ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1233-6636

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vascular diseases

Haemodynamically Unstable Patients

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Cardiovascular

Other cardiovascular diseases

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Frequency of nurse decision decision making when managing vasoactive medications using an audit tool and field notes (+/- audiovisual recording).

Timepoint [1]

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]

Types of nurse decision making decision making when managing vasoactive medications using field notes (+/- audiovisual recording).

Timepoint [2]

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]

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]

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]

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]

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]

Audio recorded focus group sessions of 30 to 60 minutes will explore social contexts of nursing management of vasoactive medications.

Timepoint [3]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Box Hill Hospital - Box Hill

Recruitment hospital [2]

Maroondah Hospital - Ringwood East

Recruitment postcode(s) [1]

3128 - Box Hill

Recruitment postcode(s) [2]

3135 - Ringwood East

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

Faculty of Health
221 Burwood Highway
Burwood, Victoria, 3125

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Eastern Health Foundation

Address [2]

5 Arnold Street
Box Hill, Victoria, 3128

Country [2]

Australia

Primary sponsor type

Hospital

Name

Eastern Health

Address

5 Arnold Street
Box Hill, Victoria, 3128

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Deakin University

Address [1]

221 Burwood Highway
Burwood, Victoria, 3125

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Eastern Health Human Research Ethics Committee

Ethics committee address [1]

5 Arnold Street 
Box Hill, Victoria, 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/05/2019

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

It is estimated that 60% of patients admitted to intensive care units receive vasoactive medication to support patient blood pressure and/or heart function. Patients presenting with infection, shock, injury, drug overdose or heart failure are prescribed vasoactive medications by doctors, and nurses are responsible for many aspects of management including preparation, administration, adjustment of doses and weaning. These medications are fast acting and need careful management to prevent harms including stroke and heart attack. Possible problems include rapid administration of the vasoactive medication or incorrect dose adjustments. There has been little research on how nurses manage vasoactive medications and many of the guidelines in current use are not based on research evidence. 
The aims of this study are to identify the frequency and types of decisions that nurses make in managing vasoactive medications, the immediate impact of these decisions on patients and the underlying decision-making processes in use. The project objectives are to observe how nurses manage vasoactive medications and the decision-making processes they use to assess patients, prepare, initiate and administer the medication and the decisions that prompt dose-adjustments, such as titration and weaning. 
A systematic review completed by the researcher and PhD supervisors identified few published studies of nurses’ management of vasoactive medications and this lack of attention, coupled with anecdotal clinical experiences, prompted the conceptualisation of this study (Hunter, Manias, & Considine, 2018). These medications are ubiquitous in intensive care settings all over the world and are managed by nurses with little or no evidence based support. The potential for risk associated with the use of vasoactive medications highlights that nurse decision making is fundamental to the safe management of vasoactive medications (Hunter et al., 2018).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Elizabeth Manias

Address

School of Nursing and Midwifery
Deakin University
221 Burwood Highway
Burwood, Victoria, 3125

Country

Australia

Phone

+61 3 9244 6958

Fax

emanias@deakin.edu.au

Contact person for public queries

Name

Stephanie Hunter

Address

Level 2.1
Box Hill Hospital
8 Arnold Street
Box Hill, Victoria, 3128

Country

Australia

Phone

+61 3 8396 8621

Fax

stephanie.hunter@easternhealth.org.au

Contact person for scientific queries

Name

Stephanie Hunter

Address

Level 2.1
Box Hill Hospital
8 Arnold Street
Box Hill, , 3128

Country

Australia

Phone

+61 3 8396 8621

Fax

stephanie.hunter@easternhealth.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Hunter, S., Considine, J., & Manias, E. (2020 ). N... [More Details]
Study results article	Yes		Hunter, S., Manias, E., Hirth, S., & Considine, J.... [More Details]

Documents added automatically

No additional documents have been identified.

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