ANZCTR - Registration

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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]

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

Condition category

Condition code

Other

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whom the treating doctors believe that the current medical condition is terminal, and that treatment should either be withdrawn or not escalated.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]

None

Comparator / control treatment

The control group will have usual, standard ICU care.

Control group

Active

Outcomes

Primary outcome [1]

Composite score for overall patient/family satisfaction

Timepoint [1]

Outcomes are measured at time of patients death, or time of patient's discharge from ICU

Primary outcome [2]

Composite score of staff satisfaction

Timepoint [2]

Outcomes are measured at time of patients death, or time of patient's discharge from ICU

Primary outcome [3]

Length of ICU stay

Timepoint [3]

Outcomes are measured at time of patients death, or time of patient's discharge from ICU

Primary outcome [4]

Length of hospital stay

Timepoint [4]

Outcomes are measured at time of patients death, or time of patient's discharge from ICU

Secondary outcome [1]

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]

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?

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Concord Repatriation General Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Concord Repatriation General Hospital Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Winston Cheung

Address

Intensive Care Unit
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139

Country

Australia

Phone

+61 2 97675000

Fax

+61 2 97675941

winston.cheung@email.cs.nsw.gov.au

Contact person for scientific queries

Name

Jeff Tan

Address

Intensive Care Unit
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139

Country

Australia

Phone

+61 2 97675000

Fax

+61 2 97675941

jeff.tan@email.cs.nsw.gov.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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