Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000110583
Ethics application status
Approved
Date submitted
23/03/2006
Date registered
27/03/2006
Date last updated
27/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The Concord Repatriation General Hospital Intensive Care Quality of Care Study
Scientific title
The effect of the Palliative Care Team on quality indicators for end-of-life care in the intensive care unit: A randomised, controlled trial
Secondary ID [1] 247 0
The Concord Repatriation General Hospital Intensive Care Quality of Care Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-of-life care in the ICU 1076 0
Condition category
Condition code
Other 1155 1155 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective randomised, controlled trial in patients in the Intensive Care Unit (ICU), in whom the treating doctors believe that the current medical condition is terminal, and that treatment should either be withdrawn or not escalated. It is speculated that involvement of a Palliative Care team during this end-of-life period may lead to better patient, family, and staff satisfaction with the care provided in the ICU. Consenting patients will be divided randomly into 2 groups. The study group will have usual, standard ICU care, plus a Palliative Care Team will consult. The study intervention will continue until the patient is discharged to the ward, or the patient dies in ICU.
Intervention code [1] 951 0
None
Comparator / control treatment
The control group will have usual, standard ICU care.
Control group
Active

Outcomes
Primary outcome [1] 1553 0
Composite score for overall patient/family satisfaction
Timepoint [1] 1553 0
Outcomes are measured at time of patients death, or time of patient's discharge from ICU
Primary outcome [2] 1554 0
Composite score of staff satisfaction
Timepoint [2] 1554 0
Outcomes are measured at time of patients death, or time of patient's discharge from ICU
Primary outcome [3] 1555 0
Length of ICU stay
Timepoint [3] 1555 0
Outcomes are measured at time of patients death, or time of patient's discharge from ICU
Primary outcome [4] 1556 0
Length of hospital stay
Timepoint [4] 1556 0
Outcomes are measured at time of patients death, or time of patient's discharge from ICU
Secondary outcome [1] 2803 0
Other end-of-life quality indicators: Satisfaction scores around patient/family centred decision making, communication, continuity of care, emotional and practical support, symptom management, spiritual support, staff support.
Timepoint [1] 2803 0
Outcomes are measured at time of patients death, or time of patient's discharge from ICU.

Eligibility
Key inclusion criteria
1. Patient has a pre-terminal or terminal condition and the treating ICU physician, and parent treating teams believe that continuing current treatment or escalating treatment is futile, and unlikely to alter the overall outcome. 2. The ICU physician deems it appropriate that a Not-For-Resuscitation (NFR) order be written for the patient. 3. The patient is unlikely to survive more than 1 week if treatment is either not escalated, or treatment is withdrawn. 4. The patient is expected to stay in the ICU for at least another 2 days. 5. A palliative care team is available to be involved in end-of-life care within the following 24 hours. 6. Patient or surrogate is willing to consent to completing the two questionnaires to be administered during the palliation process. 7. There is no reason to believe that the patient or family would object to palliative care team involvement in the patient’s end-of-life care.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 The patient is unable to give consent or participate in the decision-making process, and has no readily available legal surrogate decision-maker, or is under Guardianship Board control.2 A palliative care team is not available to see the patient within the next 24 hours.3 The patient is not likely to survive to palliative care team review.4 The patient or surrogates, or treating medical teams have already specifically requested palliative care involvement in end-of-life care.5 No independent intensive care consultant is available to approach family for consent.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised generation - bias coin technique
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1263 0
Self funded/Unfunded
Name [1] 1263 0
Country [1] 1263 0
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Country
Australia
Secondary sponsor category [1] 1118 0
None
Name [1] 1118 0
Nil
Address [1] 1118 0
Country [1] 1118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2596 0
Concord Repatriation General Hospital Human Research Ethics Committee
Ethics committee address [1] 2596 0
Ethics committee country [1] 2596 0
Australia
Date submitted for ethics approval [1] 2596 0
Approval date [1] 2596 0
Ethics approval number [1] 2596 0
CH62/6/2005-129

Summary
Brief summary
BACKGROUND

It is speculated that involvement of Palliative Care teams with patients in the Intensive Care Unit (ICU) receiving end-of-life care may lead to better patient, family, and staff satisfaction with the care provided in the ICU, but this has not been studied before. Palliative Care teams have been shown to improve many measures of outcome, such as symptom control, patient and family or carer satisfaction, and health care costs in several other medical settings.

