InfectionsNCT05443321
Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes
A study testing Health Information Exchange (HIE) platform in people with Infections and Heart Failure, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Heart Failure, COPD Exacerbation
- What is being tested?
- Health Information Exchange (HIE) platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,006 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age greater than or equal to 18 years old
- Transferred from one of the 3 included transferring hospitals (Brigham and Women's Faulkner Hospital, South Shore Hospital, Milford Regional Medical Center)
- Admitted to the general medical, cardiology, oncology, and/or ICU services at Brigham and Women's Hospital
Who cannot join
- Age < 18 years old
- Transferred from a different acute care hospital than the 3 included hospitals
- Admitted through the ER
- Direct admission from home/clinic
- Admitted to a service other than general medicine, cardiology, oncology or ICU at Brigham and Women's Hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.
Read the detailed description
The transfer of patients between acute care hospitals (inter-hospital transfer, IHT) is often undertaken to provide patients with needed specialized care that is unavailable at the transferring hospital. IHT occurs regularly, with over 100,000 Medicare patients undergoing IHT annually and with higher frequency among patients with select medical conditions (i.e., acute myocardial infarction), those who are critically ill, and those with multiple chronic conditions (MCC). Although all hospital-based care transitions expose patients to the risks of discontinuity of care, patients who undergo IHT are highly vulnerable to these risks given their illness severity and the fact that IHT involves transfer between providers, settings, and systems of care, thereby lacking potential safe-guards against potential gaps in communication.
The overall goals of this study are to leverage the investigators' extensive research experience in IHT and health information technology innovation, including an in-depth understanding of the essential clinical information required for effective HIE, to design, implement, and rigorously evaluate an intervention to improve HIE during IHT. The investigators propose to implement the intervention in 3 use cases with different levels of integration between sending and receiving hospitals. The platform will use existing data standards to ensure interoperability while also optimizing data visualization and workflow. The investigators will then evaluate the effects of the intervention on medical errors and adverse events, evaluate use and usability of the platform, and conduct a mixed methods evaluation to identify best practices for further refining, disseminating, implementing, and sustaining this intervention across different institutions. To achieve this, the Specific Aims of this study are:
Aim 1: To utilize user-centered design principles and prior knowledge and experience of essential information required during IHT to refine a currently functional inter-operable HIE platform that improves reliability of and access to necessary clinical information during IHT and to implement it in 3 use cases: hospitals within the same health system, hospitals in different systems that share a common EHR, and hospitals in different systems that use different EHRs.
Aim 2: To evaluate the impact of this intervention on clinician-reported medical errors; medical errors attributable to sub-optimal information exchange; adverse events; and other measures of patient safety and workflow, using interrupted time series methodology.
Aim 3: To evaluate the utilization and perceived usability of the HIE platform from the perspective of users who interact with the platform, including clinicians who transfer and accept IHT patients, clinicians at accepting hospitals who admit transferred patients, medical records personnel at transferring hospitals, and access center personnel at accepting hospitals; and identify facilitators and barriers to implementation.
Aim 4: To combine data on use, usability and barriers to implementation from end-users with input from steering committee members to develop a plan for further refinement of the platform and a toolkit for widespread adoption at MGB and dissemination to other similar organizations.
The proposed study will provide a novel, user-centered implementation and evaluation of HIE in order to improve the quality of care and patient outcomes during IHT, an understudied, high-risk care transition impacting a vulnerable patient group. This study includes a purposeful evaluation of IHT between hospitals with different levels of affiliation and EHR integration, in addition to rigorous evaluation of use and usability, and barriers and facilitators of implementation across different institutions to identify best practices for dissemination and implementation. The lessons learned will be used to inform successful and sustained adoption by other health care systems, thus broadly improving care provided to transferred patients.
