IIPE-PRIS Accelerating Safe Signouts (I-PASS)

Bundling Effective Resident Handoff Tools to Improve Patient Safety: A Multi-Center Pediatric Residency Quality Improvement Initiative

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.

Study Overview

• Status: Completed
• Conditions: Serious Medical Errors; Resident Sign-out
• Intervention / Treatment: Behavioral: Resident Handoff Bundle

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: Interventional
• Enrollment (Actual): 875
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital
    • San Francisco, California, United States, 94118
      • UCSF Benioff Children's Hospital
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • St. Christopher's Hospital for Children
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rates of serious medical errors	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

Outcome Measure	Measure Description	Time Frame
Verbal and written miscommunications	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.	up to 28 months
Time spent by residents gathering and signing out data	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.	up to 28 months
Resident satisfaction with sign-out	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.	up to 28 months
Hospital- and patient-level predictors of implementation success	analysis of all outcomes above, cross-referenced with hospital indicator codes and patient severity of illness codes	up to 28 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: The Hospital for Sick Children; University of California, San Francisco; Children's Hospital Medical Center, Cincinnati; Walter Reed National Military Medical Center; Primary Children's Hospital; St. Louis Children's Hospital; Lucile Packard Children's Hospital; St. Christopher's Hospital for Children; OHSU Doernbecher Children's Hospital
• Investigators: Principal Investigator: Christopher P Landrigan, MD, MPH, Boston Children's Hospital; Study Director: Amy J Starmer, MD, MPH, Oregon Health and Sciences University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 1, 2011
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Communication; Medical errors; Resident sign-out
• Other Study ID Numbers: X10-08-0392; R18AE000029 (U.S. NIH Grant/Contract)