- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01130987
Implementing a Comprehensive Handoff Program to Improve Patient Safety
June 17, 2014 updated by: Christopher P. Landrigan, MD, MPH, Brigham and Women's Hospital
The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Following collection of baseline data on inpatient wards at both hospitals, teamwork training will be provided, accompanied by the introduction of a new computerized handoff tool that facilitates accurate transmission of data.
The effects of this combined intervention on safety and workflow will be assessed on the intervention wards at both hospitals as compared with the historical control period.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20307
- Walter Reed Army Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Washington
-
Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all internal medicine residents completing rotations through intervention units during data collection periods
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Comprehensive Handoff Program
Introduction of Computerized tool plus team training
|
Computer program that facilitates accurate transmission of patient information between residents
Training in teamwork and reorganization of handoff processes to optimize transmission of information and team care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rates of resident communication and total medical errors
Time Frame: July 2010
|
July 2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rates of all medical errors
Time Frame: July 2010
|
July 2010
|
|
Rates of verbal miscommunications
Time Frame: July 2010
|
July 2010
|
|
Rates of written miscommunications
Time Frame: July 2010
|
July 2010
|
|
Resident workflow, especially time spent updating the signout; time spent at bedside; time spent at computer
Time Frame: July 2010
|
July 2010
|
|
Resident care experience
Time Frame: July 2010
|
July 2010
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher P Landrigan, MD, MPH, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
January 12, 2010
First Submitted That Met QC Criteria
May 25, 2010
First Posted (Estimate)
May 26, 2010
Study Record Updates
Last Update Posted (Estimate)
June 18, 2014
Last Update Submitted That Met QC Criteria
June 17, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2008P002191
- BAA01 07005001
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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