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

Primary Purpose

Critical Illness, Transitions of Care

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electronic ICU Medical Transfer Tool
Sponsored by
Henry T. Stelfox, MD PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critical Illness focused on measuring Patient Transfer, Patient Discharge Summaries, Continuity of Patient Care, Intensive Care Unit, Critical Care, Health Information Exchange, Medical Order Entry Systems, Point-of-Care Systems, Medical Informatics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intensive Care Unit, Peter Lougheed Centre
  • Intensive Care Unit, Foothills Medical Centre
  • Intensive Care Unit, Rockyview General Hospital
  • Intensive Care Unit, South Health Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electronic ICU Medical Transfer Tool

Dictated ICU Medical Transfer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall completeness of ICU medical transfer of care document
Composite measure of presence of eight essential information fields in ICU transfer document
Timeliness of ICU medical transfer of care document
Availability of ICU transfer of care document in the clinical information system
Quality Ratings of ICU clinicians
ICU clincian ratings of a sample of transfer of care documents.
Adverse Event
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.
Perceptions of ICU clinicians
Survey of ICU clinicians on preparing transfer of care document and perceptions of quality.

Full Information

First Posted
May 29, 2018
Last Updated
October 4, 2021
Sponsor
Henry T. Stelfox, MD PhD
Collaborators
Canadian Frailty Network, Alberta Health services, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03590002
Brief Title
Evaluating the Effectiveness of an Electronic Medical Transfer Tool to Improve Communication During Transfers From ICU
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henry T. Stelfox, MD PhD
Collaborators
Canadian Frailty Network, Alberta Health services, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Transitions of Care
Keywords
Patient Transfer, Patient Discharge Summaries, Continuity of Patient Care, Intensive Care Unit, Critical Care, Health Information Exchange, Medical Order Entry Systems, Point-of-Care Systems, Medical Informatics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1751 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic ICU Medical Transfer Tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Dictated ICU Medical Transfer
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electronic ICU Medical Transfer Tool
Other Intervention Name(s)
ICU Transfer Tool, ICU Medical Transfer Summary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete and Timely ICU medical transfer of care document
Description
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.
Time Frame
Day 1, post patient ICU discharge
Secondary Outcome Measure Information:
Title
Overall completeness of ICU medical transfer of care document
Description
Composite measure of presence of eight essential information fields in ICU transfer document
Time Frame
Day 1, post patient ICU-discharge
Title
Timeliness of ICU medical transfer of care document
Description
Availability of ICU transfer of care document in the clinical information system
Time Frame
Day 1, post patient ICU discharge
Title
Quality Ratings of ICU clinicians
Description
ICU clincian ratings of a sample of transfer of care documents.
Time Frame
2 year
Title
Adverse Event
Description
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.
Time Frame
Post patient ICU discharge, up to 72 hours
Title
Perceptions of ICU clinicians
Description
Survey of ICU clinicians on preparing transfer of care document and perceptions of quality.
Time Frame
2 year
Other Pre-specified Outcome Measures:
Title
ICU Readmission
Description
Patient readmission to ICU after having been previously transferred from ICU to ward
Time Frame
Post patient ICU discharge, up to 72 hours
Title
Medical Emergency Team (MET) Activation
Description
Patient experienced sudden clinical deterioration that triggered MET activation
Time Frame
Post patient ICU discharge, up to 72 hours
Title
Cardiac Arrest Event
Description
Patient experienced a cardiac arrest event as recorded in hospital system by Code Blue team
Time Frame
Post patient ICU discharge, up to 72 hours
Title
Hospital Mortality
Description
Patient died within hospital after ICU stay
Time Frame
Post patient ICU discharge, up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry T Stelfox, MD, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeanna Parsons Leigh, PhD
Organizational Affiliation
Dalhouse University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit, Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Intensive Care Unit, Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Intensive Care Unit, Rockyview General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Intensive Care Unit, South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31986370
Citation
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.
Results Reference
background
PubMed Identifier
33416509
Citation
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.
Results Reference
background

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

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