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Trial registered on ANZCTR


Registration number
ACTRN12622001568707
Ethics application status
Approved
Date submitted
10/12/2022
Date registered
19/12/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
19/12/2022
Date results provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Development, Implementation and Evaluation of a Novel Intervention for Delirium in an Adult Intensive Care Unit
Scientific title
The Development, Implementation and Evaluation of a Novel Intervention, the Family Members Voice Reorientation, for Delirium in an Adult Intensive Care Unit: A Pilot Study
Secondary ID [1] 308594 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 328464 0
Condition category
Condition code
Mental Health 325499 325499 0 0
Other mental health disorders
Neurological 325569 325569 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Family Members Voice Reorientation intervention (FamVR) is a novel voice reorientation program that will record family members’ voices. The recorded voices can be played to the patient by clinical staff to provide orientation, reassurance, and comforting words to critically ill patients. The researcher will conduct the study in two phases.

Phase One – Development of FamVR content: This phase comprises the development of the FamVR intervention content in collaboration with relevant stakeholders comprising ICU clinicians, patients and families. The FamVR program content will be stored on an iPad. The program will have four domains which comprise the ICU reorientation, ICU routine, ICU procedure and free category domains. The ICU reorientation domain will contain messages in family members' voices that family members or clinical staff can play to the patient during the early days of admission, during bed moves, in the wake of the day, during change of staff and at bedtime. The ICU routine domain will contain messages that can be played to the patient before routine care, such as washing, oral and eye care, bed lining change, and nursing and medical assessments. The ICU procedure domain can be played to the patient before invasive devices such as central venous lines, oxygen masks, suctioning, urinary catheter insertion, feeding tube insertion and lines for drugs. The free domain will contain messages that the family members choose in the context of everyday events, such as the news about their family, loved ones and events; the researcher and clinical staff will
monitor his domain to ensure that appropriate messages are played to the patient.

Phase Two – Pilot study implementation in one ICU: Phase Two will start approximately 3 weeks after Phase One. The researcher will consent and educate patients, family members and staff about the FamVR. Then the FamVR will be implemented in one adult ICU. During this time, the clinical staff and the researcher will use an agitation assessment scale to monitor the effect of the FamVR on patients. If patients show increased levels of agitation during the intervention, they will no longer receive FamVR for the duration
of their ICU stay. The clinical staff are educated on using the agitation assessment scale because it is currently used in practice. However, the researcher who is an ICU clinician will provide further education about 2 weeks before implementing the intervention through a one-off 1-hour PowerPoint Presentation via Microsoft Teams which will be recorded for staff to replay in their own time. Also, the researcher will provide at least 3 face-to-face education sessions using pictures and the demonstration of the intervention on an iPad to reinforce the clinicians' knowledge and application of the assessment during this study. The family members will play the role of recording their voices in approximately 1 hour recording session; according to the scripts of the domain and the researcher will provide face-to-face education using pictures and iPad demonstration to the family members 3 days before implementing the intervention. The FamVR can be played to the patient in their absence daily as needed for each of the domains, the free category domain will be played at least twice a day. The FamVR will be administered to each patient participant from the time they are intubated in ICU to the time the breathing tube is removed. The researcher will collate information via an observational checklist that will record how long, when and how many times the FamVR was played. This phase will then evaluate the FamVR intervention by exploring the experiences of ICU staff, patients and families of the FamVR via individual interviews.

Evaluation: The pilot study implementation of the FamVR intervention is anticipated to last for four months, with 30 participants consented and recruited in the study as guided by pilot studies. The researcher will evaluate the intervention by collecting data on the experiences of patients, family members and clinical staff of integrating the FamVR into the delirium care of their loved ones or patients. Data collection for the patients and family members will be one-to-one semi-structured interviews and recorded via Microsoft Teams. The interview will be recorded audio and visual and will last approximately 60 minutes. Patients can be interviewed as a family unit with the family members or separately if they prefer. The interview will take place in the participants' natural settings to minimise the risk of travelling to the study site and their natural settings will make them more at ease. For clinician participants, the
researcher will conduct 3 focus groups with 8-12 participants in each focus group until no new information emerges (data saturation) from the focus group. If data saturation is not achieved, the researcher will undertake further focus groups until data saturation is achieved. The researcher will organise the focus groups to explore the experiences of the clinical staff of the FamVR intervention. The focus groups will comprise of doctors, nurses and physiotherapists. The focus group will be recorded via Microsoft Teams and will last for approximately 60 minutes
Intervention code [1] 325043 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333349 0
Proportion of patients who receive a Richmond Agitation-Sedation Scale (RASS) score of 0 with the FamVR intervention.
Timepoint [1] 333349 0
Daily during the 4-month implementation period of the intervention until no longer intubated.
Secondary outcome [1] 416696 0
Experiences of patients and family members assessed using one-to-one semi-structured interviews.
Timepoint [1] 416696 0
Once at the end of the 4-month implementation period of the intervention.
Secondary outcome [2] 416942 0
Experiences of ICU clinical staff assessed using focus group interviews.
Timepoint [2] 416942 0
Once at the end of the 4-month implementation period of the intervention.

