The WikiTrauma Interrupted Time Series Protocol (WikiTrauma)

July 26, 2019 updated by: Patrick Archambault, Laval University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Pascal Y Smith

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wiki101 and WikiTrauma

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite performance indicator score (change is assessed)
Time Frame: 30 months prior to implementation and up to 12 months later
Composite performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry
30 months prior to implementation and up to 12 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications (change is assessed)
Time Frame: 30 months prior to implementation and up to 12 months later
Rate of complication in the trauma center
30 months prior to implementation and up to 12 months later
Mortality rate (change is assessed)
Time Frame: 30 months prior to implementation and up to 12 months later
Mortality rate in the trauma center
30 months prior to implementation and up to 12 months later
Length of stay (change is assessed)
Time Frame: 30 months prior to implementation and up to 12 months later
Length of stay in the trauma center
30 months prior to implementation and up to 12 months later
Functional Independence Measure (FIM) (change is assessed)
Time Frame: 30 months prior to implementation and up to 12 months later
an 18-item of physical, psychological and social function
30 months prior to implementation and up to 12 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrick M Archambault, MD MSc FRCPC, CISSS Chaudières-Appalaches (Hôtel-Dieu de Lévis)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wiki Implementation 1415-041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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