Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000999831
Ethics application status
Approved
Date submitted
21/06/2021
Date registered
29/07/2021
Date last updated
29/07/2021
Date data sharing statement initially provided
29/07/2021
Date results information initially provided
29/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrating the Choosing Wisely five questions into family meetings in the Intensive Care Unit: a randomised controlled trial.
Scientific title
Integrating the Choosing Wisely five questions into family meetings in the Intensive Care Unit: a randomised controlled trial investigating the effect on family perceived involvement in decision making.
Secondary ID [1] 304552 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surrogate decision making by families in the Intensive Care Unit 322428 0
Critical illness 322790 0
Condition category
Condition code
Public Health 320081 320081 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm: families received the Choosing Wisely five questions as printed prompts prior to a family meeting with clinicians.

Physical/informational materials: printed copy of the Choosing Wisely five questions and an explanation of how to use them as pre-reading. It was anticipated that it would take roughly 5-10 minutes to give the prompt and explain it to family member/s. Family member/s would then have an estimated 15-30 minutes to read over the paperwork prior to the family meeting. Family member/s could elect to take the printed prompts into the family meeting with the clinician and utilise them as much or as little as they wanted during the meeting. This prompt sheet was designed specifically for this study.

Mode of delivery: the printed materials were given to family member/s by an Intensive Care Unit (ICU) staff member, for example, a doctor or nurse. The family had time to read the materials prior to their family meeting. The family member/s were able to discuss the printed prompt with a staff member if they required any clarification.

The number of times the intervention will be delivered and over what period of time including the number of sessions: ICU staff members invited families to participate if they met the inclusion and exclusion criteria. This was ad hoc, whenever a family meeting was planned in the unit.

The location where the intervention occurs: in the ICU of one of three hospitals (Sir Charles Gairdner Hospital, Rockingham General Hospital, St John of God Midland Public and Private Hospital) participating in the study, in Perth, Western Australia.

Any strategies to monitor adherence to the intervention: staff were not required to check adherence with the pre-reading. Staff encouraged the family member/s to complete the family survey at the conclusion of the family meeting.
Intervention code [1] 320900 0
Treatment: Other
Comparator / control treatment
The control group were given a document stating that they had no pre-reading to complete and that they would participate in the family meeting as per usual operating practices.
Control group
Active

Outcomes
Primary outcome [1] 327956 0
Any change in the level of family perceived involvement in decision making assessed by an adapted version of the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey.
Timepoint [1] 327956 0
The primary outcome was measured by family completion of a survey immediately following the family meeting.

The survey questions were adapted from the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey. This is a validated tool for assessing various markers of family satisfaction with regards to patient care in the ICU. The family survey included four questions from the “Process of Making Decisions” section of the FS-ICU 24. The primary outcome was measured with the survey question “did you feel included in the decision making process?”. Responses were scored from one to five on a scale ranging from “I felt excluded” to “I felt very included”.
Secondary outcome [1] 397081 0
How well supported families felt using an adapted version of the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey.
Timepoint [1] 397081 0
This secondary outcome was measured by family completion of a survey immediately following the family meeting.

The survey questions were adapted from the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey. This is a validated tool for assessing various markers of family satisfaction with regards to patient care in the ICU. The family survey included four questions from the “Process of Making Decisions” section of the FS-ICU 24.

This secondary outcome was measured by: "Did you feel supported during the decision making process?" Possible answers: I felt totally overwhelmed, I felt slightly overwhelmed, I felt neither overwhelmed nor supported, I felt supported, I felt very supported.
Secondary outcome [2] 397082 0
Whether families felt they received an explanation/s that they understood using an adapted version of the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey.
Timepoint [2] 397082 0
This secondary outcome was measured by family completion of a survey immediately following the family meeting.

The survey questions were adapted from the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey. This is a validated tool for assessing various markers of family satisfaction with regards to patient care in the ICU. The family survey included four questions from the “Process of Making Decisions” section of the FS-ICU 24.

