CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 648 enrolled
Drug / intervention
Intervention: Population Health Coordinatorother
Likely dose
Not stated in record
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Search/NCT05713916
NCT05713916N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Feb 6, 2023·Updated Nov 22, 2024

In Brief

A clinical study evaluating Intervention: Population Health Coordinator for Hypertrophy, Left Ventricular and 2 related conditions. Completed, enrolled 648 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedFeb 6, 2023
Enrollment StartMar 20, 2023
Primary CompletionJun 28, 2024
Study CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.4 years ago

Interventions

Intervention: Population Health Coordinatorother

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.