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Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy (NOTIFY-LVH)

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05713916
Collaborator
(none)
600
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Hypertension and its downstream consequences account for more cardiovascular deaths than any other modifiable risk factor. Critically, many patients have evidence of cardiac damage from hypertension before it is diagnosed or treated. Despite this recognition, there are often barriers in healthcare delivery that contribute to substandard treatment. Thus, there is an urgent need to validate alternative population-based screening and intervention strategies.

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 in individuals with evidence of thickened heart muscle -- known as left ventricular hypertrophy (LVH) -- on previously performed echocardiograms (heart ultrasounds).

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention: Population Health Coordinator
 N/A

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 patients without established cardiovascular care, 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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized pragmatic clinical trialRandomized pragmatic clinical trial
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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, the population health coordinator will offer to coordinate a visit with a cardiologist to discuss the finding of LVH.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants who are initiated on an antihypertensive medication [9 months from the start of follow-up]

    Collected from electronic health record data based on electronic prescribing data

Secondary Outcome Measures

  1. Number of participants who receive new diagnoses of hypertension [9 months from the start of follow-up]

    Collected from electronic health record data

  2. Number of participants who are diagnosed with alternate causes of LVH (e.g., infiltrative cardiomyopathy, hypertrophic cardiomyopathy, etc.) that were not previously identified [9 months from the start of follow-up]

    Collected from electronic health record data

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Jason H Wasfy, MD, Massachussets General Hospital
  • Study Director: Adam N Berman, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jason H. Wasfy, M.D.,M.Phil., Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05713916
Other Study ID Numbers:
  • 2022P002383
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jason H. Wasfy, M.D.,M.Phil., Associate Professor of Medicine, Massachusetts General Hospital
Left ventricular hypertrophy
Pragmatic clinical trial
Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy, Left Ventricular
Hypertrophy

Study Results

No Results Posted as of Feb 8, 2023