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The WikiTrauma Interrupted Time Series Protocol (WikiTrauma)

Primary Purpose

Trauma

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wiki101 and WikiTrauma
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Trauma focused on measuring interrupted time series, wiki, quality improvement, knowledge translation, trauma care, stakeholder engagement, adaptating knowledge tools

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • decision makers (eg, trauma program coordinators) or,
  • health care professionals (eg, emergency physicians, critical care physicians, trauma surgeons, nurses, respiratory therapists, physiotherapists, or pharmacists).
  • Patient representatives will be selected without any restrictions or limitations with regard to the qualifications.
  • Health care professional students and trainees (eg, residents, medical students, and nursing students) will have the same access to WikiTrauma and Wiki101 as fully certified professionals.

Sites / Locations

  • Pascal Y Smith

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wiki101 and WikiTrauma

Arm Description

Wiki101, a theory-based continuing professional development (CPD) program, will train participants at the selected trauma centers to use WikiTrauma effectively and safely to create and share different types of Knowledge Transfer (KT) tools (e.g., care protocols, order sets, patient decision aids). Participants will receive Wiki101 training and then gain access to WikiTrauma with editing rights to the knowledge implementation tools (e.g. care protocols, order sets, care pathways) found in the wiki. WikiTrauma is the wiki we created to promote best practices in trauma care and will be implemented in four trauma centers in Quebec during 12 months. During this period, we will continue to measure the impact on the quality of care.

Outcomes

Primary Outcome Measures

Composite performance indicator score (change is assessed)
Composite performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry

Secondary Outcome Measures

Rate of complications (change is assessed)
Rate of complication in the trauma center
Mortality rate (change is assessed)
Mortality rate in the trauma center
Length of stay (change is assessed)
Length of stay in the trauma center
Functional Independence Measure (FIM) (change is assessed)
an 18-item of physical, psychological and social function

Full Information

First Posted
January 18, 2018
Last Updated
July 26, 2019
Sponsor
Laval University
Collaborators
Canadian Medical Protective Association
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1. Study Identification

Unique Protocol Identification Number
NCT04035772
Brief Title
The WikiTrauma Interrupted Time Series Protocol
Acronym
WikiTrauma
Official Title
Implementation and Evaluation of a Wiki Involving Multiple Stakeholders Including Patients in the Promotion of Best Practices in Trauma Care: the WikiTrauma Interrupted Time Series Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Feasibility (barriers to implantation within the institution)
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Medical Protective Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to study the combined effect of WikiTrauma, a free collaborative database of clinical decision support tools, and Wiki101, a training course teaching participants how to use WikiTrauma, on the quality of care in four trauma centers in Quebec. The hypothesis that the theory-based intervention (Wiki101), in combination with use of WikiTrauma, will result in better adoption of best practices in trauma care, safer care (less complications), improved patient outcomes and less costly care in Canada.
Detailed Description
Trauma is the most common cause of mortality among people between the ages of 1 and 45 years, costing Canadians 19.8 billion dollars a year (2004 data), yet half of all patients with major traumatic injuries do not receive evidence-based care, and significant regional variation in the quality of care across Canada exists. Accordingly, the goal of this study is to lead a research project in which stakeholders themselves will adapt evidence-based trauma care knowledge tools to the varied institutional contexts and cultures. This will be done by developing and assessing the combined impact of WikiTrauma, a free collaborative database of clinical decision support tools, and Wiki101, a training course teaching participants how to use WikiTrauma. WikiTrauma has the potential to ensure that all stakeholders (eg, patients, clinicians, and decision makers) can all contribute to, and benefit from, evidence-based clinical knowledge about trauma care that is tailored to the needs and clinical setting. The main goal will be to study the combined effect of WikiTrauma and Wiki101 on the quality of care in four trauma centers in Quebec. First, the wiki will be pilot-tested with potential users to create a version ready to test in practice. A rapid, iterative prototyping process with 15 health professionals from nonparticipating centers will allow to identify and resolve usability issues prior to finalizing the definitive version for the interrupted time series. Second, an interrupted time series will be performed to measure the impact of the combined intervention on the quality of care in four trauma centers that will be selected;one level I, one level II, and two level III centers. Participants will be health care professionals working in the selected trauma centers. Also, five patient representatives will be recruited to participate in the creation of knowledge tools destined for the use (eg, handouts). All participants will be invited to complete the Wiki101 training and then use, and contribute to, WikiTrauma for 12 months. The primary outcome will be the change over time of a validated, composite, performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry. The project was funded in November 2014 by the Canadian Medical Protective Association. The trial will start in early 2015 and preliminary results should be available in June 2016. Two trauma centers have already agreed to participate and two more will be recruited in the next months. This study is expected to add important and unique evidence about the effectiveness, safety, and cost savings of using collaborative platforms to adapt knowledge implementation tools across jurisdictions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
interrupted time series, wiki, quality improvement, knowledge translation, trauma care, stakeholder engagement, adaptating knowledge tools

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wiki101 and WikiTrauma
Arm Type
Experimental
Arm Description
Wiki101, a theory-based continuing professional development (CPD) program, will train participants at the selected trauma centers to use WikiTrauma effectively and safely to create and share different types of Knowledge Transfer (KT) tools (e.g., care protocols, order sets, patient decision aids). Participants will receive Wiki101 training and then gain access to WikiTrauma with editing rights to the knowledge implementation tools (e.g. care protocols, order sets, care pathways) found in the wiki. WikiTrauma is the wiki we created to promote best practices in trauma care and will be implemented in four trauma centers in Quebec during 12 months. During this period, we will continue to measure the impact on the quality of care.
Intervention Type
Other
Intervention Name(s)
Wiki101 and WikiTrauma
Intervention Description
Wiki101 is a theory-based continuing professional development course to teach healthcare professionals how to use WikiTrauma. WikiTrauma is a wiki containing implementation tools built upon the Google Sites platform.
Primary Outcome Measure Information:
Title
Composite performance indicator score (change is assessed)
Description
Composite performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry
Time Frame
30 months prior to implementation and up to 12 months later
Secondary Outcome Measure Information:
Title
Rate of complications (change is assessed)
Description
Rate of complication in the trauma center
Time Frame
30 months prior to implementation and up to 12 months later
Title
Mortality rate (change is assessed)
Description
Mortality rate in the trauma center
Time Frame
30 months prior to implementation and up to 12 months later
Title
Length of stay (change is assessed)
Description
Length of stay in the trauma center
Time Frame
30 months prior to implementation and up to 12 months later
Title
Functional Independence Measure (FIM) (change is assessed)
Description
an 18-item of physical, psychological and social function
Time Frame
30 months prior to implementation and up to 12 months later

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: decision makers (eg, trauma program coordinators) or, health care professionals (eg, emergency physicians, critical care physicians, trauma surgeons, nurses, respiratory therapists, physiotherapists, or pharmacists). Patient representatives will be selected without any restrictions or limitations with regard to the qualifications. Health care professional students and trainees (eg, residents, medical students, and nursing students) will have the same access to WikiTrauma and Wiki101 as fully certified professionals.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick M Archambault, MD MSc FRCPC
Organizational Affiliation
CISSS Chaudières-Appalaches (Hôtel-Dieu de Lévis)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pascal Y Smith
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada

12. IPD Sharing Statement

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The WikiTrauma Interrupted Time Series Protocol

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