Critical IllnessNCT03590002
Evaluating the Effectiveness of an Electronic Medical Transfer Tool to Improve Communication During Transfers From ICU
A study testing Electronic ICU Medical Transfer Tool in people with Critical Illness and Transitions of Care, run by Henry T. Stelfox, MD PhD at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Transitions of Care
- What is being tested?
- Electronic ICU Medical Transfer Tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,751 participants
- Where
- 4 sitesCanada
- Study dates
- 30 Jul 2018to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical-surgical ICU patient
- ICU disposition on transfer is 'alive'
- Transfer to another patient care unit
Who cannot join
- ICU discharge to home/community residence
- ICU discharge by death
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Intensive Care Unit, Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Intensive Care Unit, Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Intensive Care Unit, Rockyview General Hospital
Calgary, Alberta, T2V 1P9
Intensive Care Unit, South Health Campus
Calgary, Alberta, T3M 1M4
About this study
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
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).
Read the 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.
- Conditions
- Critical Illness, Transitions of Care
- Being tested
- Electronic ICU Medical Transfer Tool
- 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
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic ICU Medical Transfer ToolDevice
Also called ICU Transfer Tool, ICU Medical Transfer Summary
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, post patient ICU discharge
Secondary outcomes (5)
Overall completeness of ICU medical transfer of care document
Composite measure of presence of eight essential information fields in ICU transfer document
Measured: Day 1, post patient ICU-discharge
Timeliness of ICU medical transfer of care document
Availability of ICU transfer of care document in the clinical information system
Measured: Day 1, post patient ICU discharge
Quality Ratings of ICU clinicians
ICU clincian ratings of a sample of transfer of care documents.
Measured: 2 year
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.
Measured: Post patient ICU discharge, up to 72 hours
Perceptions of ICU clinicians
Survey of ICU clinicians on preparing transfer of care document and perceptions of quality.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start30 Jul 2018
- Primary completion9 Sep 2020
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 1,751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry T. Stelfox, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network, Alberta Health services, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Henry T. Stelfox, MD PhD, University of Calgary
- Investigators
- Henry T Stelfox, MD, PhD, Principal investigator, University of CalgaryJeanna Parsons Leigh, PhD, Principal investigator, Dalhouse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590002
- Sponsor's protocol ID
- 17-2317
- Status last verified
- Oct 2021
- First submitted
- 29 May 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 31986370Parsons 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.
PubMed 33416509
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03590002
- Acronym / sponsor ID
- 17-2317
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,751 participants (actual)
- Lead sponsor
- Henry T. Stelfox, MD PhDUniversity, hospital or other
- Collaborators
- Canadian Frailty Network, Alberta Health services, Canadian Institutes of Health Research (CIHR)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electronic ICU Medical Transfer Tool | Experimental | Device: Electronic ICU Medical Transfer ToolICUs 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medical-surgical ICU patient
- ICU disposition on transfer is 'alive'
- Transfer to another patient care unit
Key exclusion criteria (2 listed)
- ICU discharge to home/community residence
- ICU discharge by death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic ICU Medical Transfer ToolAlso: ICU Transfer Tool, ICU Medical Transfer SummaryPatient 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. | Device | Electronic ICU Medical Transfer Tool |
Primary outcome
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.
5 secondary outcomes
Overall completeness of ICU medical transfer of care document
Time frame: Day 1, post patient ICU-discharge
Timeliness of ICU medical transfer of care document
Time frame: Day 1, post patient ICU discharge
Quality Ratings of ICU clinicians
Time frame: 2 year
Adverse Event
Time frame: Post patient ICU discharge, up to 72 hours
Perceptions of ICU clinicians
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Background: PubMed 31986370Parsons 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.
- Background: PubMed 33416509Parsons 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry T Stelfox, MD, PhD principal investigator
University of Calgary
Jeanna Parsons Leigh, PhD principal investigator
Dalhouse University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic ICU Medical Transfer Tool in people with Critical Illness and Transitions of Care, run by Henry T. Stelfox, MD PhD at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete and Timely ICU medical transfer of care document (time frame: Day 1, post patient ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590002, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.