Plain English Summary
Background and study aims
Recent studies estimate that 40,000-100,000 deaths per year occur in American hospitals as a result of medical errors. It is estimated that around a third of these deaths are due, at least in part, to communication errors among health-care providers. It is therefore vital to introduce a standardized method of communicating patient information to staff when shift changes take place (hand off). The aim of this study is to look at a standardized verbal hand-off curriculum for communication between staff in intensive care units (ICUs). The curriculum is passed on “IPASS", a hand-off bundle which was developed at Boston Children's Hospital. The aim of this study is to find out whether this communication handoff curriculum will decrease health-care provider communication errors.
Who can participate?
Health-care providers in participating intensive care units.
What does the study involve?
Participating ICUs are randomly allocated in blocks of two to one of two groups. Those in the first group receive the new communication handoff curriculum. This involves an online learning module and training on-site about how to implement the curriculum, followed by starting to use it on the ward. Those in the second group continue to use their usual hand off communication procedure. Every day, participants complete text message based surveys to give their views on the curriculum. Participants in both groups are followed for eight months, having their hand offs observed each week. At the end of the study, patient databases are assessed to see if the new curriculum has affective patient death and complication rates.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to those taking part in the study.
Where is the study run from?
Eight ICUs in University of Washington Medical Center (USA)
When is the study starting and how long is it expected to run for?
March 2015 to October 2016
Who is funding the study?
The University of Tampa (USA)
Who is the main contact?
Dr Brodie Parent
bparent@uw.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Brodie Parent
ORCID ID
Contact details
University of Washington
Department of Surgery
1959 NE Pacific St
Seattle
98195
United States of America
+1 (0)202 641 0975
bparent@uw.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UWIPASS17
Study information
Scientific title
A standardized handoff curriculum and provider preparedness in the ICU
Acronym
UW-IPASS
Study hypothesis
A standardized communication handoff curriculum will decrease health-care provider communication errors.
Ethics approval
University of Washington Internal Review Board, 21/08/2015, ref: 50266
Study design
Single-centre cluster randomised stepped wedge trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Health care provider communication errors
Intervention
Participating ICUs are randomised in clusters of 2 ICUs, using a random number generator to one of two groups. Allocation is concealed from all ICU staff until launch date for each treatment arm. Blinding is not possible given the nature of the intervention.
Intervention: Providers receive the UW-IPASS Handoff curriculum, which includes:
1. An online learning module 1 month before starting an ICU rotation. The online training module is about 15 minutes and is an interactive presentation of information and self-directed learning via multiple choice questions. It is emailed to providers 1 month ahead of their time in the ICU. It introduces the concept of 'IPASS' and how it is used in handoffs. Basically, it tells providers to use the mnemonic to communicate to other providers. The mnemonic is as follows:
I= illness severity (sick or not sick patient)
P= Patient summary (details of medical history and current reason for admission)
A= Action items (a 'to-do' list for the care provider)
S= Situation awareness (If x then do y)
S= Synthesis (the receiver summarizes what they heard)
Handoff communications before this system usually only included the 'Patient summary' and 'action items' elements. This system standardizes communication so that everyone is expected to communicate these baseline elements.
2. Personal training on site on how to use the IPASS mnemonic effectively. This involves a brief 5 slide powerpoint by a local ICU expert in IPASS. They then run an interactive demonstration of how to use it in a handoff.
3. Observed weekly structured feedback on their handoffs
4. An IPASS rounding tool integrated into the electronic medical record
Control: Providers perform handoff communication per local culture and individual preference.
Both arms are surveyed throughout the study on a daily basis regarding their perceptions and experiences with handoff. Total duration of data collection/followup is 8 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Provider perceptions related to handoff quality, efficiency, avoidable adverse events, and plan of care advancement are assessed via text-message based surveys to providers, sent daily after working a shift in the intensive care unit.
Secondary outcome measures
1. Patient days of mechanical ventilation is assessed at the end of the study via a de-identified aggregate patient database
2. ICU length of stay is assessed at the end of the study via a de-identified aggregate patient database
3. Reintubations within 24 hours are assessed at the end of the study via a de-identified aggregate patient database
4. Order work-flow patterns are assessed at the end of the study via a de-identified aggregate patient database
Overall trial start date
01/03/2015
Overall trial end date
01/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 or older
2. Male or female
3. Employed as an advance-practice provider, a resident physician, fellow physician, or attending physician in one of eight adult intensive care units
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
No exclusion criteria.
Recruitment start date
01/08/2015
Recruitment end date
01/06/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Washington Medical Center
1959 NE Pacific Street
Seattle
98195
United States of America
Funders
Funder type
Research organisation
Funder name
Patient Safety and Innovations Project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plan to publish spring 2017 in a peer reviewed journal.
IPD Sharing plan:
The datasets collected in this study contain sensitive information regarding communication errors which the researchers are not authorized to disclose to the general public. The data is held in a secure server at the University of Washington.
Intention to publish date
31/03/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29299602