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

Not Applicable

Completed

• Conditions: Cardiomyopathies; Hypertension; Hypertrophy, Left Ventricular

• Registration Number: NCT05713916
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-02-06
• Study Start: 2023-03-20
• Primary Completion: 2024-06-28
• Study Completion: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 648

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants who are initiated on an antihypertensive medication	12 months from the start of follow-up	Collected from electronic health record data based on electronic prescribing data

Secondary Outcome Measures

Name	Time	Method
Number of participants who receive new diagnoses of hypertension	12 months from the start of follow-up	Collected from electronic health record data
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	Collected from electronic health record data

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States