NCT04741399

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

February 2, 2021

Last Update Submit

February 4, 2021

Conditions

Keywords

AgitationHealthcare professionals

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

Age18 Years+
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

MeSH Terms

Conditions

Accidental InjuriesPsychomotor Agitation

Condition Hierarchy (Ancestors)

Wounds and InjuriesDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

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