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IIPE-PRIS Accelerating Safe Signouts

NCT ID: NCT02403466

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

875 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-08-31

Brief Summary

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Because communication and handoff failures are a root cause of two-thirds of "sentinel events"- serious, often fatal preventable adverse events in hospitals improving handoffs has been identified by AHRQ and the Joint Commission as a priority in nationwide efforts to improve patient safety. Comparative Effectiveness Research on handoff tools and processes has identified specific strategies to improve handoffs and reduce medical errors: 1) team training; 2) verbal mnemonics; and 3) use of written/computerized tools to supplement verbal sign-outs. To accelerate residents' use of CER-based handoff practices and improve patient safety, the investigators are implementing the three inventions above as a Resident Handoff Bundle (RHB) in eight pediatric hospitals in the United States and Canada.

Detailed Description

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The I-PASS Study was initiated in response to mounting evidence that communication and handoff failures are a root cause of two-thirds of "sentinel events" - serious, often fatal, preventable adverse events in hospitals. The Agency on Healthcare Research and Quality (AHRQ) and Joint Commission have identified improving handoffs in care as a priority in nationwide efforts to improve patient safety. Research on handoff tools and processes has identified team training, introduction of verbal mnemonics, and use of written or computerized tools as strategies to improve handoffs and reduce medical errors. This study was designed to evaluate the effect of a resident handoff bundle (RHB) comprised of these three strategies in addressing medical errors, verbal and written miscommunications, and resident workflow and satisfaction.

The US Department of Health and Human Services granted $3 million in funding, with additional support provided by member institutional and private foundations. A total of nine hospitals in the United States and Canada will serve as data collection sites for the study (see list below). Staggered six-month waves of baseline data collection of medical errors and resident workflow, satisfaction, and miscommunications began in January 2010. Each site has a six-month wash-in period to implement the RHB intervention before embarking upon an additional six months of post-intervention data collection. Analysis and dissemination will begin upon completion of data collection at the last wave of sites in April 2013.

Study Sites:

Children's Hospital Boston (Boston, MA) - Coordinating Site Brigham and Women's Hospital (Boston, MA) - Data Coordinating Center

Lucile Packard Children's Hospital (Palo Alto, CA) UCSF Benioff Children's Hospital (San Francisco, CA) OHSU Doernbecher Children's Hospital (Portland, OR) Primary Children's Medical Center (Salt Lake City, UT) St. Louis Children's Hospital (St. Louis, MO) Cincinnati Children's Hospital Medical Center (Cincinnati, OH) Hospital for Sick Children (Toronto, ON) National Capital Consortium (Washington, DC) St. Christopher's Hospital for Children (Philadelphia, PA)

Study Leadership:

Principal Investigator: Christopher Landrigan, MD, MPH Project Leader: Amy Starmer, MD, MPH

Conditions

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Serious Medical Errors Resident Sign-out

Keywords

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Medical errors Communication Resident sign-out

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Resident Handoff Bundle

bundle of interventions designed to improve handoff, including: training of residents in teamwork and handoff techniques; redesign of verbal handoff processes; implementation of handoff mnemonic (I-PASS); implementation of structured written / computerized handoff tool; faculty training in handoffs

Group Type EXPERIMENTAL

Resident Handoff Bundle

Intervention Type BEHAVIORAL

1\) team training, 2) verbal mnemonics, and 3) standardization of written/computerized handoff tools

Interventions

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Resident Handoff Bundle

1\) team training, 2) verbal mnemonics, and 3) standardization of written/computerized handoff tools

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The study will also include direct observation of house staff residents on the medical service. While implementation of the RHB itself is a QI protocol, the observation and collection of data from residents is research. We will therefore obtain informed consent from residents for participation in the research related to the effects on their care processes and experiences of implementation of the RHB. Participation will be voluntary.
* All resident physicians rotating through study teams during the two 6 month periods of data collection will be included in the study if informed consent is granted. No resident physicians will be excluded on the basis of age, gender, ethnicity, race, or other demographic features. We anticipate enrolling a maximum of 70 resident physicians per site. This number may be significantly less due to the fact that certain residents may rotate through data collection study units more than once during the study period.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lucile Packard Children's Hospital

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Primary Children's Hospital

OTHER

Sponsor Role collaborator

St. Louis Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

St. Christopher's Hospital for Children

OTHER

Sponsor Role collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

OHSU Doernbecher Children's Hospital

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christopher Landrigan

Research Director, Children's Hospital Boston Inpatient Pediatrics Service Director, Sleep and Patient Safety Program, Brigham and Women's Hospital Associate Professor of Medicine and Pediatrics, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher P Landrigan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Amy J Starmer, MD, MPH

Role: STUDY_DIRECTOR

Oregon Health and Sciences University

Locations

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Lucile Packard Children's Hospital

Palo Alto, California, United States

Site Status

UCSF Benioff Children's Hospital

San Francisco, California, United States

Site Status

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status

Primary Children's Medical Center

Salt Lake City, Utah, United States

Site Status

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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R18AE000029

Identifier Type: NIH

Identifier Source: secondary_id

View Link

X10-08-0392

Identifier Type: -

Identifier Source: org_study_id