Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke

NCT ID: NCT05643001

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-03-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

In-patient and out-patient electronic health record alert

Intervention Type: 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)

Interventions

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)

Intervention Type: OTHER

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

• Patients presenting with subdural or epidural hematoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christopher D. Anderson, MD, MMSc

Division Chief of Stroke and Cerebrovascular Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher D Anderson, MD MMSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P001597

Identifier Type: -

Identifier Source: org_study_id