Clinical trial NCT04035772: The WikiTrauma Interrupted Time Series Protocol
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
Overall status: TERMINATED
Phase: NA
Conditions: Trauma
Keywords: interrupted time series
wiki
quality improvement
knowledge translation
trauma care
stakeholder engagement
adaptating knowledge tools
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Medical Protective Association
First posted: 2019-07-29
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Composite performance indicator score (change is assessed)
timeFrame: 30 months prior to implementation and up to 12 months later
Secondary outcomes:
measure: Rate of complications (change is assessed)
timeFrame: 30 months prior to implementation and up to 12 months later
measure: Mortality rate (change is assessed)
timeFrame: 30 months prior to implementation and up to 12 months later
measure: Length of stay (change is assessed)
timeFrame: 30 months prior to implementation and up to 12 months later
measure: Functional Independence Measure (FIM) (change is assessed)
timeFrame: 30 months prior to implementation and up to 12 months later
Other outcomes:
Locations:
city: Lévis
country: Canada
facility: Pascal Y Smith
state: Quebec
Study officials:
affiliation: CISSS Chaudières-Appalaches (Hôtel-Dieu de Lévis)
name: Patrick M Archambault, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: