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Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke

Primary Purpose

Hemorrhagic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-patient and out-patient electronic health record alert
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hemorrhagic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18 years or older Presenting with a primary diagnosis of hemorrhagic stroke admitted to Massachusetts General Hospital inpatient stroke service Exclusion Criteria: Patients not meeting above inclusion criteria Patients presenting with subdural or epidural hematoma

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electronic Health Record Notification

Arm Description

For eligible patients presenting with an acute hemorrhagic stroke, a recommendation to measure low-density lipoprotein (LDL) and glycated hemoglobin A1c (HbA1c) together with their last measurement dates will be displayed in the patient's electronic health record through a best practice alert (BPA). The alert will display for the patient's provider when they first open the patient's chart. The provider may accept the automatically generated orders for both measurements displayed in the BPA, may modify one or both of the orders, or choose to dismiss the BPA. For patients that follow-up with the out-patient stroke clinic and received the in-patient intervention, a second BPA will suggest referrals to sleep study and audiology. The alert will display for the patient's provider when they first open the patient's chart. The provider may accept one or both of the referrals suggested by the BPA, or may choose to dismiss the BPA.

Outcomes

Primary Outcome Measures

Proportion of patients with LDL measurements
Proportion of patients with any LDL measurements in the 12-months period surrounding acute hemorrhagic stroke (6-months before and 6-months follow-up following discharge). LDL measurements will be ascertained based on electronic health record documentation.
Proportion of patients with HbA1c measurements
Proportion of patients with any HbA1c measurements in the 12-months period surrounding acute hemorrhagic stroke (6-months before and 6-months follow-up following discharge). HbA1c measurements will be ascertained based on electronic health record documentation.

Secondary Outcome Measures

Proportion of patients with management of obstructive sleep apnea
Proportion of patients with any attempt of management for obstructive sleep apnea (referral to a sleep specialist, sleep study, appointment at sleep specialist, new treatment for sleep apnea) in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Management attempts will be ascertained based on electronic health record documentation among the patients for which the outpatient notification was displayed within this time period.
Proportion of patients with management of hearing impairment
Proportion of patients with any attempt of management for hearing impairment (referral for audiology, audiology, appointment at ENT, new hearing aids) in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Management attempts will be ascertained based on electronic health record documentation among the patients for which the outpatient notification was displayed within this time period.
Proportion of patients with intensification of lipid-lowering therapy
Proportion of patients with prescription of a new lipid-lowering medication or increase in dose of an existing lipid-lowering medication in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Medication prescriptions will be ascertained based on electronic health record documentation.
Proportion of patients with intensification of antidiabetic therapy
Proportion of patients with prescription of a new antidiabetic medication or increase in dose of an existing antidiabetic medication in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Medication prescriptions will be ascertained based on electronic health record documentation.

Full Information

First Posted
November 30, 2022
Last Updated
March 14, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Boston University, Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT05643001
Brief Title
Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke
Official Title
Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston University, Tufts University

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 overall goal of this study is to increase health care provider awareness for common risk factors and comorbidities in patients with hemorrhagic stroke that are related to impaired brain health, to ultimately improve patients management and associated outcomes. The specific objective is to test the performance and effectiveness of a custom electronic health record (EHR)-based notification module at time of index hospitalization and at follow-up for hemorrhagic stroke survivors, before disparities in access to outpatient care may limit opportunities to intervene. The investigators hypothesize that notification of health care providers through the EHR will increase measurements of low-density lipoprotein (LDL) and glycated hemoglogbin A1c (HbA1c) and increase evaluation and management rates for obstructive sleep apnea and hearing impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electronic Health Record Notification
Arm Type
Experimental
Arm Description
For eligible patients presenting with an acute hemorrhagic stroke, a recommendation to measure low-density lipoprotein (LDL) and glycated hemoglobin A1c (HbA1c) together with their last measurement dates will be displayed in the patient's electronic health record through a best practice alert (BPA). The alert will display for the patient's provider when they first open the patient's chart. The provider may accept the automatically generated orders for both measurements displayed in the BPA, may modify one or both of the orders, or choose to dismiss the BPA. For patients that follow-up with the out-patient stroke clinic and received the in-patient intervention, a second BPA will suggest referrals to sleep study and audiology. The alert will display for the patient's provider when they first open the patient's chart. The provider may accept one or both of the referrals suggested by the BPA, or may choose to dismiss the BPA.
Intervention Type
Other
Intervention Name(s)
In-patient and out-patient electronic health record alert
Intervention Description
Electronic health record best practice alert which suggests measurement of LDL and HbA1c (in-patient) and referrals to sleep study and audiology (out-patient)
Primary Outcome Measure Information:
Title
Proportion of patients with LDL measurements
Description
Proportion of patients with any LDL measurements in the 12-months period surrounding acute hemorrhagic stroke (6-months before and 6-months follow-up following discharge). LDL measurements will be ascertained based on electronic health record documentation.
Time Frame
12 months
Title
Proportion of patients with HbA1c measurements
Description
Proportion of patients with any HbA1c measurements in the 12-months period surrounding acute hemorrhagic stroke (6-months before and 6-months follow-up following discharge). HbA1c measurements will be ascertained based on electronic health record documentation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of patients with management of obstructive sleep apnea
Description
Proportion of patients with any attempt of management for obstructive sleep apnea (referral to a sleep specialist, sleep study, appointment at sleep specialist, new treatment for sleep apnea) in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Management attempts will be ascertained based on electronic health record documentation among the patients for which the outpatient notification was displayed within this time period.
Time Frame
6-months
Title
Proportion of patients with management of hearing impairment
Description
Proportion of patients with any attempt of management for hearing impairment (referral for audiology, audiology, appointment at ENT, new hearing aids) in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Management attempts will be ascertained based on electronic health record documentation among the patients for which the outpatient notification was displayed within this time period.
Time Frame
6-months
Title
Proportion of patients with intensification of lipid-lowering therapy
Description
Proportion of patients with prescription of a new lipid-lowering medication or increase in dose of an existing lipid-lowering medication in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Medication prescriptions will be ascertained based on electronic health record documentation.
Time Frame
6-months
Title
Proportion of patients with intensification of antidiabetic therapy
Description
Proportion of patients with prescription of a new antidiabetic medication or increase in dose of an existing antidiabetic medication in the 6-months period follow-up following discharge after acute hemorrhagic stroke. Medication prescriptions will be ascertained based on electronic health record documentation.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or older Presenting with a primary diagnosis of hemorrhagic stroke admitted to Massachusetts General Hospital inpatient stroke service Exclusion Criteria: Patients not meeting above inclusion criteria Patients presenting with subdural or epidural hematoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher D Anderson, MD MMSc
Phone
617-732-7432
Email
cdanderson@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ernst Mayerhofer, MD
Email
emayerhofer@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Anderson, MD MMSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernst Mayerhofer, MD
Email
emayerhofer@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christina Kourkoulis, BS
Phone
617-726-5358
Email
ckourkoulis@partners.org
First Name & Middle Initial & Last Name & Degree
Christopher D Anderson, MD MMSc

12. IPD Sharing Statement

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Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke

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