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

Primary Purpose

Hypertrophy, Left Ventricular, Hypertension, Cardiomyopathies

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention: Population Health Coordinator
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophy, Left Ventricular focused on measuring Left ventricular hypertrophy, Pragmatic clinical trial

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 30-75 years Transthoracic echocardiogram as of 1/1/2019 LVH on echocardiogram Mass General Brigham PCP affiliation with at least 1 PCP practice visit within the last 24 months Exclusion Criteria: Current or previous outpatient blood pressure medication prescription Moderate or severe aortic stenosis Severe concentric LVH Asymmetric LVH History of prosthetic heart valve Bicuspid aortic valve Known cardiomyopathy (or had an outpatient visit diagnosis for a cardiomyopathy) Autonomic dysfunction History of heart or lung transplantation Active cancer treatment plan Active pregnancy Dementia Individuals whose primary address is in a nursing home or long-term care facility

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: Population Health Coordinator

Observation: Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants who are initiated on an antihypertensive medication
Collected from electronic health record data based on electronic prescribing data

Secondary Outcome Measures

Number of participants who receive new diagnoses of hypertension
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
Collected from electronic health record data

Full Information

First Posted
January 26, 2023
Last Updated
March 21, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05713916
Brief Title
Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy
Acronym
NOTIFY-LVH
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy, Left Ventricular, Hypertension, Cardiomyopathies
Keywords
Left ventricular hypertrophy, Pragmatic clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized pragmatic clinical trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Population Health Coordinator
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation: Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention: Population Health Coordinator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who are initiated on an antihypertensive medication
Description
Collected from electronic health record data based on electronic prescribing data
Time Frame
12 months from the start of follow-up
Secondary Outcome Measure Information:
Title
Number of participants who receive new diagnoses of hypertension
Description
Collected from electronic health record data
Time Frame
12 months from the start of follow-up
Title
Number of participants who are diagnosed with alternate causes of LVH (e.g., infiltrative cardiomyopathy, hypertrophic cardiomyopathy, etc.) that were not previously identified
Description
Collected from electronic health record data
Time Frame
12 months from the start of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 30-75 years Transthoracic echocardiogram as of 1/1/2019 LVH on echocardiogram Mass General Brigham PCP affiliation with at least 1 PCP practice visit within the last 24 months Exclusion Criteria: Current or previous outpatient blood pressure medication prescription Moderate or severe aortic stenosis Severe concentric LVH Asymmetric LVH History of prosthetic heart valve Bicuspid aortic valve Known cardiomyopathy (or had an outpatient visit diagnosis for a cardiomyopathy) Autonomic dysfunction History of heart or lung transplantation Active cancer treatment plan Active pregnancy Dementia Individuals whose primary address is in a nursing home or long-term care facility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason H Wasfy, MD
Organizational Affiliation
Massachussets General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam N Berman, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Individual patient data (de-identified) will made available upon reasonable request 6 months after publication of the trial's main findings.
IPD Sharing 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.
Citations:
PubMed Identifier
25210095
Citation
Cheng S, Claggett B, Correia AW, Shah AM, Gupta DK, Skali H, Ni H, Rosamond WD, Heiss G, Folsom AR, Coresh J, Solomon SD. Temporal trends in the population attributable risk for cardiovascular disease: the Atherosclerosis Risk in Communities Study. Circulation. 2014 Sep 2;130(10):820-8. doi: 10.1161/CIRCULATIONAHA.113.008506. Epub 2014 Aug 11.
Results Reference
background
PubMed Identifier
34644171
Citation
Sakhuja S, Colvin CL, Akinyelure OP, Jaeger BC, Foti K, Oparil S, Hardy ST, Muntner P. Reasons for Uncontrolled Blood Pressure Among US Adults: Data From the US National Health and Nutrition Examination Survey. Hypertension. 2021 Nov;78(5):1567-1576. doi: 10.1161/HYPERTENSIONAHA.121.17590. Epub 2021 Oct 13.
Results Reference
background
PubMed Identifier
26836726
Citation
Washington AE, Coye MJ, Boulware LE. Academic Health Systems' Third Curve: Population Health Improvement. JAMA. 2016 Feb 2;315(5):459-60. doi: 10.1001/jama.2015.18550. No abstract available.
Results Reference
background
PubMed Identifier
33201729
Citation
Scirica BM, Cannon CP, Fisher NDL, Gaziano TA, Zelle D, Chaney K, Miller A, Nichols H, Matta L, Gordon WJ, Murphy S, Wagholikar KB, Plutzky J, MacRae CA. Digital Care Transformation: Interim Report From the First 5000 Patients Enrolled in a Remote Algorithm-Based Cardiovascular Risk Management Program to Improve Lipid and Hypertension Control. Circulation. 2021 Feb 2;143(5):507-509. doi: 10.1161/CIRCULATIONAHA.120.051913. Epub 2020 Nov 17. No abstract available.
Results Reference
background
PubMed Identifier
30354654
Citation
Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e484-e594. doi: 10.1161/CIR.0000000000000596. No abstract available.
Results Reference
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Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy

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