ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001392459

Ethics application status

Approved

Date submitted

7/09/2016

Date registered

7/10/2016

Date last updated

26/04/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Pilot assessment of the utility and acceptability of a new ‘goals of care and not for cardiopulmonary resuscitation’ documentation tool/form

Scientific title

Pilot assessment of the utility of and acceptability to emergency department doctors of a new 'goals of care and not for cardiopulmonary resuscitation' documentation tool/form at Cabrini Emergency Department for use in all patients requiring a goals of care discussion as determined by their emergency department doctor during the study period.

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1186-8231

Trial acronym

n/a

Linked study record

Health condition

Health condition(s) or problem(s) studied:

End of life care

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

See attached form for the intervention. This is a form that can be utilised by physicians to document conversations with patients and families about end of life management plans.

This form will replace the usual not for CPR (cardiopulmonary resuscitation) form currently utilised at Cabrini hospital. All current forms will be replaced in the Emergency Department for the duration of the study by the new form that is being studied. Forms will not be replaced in other locations in the Cabrini network.

Doctors will receive face-to-face and email education about the new form in the two weeks preceding the intervention. The education will be delivered by an emergency physician (KW) in the emergency department face-to-face and will be a 5-10 minute conversation showing them the form and pointing out the sections available for use. The email will be similar, advising them that the usual forms will be replaced by the study forms with an attachment to the email including a copy of the form. There will be the opportunity for doctors to ask questions about the form face-to-face or via email. There are no educational tools other than the form, nor is there education in how to conduct a conversation about goals-of-care or resuscitation appropriateness/futility.

Only doctors will complete the forms and we anticipate using approximately 150 forms during a 12 week study period. Doctors are also able to document conversations in the regular medical notes if they prefer but there will be no other not for CPR forms available.

Adherence to using this form (rather than the usual not for CPR form) will be measured by retrospective review of all medical notes of patients enrolled in the study.

All doctors in the ED will receive an email with the trial form attached and a 500 word description of the aim of the study. One paragraph explanation for each of the sections to be completed will be provided. Doctors will be asked to time the conversations on their phones and enter the data at the bottom of the form.

See form attached to ANZCTR registration record for the intervention

Intervention code [1]

Behaviour

Comparator / control treatment

Retrospective review of comparison group of patients (1 month before implementation). A group of patients matched for age/gender and SPICT status who were admitted from ED to the ward will be selected by research staff and Dr Katie Walker. The comparison group will be reviewed retrospectively for patient outcomes (length of stay; discharge or death) and evidence of discussion documentation (on the form and/or in the patient notes). The comparison group will also provide a baseline NFR rate.

The Supportive & Palliative Care Indicators tool (SPICT) will be used retrospectively to identify those patients admitted via ED who were at risk of dying within 12 months. The tool identifies evidence of general deteriorating health, as well as evidence of advance medical conditions to identify those patients at risk of dying, akin to the 'surprise question' (would you be surprised if this patient died in the next 12 months). Patients determined to be at risk are those for whom goals of care discussions should be conducted, and limitations of treatment considered.

Control group

Historical

Outcomes

Primary outcome [1]

The attitudes to and experiences of doctors using the new form in the Emergency Department to document of end-of-life discussions, goals of care discussions and limits of treatment discussion and/or decisions.

This will be evaluated by surveys and semi-structured interviews with doctors, designed for this study (attached).

This is a composite outcome as the numbers of participants is small.

Timepoint [1]

October 1st to November 30th 2016

Survey will be sent one week post intervention. Interviews 1-4 weeks post intervention.

Secondary outcome [1]

Establishment of the average duration (in minutes) and standard deviation of end-of-life/goals of care discussions in Emergency patients at Cabrini Emergency Department

This will be measured by each physician completing a form estimating (or timing) the duration of the conversation and documenting this on the form.

Timepoint [1]

October 1st to November 30th 2016

Documentation will be audited 1-4 weeks post intervention.

Secondary outcome [2]

Evaluation of the utility of each section of the form to physicians as measured by the completion rate of each section of the form.

This will be retrospectively assessed by reviewing each study form and determining in a binary fashion, whether each section was utilised or not

Timepoint [2]

October 1st to November 30th 2016

Documentation will be audited 1-4 weeks post intervention

Secondary outcome [3]

To determine whether a form containing these end-of-life discussion sections, facilitates discussion with patients and their carers about these issues

This will be evaluated by surveys and semi-structured interviews with doctors and nursing staff, designed for this study (attached).

