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Trial registered on ANZCTR


Registration number
ACTRN12614000590662
Ethics application status
Approved
Date submitted
28/05/2014
Date registered
4/06/2014
Date last updated
4/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Control Trial for Advance Care Planning and Symptom Management for patients identified in the emergency department and followed up at home
Scientific title
A randomised control trial for Advanced Care Planning plus Symptom Management and Support for patients with advanced progressive life-threatening health conditions who present to the Emergency Department at Prince of Wales Hospital.
Secondary ID [1] 284684 0
Nil.
Universal Trial Number (UTN)
Nil.
Trial acronym
Plan EARLY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced progressive life-threatening illnesses 292024 0
ischaemic heart disease (IHD) 292025 0
cardiovascular disease (CVD)
292026 0
life-threatening malignancy 292027 0
dementia 292028 0
chronic lung disease (including COPD) 292029 0
heart failure 292030 0
diabetes 292031 0
renal failure 292032 0
progressive neuro-degenerative disorders 292033 0
advance care planning 292034 0
end of life care 292035 0
health care utilisation 292036 0
Condition category
Condition code
Public Health 292370 292370 0 0
Health service research
Public Health 292371 292371 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Advanced Care Planning (ACP) plus Symptom Management and Support (SMS) is a two-pronged intervention. The ACP prong of the intervention is a series of nurse-lead discussions which explore and identify values and concerns relating to the participant’s health care and management of care at end of life. The discussions will include the patient and the patient's carer if available and willing to participate in the discussion. It is anticipated that the discussions will take place over the course of up to four visit about 1 - 1.5 hours in length. The sessions will be scheduled at the participant's convenience, but likely not more than once per week. The ACP process will involve identification of an appropriate substitute decision maker and may involve the writing of an informal advance care plan to guide others in making substitute decisions and/or the writing of a formal Advance Care Directive. The ACP prong will also include documentation of the ACP or ACD in the participant’s medical record and appropriate communication of ACP/ACD documents to relevant health care providers including General Practitioners (GPs), Residential Aged Care Facility (RACF) staff, specialists, NSW Ambulance, ED staff and community health nurses.

The SMS prong of the intervention is an education component provided to the participants’ GPs and other health care providers. The education component includes: in-service style training by a member of the research team conducted at baseline and repeated at 6 months; individualised education regarding palliative care; provision of a symptom management resource list; letter to GP with information about Plan Early and ACP, written information about referral to specialist palliative care, and 6 weekly follow-up telephone calls to GP and family; and education and training of RACF staff and General Practitioners in the SELHD Terminal Care Plan.

In addition, the research nurse will schedule home visits with the participant and carer to administer questionnaires
at 9 week intervals for six months or until death, whichever is sooner.
Intervention code [1] 289470 0
Treatment: Other
Intervention code [2] 289471 0
Behaviour
Comparator / control treatment
Standard treatment. Standard treatment will be usual care, which is standard evidence-based care provided at the discretion of the patient’s GP and other health care providers. As health conditions will vary among participants in the control group, usual care is also expected to vary.

In addition, the research assistant will send questionnaires to the participant and their carer at 9 week intervals for six months or until death, whichever is sooner. Questionnaires which are not returned are followed up by telephone from the research assistant.
Control group
Active