This secondary outcome was measured by: "How well did the ICU doctor provide you with explanation/s that you understood?" Possible answers: poor, fair, good, very good, excellent.
Secondary outcome [3] 397083 0
Whether families felt they had adequate time for decision making using an adapted version of the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey.
Timepoint [3] 397083 0
This secondary outcome was measured by family completion of a survey immediately following the family meeting.

The survey questions were adapted from the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24) survey. This is a validated tool for assessing various markers of family satisfaction with regards to patient care in the ICU. The family survey included four questions from the “Process of Making Decisions” section of the FS-ICU 24.

This secondary outcome was measured by: "When making decisions, did you have adequate time to have your concerns addressed and questions answered?" Possible answers: I could have used more time, I had adequate time.
Secondary outcome [4] 397084 0
Frequency of uptake of the Choosing Wisely five questions by family member/s assessed by ICU doctor and nurse completion of a study-specific survey.
Timepoint [4] 397084 0
This secondary outcome was measured by ICU doctor and nurse completion of a survey immediately following the family meeting.

ICU doctors and nurses were asked to answer either yes or no to: "Did the family use any of the five Choosing Wisely questions in today’s family meeting?"
Secondary outcome [5] 397085 0
Whether use of the questions by family member/s was helpful assessed by ICU doctor and nurse completion of a study-specific survey.
Timepoint [5] 397085 0
This secondary outcome was measured by ICU doctor and nurse completion of a survey immediately following the family meeting.

ICU doctors and nurses were asked to answer "Did you find family use of the five Choosing Wisely questions helpful during today’s family meeting?" Possible answers: not helpful at all, somewhat unhelpful, neither helpful nor unhelpful, somewhat helpful, very helpful.
Secondary outcome [6] 397086 0
Whether use of the questions by family member/s slowed the meeting assessed by ICU doctor and nurse completion of a study-specific survey.
Timepoint [6] 397086 0
This secondary outcome was measured by ICU doctor and nurse completion of a survey immediately following the family meeting.

ICU doctors and nurses were asked to answer "Did you find that family use of the five Choosing Wisely questions slowed the meeting down?" Possible answers: slowed the meeting to a significant degree, somewhat slowed the meeting, no change, somewhat hastened the meeting, significantly hastened the meeting.
Secondary outcome [7] 397087 0
Whether a goals of care discussion had taken place during the patient's admission assessed by ICU doctor and nurse completion of a study-specific survey.
Timepoint [7] 397087 0
This secondary outcome was measured by ICU doctor and nurse completion of a survey immediately following the family meeting.

ICU doctors and nurses were asked "has a goals of care discussions taken place during this admission?" Possible answers: yes, no, not applicable.
Secondary outcome [8] 397089 0
Perceived most important message from the family meeting assessed by family completion of a study-specific survey.
Timepoint [8] 397089 0
This secondary outcome was measured by family completion of a survey immediately following the family meeting.

The family member was asked to answer "What do you think the most important message was from today’s family meeting?" Space was provided for a free text answer.
Secondary outcome [9] 398107 0
Perceived most important message from the family meeting assessed by doctor completion of a study-specific survey.
Timepoint [9] 398107 0
This secondary outcome was measured by doctor completion of a survey immediately following the family meeting.

The ICU doctor was asked to answer "What do you think the most important message was from today’s family meeting?" Space was provided for a free text answer.
Secondary outcome [10] 398108 0
Perceived most important message from the family meeting assessed by nurse completion of a study-specific survey.
Timepoint [10] 398108 0
This secondary outcome was measured by nurse completion of a survey immediately following the family meeting.

The nurse was asked to answer "What do you think the most important message was from today’s family meeting?" Space was provided for a free text answer.

Eligibility
Key inclusion criteria
The inclusion criterion was any family member/s who were to attend and participate in a family meeting with the ICU doctor. The family member who was most likely to act as the patient’s surrogate decision maker was asked to complete the post-family meeting survey. This was typically the patient’s next of kin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criterion was family member or patient age less than 18 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
On agreeing to participate, the family member/s received an envelope containing documents that allocated them to either the control or intervention group. The envelopes were prepared by the study lead author who was independent of the family meeting and did not attend the family meeting.

