Experiences and Attitudes Towards Agitated Behaviours in TBI ICU Patients: a Protocol for an Interprofessional Mixed-method Study
EXSTATIC
EXperienceS and aTtitudes Towards Agitated Behaviours in Tbi ICu Patients (EXSTATIC): a Protocol for an Interprofessional Mixed-method Study
1 other identifier
observational
98
0 countries
N/A
Brief Summary
EXSTATIC is a multicenter mixed methods convergent study exploring experiences and attitudes of ICU healthcare professionals caring of agitated traumatic brain injury (TBI) patients. The study aims to explore the experiences and attitudes of ICU nurses and other ICU healthcare professionals on the management of agitation in acute TBI patients. This project includes three qualitative methods and one quantitative method. First step consists in structured observations of the daily routine of ICU healthcare professionals when TBI patient admitted in the ICU develops agitation. This step will allow us to raise emerging research questions from the field and to develop subsequent steps. Secondly, we will conduct semi-structured interviews with ICU nurses. Themes emerged in the interviews are essential to understand nurses' experiences and attitudes towards TBI agitated patients and describe their relational role amongst patients, other professionals and families. A retrospective cohort of TBI patients gathered through medical files will follow aiming to document in which way observations in the two first phases are reflected in the clinical notes. Finally, different ICU healthcare professionals will be invited to participate in focus groups to identify further themes in semi-structured interviews in nurses, compare them and prioritize which are the most relevant to nurses experiences and which ones need to be addressed for their future practice. The integration of the different methods will be done using sequential steps of the research (the previous informing the next one) and by the integration of results for each step. Qualitative data will be evaluated following the grounded theory using thematic analysis. Quantitative data will be analysed using descriptive statistics. Qualitative and quantitative results will be combined in a convergent interactive interpretative design. Race and gender perspective will be integrated in collection, analysis and interpretation of data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedFebruary 5, 2021
February 1, 2021
9 months
February 2, 2021
February 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To explore the experiences and attitudes of the healthcare professionals managing agitation of TBI patients in two ICUs of level-1 Canadian trauma hospitals
To unveil the perceptions, the practices, the consequences and the risks of handling TBI agitated patients.
December 2020-October 2021
Eligibility Criteria
ICU healthcare professionals ICU TBI patients
You may qualify if:
- All professionals belonging to the intensive care team (nurses, occupational therapists, beneficiary attendants, ICU physicians, physiotherapists, respiratory therapists, pharmacists, unit coordinators), employed full-time or part-time in any shift with a minimum of 1 year of trauma intensive care experience can be included to participate in the semi-structured interviews and focus groups
- All patients suffering from a TBI with an abnormal CT scan admitted to the ICU will be included for the structured observation
- In the retrospective observational study, a convenience sample of 25 patients per centre (50 patients in total) admitted six months before the observational period will be included for data collection.
You may not qualify if:
- Temporary staff, students or residents will be excluded from semi-structured interviews and focus groups
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Saavedra-Mitjans M, David PM, Frenette AJ, Arbour C, Perreault M, Williams V, Bernard F, Williamson D. EXperienceS and aTtitudes towards Agitated behaviours in Traumatic brain injury in the Intensive Care unit patients (EXSTATIC): a protocol for an interprofessional mixed-method study. BMJ Open. 2021 Jul 14;11(7):e045816. doi: 10.1136/bmjopen-2020-045816.
PMID: 34261680DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 5, 2021
Study Start
February 10, 2021
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
February 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share