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IIPE-PRIS Accelerating Safe Signouts (I-PASS)

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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

Tracking Information
First Submitted Date  ICMJE August 1, 2011
First Posted Date  ICMJE March 31, 2015
Last Update Posted Date March 31, 2015
Study Start Date  ICMJE September 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IIPE-PRIS Accelerating Safe Signouts
Official Title  ICMJE Bundling Effective Resident Handoff Tools to Improve Patient Safety: A Multi-Center Pediatric Residency Quality Improvement Initiative
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Serious Medical Errors
  • Resident Sign-out
Intervention  ICMJE Behavioral: Resident Handoff Bundle
1) team training, 2) verbal mnemonics, and 3) standardization of written/computerized handoff tools
Study Arms  ICMJE 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
Intervention: Behavioral: Resident Handoff Bundle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
875
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02403466
Other Study ID Numbers  ICMJE X10-08-0392
R18AE000029 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Landrigan, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Christopher P Landrigan, MD, MPH Boston Children’s Hospital
Study Director: Amy J Starmer, MD, MPH Oregon Health and Sciences University
PRS Account Boston Children’s Hospital
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP