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

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ClinicalTrials.gov Identifier: NCT04741399
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
Centre Universitaire de Santé McGill
Information provided by (Responsible Party):
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Tracking Information
First Submitted Date February 2, 2021
First Posted Date February 5, 2021
Last Update Posted Date February 5, 2021
Estimated Study Start Date February 10, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2021)
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 ]
To unveil the perceptions, the practices, the consequences and the risks of handling TBI agitated patients.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Experiences and Attitudes Towards Agitated Behaviours in TBI ICU Patients: a Protocol for an Interprofessional Mixed-method Study
Official Title EXperienceS and aTtitudes Towards Agitated Behaviours in Tbi ICu Patients (EXSTATIC): a Protocol for an Interprofessional Mixed-method Study
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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ICU healthcare professionals ICU TBI patients
Condition
  • Trauma Injury
  • Intensive Care Neurological Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 4, 2021)
98
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Temporary staff, students or residents will be excluded from semi-structured interviews and focus groups
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04741399
Other Study ID Numbers MP-32-2021-2198
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study Sponsor Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborators Centre Universitaire de Santé McGill
Investigators Not Provided
PRS Account Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Verification Date February 2021