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IIPE-PRIS Accelerating Safe Signouts (I-PASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02403466
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Collaborators:
Lucile Packard Children's Hospital
University of California, San Francisco
Primary Children's Hospital
St. Louis Children's Hospital
Children's Hospital Medical Center, Cincinnati
St. Christopher's Hospital for Children
Walter Reed National Military Medical Center
The Hospital for Sick Children
OHSU Doernbecher Children's Hospital
Information provided by (Responsible Party):
Christopher Landrigan, Boston Children’s Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Serious Medical Errors Resident Sign-out Behavioral: Resident Handoff Bundle Not Applicable

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 875 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Bundling Effective Resident Handoff Tools to Improve Patient Safety: A Multi-Center Pediatric Residency Quality Improvement Initiative
Study Start Date : September 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Arm Intervention/treatment
Experimental: 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
Behavioral: Resident Handoff Bundle
1) team training, 2) verbal mnemonics, and 3) standardization of written/computerized handoff tools




Primary Outcome Measures :
  1. Rates of serious medical errors [ Time Frame: Continuous collection during data collection phase of study (total of 12 months over an 18 month period matched by time of year (i.e., 6 months pre, 6 months wash-in with no data collection, 6 months post-intervention data collection) ]

Secondary Outcome Measures :
  1. Verbal and written miscommunications [ Time Frame: up to 28 months ]
    Residents will be assessed for 1 month periods at a time, both before and after implementing the intervention. This information will be collected in staggered 18-month intervals across all study sites over the course of a 28 month period.

  2. Time spent by residents gathering and signing out data [ Time Frame: up to 28 months ]
    Residents will be assessed for 1 month periods at a time, both before and after implementing the intervention. This information will be collected in staggered 18-month intervals across all study sites over the course of a 28 month period.

  3. Resident satisfaction with sign-out [ Time Frame: up to 28 months ]
    Residents will be assessed for 1 month periods at a time, both before and after implementing the intervention. This information will be collected in staggered 18-month intervals across all study sites over the course of a 28 month period.

  4. Hospital- and patient-level predictors of implementation success [ Time Frame: up to 28 months ]
    analysis of all outcomes above, cross-referenced with hospital indicator codes and patient severity of illness codes



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

  • The only exclusion criteria will be residents who do not rotate through study units during the data collection periods

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403466


Locations
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United States, California
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94118
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19140
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Boston Children’s Hospital
Lucile Packard Children's Hospital
University of California, San Francisco
Primary Children's Hospital
St. Louis Children's Hospital
Children's Hospital Medical Center, Cincinnati
St. Christopher's Hospital for Children
Walter Reed National Military Medical Center
The Hospital for Sick Children
OHSU Doernbecher Children's Hospital
Investigators
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Principal Investigator: Christopher P Landrigan, MD, MPH Boston Children’s Hospital
Study Director: Amy J Starmer, MD, MPH Oregon Health and Sciences University

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Responsible Party: 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, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02403466     History of Changes
Other Study ID Numbers: X10-08-0392
R18AE000029 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Christopher Landrigan, Boston Children’s Hospital:
Medical errors
Communication
Resident sign-out