Evaluating the Effectiveness of an Electronic Medical Transfer Tool to Improve Communication During Transfers From ICU

October 4, 2021 updated by: Henry T. Stelfox, MD PhD

A Cluster-specific Pre-post Trial With Randomized and Staggered Implementation to Evaluate the Effectiveness of an Electronic ICU Medical Transfer of Care Document to Improve Communication During ICU-to-Ward Transfers of Care

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).

Study Overview

Status

Completed

Detailed Description

Background: Transfers of care within hospital are vulnerable periods in health care delivery. The complete, accurate, and timely communication of essential patient information is particularly critical in transfers of care from the intensive care unit (ICU) to an inpatient ward. The ICU generally has the most vulnerable patients, the highest resource use, and most complex system of multi professional coordinated care within the hospital. Communication breakdowns between ICU and receiving inpatient medical teams can have profound implications on the quality, delivery and cost of patient care. Ineffective transfers may result in adverse events, redundant testing, increased hospital stays, and readmission to ICU or hospital.

The written transfer summary is a widely used and important means to present and prioritize patient information to healthcare providers. Unlike verbal reporting, written communication is durable and accessible to many providers at many points in time, making it a critical component in facilitating continuity of patient care. Despite known shortcomings, dictation remains standard practice in many hospitals to complete ICU medical transfer summaries. Although the optimal content and structure for transfer summaries have not been agreed upon in the scientific community, it is clear that standardization can help minimize both the incidence and impact of information gaps during transfer. Computer-enabled tools that remind and guide the user to document essential content (e.g., goals of care, medications) have been found to improve the relevance, consistency, and readability of information in transfer summaries.

Methods: This study will use a cluster-specific pre-post trial design with randomized and staggered implementation to assess the effectiveness of an electronic transfer of care tool developed in the primary clinical information system (Sunrise Clinical Manager, Eclipsys Corporation, Boca Raton, FL) by a multidisciplinary team of healthcare providers and clinical documentation specialists. Four adult medical surgical ICUs in one Canadian city will begin as control sites (i.e., no electronic medical transfer tool available) and subsequently be allocated in a random order to cross over to intervention sites (i.e., electronic medical transfer tool available) at regular intervals. Implementation intervals will be matched to medical resident rotation block dates, which occur every four weeks; a single study interval will encompass two resident blocks. Users--physicians and nurse practitioners responsible for completing ICU medical transfer summaries--will have access to the electronic medical transfer tool at intervention sites, in addition to standard dictation services. A multi-component knowledge translation (KT) strategy designed to facilitate adoption of the tool will be tailored and delivered to ICUs prior to implementation at the site. The KT strategy will encompass education, point-of-care support, and audit and feedback.

Data will be collected both prospectively and retrospectively to measure perceived (prospective user survey) and actual (retrospective chart review) quality of the transfer summaries. The primary outcome will be a binary composite measure of two transfer summary conditions, manually collected retrospectively: (1) presence of four essential information elements (goals of care designation, diagnosis, active issues on transfer, medications to continue) and (2) availability of the transfer summary to accepting clinicians at the time of patient transfer. Transfer summaries that meet these two conditions will be coded as "Present"; those that do not will be coded as "Absent". Patient clinical outcome data also will be retrospectively collected from hospital clinical information systems and paper charts. All study outcomes will be compared between baseline (pre-implementation) and intervention (post-implementation) periods for all ICUs.

Discussion: The evaluation of the electronic medical ICU transfer tool will contribute to our understanding how computer-based structured documentation can improve communication between medical teams and potentially better patient safety.

Study Type

Interventional

Enrollment (Actual)

1751

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Intensive Care Unit, Peter Lougheed Centre
      • Calgary, Alberta, Canada, T2N 2T9
        • Intensive Care Unit, Foothills Medical Centre
      • Calgary, Alberta, Canada, T2V 1P9
        • Intensive Care Unit, Rockyview General Hospital
      • Calgary, Alberta, Canada, T3M 1M4
        • Intensive Care Unit, South Health Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Electronic ICU Medical Transfer Tool
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.
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.
Other Names:
  • ICU Transfer Tool
  • ICU Medical Transfer Summary
NO_INTERVENTION: Dictated ICU Medical Transfer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete and Timely ICU medical transfer of care document
Time Frame: Day 1, post patient ICU discharge
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall completeness of ICU medical transfer of care document
Time Frame: Day 1, post patient ICU-discharge
Composite measure of presence of eight essential information fields in ICU transfer document
Day 1, post patient ICU-discharge
Timeliness of ICU medical transfer of care document
Time Frame: Day 1, post patient ICU discharge
Availability of ICU transfer of care document in the clinical information system
Day 1, post patient ICU discharge
Quality Ratings of ICU clinicians
Time Frame: 2 year
ICU clincian ratings of a sample of transfer of care documents.
2 year
Adverse Event
Time Frame: Post patient ICU discharge, up to 72 hours
Adverse Event is defined as an injury or harm related to (or from) the delivery of care. A two-stage manual abstraction process based on the Institute for Healthcare Improvement Global Trigger Tool (GTT) method of chart review will be applied retrospectively to a random sample of patients.
Post patient ICU discharge, up to 72 hours
Perceptions of ICU clinicians
Time Frame: 2 year
Survey of ICU clinicians on preparing transfer of care document and perceptions of quality.
2 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Readmission
Time Frame: Post patient ICU discharge, up to 72 hours
Patient readmission to ICU after having been previously transferred from ICU to ward
Post patient ICU discharge, up to 72 hours
Medical Emergency Team (MET) Activation
Time Frame: Post patient ICU discharge, up to 72 hours
Patient experienced sudden clinical deterioration that triggered MET activation
Post patient ICU discharge, up to 72 hours
Cardiac Arrest Event
Time Frame: Post patient ICU discharge, up to 72 hours
Patient experienced a cardiac arrest event as recorded in hospital system by Code Blue team
Post patient ICU discharge, up to 72 hours
Hospital Mortality
Time Frame: Post patient ICU discharge, up to 60 days
Patient died within hospital after ICU stay
Post patient ICU discharge, up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeanna Parsons Leigh, PhD, Dalhouse University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 30, 2018

Primary Completion (ACTUAL)

September 9, 2020

Study Completion (ACTUAL)

September 15, 2021

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (ACTUAL)

July 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

To be determined once the DDMS is developed.

IPD Sharing Access Criteria

To be determined once the DDMS is developed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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