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

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
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

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.

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

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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