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SurgeCon: An Emergency Department Surge Management Platform (SurgeCon)

Primary Purpose

Length of Stay, Emergency Departments

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SurgeCon
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Length of Stay focused on measuring SurgeCon, Emergency Department, Stepped-Wedge Design, Randomized Trials, Wait Time

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Burin Peninsula Healthcare CentreRecruiting
  • Dr. G.B. Cross Memorial HospitalRecruiting
  • Health Sciences CentreRecruiting
  • St. Clare's Mercy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Hospital site 1

Hospital site 2

Hospital site 3

Hospital site 4

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Length of stay
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
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
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
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
Cost of providing emergency department services (this includes but not limited to the cost of pharmacy, lab tests, diagnostic imaging, and therapeutic interventions).

Full Information

First Posted
March 3, 2021
Last Updated
September 6, 2022
Sponsor
Memorial University of Newfoundland
Collaborators
Canadian Institutes of Health Research (CIHR), Government of Newfoundland and Labrador, Eastern Health, Trinity Conception Placentia Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04789902
Brief Title
SurgeCon: An Emergency Department Surge Management Platform
Acronym
SurgeCon
Official Title
A Stepped Wedge Cluster Randomized Trial Designed to Evaluate the Effects of SurgeCon: A Quality Improvement Surge Management Platform
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland
Collaborators
Canadian Institutes of Health Research (CIHR), Government of Newfoundland and Labrador, Eastern Health, Trinity Conception Placentia Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Length of Stay, Emergency Departments
Keywords
SurgeCon, Emergency Department, Stepped-Wedge Design, Randomized Trials, Wait Time

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
20280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hospital site 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Hospital site 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Hospital site 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Hospital site 4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SurgeCon
Intervention Description
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 Measure Information:
Title
Length of stay
Description
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 Frame
31 Months
Title
Time to physician's initial assessment
Description
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.
Time Frame
31 Months
Title
Number of patients left without being seen
Description
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.
Time Frame
31 Months
Secondary Outcome Measure Information:
Title
Patient satisfaction and patient reported experiences with ED wait time
Description
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.
Time Frame
31 Months
Title
Economic impact of intervention on emergency department services
Description
Cost of providing emergency department services (this includes but not limited to the cost of pharmacy, lab tests, diagnostic imaging, and therapeutic interventions).
Time Frame
31 Months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All individuals who visit any of the four selected emergency departments during the study period will be included. Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shabnam Shabnam, PhD
Phone
7097772142
Email
Shabnam.Asghari@med.mun.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Hurley, MEnvSc
Phone
7098646296
Email
ogh758@mun.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shabnam Shabnam, PhD
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burin Peninsula Healthcare Centre
City
Burin
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0E1E0
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Kennedy
Email
Elizabeth.Kennedy@easternhealth.ca
Facility Name
Dr. G.B. Cross Memorial Hospital
City
Clarenville
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A5A1K3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Kennedy
Email
Elizabeth.Kennedy@easternhealth.ca
Facility Name
Health Sciences Centre
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Kennedy
Email
Elizabeth.Kennedy@easternhealth.ca
Facility Name
St. Clare's Mercy Hospital
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C5B8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Kennedy
Email
Elizabeth.Kennedy@easternhealth.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
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SurgeCon: An Emergency Department Surge Management Platform

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