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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 30, 2027
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Brigham & Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total clinician-reported medical errors Collected via a survey of admitting clinicians 48-72 hours after patient transfer. Up to 72 hours after transfer
Secondary Clinician-reported medical errors attributable to poor information exchange Collected via a survey of admitting clinicians 48-72 hours after patient transfer. Up to 72 hours after transfer
Secondary Total clinician-reported adverse events Collected via a survey of admitting clinicians 48-72 hours after patient transfer. Up to 72 hours after transfer
Secondary Preventable clinician-reported adverse events Collected via a survey of admitting clinicians 48-72 hours after patient transfer. Up to 72 hours after transfer
Secondary Ameliorable clinician-reported adverse events Collected via a survey of admitting clinicians 48-72 hours after patient transfer. Up to 72 hours after transfer
Secondary Clinician-reported quality of clinical information available Collected via a survey of admitting clinicians 48-72 hours after patient transfer. Up to 72 hours after transfer
Secondary Length of stay after transfer Collected from administrative data From time-of-day and date of transfer to time-of-day and date of hospital discharge
Secondary Rapid response or ICU transfer within 72-hours of patient transfer Collected from administrative data Up to 72-hours after transfer
Secondary 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 Up to 3 days prior to transfer
Secondary 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 Up to 24-hours after transfer
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