Hemorrhagic StrokeNCT05643001
Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke
A study testing In-patient and out-patient electronic health record alert in people with Hemorrhagic Stroke, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Stroke
- What is being tested?
- In-patient and out-patient electronic health record alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Presenting with a primary diagnosis of hemorrhagic stroke admitted to Massachusetts General Hospital inpatient stroke service
Who cannot join
- Patients not meeting above inclusion criteria
- Patients presenting with subdural or epidural hematoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- Being tested
- In-patient and out-patient electronic health record alert
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-patient and out-patient electronic health record alertOther
Electronic health record best practice alert which suggests measurement of LDL and HbA1c (in-patient) and referrals to sleep study and audiology (out-patient)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: In-patient and out-patient electronic health record alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start15 Mar 2023
- Primary completion18 Apr 2024
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Tufts University
- Responsible party
- Principal investigator, Christopher D. Anderson, MD, MMSc, Brigham and Women's Hospital
- Investigators
- Christopher D Anderson, MD MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643001
- Sponsor's protocol ID
- 2021P001597
- Status last verified
- May 2024
- First submitted
- 30 Nov 2022
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41334749
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT05643001
- Acronym / sponsor ID
- 2021P001597
- Conditions
- Hemorrhagic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University, Tufts University
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic Health Record Notification | Experimental | Other: In-patient and out-patient electronic health record alertFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years or older
- Presenting with a primary diagnosis of hemorrhagic stroke admitted to Massachusetts General Hospital inpatient stroke service
Key exclusion criteria (2 listed)
- Patients not meeting above inclusion criteria
- Patients presenting with subdural or epidural hematoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-patient and out-patient electronic health record alertElectronic health record best practice alert which suggests measurement of LDL and HbA1c (in-patient) and referrals to sleep study and audiology (out-patient) | Other | Electronic Health Record Notification |
Primary outcome
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.
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.
4 secondary outcomes
Proportion of patients with management of obstructive sleep apnea
Time frame: 6-months
Proportion of patients with management of hearing impairment
Time frame: 6-months
Proportion of patients with intensification of lipid-lowering therapy
Time frame: 6-months
Proportion of patients with intensification of antidiabetic therapy
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Derived from this study: PubMed 41334749Prapiadou 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.
- Individual participant dataSharing planned: No
Related trials for Hemorrhagic Stroke
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Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
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Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
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Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Anderson, MD MMSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-patient and out-patient electronic health record alert in people with Hemorrhagic Stroke, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with LDL measurements (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.