- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04789902
SurgeCon: An Emergency Department Surge Management Platform (SurgeCon)
A Stepped Wedge Cluster Randomized Trial Designed to Evaluate the Effects of SurgeCon: A Quality Improvement Surge Management Platform
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Emergency Department (ED) wait times and overcrowding is a national problem of considerable magnitude with few favorable solutions. Canadian EDs are failing to meet national targets and have some of the longest wait times compared to peer industrialized countries. For patients, long wait times mean pain or discomfort for hours before being seen. To address these challenges, the investigators propose "SurgeCon", a quality improvement platform to reduce ED wait times and improve patient satisfaction. This study will investigate the effects of SurgeCon on health system key performance outcomes and patient-reported experience and satisfaction. The study uses a comparative effectiveness-implementation hybrid design. This type of hybrid design has been recommended to help achieve rapid translational gains that can hasten the movement of interventions from research to practice to public health impact. In our hybrid design, the investigators will use a pragmatic stepped wedge cluster randomized trial (SW-CRT) design that enrols four 24/7 on-site ED physician support (category A) hospitals into a 31-month trial. At the beginning of the trial, participating sites will operate under a 'usual care' model as a control condition. Each site will transition from providing 'usual care' to the new 'care model' at predetermined periods during the study. At the end of the trial, each of the sites will have eventually transitioned to the SurgeCon enabled care model. Each cluster in this trial will be randomly assigned to an arm of the trial as is the case with most stepped wedge trials.
The platform includes an eHealth component, a training program for ED staff, and a series of quality improvement initiatives. SurgeCon optimizes patient flow and creates a more patient-centric environment; it monitors ED capacity in real-time and helps address overcrowding by prescribing a series of actions customized to maximize patient flow in response to the level of demand in the ED. SurgeCon was recently piloted in a rural hospital and was associated with dramatic improvements in ED efficiency. Our time series analysis showed a significant decrease in the number of patients who left the ED without being seen by a physician (LWBS) (12.1% to 4.6%, p<0.004), time to physician initial assessment (PIA) (104.3 minutes to 42.2 minutes, p<0.001), and length of stay in the ED (LOS) (199.4 minutes to 134.4 minutes p<0.002).
The investigators plan to implement and evaluate SurgeCon in other hospitals in Newfoundland and Labrador (NL) to determine whether these results can be reproduced in urban and other rural EDs. SurgeCon will be considered a completely successful intervention if it requires minimal resources from the ED/health system for its continued operation, improves patient satisfaction and outcomes, and creates better value ED services by reducing the cost of providing the services. The payer organization that will be a rewarding success is the Eastern Health regional health authority (EH) in NL. As the largest health authority in NL, EH is a key organization for the delivery of care and setting provincial standards. It is responsible for managing both rural and urban hospitals and reflects the diversity of institutions across the rest of Canada.
SurgeCon's evaluation and implementation strategy will include a four-stage iterative process: 1. Exploration (month 1-10); 2. Adoption (months 11-12, 17-18, 23-24 and 29-30); 3. Active Implementation (months 13-36); 4. Sustainment (months 19-48). To measure success, the investigators will use an innovative comparative effectiveness implementation hybrid design. The investigators will test the effects of SurgeCon on ED key performance indicators (LOS, PIA, and LWBS) and patient-reported experiences (PREMs), while also capturing data related to its implementation across participating EDs. Our innovative clinical trial (iCT) design will test the effectiveness of SurgeCon using a pragmatic stepped wedge cluster randomized controlled trial accompanied by a cost-effectiveness analysis. Our stepped-wedge iCT design will assign each hospital to a step through a random ordering process. In addition to ED key performance indicators (KPI) and PREMs, the investigators will also measure implementation outcomes related to SurgeCon's scalability, adaptability, sustainability and overall costs. Implementation outcomes will be evaluated by patients, providers/staff and health system managers using a mixed methods process. The hybrid evaluation/implementation design represents an integrated knowledge translation approach that will ensure research findings are eventually integrated into policy and practice. Moreover, a multidisciplinary research team including patient partners, decision-makers, frontline clinicians, and researchers will lead this research.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Newfoundland and Labrador
-
Burin, Newfoundland and Labrador, Canada, A0E1E0
- Burin Peninsula Healthcare Centre
-
Clarenville, Newfoundland and Labrador, Canada, A5A1K3
- Dr. G.B. Cross Memorial Hospital
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Health Sciences Centre
-
St. John's, Newfoundland and Labrador, Canada, A1C5B8
- St. Clare's Mercy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All individuals who visit any of the four selected emergency departments during the study period will be included.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
31 Months
|
|
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.
|
31 Months
|
|
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.
|
31 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
31 Months
|
|
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).
|
31 Months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shabnam Shabnam, PhD, Memorial University of Newfoundland
Publications and helpful links
General Publications
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- Killip S, Mahfoud Z, Pearce K. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004 May-Jun;2(3):204-8. doi: 10.1370/afm.141.
- Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
- Torjesen I. Latest waiting time figures for emergency departments in England are worse on record. BMJ. 2018 Apr 12;361:k1658. doi: 10.1136/bmj.k1658. No abstract available.
- Vezyridis P, Timmons S. National targets, process transformation and local consequences in an NHS emergency department (ED): a qualitative study. BMC Emerg Med. 2014 Jun 13;14:12. doi: 10.1186/1471-227X-14-12.
- Chang AM, Lin A, Fu R, McConnell KJ, Sun B. Associations of Emergency Department Length of Stay With Publicly Reported Quality-of-care Measures. Acad Emerg Med. 2017 Feb;24(2):246-250. doi: 10.1111/acem.13102.
- Carter AJ, Chochinov AH. A systematic review of the impact of nurse practitioners on cost, quality of care, satisfaction and wait times in the emergency department. CJEM. 2007 Jul;9(4):286-95. doi: 10.1017/s1481803500015189.
- Maggio PM, Brundage SI, Hernandez-Boussard T, Spain DA. Commitment to COT verification improves patient outcomes and financial performance. J Trauma. 2009 Jul;67(1):190-4; discussion 194-5. doi: 10.1097/TA.0b013e3181a51b2f.
- Jarvis PR. Improving emergency department patient flow. Clin Exp Emerg Med. 2016 Jun 30;3(2):63-68. doi: 10.15441/ceem.16.127. eCollection 2016 Jun.
- Schroeppel TJ, Sharpe JP, Magnotti LJ, Weinberg JA, Croce MA, Fabian TC. How to increase the burden on trauma centers: implement the 80-hour work week. Am Surg. 2014 Jul;80(7):659-63.
- Schroeppel TJ, Sharpe JP, Magnotti LJ, Weinberg JA, Croce MA, Fabian TC. How to Further Decrease the Efficiency of Care at a Level I Trauma Center: Implement the Amended Resident Work Hours. Am Surg. 2015 Jul;81(7):698-703.
- Christmas E, Johnson I, Locker T. The impact of 24 h consultant shop floor presence on emergency department performance: a natural experiment. Emerg Med J. 2013 May;30(5):360-2. doi: 10.1136/emermed-2012-201369. Epub 2012 Jun 1.
- Han JH, Zhou C, France DJ, Zhong S, Jones I, Storrow AB, Aronsky D. The effect of emergency department expansion on emergency department overcrowding. Acad Emerg Med. 2007 Apr;14(4):338-43. doi: 10.1197/j.aem.2006.12.005.
- Mumma BE, McCue JY, Li CS, Holmes JF. Effects of emergency department expansion on emergency department patient flow. Acad Emerg Med. 2014 May;21(5):504-9. doi: 10.1111/acem.12366.
- van Veelen MJ, van den Brand CL, Reijnen R, van der Linden MC. Effects of a general practitioner cooperative co-located with an emergency department on patient throughput. World J Emerg Med. 2016;7(4):270-273. doi: 10.5847/wjem.j.1920-8642.2016.04.005.
- Morin C, Choukroun J, Callahan JC. Safety and efficiency of a redirection procedure toward an out of hours general practice before admission to an emergency department, an observational study. BMC Emerg Med. 2018 Aug 22;18(1):26. doi: 10.1186/s12873-018-0173-6.
- Barker D, McElduff P, D'Este C, Campbell MJ. Stepped wedge cluster randomised trials: a review of the statistical methodology used and available. BMC Med Res Methodol. 2016 Jun 6;16:69. doi: 10.1186/s12874-016-0176-5.
- Beard E, Lewis JJ, Copas A, Davey C, Osrin D, Baio G, Thompson JA, Fielding KL, Omar RZ, Ononge S, Hargreaves J, Prost A. Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014. Trials. 2015 Aug 17;16:353. doi: 10.1186/s13063-015-0839-2.
- 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.
- Martin J, Taljaard M, Girling A, Hemming K. Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials. BMJ Open. 2016 Feb 4;6(2):e010166. doi: 10.1136/bmjopen-2015-010166.
- Kumar A, Chakraborty BS. Interim analysis: A rational approach of decision making in clinical trial. J Adv Pharm Technol Res. 2016 Oct-Dec;7(4):118-122. doi: 10.4103/2231-4040.191414.
- Shippee ND, Domecq Garces JP, Prutsky Lopez GJ, Wang Z, Elraiyah TA, Nabhan M, Brito JP, Boehmer K, Hasan R, Firwana B, Erwin PJ, Montori VM, Murad MH. Patient and service user engagement in research: a systematic review and synthesized framework. Health Expect. 2015 Oct;18(5):1151-66. doi: 10.1111/hex.12090. Epub 2013 Jun 3.
- Kamine TH, Rembisz A, Barron RJ, Baldwin C, Kromer M. Decrease in Trauma Admissions with COVID-19 Pandemic. West J Emerg Med. 2020 May 22;21(4):819-822. doi: 10.5811/westjem.2020.5.47780.
