Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000701729
Ethics application status
Approved
Date submitted
28/04/2022
Date registered
16/05/2022
Date last updated
27/04/2023
Date data sharing statement initially provided
16/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Better management of breathlessness in the ICU (BreatheICU):
A cross-sectional national clinician survey and consumer interview study.
Scientific title
Better management of breathlessness in the ICU (BreatheICU):
A cross-sectional national clinician survey and consumer interview study.
Secondary ID [1] 306991 0
Nil known
Universal Trial Number (UTN)
U1111-1277-5515
Trial acronym
BreatheICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathlessness 326108 0
Condition category
Condition code
Respiratory 323438 323438 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study Part 1– Cross-sectional National Descriptive Clinician Survey.
Medical, nursing and allied health staff of Australian adult ICU’s will be invited to participate in a single survey (approximately 15mins in duration) exploring their perceptions regarding assessment and management of breathlessness. Survey questions will be based on existing published surveys used to assess attitudes toward dyspnoea assessment and management in doctors and ICU nurses. Questions include non-identifiable demographic data, and Likert-style statements inviting respondents to indicate their level of agreement concerning the importance of dyspnoea in clinical care; current assessment and management of dyspnoea; use and benefits of routine dyspnoea assessment; management of dyspnoea. In order to develop a ‘knowledge bank’, open-ended question responses will also be included, inviting responders to provide information on any strategies they have found personally useful for managing dyspnoea. We propose to reach the target population for this study through collaboration with both the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group (CTG), and the Cardiothoracic Special Interest Group of the Australian Physiotherapy Association.

Study Part 2 - Interviews with consumers.
A purposive sample of patients admitted to the ICU with and without respiratory disease (n=20 patients) over a four-month period will be recruited. Clinical staff at The Queen Elizabeth Hospital, South Australia (TQEH) will screen ICU patients Monday to Friday meeting the inclusion criteria. The aim of the interview is to explore the experience of breathlessness in people who have been cared for within the ICU environment. A topic guide will be developed based on previous interview studies and in conjunction with local consumer representatives who are part of the study reference group. The interview will be conducted on the day of ICU discharge or as close as practical. It will be a maximum of 30 minutes duration (interview can be offered as 2 shorter sessions if appropriate) and consist of 3 to 5 key questions specific to the participants ICU experience with prompts for experiences of symptoms of breathlessness.

Post-study reference group:
At the end of the interview, participants will be provided with an option to join a post-study reference group, to consider and reflect upon the study findings. This would involve further communication by telephone and email with the study investigators on a maximum of 2 occasions (for approx. 30mins) after analysis of the data. Interested participants would be invited to collaborate with interpretation of study results and development of proposed actions and recommendations from the study findings.
Intervention code [1] 323441 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331174 0
To investigate perceptions and beliefs of Australian ICU clinicians about dyspnoea assessment and management in patients managed within the ICU setting, using a questionnaire designed for the study.
Timepoint [1] 331174 0
Once off survey
Secondary outcome [1] 409094 0
To explore, using a semi-structured interview process, the experience of dyspnoea in people who have been cared for within a local ICU environment. The interview will involve a 30min face to face interview with a senior clinician at the time of discharge from ICU.
Timepoint [1] 409094 0
Assessed at the time of the patient's discharge from ICU to a ward setting.

Eligibility
Key inclusion criteria
Survey
Medical, nursing and allied health staff of Australian adult ICU’s will be invited to participate in a single survey. With endorsement of the study by the ANZICS CTG we anticipate the survey will be able to be distributed to over 70 ANZICS CTG member ICU’s in Australia, reaching a minimum of 500 eligible clinicians on the CTG mailing list. Mailing list recipients will be encouraged to forward the survey invitation to eligible clinicians within their networks (snowballing).

Interviews
A purposive sample of patients admitted to the ICU with and without respiratory disease (n=20 patients) over a four-month period will be recruited. Clinical staff at The Queen Elizabeth Hospital, South Australia (TQEH) will screen ICU patients Monday to Friday for the following inclusion criteria:
• Aged over 18 years
• English speaking
• ICU stay of >48 hours
• Planned for discharge from the ICU to the ward
• Capacity to provide consent to participate

Patients meeting the above inclusion criteria will be asked a single screening question - “Did you ever feel breathless during your time in ICU?”. Those indicating ‘yes’ will be invited to participate in a semi-structured interview.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No specific groups are to be excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Survey-data:
Given the recruitment strategy planned (inclusion of snowballing), the total number of potential participants is unknown and consequently response rates will be unable to calculated. Descriptive reporting of demographic data and response rates for each survey item will be calculated (frequency, proportion). Where possible, demographic data (professional discipline, state/territory, geographic location (metropolitan/rural) will be compared to national data (ANZICS CTG membership demographics, national ICU workforce data) to estimate representativeness of the respondent’s sample. Ratings for agreement (Likert-scale items) will be reported as mean and standard deviation unless data are not normally distributed (median, interquartile range). Open ended questions will be coded for content (independently by two members of the research team) to highlight common recurring views.

