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Trauma InjuryEXSTATICNCT04741399

Experiences and Attitudes Towards Agitated Behaviours in TBI ICU Patients: a Protocol for an Interprofessional Mixed-method Study

An observational study of Trauma Injury and Intensive Care Neurological Disorder, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
98 participants
Where
No sites listed yet
Study dates
10 Feb 2021to 31 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: ICU healthcare professionals ICU TBI patients

Who may be able to join

  • 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.

Who cannot join

  • Temporary staff, students or residents will be excluded from semi-structured interviews and focus groups

About this study

Official title: EXperienceS and aTtitudes Towards Agitated Behaviours in Tbi ICu Patients (EXSTATIC): a Protocol for an Interprofessional Mixed-method Study

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.

Read the detailed description

A convergent design will be performed using three qualitative research methods (structured observations, semi-structured interviews and focus groups) and a quantitative research method (retrospective observational study).

First, a researcher will observe the daily ICU routine, in two ICU units, when a TBI-patient is admitted. In this first step, the specific objective is to observe the care of TBI patients during periods of agitation, to understand how it affects the actions of healthcare professionals and their interactions with each other and other actors present in the unit. These observations will enable researchers to detect non-verbal expression of feelings, interactions and communication between patients, their family and health professionals as well as interactions between health professionals at the bedside. The observations will also enable us to map bedside clinical activities made by health professionals and the time spent doing them. The goal is to develop a repertoire of situations combining the degree of agitation, the resources present, the experience and the effects on the staff, the patient and their relatives, the actions and medical decisions in response to agitation. The data gathered in this phase will inform the interview guide for the semi-structured interviews.

In the second phase, we will conduct semi-structured interviews with ICU nurses to explore their experiences and attitudes towards the care of TBI patients with agitated behaviours. Nurses will be interviewed as they are the healthcare professionals most present at the bedside of TBI patients and their families. Semi-structured interviews enable to explore nurse's perspectives and experiences. This will also allow us to investigate how these experiences can predict their reactions to agitated behaviours, and how these reactions are shared between different health professionals or also with hospital health personnel. This particular phase enables us to uncover unanticipated themes.

We will then undertake a retrospective observational study aiming to describe the documentation of agitated behaviours in TBI patients and interventions to manage them. In this step, the objective is to substantiate the documentation of the significant elements identified in the first two phases of the study. This third phase will be complementary to the previous two phases and will allow to document in which way observations in the first two phases are reflected in the clinical notes. A convenience sample of consecutive admissions for TBI with an abnormal CT-scan will be reviewed.

Finally, interprofessional focus groups will be conducted in order to gain insights into ICU healthcare professionals experiences and explore their attitudes and needs when TBI patients develop agitation. Group process can help people to explore and clarify their views and to share ideas and perceptions. All healthcare professional who participate in the care of TBI patients in the ICU will be solicited for participation. Specifically, the aim is to discuss the various themes identified in the previous steps and understand their relational dimension among different healthcare professionals.

The integration of the different methods will be done by the connection of the different steps and by the integration of results for each step. This multistep approach allows to identify organizational, cultural factors and to better understand social interactions as well as health care delivery process.

Keywords
Agitation, Healthcare professionals
Medical subject headings
Accidental Injuries, Psychomotor Agitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: December 2020-October 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start10 Feb 2021 (estimated)
  3. Primary completion31 Oct 2021 (estimated)
  4. Study completion31 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04741399
Sponsor's protocol ID
MP-32-2021-2198
Acronym
EXSTATIC
Status last verified
Feb 2021
First submitted
2 Feb 2021
Last updated
5 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34261680

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma Injury and Intensive Care Neurological Disorder, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To explore the experiences and attitudes of the healthcare professionals managing agitation of TBI patients in two ICUs of level-1 Canadian trauma hospitals (time frame: December 2020-October 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04741399, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.

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