Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000105347
Ethics application status
Approved
Date submitted
22/12/2016
Date registered
18/01/2017
Date last updated
18/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Goals-of-Care (GOC) with Not-for-Resuscitation (NFR) Orders in Medical and Oncology Patients. A quasi-experimental comparative pre-and-post study.
Scientific title
Comparing Goals-of-Care (GOC) with Not-for-Resuscitation (NFR) Orders in Medical and Oncology Patients. A quasi-experimental comparative pre-and-post study investigating uptake, utilisation in conjunction with staff and patient satistfaction.
Secondary ID [1] 290429 0
None
Universal Trial Number (UTN)
U1111-1189-2687
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Therapeutic goals 300775 0
End of life / palliative care 300776 0
Doctor-patient communication 300777 0
Condition category
Condition code
Public Health 300609 300609 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a quasi-experimental pre-and post study. The pre-component / retrospective control phase (March 1st - September 30th 2016) will be the current hospital Not-for-Resuscitation (NFR) form. The post-component / intervention phase (March 1st - September 30th 2017) will involve replacement of the NFR form with a new Goals-of-Care (GOC) on two hospital wards that predominately care for oncology and medical patients in a large Australian private hospital.

The GOC form has been designed to be more explicit to delineating the care pathways for individual patients. The original NFR form is completed on an ad-hoc basis at any point in a patient's hospital admission with a binary outcome pathway of essentially full resuscitation or palliation. The intent for the new GOC form is that it will be completed for every inpatient hospital admission and offers 4 distinct care pathways
(A) All life sustaining treatment i.e full active resuscitation
(B) Life extending treatment - with treatment ceilings regarding ICU and MER call feasibility (C) Active ward based treatment - with symptom and comfort care i.e not for ICU
(D) Optimal comfort treatment i.e essentially good palliative care.
This study aims to have the new GOC form completed within 48 hours of admission. Where a patient clearly qualifies for Treatment Goal A - all life sustaining treatment, then the box is ticked and patient discussion is not necessary. Where the treating doctors are uncertain then the study requests a discussion with the treating specialist and patient as appropriate. It is hoped that the new GOC will trigger a greater consideration on the most appropriate care pathway for a patient early in their admission. Changes in the care pathway will be monitored as part of the outcomes.

Prior to the introduction of the GOC form (intervention phase) on March 1st 2017 there will be a series of educational activities coordinated and run by the Department of Palliative Care. These will include::
(1) Three online short videos between 11 -18 minutes that can be watched at http://ww2.health.wa.gov.au/Articles/A_E/Advance-CPR-decision-making-in-the-hospital-setting . This activity is already available and we are encouraging for all hospital staff to review them prior to the new GOC form intervention.
(2) Hospital grand round presentations - two in total - each lasting 45 minutes with time for questions and answers. These will be conducted in November 2016 and February 2017. All hospital staff will be encouraged to attend these sessions.
(3) Junior medical staff teaching sessions. These will be for all RMO and registrars regardless of which wards they work on as they will rotate positions through the year and have after-hours ward cover that may involve one of the intervention wards. There will be four x 45 minute sessions to be held in January, February and March 2017 during dedicated routine JMO teaching sessions.
(4) Nursing education sessions two x 45 minute sessions (4 in total) on the designated wards (oncology and general medicine wards) for the GOC intervention. There will be a separate 45 minute session for the ICU nurses who are involved in the Medical Emergency Response Team in February 2017. These will be arranged at handover times in January and February 2017 and conducted by the clinical nurse consultant in palliative care.
(5) Specific senior medical training sessions. There will be 2 x 1 hour long case scenario and simulations sessions arranged for senior clinician staff in February 2017. Only senior staff involved in the studied wards will be invited. These include the specialists in the fields of oncology, haematology and internal medicine specialties. Senior staff training sessions will be strongly encouraged but voluntary.

If necessary, additional training sessions will be arranged in the first three months after the introduction of the new GOC based on staff feedback and research monitoring for compliance.