- Conditions
- Infections, Heart Failure, COPD Exacerbation, Asthma, Gastrointestinal Diseases, Cardiac Event
- Being tested
- Health Information Exchange (HIE) platform
- Medical subject headings
- Infections, Heart Failure, Asthma, Gastrointestinal Diseases, Cardiovascular Diseases, Arrhythmias, Cardiac, Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Information Exchange (HIE) platformOther
An improved health information exchange (HIE) platform will be developed at the start of the study with key stakeholder input. This platform will be implemented for use after baseline data collection, and will allow for improved data exchange between transferring and accepting hospital. We will allow for a 6-month wash-in period prior to intervention data collection.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | The baseline arm will include all included patient transfers from the 3 participating transfer hospitals to the 1 accepting hospital during the 1-year pre-intervention phase. They will not receive any intervention, but rather usual care |
| Intervention | Experimental | The intervention arm will include all included patient transfers from the 3 participating transfer hospitals to the 1 accepting hospital during the 1-year intervention phase. They will receive the intervention, which will include utilization of the developed health information exchange platform to transfer clinical information between transferring and accepting hospital. The intervention will not interact directly with the patient, but rather their clinical data. Receives: Other: Health Information Exchange (HIE) platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clinician-reported medical errors
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Measured: Up to 72 hours after transfer
Secondary outcomes (9)
Clinician-reported medical errors attributable to poor information exchange
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Measured: Up to 72 hours after transfer
Total clinician-reported adverse events
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Measured: Up to 72 hours after transfer
Preventable clinician-reported adverse events
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Measured: Up to 72 hours after transfer
Ameliorable clinician-reported adverse events
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Measured: Up to 72 hours after transfer
Clinician-reported quality of clinical information available
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Measured: Up to 72 hours after transfer
Length of stay after transfer
Collected from administrative data
Measured: From time-of-day and date of transfer to time-of-day and date of hospital discharge
Rapid response or ICU transfer within 72-hours of patient transfer
Collected from administrative data
Measured: Up to 72-hours after transfer
Time between acceptance of transfer to patient arrival
Collected from administrative data. From time documented that the patient was accepted for transfer until the time the patient arrives at the transferring hospital
Measured: Up to 3 days prior to transfer
Time between transferred patient arrival and entry of admission orders
Collected from administrative data. From time documented that the transferred patient arrived at the accepting hospital until the time that the admission orders were placed
Measured: Up to 24-hours after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Nov 2022
- Primary completion22 Dec 2025
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- pre-post interrupted time series analysis
- Masking
- None (open label)
- Enrolment
- 1,006 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Stephanie Mueller, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443321
- Sponsor's protocol ID
- 2022P001284
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant data will not be shared with any researchers outside of this study. All data will only be shared in aggregate to any member outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes
- ClinicalTrials.gov ID
- NCT05443321
- Acronym / sponsor ID
- 2022P001284
- Conditions
- Infections, Heart Failure, COPD Exacerbation, Asthma, Gastrointestinal Diseases, Cardiac Event
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,006 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Jul 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.
Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.
Detailed description
The transfer of patients between acute care hospitals (inter-hospital transfer, IHT) is often undertaken to provide patients with needed specialized care that is unavailable at the transferring hospital. IHT occurs regularly, with over 100,000 Medicare patients undergoing IHT annually and with higher frequency among patients with select medical conditions (i.e., acute myocardial infarction), those who are critically ill, and those with multiple chronic conditions (MCC). Although all hospital-based care transitions expose patients to the risks of discontinuity of care, patients who undergo IHT are highly vulnerable to these risks given their illness severity and the fact that IHT involves transfer between providers, settings, and systems of care, thereby lacking potential safe-guards against potential gaps in communication.
The overall goals of this study are to leverage the investigators' extensive research experience in IHT and health information technology innovation, including an in-depth understanding of the essential clinical information required for effective HIE, to design, implement, and rigorously evaluate an intervention to improve HIE during IHT. The investigators propose to implement the intervention in 3 use cases with different levels of integration between sending and receiving hospitals. The platform will use existing data standards to ensure interoperability while also optimizing data visualization and workflow. The investigators will then evaluate the effects of the intervention on medical errors and adverse events, evaluate use and usability of the platform, and conduct a mixed methods evaluation to identify best practices for further refining, disseminating, implementing, and sustaining this intervention across different institutions. To achieve this, the Specific Aims of this study are:
Aim 1: To utilize user-centered design principles and prior knowledge and experience of essential information required during IHT to refine a currently functional inter-operable HIE platform that improves reliability of and access to necessary clinical information during IHT and to implement it in 3 use cases: hospitals within the same health system, hospitals in different systems that share a common EHR, and hospitals in different systems that use different EHRs.
