NCT01134419

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

May 25, 2010

Last Update Submit

May 15, 2013

Conditions

Keywords

Patient SafetyMedical ErrorsHandoffSign-outResidentInternGraduate Medical Education

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Rates of total medical errors

    July 2010

  • Minutes residents spend updating the signout; minutes spent in direct patient care; minutes spent working at computer

    July 2010

  • Resident reported experience of care

    July 2010

  • Rates of verbal miscommunications

    July 2010

  • Rates of written miscommunications

    July 2010

Study Arms (2)

Computerized Handoff Tool plus training

EXPERIMENTAL

Computerized handoff tool implemented together with team training for residents

Other: Computerized handoff toolOther: Team training

Team training only

ACTIVE COMPARATOR

No computerized tool

Other: Team training

Interventions

Informatics tool to aid in transfer of patient care information

Computerized Handoff Tool plus training

Teamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications

Computerized Handoff Tool plus trainingTeam training only

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all residents working on study units during study period, except as below

You may not qualify if:

  • residents on the teamwork only unit who have previously been on the primary intervention unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Christopher P Landrigan, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research and Fellowship Director, Inpatient Pediatrics Service

Study Record Dates

First Submitted

May 25, 2010

First Posted

June 2, 2010

Study Start

July 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations