SurgeCon: An Emergency Department Surge Management Platform

Sponsor

Memorial University of Newfoundland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04789902

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), Government of Newfoundland and Labrador (Other), Eastern Health (Other), Trinity Conception Placentia Health Foundation (Other)

20,280

Enrollment

Locations

Arms

35.9

Anticipated Duration (Months)

5070

Patients Per Site

141.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 powerThis 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 :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Length of stay [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 [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 [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

Patient satisfaction and patient reported experiences with ED wait time [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burin Peninsula Healthcare Centre	Burin	Newfoundland and Labrador	Canada	A0E1E0
2	Dr. G.B. Cross Memorial Hospital	Clarenville	Newfoundland and Labrador	Canada	A5A1K3
3	Health Sciences Centre	Saint John's	Newfoundland and Labrador	Canada	A1B 3V6
4	St. Clare's Mercy Hospital	Saint John's	Newfoundland and Labrador	Canada	A1C5B8