- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443321
Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Baseline
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
|
|
|
Experimental: Intervention
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 72 hours after transfer
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician-reported medical errors attributable to poor information exchange
Time Frame: Up to 72 hours after transfer
|
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
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Up to 72 hours after transfer
|
|
Total clinician-reported adverse events
Time Frame: Up to 72 hours after transfer
|
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
|
Up to 72 hours after transfer
|
|
Preventable clinician-reported adverse events
Time Frame: Up to 72 hours after transfer
|
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
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Up to 72 hours after transfer
|
|
Ameliorable clinician-reported adverse events
Time Frame: Up to 72 hours after transfer
|
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
|
Up to 72 hours after transfer
|
|
Clinician-reported quality of clinical information available
Time Frame: Up to 72 hours after transfer
|
Collected via a survey of admitting clinicians 48-72 hours after patient transfer.
|
Up to 72 hours after transfer
|
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Length of stay after transfer
Time Frame: From time-of-day and date of transfer to time-of-day and date of hospital discharge
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Collected from administrative data
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From time-of-day and date of transfer to time-of-day and date of hospital discharge
|
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Rapid response or ICU transfer within 72-hours of patient transfer
Time Frame: Up to 72-hours after transfer
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Collected from administrative data
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Up to 72-hours after transfer
|
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Time between acceptance of transfer to patient arrival
Time Frame: Up to 3 days prior to transfer
|
Collected from administrative data.
From time documented that the patient was accepted for transfer until the time the patient arrives at the transferring hospital
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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
|
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
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Up to 24-hours after transfer
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Musculoskeletal Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Disease Attributes
- Connective Tissue Diseases
- Immune System Diseases
- Respiratory Tract Diseases
- Digestive System Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Heart Failure
- Gastrointestinal Diseases
- Asthma
- Cardiovascular Diseases
- Urologic Diseases
- Critical Illness
- Infections
- Renal Insufficiency
- Shock
- Kidney Diseases
- Nervous System Diseases
- Hematologic Diseases
- Arrhythmias, Cardiac
- Rheumatic Diseases
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Records
- Medical Records Systems, Computerized
- Medical Records
- Electronic Health Records
- Health Information Exchange
Other Study ID Numbers
- 2022P001284
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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