The education will focus on -> the reasons for the change in forms from NFR to GOC; the content of the new GOC form and how it differs from the old NFR form; how, when and on who to complete the new GOC form for; and describe the surrounding research project.
During the intervention (GOC) phase, all old NFR forms will be removed and replaced with the intervention GOC form. The intervention will be applied to every patient admitted to one of three medical / oncology wards over a six-month period. It will be completed by junior medical officers (JMOs) and consultant physicians within the first 48 hours of all admissions. Each GOC form will apply for the entire admission but can be changed by the treating team at time points later in the admission if the patients' clinical situation changes. If a patient is re-admitted during the same time period a new form will need to be completed.
All the interventions (GOC forms) will be personalised according to the treating teams overall management strategy for the patient at any given time.
Intervention adherence will be assessed by the number of forms completed, the date and time they where completed, and the number of times they are altered during a patient's admission.
Intervention code [1] 296274 0
Behaviour
Comparator / control treatment
The control group will be a pre-comparision group and retrospectively involve all patients admitted over a six-month period (March 1st - September 30th 2016) on two medical / oncology wards utilising the current standard-of-care Not-for-Resuscitation (NFR) form. Data on the comparator group will be retrospectively collected by accessing records from the Department of Clinical Safety and Quality and by reviewing individual patient records from the Department of Medical Records. The researchers are not seeking to to influence behaviour at all during this phase which will be truly observational. In its current version the NFR form is completed in a truly ad-hoc manner in less than 20% of patients admitted to the proposed wards to be studied
Control group
Historical

Outcomes
Primary outcome [1] 300024 0
Number of patients dying in hospital with either a Not-for-Resuscitation (NFR) form or Goals-of-Care (GOC) competed within 48 hours of hospital admission.
Timepoint [1] 300024 0
Time between completion of NFR or GOC form and in-hospital death.
Secondary outcome [1] 328825 0
Number of Patients with completed NFR or GOC forms.
Timepoint [1] 328825 0
During hospital admission.
Secondary outcome [2] 328826 0
Number of Patients with completed NFR or GOC forms completed within 48 hours of hospital admission.
Timepoint [2] 328826 0
First 48 hours of admission
Secondary outcome [3] 328827 0
Number of NFR or GOC forms substantially altered during a patients hospital admission.
Timepoint [3] 328827 0
During hospital admission.
Secondary outcome [4] 328828 0
Healthcare provider (doctors and nurses) satisfaction with NFR and GOC forms via surveys and small focus groups. These surveys have been designed specifically for the study based on local environment factors with some relevant sections drawn from previously validated palliative care surveys such as the QUEST and QEOLC surveys. This includes that the hospital is private and not public, and that the patients will be oncology and medical patients and not surgical patients. Surveys will be conducted both before and after the introduction of the new GOC form allowing for a comparison in attitudes towards the two forms.
Timepoint [4] 328828 0
Prior to intervention (assess control NFR form) and in the first 2 months after intervention (assess intervention GOC form) is completed.
Secondary outcome [5] 328829 0
Patient satisfaction with communication and expectations surrounding NFR and GOC forms via surveys and small focus groups. These surveys have been designed specifically for the study based on local environment factors with some relevant sections drawn from previously validated palliative care surveys such as the QUEST and QEOLC surveys. This includes that the hospital is private and not public, and that the patients will be oncology and medical patients and not surgical patients. Surveys will be conducted both before and after the introduction of the new GOC form allowing for a comparison in attitudes towards the two forms.
Timepoint [5] 328829 0
Prior to intervention (assess control NFR form) and in the first 2 months after intervention (assess intervention GOC form) is completed.

Eligibility
Key inclusion criteria
(1) All medical, medical specialty (e.g. geriatrics, nephrology, respiratory), haematology or oncology patients admitted to one of 3 wards in a large 580 bed private hospital.
(2) All medical and nursing staff working on the designated wards and caring for the patients listed above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Surgical, surgical specialty, obstetric and gynaecology, paediatric and mental health patients.

