NCT03590002

Brief Summary

The transfer of patients from the intensive care unit (ICU) to a medical or surgical hospital ward is a particularly high risk transfer that may expose patients to complications or adverse events if there are communication breakdowns between sending and receiving medical teams. Current dictation practice often falls short in producing optimal clinical documentation on patients being transferred from the ICU to the ward. The use of an electronic transfer of care tool to standardize communication may improve the quality of information exchanged between ICU and ward medical teams during ICU transfers, compared to dictation. This study will stagger implementation of a new electronic ICU medical transfer of care tool across four adult medical-surgical ICUs in one city. It is anticipated that the electronic ICU transfer tool will positively impact two inter-related goals: (1) improve the completeness and timeliness of clinical documentation on transfer, and (2) reduce the incidence of associated adverse patient clinical outcomes after transfer (e.g., adverse events, ICU readmission).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,751

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

May 29, 2018

Last Update Submit

October 4, 2021

Conditions

Keywords

Patient TransferPatient Discharge SummariesContinuity of Patient CareIntensive Care UnitCritical CareHealth Information ExchangeMedical Order Entry SystemsPoint-of-Care SystemsMedical Informatics

Outcome Measures

Primary Outcomes (1)

  • Complete and Timely ICU medical transfer of care document

    Binary measure of the presence/absence of two conditions (1) presence of four essential information elements in ICU transfer document (GOC designation, diagnosis, active health issues, and active medications), and (2) availability of the document to accepting medical team at the time of patient transfer. Both conditions must be met to be coded as present.

    Day 1, post patient ICU discharge

Secondary Outcomes (5)

  • Overall completeness of ICU medical transfer of care document

    Day 1, post patient ICU-discharge

  • Timeliness of ICU medical transfer of care document

    Day 1, post patient ICU discharge

  • Quality Ratings of ICU clinicians

    2 year

  • Adverse Event

    Post patient ICU discharge, up to 72 hours

  • Perceptions of ICU clinicians

    2 year

Other Outcomes (4)

  • ICU Readmission

    Post patient ICU discharge, up to 72 hours

  • Medical Emergency Team (MET) Activation

    Post patient ICU discharge, up to 72 hours

  • Cardiac Arrest Event

    Post patient ICU discharge, up to 72 hours

  • +1 more other outcomes

Study Arms (2)

Electronic ICU Medical Transfer Tool

EXPERIMENTAL

ICUs allocated to the experimental arm will have access to the electronic Medical Transfer of Care Documentation Tool within the clinical information system (CIS) in order to prepare ICU transfer of care documents for the receiving medical care team.

Device: Electronic ICU Medical Transfer Tool

Dictated ICU Medical Transfer

NO INTERVENTION

Usual Care, ICUs in the control group will only have access to the dictation documentation system as the standard method to prepare ICU medical transfer documents. New ICU medical staff responsible for preparing transfer documents will receive the usual training on the dictation system.

Interventions

Patient transfers of care from the ICU to inpatient wards prepared using the electronic ICU medical transfer tool within the health zone's clinical information system, Sunrise Clinical Manager.

Also known as: ICU Transfer Tool, ICU Medical Transfer Summary
Electronic ICU Medical Transfer Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medical-surgical ICU patient
  • ICU disposition on transfer is 'alive'
  • Transfer to another patient care unit

You may not qualify if:

  • ICU discharge to home/community residence
  • ICU discharge by death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Intensive Care Unit, Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Intensive Care Unit, Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Intensive Care Unit, Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

Intensive Care Unit, South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Related Publications (2)

  • Parsons Leigh J, Brundin-Mather R, Zjadewicz K, Soo A, Stelfox HT. Improving transitions in care from intensive care units: Development and pilot testing of an electronic communication tool for healthcare providers. J Crit Care. 2020 Apr;56:265-272. doi: 10.1016/j.jcrc.2020.01.019. Epub 2020 Jan 18. No abstract available.

    PMID: 31986370BACKGROUND
  • Parsons Leigh J, Brundin-Mather R, Whalen-Browne L, Kashyap D, Sauro K, Soo A, Petersen J, Taljaard M, Stelfox HT. Effectiveness of an Electronic Communication Tool on Transitions in Care From the Intensive Care Unit: Protocol for a Cluster-Specific Pre-Post Trial. JMIR Res Protoc. 2021 Jan 8;10(1):e18675. doi: 10.2196/18675.

    PMID: 33416509BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henry T Stelfox, MD, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR
  • Jeanna Parsons Leigh, PhD

    Dalhouse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: All study ICUs will begin as control sites (i.e., no electronic medical transfer tool available). ICUs will be randomly allocated to cross over to the intervention (i.e., electronic medical transfer tool available) at regular intervals (approximately every eight weeks) until all ICUs receive the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2018

First Posted

July 18, 2018

Study Start

July 30, 2018

Primary Completion

September 9, 2020

Study Completion

September 15, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

De-identified study data will be uploaded into the primary funding agency, Canadian Frailty Network (CFN), digital data management system (DDMS) which is currently being developed by the CFN.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
To be determined once the DDMS is developed.
Access Criteria
To be determined once the DDMS is developed.

Locations