Interview-data:
Demographic and clinical characteristics (comorbidities, intubation and mechanical ventilation duration/variable) will be gained from the patient medical record post-interview for subjects participating in the interview and reported descriptively. Transcript data will be analysed using reflexive thematic analysis involving five explicitly defined stages (familiarisation, initial coding, constructing, reviewing and finalising themes) each completed by two researchers to promote triangulation and credibility. Verbatim quotations from a range of participants will be included to illustrate connections between the data and themes. Study conduct and reporting will be consistent with reporting guidelines for surveys and qualitative studies (COREQ) respectively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2022
Actual
18/10/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
160
Accrual to date
152
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 24616 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 40223 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 311303 0
Charities/Societies/Foundations
Name [1] 311303 0
Physiotherapy Research Foundation
Country [1] 311303 0
Australia
Primary sponsor type
Individual
Name
Mr Leigh Rushworth
Address
CALHN Physiotherapy Department
28 Woodville Rd, Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 312666 0
Individual
Name [1] 312666 0
A/Prof Kylie Johnston
Address [1] 312666 0
University of South Australia, City East Campus
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country [1] 312666 0
Australia
Secondary sponsor category [2] 312679 0
Individual
Name [2] 312679 0
Prof Marie Williams
Address [2] 312679 0
University of South Australia, City East Campus
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country [2] 312679 0
Australia
Secondary sponsor category [3] 312680 0
Individual
Name [3] 312680 0
Ms Patricia Williams
Address [3] 312680 0
TQEH Department of Intensive Care Medicine
28 Woodville Rd, Woodville South SA 5011
Country [3] 312680 0
Australia
Secondary sponsor category [4] 312681 0
Individual
Name [4] 312681 0
Dr Nikki Yeo
Address [4] 312681 0
TQEH Department of Intensive Care Medicine
28 Woodville Rd, Woodville South SA 5011
Country [4] 312681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310805 0
CALHN Human Research Ethics Committee.
Ethics committee address [1] 310805 0
CALHN Research Services, Central Adelaide Local Health Network Inc. SA Health
Level 3, Roma Mitchell Building, 136 North Terrace, Adelaide, SA 5000
Ethics committee country [1] 310805 0
Australia
Date submitted for ethics approval [1] 310805 0
11/03/2022
Approval date [1] 310805 0
07/07/2022
Ethics approval number [1] 310805 0
16181
Ethics committee name [2] 312909 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 312909 0
University of South Australia, GPO Box 2471, Adelaide SA 5001.
Ethics committee country [2] 312909 0
Australia
Date submitted for ethics approval [2] 312909 0
18/07/2022
Approval date [2] 312909 0
19/07/2022
Ethics approval number [2] 312909 0
204869

Summary
Brief summary
In settings of care for people who cannot breathe without support such as intensive care units (ICU), dyspnoea (the experience of difficulty breathing) is a frequent and terrifying problem. Recent reports indicate that dyspnoea in the ICU is just as commonly experienced as pain (47% report mod-severe dyspnoea vs 41% pain, n=138 ICU patients [Gentzler et al. 2019]), yet dyspnoea by comparison is poorly recognised, underassessed and under-treated. This results in increased length of ICU stay, poorer physical and long-term psychological outcomes; and occurs despite the availability of potentially suitable assessment tools and evidence-based effective interventions for dyspnoea in the ICU. Implementation of dyspnoea assessment and management in Australian ICUs is largely unexplored.

This project aims to address explore this issue through two research questions: 1. What are the perceptions and beliefs of Australian ICU clinicians about dyspnoea assessment and management in patients in the ICU setting? 2. What is the experience of dyspnoea in people who have been cared for within an ICU environment?

Methodology: The project will be conducted in two parts within an action research framework: 1. A cross-sectional national descriptive survey of medical, nursing and allied health clinicians working within Australian ICU’s, to explore attitudes and practices in dyspnoea assessment and management. 2. Semi-structured interviews with a purposive sample of ICU patients from a local facility, to explore the experience of breathlessness in people who have been cared for within the ICU environment.

Significance: Internationally, addressing assessment and management of dyspnoea in ICU settings has been recognised as an ethical and moral imperative to lessen suffering, improve patient outcomes, and reduce health care costs associated with delayed time in the ICU and post-ICU morbidity. To date, there is no Australian data available on prevalence, assessment practices and management strategies on dyspnoea within the ICU setting. This study aims to gain an understanding of current Australian practice using a collaborative participatory action research approach to focus on patient and clinician-valued priorities and solutions. The findings from this study will provide a foundation for developing strategies to translate breathlessness science and evidence-based interventions into clinical practice in the ICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118934 0
Mr Leigh Rushworth
Address 118934 0
CALHN Physiotherapy Department- The Queen Elizabeth Hospital
28 Woodville Rd, Woodville South, SA 5011
Country 118934 0
Australia
Phone 118934 0
+61 0882226621
Fax 118934 0
Email 118934 0
leigh.rushworth@sa.gov.au
Contact person for public queries
Name 118935 0
Mr Leigh Rushworth
Address 118935 0
CALHN Physiotherapy Department- The Queen Elizabeth Hospital
28 Woodville Rd, Woodville South, SA 5011
Country 118935 0
Australia
Phone 118935 0
+61 0882226621
Fax 118935 0
Email 118935 0
leigh.rushworth@sa.gov.au
Contact person for scientific queries
Name 118936 0
Ms Patricia Williams
Address 118936 0
TQEH Department of Intensive Care Medicine,
28 Woodville Rd, Woodville South SA 5011
Country 118936 0
Australia
Phone 118936 0
+61 0882226000
Fax 118936 0
Email 118936 0
tricia.williams@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only summary results and verbatim quotations from a range of participants will be disseminated


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15869Study protocol  leigh.rushworth@sa.gov.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.