Timepoint [3]

October 1st to November 30th 2016

Interviews will be conducted 1-4 weeks post intervention

Secondary outcome [4]

To determine whether this form prompts decisions about setting treatment limits for patients (i.e. not for cardiopulmonary resuscitation)

This will be evaluated by semi-structured interviews with doctors

Timepoint [4]

October 1st to November 30th 2016

Interviews will be conducted 1-4 weeks post intervention

Eligibility

Key inclusion criteria

Patients attending Cabrini Emergency Department between the time periods of October 1st to November 30th 2016 for whom an attending doctor determines that an end-of-life/goals of care discussion is appropriate.
All doctors who work in the Emergency Department are eligible to take part in the study.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

patients age less than 18 years
no exclusion criteria for doctors

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Nil

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Nil

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

All doctors attending the ED will be eligible for enrolment. All doctors wishing to document a Not for CPR decision will be required to utilise this form. The goals of care page is optional as are all sections individually within the form.

All forms will be sequentially numbered and a requirement of obtaining a form will be to provide the patient Universal Record number to the researchers to enable tracking of the patient records. Note that the form contains a research data entry space to record the estimated duration of the conversation and documentation of the discussion.

Doctors who use a form are eligible for semi-structured interview. All those using a form will approached face-to-face and by email to invite participation.

Interviews will be recorded and transcribed into NVivo. Data will be coded into themes and analysed by two researchers with experience in qualitative research. Any dissent will be reviewed by a third researcher. Interviews will continue until theme saturation is obtained.

The duration of consultations times will be analysed by simple descriptive statistics (mean, median, SD)

Retrospective medical review will be undertaken to determine the completion rate of each section of the form. Simple descriptive statistics will be used to analyse this data. (mean, median, SD)

No sample size calculations as this is a qualitative study. On prior experience we anticipate that at least two not-for-CPR documents are completed each day in the ED. Over a 12 week period, we anticipate that approximately 150 trial forms will be used and therefore each doctor is likely to complete at least 5 forms.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

18/10/2016

Actual

1/12/2016

Date of last participant enrolment

Anticipated

18/01/2017

Actual

28/02/2017

Date of last data collection

Anticipated

18/03/2017

Actual

28/08/2017

Sample size

Target

150

Accrual to date

Final

108

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Cabrini Hospital - Malvern - Malvern

Recruitment postcode(s) [1]

3144 - Malvern

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Cabrini Hospital

Address [1]

Cabrini-Monash University Department of Medicine
Cabrini Insitute
154 Wattletree Rd
Malvern
Vic
3144

Country [1]

Australia

Primary sponsor type

Individual

Name

Michele Levinson

Address

Cabrini-Monash University Department of Medicine
Cabrini Insitute
154 Wattletree Rd
Malvern
Vic
3144

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Katie Walker

Address [1]

Emergency Department
Cabrini Hospital
183 Wattletree Rd
Malvern
Vic
3144

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Erin O'Callaghan

Address [1]

Emergency Department
Cabrini Hospital
183 Wattletree Rd
Malvern
Vic
3144

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Amber Mills

Address [2]

Cabrini-Monash University Department of Medicine
Cabrini Institute
154 Wattletree Rd
Malvern
Vic
3144

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Gaya Sritharan

Address [3]

Cabrini-Monash University Department of Medicine
Cabrini Insitute
154 Wattletree Rd
Malvern
Vic
3144

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Anthea Gellie

Address [4]

Cabrini-Monash University Department of Medicine
Cabrini Institute
154 Wattletree Rd
Malvern
Vic
3144

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Georgina Johnstone

Address [5]

Cabrini-Monash University Department of Medicine
Cabrini Institute
154 Wattletree Rd
Malvern
Vic
3144

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cabrini Human Research Ethics committee

Ethics committee address [1]

Cabrini Institute
154 Wattletree Rd
Malvern
3144
Vic

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2016

Approval date [1]

15/09/2016

Ethics approval number [1]

CHREC 02-24-10-16

Summary

Brief summary

Health care delivered at the end of life should aim to deliver the outcomes desirable to the patient and family. Understanding the priorities for the outcome of care requires open and honest communication about health care options, prognosis, likelihood of survival and risks for cognitive impairment or functional decline. As prediction of death in any one admission is difficult, conversation about goals of care and undesirable outcomes should occur for those patients who are at risk of dying in the next 12 months (Gibbins, McCoubrie, Alexander, Kinzel, & Forbes, 2009).

