- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05876429
Optimizing the Safety of Inter-Hospital Transfer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inter-hospital transfer (IHT), commonly performed to provide patients with more specialized care, involves transfer of patients between providers, settings and systems of care, leaving these patients vulnerable to the risks of discontinuity of care. Standardized communication tools, which have been successful at reducing patient harm among other similar hospital-based care transitions (i.e., intra-hospital patient handoffs), have been under-utilized during IHT to-date, leaving the process largely non-standardized and variable.
The overall goal of this proposal is to optimize patient safety during IHT to GMS, cardiology and oncology services, collectively comprising nearly 50% of all IHT to Brigham and Women's Hospital (BWH), by leveraging our pilot work to design, implement and rigorously evaluate a standardized communication tool to be used during IHT. We propose the following Specific Aims to accomplish this goal:
Aim 1. Utilize pilot data and stakeholder input to revise the standardized accept note.
Aim 2a. Implement the revised standardized accept note for all patients transferred from another acute care hospital to the GMS, cardiology, and oncology inpatient services at BWH.
Aim 2b. Shift the responsibility of documentation of the accept note from a diffuse group of individual clinicians to a small group of dedicated nurses within the Access Center.
Aim 3. Prospectively evaluate the impact of the intervention on patient safety outcomes, including: clinician-reported medical errors and adverse events, length of stay after transfer, rapid-response or code within 6-hours of transfer, ICU-transfer within 24-hours of transfer, and 3-day and in-hospital mortality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- source of admission is inpatient transfer from another acute care hospital
- admitted to general medical service
- admitted to cardiology service
- admitted to oncology service
- admitted to ICU service
- age >= 18
Exclusion Criteria:
- source of admission is other than inpatient transfer
- admitted to service other than listed above
- age < 18
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 |
|---|---|
|
Active Comparator: Pre-Intervention: Current Transfer Process
Control: Transfer patients are admitted per usual based on existing processes for GMS, Cardiology, and Oncology services.
Data collection assesses clinician reported feedback on the logistics for each patient transfer, and issues along the transfer supply chain.
|
Maintain existing transfer patient admission processes, across GMS, Cardiology, and Oncology services.
|
|
Experimental: Post-Intervention: Implementing Standardized Accept Note
Intervention Arm: After engaging stakeholders and finalizing a standardized accept note for transfer patients, appropriate staff will be trained on the use of the note and the note will be implemented in the transfer patient admission process.
Data collection will assess clinician reported feedback on the logistics for each patient transfer, and issues along the transfer supply chain, post-intervention.
|
A standardized accept note for transfer patients will be implemented, after stakeholder engagement and subsequent finalization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinician-reported medical errors and adverse events
Time Frame: Up to 2 weeks
|
Medical errors and adverse events measured as the total number of medical errors per patient
|
Up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of any adverse event after transfer
Time Frame: up to 2 weeks
|
Clinician reported adverse events for each transferred patient
|
up to 2 weeks
|
|
Preventable adverse event after transfer
Time Frame: up to 2 weeks
|
up to 2 weeks
|
|
|
Ameliorable adverse event after transfer
Time Frame: up to 2 weeks
|
up to 2 weeks
|
|
|
Length of stay of hospitalization after transfer
Time Frame: up to 2 weeks
|
up to 2 weeks
|
|
|
ICU-transfer within 24 hours of transfer
Time Frame: Up to 24 hours
|
Up to 24 hours
|
|
|
In-hospital mortality
Time Frame: up to 30 weeks
|
up to 30 weeks
|
|
|
presence of accept note
Time Frame: Up to 24 hours
|
Up to 24 hours
|
|
|
timeliness of accept note
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Mueller, M.D., M.P.H., Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 2020P001945
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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