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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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The main questions our trial aims to answer are:

1. Can a centralized intervention designed to support and alert clinicians to the presence of LVH in their patients who are not being treated with blood pressure medications increase the diagnosis and treatment of hypertension?
2. Can a centralized clinical support intervention aimed at thoroughly screening for hypertension in individuals with LVH lead to an increase in the diagnosis of other causes of thickened heart muscle such as infiltrative and genetic cardiomyopathies?

For subjects randomized to the intervention arm, centralized population health coordinators will notify the established longitudinal specialty provider (cardiologist or nephrologist) or the primary care physician (PCP) that their patient has a recent echocardiogram demonstrating LVH. The outpatient clinician will be notified via the electronic health record 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. Through a structured correspondence with the identified clinician, the population health coordinator will offer to schedule a dedicated visit for the provider and their patient to discuss the finding of LVH. 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 subjects 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.

Researchers will compare subjects randomized to the intervention arm against those randomized to the observation arm to determine if there are: (1) higher rates of initiation of blood pressure medications, (2) increased diagnoses of hypertension, and (3) increased diagnoses of alternate causes of thickened heart muscle in subjects randomized to the intervention arm of the trial.

Conditions

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Hypertrophy, Left Ventricular Hypertension Cardiomyopathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized pragmatic clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention: Population Health Coordinator

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.

Group Type EXPERIMENTAL

Intervention: Population Health Coordinator

Intervention Type 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.

Observation: Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention: Population Health Coordinator

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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Current or previous outpatient blood pressure medication prescription
2. Moderate or severe aortic stenosis
3. Severe concentric LVH
4. Asymmetric LVH
5. History of prosthetic heart valve
6. Bicuspid aortic valve
7. Known cardiomyopathy (or had an outpatient visit diagnosis for a cardiomyopathy)
8. Autonomic dysfunction
9. History of heart or lung transplantation
10. Active cancer treatment plan
11. Active pregnancy
12. Dementia
13. Individuals whose primary address is in a nursing home or long-term care facility

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No