Aim 2: To evaluate the impact of this intervention on clinician-reported medical errors; medical errors attributable to sub-optimal information exchange; adverse events; and other measures of patient safety and workflow, using interrupted time series methodology.
Aim 3: To evaluate the utilization and perceived usability of the HIE platform from the perspective of users who interact with the platform, including clinicians who transfer and accept IHT patients, clinicians at accepting hospitals who admit transferred patients, medical records personnel at transferring hospitals, and access center personnel at accepting hospitals; and identify facilitators and barriers to implementation.
Aim 4: To combine data on use, usability and barriers to implementation from end-users with input from steering committee members to develop a plan for further refinement of the platform and a toolkit for widespread adoption at MGB and dissemination to other similar organizations.
The proposed study will provide a novel, user-centered implementation and evaluation of HIE in order to improve the quality of care and patient outcomes during IHT, an understudied, high-risk care transition impacting a vulnerable patient group. This study includes a purposeful evaluation of IHT between hospitals with different levels of affiliation and EHR integration, in addition to rigorous evaluation of use and usability, and barriers and facilitators of implementation across different institutions to identify best practices for dissemination and implementation. The lessons learned will be used to inform successful and sustained adoption by other health care systems, thus broadly improving care provided to transferred patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre-post interrupted time series analysis
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –The baseline arm will include all included patient transfers from the 3 participating transfer hospitals to the 1 accepting hospital during the 1-year pre-intervention phase. They will not receive any intervention, but rather usual care |
| Intervention | Experimental | Other: Health Information Exchange (HIE) platformThe intervention arm will include all included patient transfers from the 3 participating transfer hospitals to the 1 accepting hospital during the 1-year intervention phase. They will receive the intervention, which will include utilization of the developed health information exchange platform to transfer clinical information between transferring and accepting hospital. The intervention will not interact directly with the patient, but rather their clinical data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years old
- Transferred from one of the 3 included transferring hospitals (Brigham and Women's Faulkner Hospital, South Shore Hospital, Milford Regional Medical Center)
- Admitted to the general medical, cardiology, oncology, and/or ICU services at Brigham and Women's Hospital
Key exclusion criteria (5 listed)
- Age < 18 years old
- Transferred from a different acute care hospital than the 3 included hospitals
- Admitted through the ER
- Direct admission from home/clinic
- Admitted to a service other than general medicine, cardiology, oncology or ICU at Brigham and Women's Hospital
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 |
|---|---|---|
| Health Information Exchange (HIE) platformAn improved health information exchange (HIE) platform will be developed at the start of the study with key stakeholder input. This platform will be implemented for use after baseline data collection, and will allow for improved data exchange between transferring and accepting hospital. We will allow for a 6-month wash-in period prior to intervention data collection. | Other | Intervention |
Primary outcome
Total clinician-reported medical errors
Time frame: Up to 72 hours after transfer
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
9 secondary outcomes
Clinician-reported medical errors attributable to poor information exchange
Time frame: Up to 72 hours after transfer
Total clinician-reported adverse events
Time frame: Up to 72 hours after transfer
Preventable clinician-reported adverse events
Time frame: Up to 72 hours after transfer
Ameliorable clinician-reported adverse events
Time frame: Up to 72 hours after transfer
Clinician-reported quality of clinical information available
Time frame: Up to 72 hours after transfer
Length of stay after transfer
Time frame: From time-of-day and date of transfer to time-of-day and date of hospital discharge
Rapid response or ICU transfer within 72-hours of patient transfer
Time frame: Up to 72-hours after transfer
Time between acceptance of transfer to patient arrival
Time frame: Up to 3 days prior to transfer
Time between transferred patient arrival and entry of admission orders
Time frame: Up to 24-hours after transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. Individual Participant data will not be shared with any researchers outside of this study. All data will only be shared in aggregate to any member outside the study team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Information Exchange (HIE) platform in people with Infections and Heart Failure, run by Brigham and Women's 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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 23 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total clinician-reported medical errors (time frame: Up to 72 hours after transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.