Resident Sign-out Clinical Trial
— I-PASSOfficial title:
Bundling Effective Resident Handoff Tools to Improve Patient Safety: A Multi-Center Pediatric Residency Quality Improvement Initiative
| Verified date | March 2015 |
| Source | Children's Hospital Boston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 875 |
| Est. completion date | August 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hospital for Sick Children | Toronto | Ontario |
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Children's Hospital Boston | Boston | Massachusetts |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Lucile Packard Children's Hospital | Palo Alto | California |
| United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
| United States | Primary Children's Medical Center | Salt Lake City | Utah |
| United States | UCSF Benioff Children's Hospital | San Francisco | California |
| United States | St. Louis Children's Hospital | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Boston | Children's Hospital Medical Center, Cincinnati, Lucile Packard Children's Hospital, OHSU Doernbecher Children's Hospital, Primary Children's Hospital, St. Christopher's Hospital for Children, St. Louis Children's Hospital, The Hospital for Sick Children, University of California, San Francisco, Walter Reed National Military Medical Center |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | Yes | |
| Secondary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |