Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05443321 |
Other study ID # |
2022P001284 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2022 |
Est. completion date |
June 30, 2027 |
Study information
Verified date |
May 2023 |
Source |
Brigham and Women's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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.