Study design
Purpose of the study
Educational / counselling / training
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)
Pre and post intervention. Two six month periods with the current standard-of-treatment NFR form in the first 6 months and the new GOC form in the second six months.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A quasi-experimental comparative pre-and-post study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE
The primary outcome is the number of patients dying with NFR or GOC forms filled in prior to their death. Based on a six-month sample from 2015 on the wards to be involved out current completion rate is ~75%. We Aim to see this increase to over 90%. Using 95% confidence interval and accepting a power of 80% we estimate that we would need a sample size of ~100 participants. However because this trial is also a proof-of-concept trial to monitor complaince and completion rates of teh new GOC form the study will run over two 6 month periods that will provide a total sample size of between 1100 and 1200 patients based on 2015 admission numbers.
STATISTICAL ANALYSIS
a) Categorical will be analyzed by chi-squared test.
b) Continuous variables with normal distributions will be analyzed by the Student t-Test.
c) Continuous variables with skewed distributions will be analyzed by the Mann-Whitney test.
d) Multi-variable logistic regression was used to assess the determinants of NFR and GoC completion rate. The covariates assessed will include age, gender, specialty, primary diagnosis.
e) All statistical tests will be 2-tailed and performed using SPSS for Windows (IBM Corp., 2013. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.). A ‘P’ value < 0.05 was taken as significant in this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
28/02/2018
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7174 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 14935 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 294837 0
Hospital
Name [1] 294837 0
St John of God Subiaco Hospital
Country [1] 294837 0
Australia
Primary sponsor type
Individual
Name
David Morgan
Address
Department of Intensive Care Medicine
St John of God Subiaco Hospital
12 Salvado Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 293679 0
Individual
Name [1] 293679 0
Derek Eng
Address [1] 293679 0
Department of Palliative Care Medicine
St John of God Subiaco Hospital
12 Salvado Road
Subiaco WA 6008
Country [1] 293679 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296223 0
St John of God Healthcare
Ethics committee address [1] 296223 0
St John of God Health Care Human Research Ethics Committee
12 Salvado Road
Subiaco WA 6008
Ethics committee country [1] 296223 0
Australia
Date submitted for ethics approval [1] 296223 0
26/10/2016
Approval date [1] 296223 0
30/11/2016
Ethics approval number [1] 296223 0
StJOG HREC #1070

Summary
Brief summary
SUMMARY
This study aims to compare the current standard-of-treatment Not-for-Resuscitation (NFR) form with the soon to be introduced Goals-of-Care (GOC) form. The purpose of these two forms is to help guide the clinical staff in defining the overarching treatment goals for hospitalised patients, especially potential limitations-in-therapy, but with some fundamental and important differences.
The overall design is a quasi-experimental pre and post study over two 6-month periods that will be conducted on the predominately medical and oncological wards of 71, 72 and 35 at St John of God Subiaco Hospital. These wards where specifically chosen because they incorporate healthcare disciplines with a higher burden of advanced disease states (e.g. cancer) and frailty (e.g. old age) requiring a greater awareness of end-of-life issues.
The first six-month period will be considered the control period and will investigate the current standard-of-practice NFR form. The second 6-month period will be considered the intervention and investigate the new GOC form. Within each research period the investigators will collect both qualitative (patient and clinical staff surveys and interviews) and quantitative (categorical and continuous variables) data.
Before the introduction of the intervention GOC period an education programme about the new form will be undertaken with the relevant clinical staff. The hypothesis of this study is that the new GOC form will lead to an earlier, greater and more controlled delineation of appropriate patient treatment plans by primary care teams at the expense of an increased clinical staff workload.

IMPORTANT PLANNED DIFFERENCES BETWEEN THE USE OF GOALS-OF-CARE & NOT-FOR-RESUSCITATION FORMS
a) The GOC care form has four clinical pathways compared to the two clinical pathways on the NFR form.
b) The GOC form has to be completed for all patients, where the NFR form is completed in an ad-hoc manner. Where patients are clearly for full resuscitation (GOC category A), then any doctor can complete the GOC form without prior patient discussion buy “ticking” Category A and signing and dating the form. All other categories require consultant input.
c) The investigators are designating that the GOC form must be completed within 48 hours of admission. There is not designation of timing for the NFR form
Trial website
Nil
Trial related presentations / publications
Nil at present
Public notes
Nil

Contacts
Principal investigator
Name 70058 0
Dr David Morgan
Address 70058 0
Department of Intensive Care Medicine
St John of God Hospital Subiaco
12 Salvado Road, Subiaco.
Perth, WA 6008
AUSTRALIA
Country 70058 0
Australia
Phone 70058 0
+61 8 9382 6111
Fax 70058 0
Email 70058 0
[email protected]
Contact person for public queries
Name 70059 0
Dr David Morgan
Address 70059 0
Department of Intensive Care Medicine
St John of God Hospital Subiaco
12 Salvado Road, Subiaco.
Perth, WA 6008
AUSTRALIA
Country 70059 0
Australia
Phone 70059 0
+61 8 9382 6111
Fax 70059 0
Email 70059 0
[email protected]
Contact person for scientific queries
Name 70060 0
Dr David Morgan
Address 70060 0
Department of Intensive Care Medicine
St John of God Hospital Subiaco
12 Salvado Road, Subiaco.
Perth, WA 6008
AUSTRALIA
Country 70060 0
Australia
Phone 70060 0
+61 8 9382 6111
Fax 70060 0
Email 70060 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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