Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhagic Stroke
• Intervention / Treatment: Other: In-patient and out-patient electronic health record alert

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher D Anderson, MD MMSc; Phone Number: 617-732-7432; Email: cdanderson@partners.org
• Study Contact Backup: Name: Ernst Mayerhofer, MD; Email: emayerhofer@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Ernst Mayerhofer, MD; Email: emayerhofer@mgh.harvard.edu
      • Principal Investigator: Christopher D Anderson, MD MMSc
      • Contact: Christina Kourkoulis, BS; Phone Number: 617-726-5358; Email: ckourkoulis@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electronic Health Record Notification; 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.

Other: In-patient and out-patient electronic health record alert; Electronic health record best practice alert which suggests measurement of LDL and HbA1c (in-patient) and referrals to sleep study and audiology (out-patient)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-months
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.	6-months
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.	6-months
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.	6-months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Boston University; Tufts University
• Investigators: Principal Investigator: Christopher D Anderson, MD MMSc, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: 2021P001597

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No