SurgeCon: An Emergency Department Surge Management Platform (SurgeCon)
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ClinicalTrials.gov Identifier: NCT04789902 |
Recruitment Status :
Recruiting
First Posted : March 10, 2021
Last Update Posted : November 13, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Length of Stay Emergency Departments | Other: SurgeCon | Not Applicable |
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 : | September 1, 2024 |
Estimated Study Completion Date : | September 1, 2024 |
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.
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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).
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.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All individuals who visit any of the four selected emergency departments during the study period will be included.
Exclusion Criteria:
- none
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
Contact: Shabnam Shabnam, PhD | 7097772142 | Shabnam.Asghari@med.mun.ca | |
Contact: Oliver Hurley, MEnvSc | 7098646296 | ogh758@mun.ca |
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 |
Principal Investigator: | Shabnam Shabnam, PhD | Memorial University of Newfoundland |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | November 13, 2023 |
Last Verified: | November 2023 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SurgeCon Emergency Department Stepped-Wedge Design Randomized Trials Wait Time |
Emergencies Disease Attributes Pathologic Processes |