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OpenTrials
Completed

NCT Number: NCT05643001

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Proportion of patients with LDL measurements

    Time frame: 12 months

    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.

  2. Proportion of patients with HbA1c measurements

    Time frame: 12 months

    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 outcomes

  1. Proportion of patients with management of obstructive sleep apnea

    Time frame: 6-months

    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.

  2. Proportion of patients with management of hearing impairment

    Time frame: 6-months

    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.

  3. Proportion of patients with intensification of lipid-lowering therapy

    Time frame: 6-months

    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.

  4. Proportion of patients with intensification of antidiabetic therapy

    Time frame: 6-months

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston University
  • Tufts University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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