Implementing a Comprehensive Handoff Program to Improve P... | NCT01130987

Studies
Implementing a Comprehensive Handoff Program to Improve Patient Safety

NCT01130987

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Jun 18, 2014Estimated

Enrollment

92Actual

Phase

Not Applicable

Conditions

Medical Errors

Interventions

Computerized handoff tool
Team training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BAA01 07005001

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 12, 2010

First Submission Date that Met QC Criteria

May 25, 2010

First Posted Date

May 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2014

Last Update Posted Date

Jun 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher P. Landrigan, MD, MPH, Director, Sleep and Patient Safety Program, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
United States Department of Defense	FED
Walter Reed Army Medical Center	FED
Madigan Army Medical Center	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Comprehensive Handoff Program	Experimental	Introduction of Computerized tool plus team training	Other: Computerized handoff tool Behavioral: Team training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computerized handoff tool	Other	Computer program that facilitates accurate transmission of patient information between residents	Comprehensive Handoff Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rates of resident communication and total medical errors		July 2010

Secondary Outcomes

Measure	Description	Time Frame
Rates of all medical errors		July 2010
Rates of verbal miscommunications		July 2010
Rates of written miscommunications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all internal medicine residents completing rotations through intervention units during data collection periods

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher P Landrigan, MD, MPH	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walter Reed Army Medical Center		Bethesda	Maryland	20307	United States
Brigham and Women's Hospital