Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SurgeCon: An Emergency Department Surge Management Platform (SurgeCon)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04789902
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Government of Newfoundland and Labrador
Eastern Health
Trinity Conception Placentia Health Foundation
Information provided by (Responsible Party):
Shabnam Asghari, Memorial University of Newfoundland

Brief Summary:
Wait times and overcrowding are challenging emergency departments (EDs) around the world. Several countries with advanced healthcare systems cannot keep pace with patient demand, and Canada ranks among the longest wait times compared to peer-industrialized countries. In fact, the Canadian Institute for Health Information (CIHI) identified an 11% increase in ED wait times from 2015-2016 to 2016-2017. This translates to long wait times that deter patients from pursuing necessary care and increases their likelihood of leaving without being seen by an ED physician. In Newfoundland and Labrador (NL), this issue has precipitated strikingly serious situations regarding long wait times that have made the province a case-in-point for ED issues. To counter this, the investigators propose an innovative quality-improvement intervention called SurgeCon that includes a protocol-driven software platform and several other initiatives to reduce wait times and improve the sustainability of health systems without significant workforce changes. The investigators piloted SurgeCon at the ED in Carbonear, Newfoundland and Labrador (NL) and found there was a 32% reduction in ED wait time.

Condition or disease Intervention/treatment Phase
Length of Stay Emergency Departments Other: SurgeCon Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20280 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a stepped-wedge cluster randomized trial (SW-CRT) design, where the sequential crossover will occur in one direction. SW-CRT is a flexible CRT design progressively being used in trial arms with varying delays in switching from the control condition to the active intervention condition state. This study will include the implementation of the intervention in four different rural and urban hospitals. Therefore, one hospital will be randomly allocated using a stratified sampling technique to each of four sequences, which will determine the order in which the intervention is implemented across participating hospitals or clusters. This allocation of one cluster to each sequence maximizes the statistical power
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Stepped Wedge Cluster Randomized Trial Designed to Evaluate the Effects of SurgeCon: A Quality Improvement Surge Management Platform
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Hospital site 1
This site will provide usual ED care during the control period which will last for the first six months of the study. After six months this site will begin transitioning to the SurgeCon management platform which they will use until the end of the study.
Other: SurgeCon
The SurgeCon intervention is a pragmatic ED management platform that includes three distinct intervention components which include 1) Restructuring ED Organization & Workflow, 2) Establishing a Patient-Centric ED Environment, and 3) E-Health Action-Based ED Management that together act to improve ED efficiency and patient satisfaction and value of care.

Experimental: Hospital site 2
This site will provide usual ED care during the control period which will last for the first 12 months of the study. After 12 months this site will begin transitioning to the SurgeCon management platform which they will use until the end of the study.
Other: SurgeCon
The SurgeCon intervention is a pragmatic ED management platform that includes three distinct intervention components which include 1) Restructuring ED Organization & Workflow, 2) Establishing a Patient-Centric ED Environment, and 3) E-Health Action-Based ED Management that together act to improve ED efficiency and patient satisfaction and value of care.

Experimental: Hospital site 3
This site will provide usual ED care during the control period which will last for the first 18 months of the study. After 18 months this site will begin transitioning to the SurgeCon management platform which they will use until the end of the study.
Other: SurgeCon
The SurgeCon intervention is a pragmatic ED management platform that includes three distinct intervention components which include 1) Restructuring ED Organization & Workflow, 2) Establishing a Patient-Centric ED Environment, and 3) E-Health Action-Based ED Management that together act to improve ED efficiency and patient satisfaction and value of care.

Experimental: Hospital site 4
This site will provide usual ED care during the control period which will last for the first 24 months of the study. After 24 months this site will begin transitioning to the SurgeCon management platform which they will use until the end of the study.
Other: SurgeCon
The SurgeCon intervention is a pragmatic ED management platform that includes three distinct intervention components which include 1) Restructuring ED Organization & Workflow, 2) Establishing a Patient-Centric ED Environment, and 3) E-Health Action-Based ED Management that together act to improve ED efficiency and patient satisfaction and value of care.