Completion of an NFR form is often the result of the conversation regarding outcomes acceptable to the patient or which may have a reasonable chance of success.   The survival to discharge outcomes for CPR in those aged 80 years and over is poor and there is significant morbidity especially in impaired cognitive function. However, the completion rate of NFR in the first 24 hours for those patients aged 80 years and over admitted acutely unwell to public or private hospitals is less than 20%. (Levinson and Mills, 2016 (in press)). The rate is significantly lower in private compared to public hospitals. Hospitals and the Australasian College for Emergency Medicine policy around NFR documentation strongly encourages discussion of resuscitation status with the patient. While NFR completion does not confirm that discussion of goals of care has occurred, absence of NFR in those who have a poor outcome from CPR (hospital inpatients aged 80+ years) is highly suggestive of an absence of goals of care discussion at least as it relates to acute deterioration and resuscitation.

There are many published barriers to end of life conversations. These include time, knowledge of the law, expertise and a desire not to rob the patient of hope.
At Cabrini there are no decision-making tools to assist with the issues to be addressed at end of life. There is a perceived need for a goals of care discussion to be documented in the patient file (personal communication senior nursing staff 4S, 3C and MET registrars) associated with the completion of NFR if appropriate to improve patient centred care and reduce futile cardiopulmonary resuscitation. 

The aim of this study is to evaluate the utility and relevance of a document to assist with the conversation about goals of care at the end of life, and to facilitate the completion of Not For Resusitation forms where appropriate in the Emergency Department at Cabrini Malvern.

The forms will be trialed over a 12 week period. At the end of this time, the forms will be evaluated for: 
Adequacy and completeness of the documentation
the utility and acceptability of the GCR forms in guiding and promoting discussion
Evaluate the interviews for themes relating to use of the forms.
Evaluation of patient outcomes (length of stay; discharge or death) and evidence of discussion documentation

Trial website

Trial related presentations / publications

publication: Mills AC, Levinson M, Dunlop WA, et al. Testing a new form to document 'Goals-of-Care' discussions regarding plans for end-of-life care for patients in an Australian emergency department. Emergency medicine Australasia : EMA. 2018.

presentation: Walker KJ, Testing a new form to document 'Goals-of-Care' discussions regarding plans for end-of-life care for patients in an Australian emergency department. ACEM Annual Scientific Meeting, Sydney, November 2017

Public notes

Attachments [1]

/AnzctrAttachments/371357-Combined_discussion_NFCPR_form.pdf (Supplementary information)

Attachments [2]

/AnzctrAttachments/371357-Doctors Survey Questions.docx (Supplementary information)

Attachments [3]

/AnzctrAttachments/371357-Interview questions_final.docx (Supplementary information)

Attachments [4]

/AnzctrAttachments/371357-Nurses Survey Questions.docx (Supplementary information)

Attachments [5]

/AnzctrAttachments/371357-CHREC approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

A/Prof Michele Levinson

Address

Cabrini-Monash University Department of Medicine
Cabrini Institute
154 Wattletree Rd
Malvern
Vic
3144

Country

Australia

Phone

+61 3 9508 3466

Fax

mlevinson@cabrini.com.au

Contact person for public queries

Name

Michele Levinson

Address

Cabrini-Monash University Department of Medicine
Cabrini Institute
154 Wattletree Rd
Malvern
Vic
3144

Country

Australia

Phone

+61 3 9508 3466

Fax

mlevinson@cabrini.com.au

Contact person for scientific queries

Name

Michele Levinson

Address

Cabrini-Monash University Department of Medicine
Cabrini Institute
154 Wattletree Rd
Malvern
Vic
3144

Country

Australia

Phone

+61 3 9508 3466

Fax

mlevinson@cabrini.com.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

Source	Title	Year of Publication	DOI
Embase	Testing a new form to document 'Goals-of-Care' discussions regarding plans for end-of-life care for patients in an Australian emergency department.	2018	https://dx.doi.org/10.1111/1742-6723.12986

N.B. These documents automatically identified may not have been verified by the study sponsor.

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