- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01134419
Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety
May 15, 2013 updated by: Christopher Landrigan, Boston Children'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 pediatric residents on inpatient units at Children's Hospital Boston - 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 two inpatient pediatric wards, teamwork training is to be provided to all pediatric residents.
On our primary intervention unit, this will be 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 primary intervention ward as compared with the historical control unit and the concurrent unit that received teamwork training without the computerized tool.
Study Type
Interventional
Enrollment (Actual)
84
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
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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-
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 residents working on study units during study period, except as below
Exclusion Criteria:
- residents on the teamwork only unit who have previously been on the primary intervention unit
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computerized Handoff Tool plus training
Computerized handoff tool implemented together with team training for residents
|
Informatics tool to aid in transfer of patient care information
Teamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications
|
Active Comparator: Team training only
No computerized tool
|
Teamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of resident-related communication and total medical errors
Time Frame: July 2010
|
Resident-related medical errors (including medication-related, diagnostic, and procedural) detected using a multi-pronged prospective surveillance methodology that involves 5d/week chart review, review of hospital incident reports, and collection of staff reports.
Resident-related defined as involving a resident research subject.
Communication errors are those medical errors attributable to communication failures.
|
July 2010
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of total medical errors
Time Frame: July 2010
|
As above, but includes both those errors involving residents and those involving all other clinical personnel.
|
July 2010
|
Minutes residents spend updating the signout; minutes spent in direct patient care; minutes spent working at computer
Time Frame: July 2010
|
July 2010
|
|
Resident reported experience of care
Time Frame: July 2010
|
Self-reported, Likert scales on survey instruments.
|
July 2010
|
Rates of verbal miscommunications
Time Frame: July 2010
|
Detected by direct observation, audio recording, then rating using study instrument developed for this purpose.
|
July 2010
|
Rates of written miscommunications
Time Frame: July 2010
|
Detected by detailed review of written signouts, rated using study instrument developed for this purpose.
|
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, Boston Children'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)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
May 25, 2010
First Submitted That Met QC Criteria
June 1, 2010
First Posted (Estimate)
June 2, 2010
Study Record Updates
Last Update Posted (Estimate)
May 16, 2013
Last Update Submitted That Met QC Criteria
May 15, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- X09-01-0040
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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