Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04741399 |
| Other study ID # |
MP-32-2021-2198 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2021 |
| Est. completion date |
October 31, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
