An interventional study of Health Information Exchange (HIE) platform in Infections, Heart Failure and COPD Exacerbation, sponsored by Brigham and Women's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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.
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 1,006 is above the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
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
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.
Other: Health Information Exchange (HIE) platform
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.
Total clinician-reported medical errors
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Time frame: Up to 72 hours after transfer
Clinician-reported medical errors attributable to poor information exchange
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Time frame: Up to 72 hours after transfer
Total clinician-reported adverse events
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Time frame: Up to 72 hours after transfer
Preventable clinician-reported adverse events
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Time frame: Up to 72 hours after transfer
Ameliorable clinician-reported adverse events
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
Time frame: 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.
Time frame: Up to 72 hours after transfer
Length of stay after transfer
Collected from administrative data
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
Collected from administrative data
Time frame: 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
Time frame: 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
Time frame: Up to 24-hours after transfer
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Dec 2025, 37 months.
Of 274 non-industry interventional studies with no phase under Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's 37 months is above that.
Counting every sponsor, half of 305 studies reached it within 24 months; a quarter within 10 and three quarters within 50.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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