue MK, Searl Como JM, Daly D, Sun YP, Curry WT, Del Carmen M, Morrow DA, Scirica B, Choudhry NK, Januzzi JL, Wasfy JH. A pragmatic clinical trial assessing the effect of a targeted notification and clinical support pathway on the diagnostic evaluation and treatment of individuals with left ventricular hypertrophy (NOTIFY-LVH). Am Heart J. 2023 Nov;265:40-49. doi: 10.1016/j.ahj.2023.06.014. Epub 2023 Jul 14.

  PMID: 37454754 BACKGROUND

• Berman AN, Hidrue MK, Ginder C, Shirkey L, Kwatra J, O'Kelly AC, Murphy SP, Searl Como JM, Daly D, Sun YP, Curry WT, Del Carmen MG, Blankstein R, Dodson JA, Morrow DA, Scirica BM, Choudhry NK, Januzzi JL Jr, Wasfy JH. Leveraging Preexisting Cardiovascular Data to Improve the Detection and Treatment of Hypertension: The NOTIFY-LVH Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):686-695. doi: 10.1001/jamacardio.2025.0871.

  PMID: 40162953 DERIVED

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Hypertension; Cardiomyopathies

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Jason H Wasfy, MD

  Massachussets General Hospital

  PRINCIPAL INVESTIGATOR

• Adam N Berman, MD

  Brigham and Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized pragmatic clinical trial

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: March 20, 2023
• Primary Completion: June 28, 2024
• Study Completion: October 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual patient data (de-identified) will made available upon reasonable request 6 months after publication of the trial's main findings.
• Access Criteria: Researchers who request access to individual (de-identified) patient data may need to proceed with a formal Data Use Agreement through the Mass General Brigham Institutional Review Board.

Locations

US (1)