- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590002
Evaluating the Effectiveness of an Electronic Medical Transfer Tool to Improve Communication During Transfers From ICU
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Alberta
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Calgary, Alberta, Canada, T1Y 6J4
- Intensive Care Unit, Peter Lougheed Centre
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Calgary, Alberta, Canada, T2N 2T9
- Intensive Care Unit, Foothills Medical Centre
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Calgary, Alberta, Canada, T2V 1P9
- Intensive Care Unit, Rockyview General Hospital
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Calgary, Alberta, Canada, T3M 1M4
- Intensive Care Unit, South Health Campus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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
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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
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Day 1, post patient ICU-discharge
|
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Timeliness of ICU medical transfer of care document
Time Frame: Day 1, post patient ICU discharge
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Availability of ICU transfer of care document in the clinical information system
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Day 1, post patient ICU discharge
|
|
Quality Ratings of ICU clinicians
Time Frame: 2 year
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ICU clincian ratings of a sample of transfer of care documents.
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2 year
|
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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
|
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Perceptions of ICU clinicians
Time Frame: 2 year
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Survey of ICU clinicians on preparing transfer of care document and perceptions of quality.
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2 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU Readmission
Time Frame: Post patient ICU discharge, up to 72 hours
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Patient readmission to ICU after having been previously transferred from ICU to ward
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Post patient ICU discharge, up to 72 hours
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Medical Emergency Team (MET) Activation
Time Frame: Post patient ICU discharge, up to 72 hours
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Patient experienced sudden clinical deterioration that triggered MET activation
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Post patient ICU discharge, up to 72 hours
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Cardiac Arrest Event
Time Frame: Post patient ICU discharge, up to 72 hours
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Patient experienced a cardiac arrest event as recorded in hospital system by Code Blue team
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Post patient ICU discharge, up to 72 hours
|
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Hospital Mortality
Time Frame: Post patient ICU discharge, up to 60 days
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Patient died within hospital after ICU stay
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Post patient ICU discharge, up to 60 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeanna Parsons Leigh, PhD, Dalhouse University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-2317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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