The allocation of the family member/s was concealed from the ICU staff member recruiting the family. The study pre-reading and post-family meeting surveys were contained within a sealed envelope that did not reveal study allocation on the outside. The contents of the envelopes was only revealed once the family had agreed and consented to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants was via a computer generated random number generator on Microsoft Excel. Participants were allocated by simple randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It was hypothesised that for the primary outcome, perceived involvement in decision making by surrogate decision makers in the ICU, the intervention would improve the baseline level from 50% to 80%. This statistical improvement was derived from previous studies. With an alpha level of 0.05, and power of 0.8, this gave a sample size of 72 patients (two sample comparison of proportions).

Data were summarised using frequency distributions with group comparisons made using Chi squared or Fisher’s Exact tests. Stata version 16.0 (StataCorp, College Station, TX) was used for data analysis. The qualitative data provided by study participants were grouped into themes and summarised using frequency distributions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/05/2019
Date of last participant enrolment
Anticipated
Actual
8/12/2020
Date of last data collection
Anticipated
Actual
8/12/2020
Sample size
Target
72
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19775 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 19776 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [3] 19777 0
St John of God Hospital, Midland - Midland
Recruitment postcode(s) [1] 34419 0
6009 - Nedlands
Recruitment postcode(s) [2] 34420 0
6168 - Cooloongup
Recruitment postcode(s) [3] 34421 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 308919 0
Hospital
Name [1] 308919 0
Sir Charles Gairdner Hospital
Country [1] 308919 0
Australia
Funding source category [2] 309122 0
Hospital
Name [2] 309122 0
Rockingham General Hospital
Country [2] 309122 0
Australia
Funding source category [3] 309123 0
Hospital
Name [3] 309123 0
St John of God Midland Public and Private Hospital
Country [3] 309123 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue, Nedlands, 6009 WA
Country
Australia
Secondary sponsor category [1] 309841 0
None
Name [1] 309841 0
Address [1] 309841 0
Country [1] 309841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308811 0
Quality Improvement Head of Department at the North Metropolitan Area Health Service
Ethics committee address [1] 308811 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, WA, 6009
Ethics committee country [1] 308811 0
Australia
Date submitted for ethics approval [1] 308811 0
03/05/2019
Approval date [1] 308811 0
06/05/2019
Ethics approval number [1] 308811 0
32792

Summary
Brief summary
This study was approved as a quality improvement project by the Quality Improvement Head of Department at the North Metropolitan Area Health Service (GEKO #32792).

This committee provided ethical approval for the investigators to consent and enrol participants into this interventional study.

Summary of research project: Families presenting to the Intensive Care Unit (ICU) will be randomly allocated to either the control or intervention group. The intervention group will receive the Choosing Wisely five questions as pre-reading. The control group will not participate in any pre-reading. The family will then undergo a family meeting with the ICU doctor and nurse as planned. Post-family meeting the family member/s, doctor and nurse will complete a survey. The goal of this study is to investigate whether the pre-reading improves families' perceived involvement in decision making on behalf of their family member who is a patient in the ICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111974 0
Dr Ashleigh Drury
Address 111974 0
Intensive Care Unit, level 4, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, 6009 WA
Country 111974 0
Australia
Phone 111974 0
+61 422371110
Fax 111974 0
Email 111974 0
[email protected]
Contact person for public queries
Name 111975 0
Dr Ashleigh Drury
Address 111975 0
Intensive Care Unit, level 4, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, 6009 WA
Country 111975 0
Australia
Phone 111975 0
+61 422371110
Fax 111975 0
Email 111975 0
[email protected]
Contact person for scientific queries
Name 111976 0
Dr Ashleigh Drury
Address 111976 0
Intensive Care Unit, level 4, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, 6009 WA
Country 111976 0
Australia
Phone 111976 0
+61 422371110
Fax 111976 0
Email 111976 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
Confidentiality of participants


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
Basic resultsNo 382229-(Uploaded-10-07-2021-17-05-15)-Basic results summary.docx
Plain language summaryNo Background Family members often act as surrogate ... [More Details]

Documents added automatically
No additional documents have been identified.