- Vashi AA, Sheikhi FH, Nashton LA, Ellman J, Rajagopal P, Asch SM. Applying Lean Principles to Reduce Wait Times in a VA Emergency Department. Mil Med. 2019 Jan 1;184(1-2):e169-e178. doi: 10.1093/milmed/usy165. No abstract available.
- Matthias H. The genealogy of lean production. Journal of Operations Management. 2007 2;25: doi.org/10.1016/j.jom.2006.04.001.
- El Sayed MJ, El-Eid GR, Saliba M, Jabbour R, Hitti EA. Improving Emergency Department Door to Doctor Time and Process Reliability: A Successful Implementation of Lean Methodology. Medicine (Baltimore). 2015 Oct;94(42):e1679. doi: 10.1097/MD.0000000000001679.
- Heaton HA, Castaneda-Guarderas A, Trotter ER, Erwin PJ, Bellolio MF. Effect of scribes on patient throughput, revenue, and patient and provider satisfaction: a systematic review and meta-analysis. Am J Emerg Med. 2016 Oct;34(10):2018-2028. doi: 10.1016/j.ajem.2016.07.056. Epub 2016 Jul 28.
- Bellamkonda VR, Kumar R, Scanlan-Hanson LN, Hess JJ, Hellmich TR, Bellamkonda E, Campbell RL, Hess EP, Nestler DM. Pilot Study of Kano "Attractive Quality" Techniques to Identify Change in Emergency Department Patient Experience. Ann Emerg Med. 2016 Nov;68(5):553-561. doi: 10.1016/j.annemergmed.2016.02.005. Epub 2016 Apr 26.
- Griffen D, Callahan CD, Markwell S, de la Cruz J, Milbrandt JC, Harvey T. Application of statistical process control to physician-specific emergency department patient satisfaction scores: a novel use of the funnel plot. Acad Emerg Med. 2012 Mar;19(3):348-55. doi: 10.1111/j.1553-2712.2012.01304.x.
- Boudreaux ED, Mandry CV, Wood K. Patient satisfaction data as a quality indicator: a tale of two emergency departments. Acad Emerg Med. 2003 Mar;10(3):261-8. doi: 10.1111/j.1553-2712.2003.tb02000.x.
- Mariathas HH, Hurley O, Anaraki NR, Young C, Patey C, Norman P, Aubrey-Bassler K, Wang PP, Gadag V, Nguyen HV, Etchegary H, McCrate F, Knight JC, Asghari S. A Quality Improvement Emergency Department Surge Management Platform (SurgeCon): Protocol for a Stepped Wedge Cluster Randomized Trial. JMIR Res Protoc. 2022 Mar 24;11(3):e30454. doi: 10.2196/30454.
- Anaraki NR, Jewer J, Hurley O, Mariathas HH, Young C, Norman P, Patey C, Wilson B, Etchegary H, Senior D, Asghari S. Implementation of an ED surge management platform: a study protocol. Implement Sci Commun. 2022 Mar 2;3(1):21. doi: 10.1186/s43058-021-00247-1.
- Patey C, Norman P, Araee M, Asghari S, Heeley T, Boyd S, Hurley O, Aubrey-Bassler K. SurgeCon: Priming a Community Emergency Department for Patient Flow Management. West J Emerg Med. 2019 Jul;20(4):654-665. doi: 10.5811/westjem.2019.5.42027. Epub 2019 Jul 5.
- Patey C, Asghari S, Norman P, Hurley O. Redesign of a rural emergency department to prepare for the COVID-19 pandemic. CMAJ. 2020 May 11;192(19):E518-E520. doi: 10.1503/cmaj.200509. Epub 2020 Apr 21. No abstract available.
- Anaraki NR, Mukhopadhyay M, Jewer J, Patey C, Norman P, Hurley O, Etchegary H, Asghari S. A qualitative study of the barriers and facilitators impacting the implementation of a quality improvement program for emergency departments: SurgeCon. BMC Health Serv Res. 2024 Jul 27;24(1):855. doi: 10.1186/s12913-024-11345-w.
Helpful Links
- Canadian Institute for Health Information. Emergency department wait times in Canada continuing to rise
- BBC News. Dramatic rise in waiting times at emergency departments
- How long is too long to wait in an emergency room?
- The Commonwealth Fund. The commonwealth fund 2010 international health policy survey in eleven countries.
- CBC News. Labrador senior waits 10 hours in emergency room without care for broken arm.
- CBC News. Picture of senior waiting for hours in St. John's emergency room sparks outrage.
- CBC News. St. Anthony patients kept on stretchers while beds remained in storage.
- Canadian Institute for Health Information. PROMS background document.
- Canadian Institute for Health Information. Patient experience
- Lean Production. Kaizen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20201482
- SR4-165123 (Other Grant/Funding Number: CIHR and other local provincial sponsors)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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