An interventional study of Intervention: Population Health Coordinator in Hypertrophy, Left Ventricular, Hypertension and Cardiomyopathies, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
The main questions our trial aims to answer are:
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.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's enrollment of 648 is above the median of 100 across 97 interventional studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
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.
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.
Number of participants who are initiated on an antihypertensive medication
Collected from electronic health record data based on electronic prescribing data
Time frame: 12 months from the start of follow-up
Number of participants who receive new diagnoses of hypertension
Collected from electronic health record data
Time frame: 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
Collected from electronic health record data
Time frame: 12 months from the start of follow-up
Plan to share: Yes — After study completion, we will make every effort to make de-identified subject-level data available to other researchers upon reasonable request. Individual patient data that will be available upon reasonable request will include data that are presented in our study's main publication.
Supporting information: Study protocol, Statistical analysis plan
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.
Ran from Mar 2023 to primary completion in Jun 2024, 15 months.
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