AIM

The aim of this study is to examine the effect that the Palliative Care team has on outcomes in patients receiving end-of-life care in the ICU.

HYPOTHESIS

Our hypothesis is that the involvement of the palliative care team in patients receiving end-of-life care in the ICU improves patient and staff quality indicators for end-of-life care.

RESEARCH PLAN

This pilot study is a single centre, unblinded, prospective, randomised, controlled trial in patients in the ICU, in whom the treating doctors believe that the current medical condition is terminal or pre-terminal, and that treatment should either be withdrawn or not escalated.
Patients will be eligible for the study, if they suffer from a terminal or pre-terminal condition, and if the treating ICU physician, in consultation and agreement with the treating parent team, deems it appropriate for end-of-life care to be started, and deems it appropriate that current treatment either should have limitations imposed and should not be escalated, or should be withdrawn or withheld. Enrolment will begin after the treating ICU consultant has discussed the medical issues with the patient and/or their family and has indicated that it is their professional belief that treatment should not be escalated and palliative care should be instituted.
Enrolment will be via direct approach from research staff.
Consenting patients will be divided randomly into 2 groups. The control group will have usual, standard ICU care. The study group will have usual, standard ICU care, and in addition, a Palliative Care Team will consult.
Consenting families will be asked to complete 2 questionnaires; one soon after the initial enrolment discussion, and a second questionnaire after the patient's death or transfer out of the ICU. Medical and nursing staff will also be asked to complete similar questionnaires.
The questionnaires will ask questions on several quality indicators for end-of-life care, such as communication, continuity of care, emotional and practical support, symptom management, decision making, and other aspects of support.
As outcome data is currently unknown, a blinded analysis will occur after 40 patients have been enrolled to determine the sample size required for significance. We intend to enrol 180 patients, in line with our current predictions for statistical significance.
Analysis will be on intention to treat. Non-parametric testing will be used to analyse differences between the two groups.
This study is a 3 year pilot study, with the aim of constructing a larger, multi-centre trial after completion.

OUTCOMES AND SIGNIFICANCE

The primary outcomes will be composite scores for patient/family satisfaction with care in the ICU, composite scores for staff satisfaction with care in the ICU, and length of ICU and hospital stay.
End-of-life care in the ICU is currently a significant problem in Australia. With the change in philosophy in medical care from paternalism to consumerism, many patients are now demanding expensive, but futile medical care. Many patients receive treatment and organ support, not because the treatment is indicated, but for other reasons.
Palliative Care has been shown to improve end-of-life care in many areas outside of ICU, and has also been shown to reduce health care costs in these areas.
We expect this study will be significant in demonstrating that Palliative Care teams can help improve end-of-life care outcomes, and reduce health care costs in the ICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35549 0
Address 35549 0
Country 35549 0
Phone 35549 0
Fax 35549 0
Email 35549 0
Contact person for public queries
Name 10140 0
Winston Cheung
Address 10140 0
Intensive Care Unit
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 10140 0
Australia
Phone 10140 0
+61 2 97675000
Fax 10140 0
+61 2 97675941
Email 10140 0
[email protected]
Contact person for scientific queries
Name 1068 0
Jeff Tan
Address 1068 0
Intensive Care Unit
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 1068 0
Australia
Phone 1068 0
+61 2 97675000
Fax 1068 0
+61 2 97675941
Email 1068 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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