Evaluating the Effectiveness of an Electronic Medical Transfer Tool to Improve Communication During Transfers From ICU
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03590002|
Recruitment Status : Active, not recruiting
First Posted : July 18, 2018
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Transitions of Care||Device: Electronic ICU Medical Transfer Tool||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||1751 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||July 30, 2018|
|Actual Primary Completion Date :||September 9, 2020|
|Estimated Study Completion Date :||February 2021|
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.
Device: Electronic ICU Medical Transfer Tool
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.
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.
- 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.
- 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
- 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
- Quality Ratings of ICU and Ward healthcare providers [ Time Frame: 2 year ]ICU and Ward physicians and nurse practitioner ratings of a sample of transfer of care documents.
- 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.
- Perceptions of ICU healthcare providers [ Time Frame: 2 year ]Survey of ICU physicians and nurse practitioners on preparing transfer of care document and perceptions of quality.
- 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
- Medical Emergency Team (MET) Activation [ Time Frame: Post patient ICU discharge, up to 72 hours ]Patient experienced sudden clinical deterioration that triggered MET activation
- 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
- Hospital Mortality [ Time Frame: Post patient ICU discharge, up to 60 days ]Patient died within hospital after ICU stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590002
|Intensive Care Unit, Peter Lougheed Centre|
|Calgary, Alberta, Canada, T1Y 6J4|
|Intensive Care Unit, Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Intensive Care Unit, Rockyview General Hospital|
|Calgary, Alberta, Canada, T2V 1P9|
|Intensive Care Unit, South Health Campus|
|Calgary, Alberta, Canada, T3M 1M4|
|Principal Investigator:||Henry T Stelfox, MD, PhD||University of Calgary|
|Principal Investigator:||Jeanna Parsons Leigh, PhD||Dalhouse University|