Primary Outcome Measures :
  1. Length of stay [ Time Frame: 31 Months ]
    Key Performance Indicator (KPI) data at the time of the emergency department visit. Total length of stay in the emergency department. Patients are either admitted/transferred to an inpatient unit in the hospital or discharged from the emergency department.

  2. Time to physician's initial assessment [ Time Frame: 31 Months ]
    Key Performance Indicator (KPI) data at the time of the ED visit. Also referred to as 'door to doctor' time. It is the amount of time it takes from patient arrival to being seen by a physician or their delegate.

  3. Number of patients left without being seen [ Time Frame: 31 Months ]
    Key Performance Indicator (KPI) data at the time of the ED visit. Patients who are registered and/or triaged but leave before being seen by a physician or their delegate.


Secondary Outcome Measures :
  1. Patient satisfaction and patient reported experiences with ED wait time [ Time Frame: 31 Months ]
    Patient-reported experiences and patient satisfaction will be collected via telephone interviews with patients who will be contacted 3 to 5 days after ED/hospital discharge. The telephone interviews will be conducted by a research assistant who is also an Eastern Health employee.

  2. Economic impact of intervention on emergency department services [ Time Frame: 31 Months ]
    Cost of providing emergency department services (this includes but not limited to the cost of pharmacy, lab tests, diagnostic imaging, and therapeutic interventions).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All individuals who visit any of the four selected emergency departments during the study period will be included.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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): NCT04789902


Contacts
Layout table for location contacts
Contact: Shabnam Shabnam, PhD 7097772142 Shabnam.Asghari@med.mun.ca
Contact: Oliver Hurley, MEnvSc 7098646296 ogh758@mun.ca

Locations
Layout table for location information
Canada, Newfoundland and Labrador
Burin Peninsula Healthcare Centre Recruiting
Burin, Newfoundland and Labrador, Canada, A0E1E0
Contact: Elizabeth Kennedy       Elizabeth.Kennedy@easternhealth.ca   
Dr. G.B. Cross Memorial Hospital Recruiting
Clarenville, Newfoundland and Labrador, Canada, A5A1K3
Contact: Elizabeth Kennedy       Elizabeth.Kennedy@easternhealth.ca   
Health Sciences Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Elizabeth Kennedy       Elizabeth.Kennedy@easternhealth.ca   
St. Clare's Mercy Hospital Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1C5B8
Contact: Elizabeth Kennedy       Elizabeth.Kennedy@easternhealth.ca   
Sponsors and Collaborators
Memorial University of Newfoundland
Canadian Institutes of Health Research (CIHR)
Government of Newfoundland and Labrador
Eastern Health
Trinity Conception Placentia Health Foundation
Investigators
Layout table for investigator information
Principal Investigator: Shabnam Shabnam, PhD Memorial University of Newfoundland
Additional Information:
Publications of Results:
Other Publications:
Jiang, Jiming. "Consistent Estimators in Generalized Linear Mixed Models." Journal of the American Statistical Association, vol. 93, no. 442, 1998, pp. 720-729. JSTOR, www.jstor.org/stable/2670122. Accessed 2 Mar. 2021.
Matthias H. The genealogy of lean production. Journal of Operations Management. 2007 2;25: doi.org/10.1016/j.jom.2006.04.001.

Layout table for additonal information
Responsible Party: Shabnam Asghari, Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT04789902    
Other Study ID Numbers: 20201482
SR4-165123 ( Other Grant/Funding Number: CIHR and other local provincial sponsors )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data will be made available only for the people involved in data analysis. Reports generated by the analysis will be will only include aggregate level information and will be made available to other members of the research team and will be used for publications.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shabnam Asghari, Memorial University of Newfoundland:
SurgeCon
Emergency Department
Stepped-Wedge Design
Randomized Trials
Wait Time
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes