Condition category
Not Applicable
Date applied
24/01/2017
Date assigned
27/01/2017
Last edited
26/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
+1 202 641 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 measures

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

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

Sponsor information

Organisation

University of Washington

Sponsor details

1959 NE Pacific St
Seattle
98195
United States of America

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes