Clinical trial NCT05443321: Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes
Official title: Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Infections
Heart Failure
COPD Exacerbation
Asthma
Gastrointestinal Diseases
Cardiac Event
Arrythmia
Renal Failure
Renal Disease
Rheumatic Diseases
Urologic Diseases
Neurologic Disorder
Hematologic Diseases
Oncology Problem
Shock
Critical Illness
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-07-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: pre-post interrupted time series analysis
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total clinician-reported medical errors
timeFrame: Up to 72 hours after transfer
Secondary outcomes:
measure: Clinician-reported medical errors attributable to poor information exchange
timeFrame: Up to 72 hours after transfer
measure: Total clinician-reported adverse events
timeFrame: Up to 72 hours after transfer
measure: Preventable clinician-reported adverse events
timeFrame: Up to 72 hours after transfer
measure: Ameliorable clinician-reported adverse events
timeFrame: Up to 72 hours after transfer
measure: Clinician-reported quality of clinical information available
timeFrame: Up to 72 hours after transfer
measure: Length of stay after transfer
timeFrame: From time-of-day and date of transfer to time-of-day and date of hospital discharge
measure: Rapid response or ICU transfer within 72-hours of patient transfer
timeFrame: Up to 72-hours after transfer
measure: Time between acceptance of transfer to patient arrival
timeFrame: Up to 3 days prior to transfer
measure: Time between transferred patient arrival and entry of admission orders
timeFrame: Up to 24-hours after transfer
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
References: