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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05876429
Other study ID # 2020P001945
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 17, 2020
Est. completion date June 30, 2023

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

This proposal aims to design, implement and rigorously evaluate a standardized accept note in a population of patients that have high frequency of IHT, including patients transferred to the general medical (GMS), cardiology and oncology services at a large tertiary care hospital. This study will improve scientific knowledge by quantifying the patient safety impact of an intervention to improve communication of essential clinical information during IHT. If shown effective, the results of this study can be used to improve clinical practice by establishing evidence-based communication guidelines for broad dissemination. We will also establish technical feasibility by successfully implementing this tool within our EHR (Epic, Verona, WI), allowing for feasible adoption and dissemination to other institutions with similar EHR capabilities. Lastly, we will address malpractice risk by investigating a strategic intervention aimed at reducing known contributors to patient harm during IHT, a high-risk transition in care that involves transfer of high-acuity patients between providers, settings and systems of care.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1188
Est. completion date June 30, 2023
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
New Standardized Accept Note
A standardized accept note for transfer patients will be implemented, after stakeholder engagement and subsequent finalization.
Existing Transfer Patient Admission Process
Maintain existing transfer patient admission processes, across GMS, Cardiology, and Oncology services.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital Crico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinician-reported medical errors and adverse events Medical errors and adverse events measured as the total number of medical errors per patient Up to 2 weeks
Secondary Presence of any adverse event after transfer Clinician reported adverse events for each transferred patient up to 2 weeks
Secondary Preventable adverse event after transfer up to 2 weeks
Secondary Ameliorable adverse event after transfer up to 2 weeks
Secondary Length of stay of hospitalization after transfer up to 2 weeks
Secondary ICU-transfer within 24 hours of transfer Up to 24 hours
Secondary In-hospital mortality up to 30 weeks
Secondary presence of accept note Up to 24 hours
Secondary timeliness of accept note Up to 24 hours
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