Eligibility
Key inclusion criteria
The inclusion criteria includes adults aged 18 years and older. The stakeholder group: The ICU clinical expert will be a medical doctor (consultant or senior registrar doctor) and a senior nurse who has received formal critical care training and holds a clinical position in the ICU at the time of selection for the study. For the patients and families of a person
who has survived a critical illness or a family member of someone who survived a critical illness. Those who consent to participate in the study. For Phase Two (Implementation and Evaluation): Patients and family members of a patient admitted to the ICU during the period the FamVR intervention is pilot implemented. Staff who currently holds a permanent clinical position in the ICU. A person who understands English. Those who voluntarily consent to
participate in the study. Some patients may not have the capacity to consent in Phase 2 pilot implementation; in that case, an identified consultee will consent, and the consent will be reconfirmed directly from the patient when they regain the capacity to consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be patients and their family members who were palliated or receiving end-of-life care. Participants from the stakeholder group from phase one are excluded from being participants in Phase Two Evaluation. Participants who do not speak or understand English as they would not be able to participate in interviews.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2023
Actual
6/04/2023
Date of last participant enrolment
Anticipated
Actual
8/02/2024
Date of last data collection
Anticipated
Actual
8/03/2024
Sample size
Target
30
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 25172 0
United Kingdom
State/province [1] 25172 0
London

Funding & Sponsors
Funding source category [1] 312841 0
University
Name [1] 312841 0
Edith Cowan University
Country [1] 312841 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup, Western Australia
6027
Country
Australia
Secondary sponsor category [1] 314486 0
Hospital
Name [1] 314486 0
Chelsea and Westminster Hospital NHS Foundation Trust
Address [1] 314486 0
369 Fulham Road
London SW10 9NH
Country [1] 314486 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312119 0
London - Camden and Kingscross Research Ethics Committee
Ethics committee address [1] 312119 0
Ethics committee country [1] 312119 0
United Kingdom
Date submitted for ethics approval [1] 312119 0
08/12/2022
Approval date [1] 312119 0
07/03/2023
Ethics approval number [1] 312119 0
IRAS 318820
Ethics committee name [2] 313392 0
Human Research Ethics
Ethics committee address [2] 313392 0
Ethics committee country [2] 313392 0
Australia
Date submitted for ethics approval [2] 313392 0
Approval date [2] 313392 0
04/05/2023
Ethics approval number [2] 313392 0
2023-04186-JOHNSON

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

Contacts
Principal investigator
Name 123546 0
Mr Gideon Johnson
Address 123546 0
West Middlesex University Hospital
Twickenham Road, Isleworth, TW7 6AF
Country 123546 0
United Kingdom
Phone 123546 0
+447425329396
Fax 123546 0
Email 123546 0
gideonj@our.ecu.edu.au
Contact person for public queries
Name 123547 0
Gideon Johnson
Address 123547 0
West Middlesex University Hospital
Twickenham Road, Isleworth, TW7 6AF
Country 123547 0
United Kingdom
Phone 123547 0
+447425329396
Fax 123547 0
Email 123547 0
gideon.johnson@nhs.net
Contact person for scientific queries
Name 123548 0
Gideon Johnson
Address 123548 0
West Middlesex University Hospital
Twickenham Road, Isleworth, TW7 6AF
Country 123548 0
United Kingdom
Phone 123548 0
+447425329396
Fax 123548 0
Email 123548 0
gideonj@our.ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17826Ethical approval  gideonj@our.edu.ecu.au Ethics approval from London - Camden and Kingscros... [More Details]
17827Ethical approval  gideonj@our.ecu.edu.au Reciprocal Ethics approval from Edith Cowan Univer... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.