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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01134419
Other study ID # X09-01-0040
Secondary ID
Status Completed
Phase N/A
First received May 25, 2010
Last updated May 15, 2013
Start date July 2009
Est. completion date January 2010

Study information

Verified date May 2013
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Computerized handoff tool
Informatics tool to aid in transfer of patient care information
Team training
Teamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications

Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital Boston Harvard Risk Management Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of resident-related communication and total medical errors 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 Yes
Secondary Rates of total medical errors As above, but includes both those errors involving residents and those involving all other clinical personnel. July 2010 Yes
Secondary Minutes residents spend updating the signout; minutes spent in direct patient care; minutes spent working at computer July 2010 No
Secondary Resident reported experience of care Self-reported, Likert scales on survey instruments. July 2010 No
Secondary Rates of verbal miscommunications Detected by direct observation, audio recording, then rating using study instrument developed for this purpose. July 2010 Yes
Secondary Rates of written miscommunications Detected by detailed review of written signouts, rated using study instrument developed for this purpose. July 2010 Yes
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