Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000989145p
Ethics application status
Submitted, not yet approved
Date submitted
7/06/2019
Date registered
11/07/2019
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An exploration of nurse decision making when managing high risk medications in the intensive care unit.
Scientific title
Nurse Decision Making and the Management of Vasoactive Medications in the Intensive Care Unit
Secondary ID [1] 298210 0
None
Universal Trial Number (UTN)
U1111-1233-6636
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular diseases 312890 0
Haemodynamically Unstable Patients 312891 0
Condition category
Condition code
Cardiovascular 311378 311378 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 311728 311728 0 0
Other cardiovascular diseases
Public Health 311729 311729 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A purposive sample of 25 intensive care nurses looking after 25 patients admitted to the intensive care unit for haemodynamic support and needing vasoactive medications, will be observed for a 2-4 hour period during a rostered shift. Recruitment will begin in August 2019 and conclude when the sample size has been reached. Rate of recruitment will be dictated by the number of nurses and patient dyads who meet all inclusion and no exclusion criteria and will explore the decision making processes nurses use to prepare, initiate, administer, titrate and wean vasoactive medications.
Ten nurse/patient dyads who have consented to participate in observation sessions will also be asked to allow audiovisual recording of the 2-4 hour session. The nurses from audiovisual sessions will be approached to participate in individual semi structured interviews that will take place as soon as possible after their observational session. It is anticipated that interviews will take between 20 and 40 minutes.
Focus groups will be conducted from January to March 2020 and will consist of 2 groups of intensive care nurses from each study site, with 5 to 7 nurses recruited into each of the 4 focus groups (up to 28 nurses in total). The 2 groups at each site will be designated as Expert or Intermediate to allow more junior nurses to speak freely about their experiences without embarrassment or repercussion. The focus groups will last approximately 30 to 60 minutes each, depending on group engagement with the topic.
Intervention code [1] 314518 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320126 0
Frequency of nurse decision decision making when managing vasoactive medications using an audit tool and field notes (+/- audiovisual recording).
Timepoint [1] 320126 0
The frequency of nurse decision making actions will be recorded during 2 to 4 hour observational sessions that will be conducted during a rostered nursing day/evening/night shift on any day of the week.
Primary outcome [2] 320418 0
Types of nurse decision making decision making when managing vasoactive medications using field notes (+/- audiovisual recording).
Timepoint [2] 320418 0
The types of nurse decision making actions and interventions will be recorded during 2 to 4 hour observational sessions that will be conducted during a rostered nursing day/evening/night shift on any day of the week.
Secondary outcome [1] 370624 0
Patient blood pressure responses to nurse initiated noradrenaline (norepinephrine) dose changes using invasive arterial monitoring and recorded on an audit tool and field notes (+/- audiovisual recording).
Timepoint [1] 370624 0
Patient blood pressure responses to nurse initiated changes in noradrenaline (norepinephrine) will be recorded during 2 to 4 hour observational sessions that will be conducted during a rostered nursing day/evening/night shift on any day of the week.
Secondary outcome [2] 371301 0
One on one, audio recorded, semi-structured interviews lasting 20 to 40 minutes will explore nurses' perspectives of decision making when managing vasoactive medications.
Timepoint [2] 371301 0
Nurses who have participated in the 2-4 hour observational sessions and consented to participate in audiovisual recording of these sessions will be asked to participate in semi-structured interviews as soon as possible after the observational session. If not on the same day then within the same week, at a time that suits the participant.
Secondary outcome [3] 371308 0
Audio recorded focus group sessions of 30 to 60 minutes will explore social contexts of nursing management of vasoactive medications.
Timepoint [3] 371308 0
Focus groups will be conducted from January to March 2020, once all observational and interview data has been collected.

