IIPE-PRIS Accelerating Safe Signouts

NCT02403466 | Completed

• 2 other identifiers: X10-08-0392R18AE000029
• Study Type: interventional
• Target: 875
• Locations: 2 countries
• Sites: 10

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.

Conditions

Serious Medical Errors; Resident Sign-out

Keywords

Medical errors; Communication; Resident sign-out

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Verbal and written miscommunications

  up to 28 months

• Time spent by residents gathering and signing out data

  up to 28 months

• Resident satisfaction with sign-out

  up to 28 months

• Hospital- and patient-level predictors of implementation success

  up to 28 months

Study Arms (1)

Resident Handoff Bundle

EXPERIMENTAL

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

Interventions

Resident Handoff Bundle BEHAVIORAL

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

Resident Handoff Bundle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Lucile Packard Children's Hospital: collaborator
• University of California, San Francisco: collaborator
• Primary Children's Hospital: collaborator
• St. Louis Children's Hospital: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• St. Christopher's Hospital for Children: collaborator
• Walter Reed National Military Medical Center: collaborator
• The Hospital for Sick Children: collaborator
• OHSU Doernbecher Children's Hospital: collaborator

Study Sites (10)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94118, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19140, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Christopher P Landrigan, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Amy J Starmer, MD, MPH

  Oregon Health and Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: March 31, 2015
• Study Start: September 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (9); CA (1)