Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke

NCT05643001 | Completed

• 1 other identifier: 2021P001597
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Proportion of patients with management of obstructive sleep apnea

  6-months

• Proportion of patients with management of hearing impairment

  6-months

• Proportion of patients with intensification of lipid-lowering therapy

  6-months

• Proportion of patients with intensification of antidiabetic therapy

  6-months

Study Arms (1)

Electronic Health Record Notification

EXPERIMENTAL

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

Interventions

In-patient and out-patient electronic health record alert OTHER

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

Electronic Health Record Notification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older
• Presenting with a primary diagnosis of hemorrhagic stroke admitted to Massachusetts General Hospital inpatient stroke service

You may not qualify if:

• Patients presenting with subdural or epidural hematoma

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston University: collaborator
• Tufts University: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Prapiadou S, Tack RWP, Kimball TN, Mora S, Choksi D, Duperron MG, Senff JR, Kourkoulis C, Singh SD, Yechoor N, Parodi L, Tan BYQ, Rosand J, Mayerhofer E, Anderson CD. Enhancing Comorbidity Management in Patients With Hemorrhagic Stroke via an Electronic Health Record-Linked Best Practice Alert: A Pre/Post Study. J Am Heart Assoc. 2025 Dec 16;14(24):e042302. doi: 10.1161/JAHA.125.042302. Epub 2025 Dec 3.

  PMID: 41334749 DERIVED

MeSH Terms

Conditions

Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher D Anderson, MD MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Stroke and Cerebrovascular Disease

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: March 15, 2023
• Primary Completion: April 18, 2024
• Study Completion: March 28, 2025
• Last Updated: May 8, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)