Eligibility
Key inclusion criteria
Nurse inclusion criteria:
Nurses who are employed on a permanent full time or part time basis by the intensive care unit

Patient inclusion criteria:
Patients who have been admitted to the ICU
Patient has been allocated a nurse who has previously provided written consent to participate in either video or empirical data collection
Patients who are assessed by the ICU medical team as likely to need vasoactive support for the next 12 hours
Patients who have a functional arterial line in situ and
Patients who have a central venous catheter is in situ or insertion is imminent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nurse exclusion criteria:
Nurses who have previously participated in this study
Nurses who do not have direct patient care responsibilities

Patient exclusion criteria:
Patients who are aged less than 18 years
Patients who will be out of the intensive care unit (ICU) for (i.e. for transport to Medical Imaging or
Operating Theatre) for the observation period
Patients who are assessed by the ICU treating team as unlikely to need vasoactive support for the four-hour data collection period.
Patients who have been transitioned to palliative care
Patients or their Medical Treatment Decision Makers are visibly distressed
The medical team or bedside nurse considers that it is an inappropriate time to approach the patient or Medical Treatment Decision Maker with information about the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Due to patient sampling methods, physiological data are likely to be non-normally distributed so non-parametric descriptive statistics will be expressed as medians and interquartile ranges to describe patient responses to vasoactive titrations. Frequencies of decision making events will be counted from the data collection tool and verified using video recording. Outcome measures will include:
-The change in systolic or mean arterial blood pressure that prompts a nursing action of titrating infusion dose
-The change in infusion titration in response systolic blood pressure or mean arterial pressure changes based on nurse experience or education
-Patient response to noradrenaline (norepinephrine) titration based on age, presenting diagnosis
-Degree of infusion flow rate changes
-The total dose of noradrenaline (norepinephrine) received
-The frequency of nurse decision making events related to patient haemodynamic assessment and titration of noradrenaline (norepinephrine).

Audiovisual recording of observational studies will be used to gather descriptive and exploratory data and in this study the video recording session will provide verification of accuracy of empirical data, identify observer bias in the structured data collection phase and also be used to count number of actions related to vasoactive interventions that occurred during the recording period. Thematic analysis will be used to analyse audiovisual observations and transcribed audio recorded interviews and focus group sessions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2019
Actual
Date of last participant enrolment
Anticipated
30/03/2020
Actual
Date of last data collection
Anticipated
30/03/2020
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13965 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 13966 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 26736 0
3128 - Box Hill
Recruitment postcode(s) [2] 26737 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 302752 0
University
Name [1] 302752 0
Deakin University
Country [1] 302752 0
Australia
Funding source category [2] 302993 0
Hospital
Name [2] 302993 0
Eastern Health Foundation
Country [2] 302993 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 Arnold Street
Box Hill, Victoria, 3128
Country
Australia
Secondary sponsor category [1] 302688 0
University
Name [1] 302688 0
Deakin University
Address [1] 302688 0
221 Burwood Highway
Burwood, Victoria, 3125
Country [1] 302688 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303352 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 303352 0
Ethics committee country [1] 303352 0
Australia
Date submitted for ethics approval [1] 303352 0
16/05/2019
Approval date [1] 303352 0
Ethics approval number [1] 303352 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93374 0
Prof Elizabeth Manias
Address 93374 0
School of Nursing and Midwifery
Deakin University
221 Burwood Highway
Burwood, Victoria, 3125
Country 93374 0
Australia
Phone 93374 0
+61 3 9244 6958
Fax 93374 0
Email 93374 0
[email protected]
Contact person for public queries
Name 93375 0
Stephanie Hunter
Address 93375 0
Level 2.1
Box Hill Hospital
8 Arnold Street
Box Hill, Victoria, 3128
Country 93375 0
Australia
Phone 93375 0
+61 3 8396 8621
Fax 93375 0
Email 93375 0
[email protected]
Contact person for scientific queries
Name 93376 0
Stephanie Hunter
Address 93376 0
Level 2.1
Box Hill Hospital
8 Arnold Street
Box Hill, , 3128
Country 93376 0
Australia
Phone 93376 0
+61 3 8396 8621
Fax 93376 0
Email 93376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Restrictions apply to the availability of these data which will be used under license from Eastern Health for the current study and are not publicly available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hunter, S., Considine, J., & Manias, E. (2020 ). N... [More Details]
Study results articleYes Hunter, S., Manias, E., Hirth, S., & Considine, J.... [More Details]

Documents added automatically
No additional documents have been identified.