Outcomes
Primary outcome [1] 292229 0
Symptom management measured by the Symptom Assessment Score
Timepoint [1] 292229 0
At baseline and at 9 week intervals for 6 months from randomisation or until death
Primary outcome [2] 292230 0
Patient Outcome Score - Patient
Timepoint [2] 292230 0
At baseline and at 9 week intervals for 6 months from randomisation or until death
Primary outcome [3] 292231 0
Patient Outcome Score - Carer
Timepoint [3] 292231 0
At baseline and at 9 week intervals for 6 months from randomisation or until death
Secondary outcome [1] 308463 0
Number of ED presentations identified by linkage to patient medical records
Timepoint [1] 308463 0
At 6 months after randomisation, or death if sooner
Secondary outcome [2] 308464 0
Length of stay (LOS) in ED identified by linkage to patient medical records
Timepoint [2] 308464 0
At 6 months after randomisation, or death if sooner
Secondary outcome [3] 308465 0
Number of admissions to hospital identified by linkage to patient medical records
Timepoint [3] 308465 0
At 6 months after randomisation, or death if sooner
Secondary outcome [4] 308466 0
LOS in hospital identified by linkage to patient medical records
Timepoint [4] 308466 0
At 6 months after randomisation, or death if sooner
Secondary outcome [5] 308467 0
Total case weight (NWAU)
Timepoint [5] 308467 0
At 6 months after randomisation, or death if sooner
Secondary outcome [6] 308469 0
PACE call (Tier 2 ALS)
Timepoint [6] 308469 0
At 6 months after randomisation, or death if sooner
Secondary outcome [7] 308470 0
Adavance Care Planning documented
Timepoint [7] 308470 0
At 6 months after randomisation, or death if sooner
Secondary outcome [8] 308471 0
Place of death identified by linkage to patient medical records or by contacting carer
Timepoint [8] 308471 0
At death
Secondary outcome [9] 308473 0
Advance Care Planning components in place: Identified Person Responsible, Enduring Guardian, Advance Care Plan/Directive
Timepoint [9] 308473 0
At 6 months after randomisation, or death if sooner
Secondary outcome [10] 308474 0
Utilisation of Terminal Care Plan identified by linkage to patient medical records
Timepoint [10] 308474 0
At 6 months after randomisation, or death if sooner
Secondary outcome [11] 308476 0
Number of days before death that a Not for CPR order, a NSW Ambulance Adult Palliative Care Plan or a NSW Health Resuscitation Plan was documented
Timepoint [11] 308476 0
At death, if applicable
Secondary outcome [12] 308477 0
Number of GP consults as resported by participant
Timepoint [12] 308477 0
At 6 months after randomisation, or death if sooner
Secondary outcome [13] 308478 0
Evaluation of the SMS education components based on an evaluation form distributed at the end of each education session
Timepoint [13] 308478 0
End of trial
Secondary outcome [14] 308479 0
Survival
Timepoint [14] 308479 0
At 6 months post randomisation

Eligibility
Key inclusion criteria
Patients who present to the Prince of Wales Hospital Emergency Department with any advanced progressive life-threatening illness as identified by clinical staff using the iPAL-EM screening tool guide who do not presently require referral to specialist palliative care.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prisoners, pregnant women and individuals with unstable psychotic illnesses or serious mood disorders

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)
Eligible patients are identified by clinical staff in the Prince of Wales Hospital Emergency Department using the iPAL-EM guide. The project nurse or ED staff member then introduces the trial, provides basic written information about the trial and requests permission to follow-up at a later date. The project nurse contacts the patient within one week’s time to further explain the study and schedule a home visit including the patient’s carer if the patient wishes. During the home visit, the project nurse explains the trial again and obtains the patient’s informed consent. After consenting the patient, the project nurse opens a numbered, sealed envelope containing the treatment allocation. The research assistant completed the randomisation and concealment before any home visits were scheduled. The research assistant has no contact with the eligible patients prior to randomisation and will not reveal the randomisation procedure or assignments to the project nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation with varying block sizes was selected in order to ensure an equal number of participants are randomised to each treatment group. A random number generator available online was used to conduct the randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A sample size of 500 has been chosen to allow detection of a change in survival of 12% or greater. Power is therefore also sufficient to demonstrate equivalence with regard to survival. Survival, however, is not our primary outcome measure, which is the POS (patient), a quality of life measure which requires a smaller sample size. We expect just over half to survive (pControl=0.52) to 4months. A positive change greater than or equal to 12% (corresponding to pIntervention>=0.64) would be detected as statistically significant (with alpha=0.05, beta=0.2). Effect sizes below this number would not be detected with a sample size of 500.

We will use intention to treat (ITT) analysis which includes all randomised patients in the groups, regardless of adherence to treatment received and death.

Baseline Analyses: Baseline measurements across groups will be compared to validate randomisation. Comparison of the main outcome between the control and the intervention group will be performed using the Mann-Whitney U test (for discrete categorical variables). A random intercepts model for either ordinal or multinomial logistic regression will be used to account for correlation between repeated measurements for the same person.

Secondary Analyses: Comparisons of mortality (or other binary variables) will be performed using the Pearson Chi-square test while analysis of continuous secondary variables will use t-test calculations. If needed (in the presence of not normally distributed outcomes or small frequency numbers), non-parametric methods will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2509 0
Prince of Wales Hospital - Randwick

Funding & Sponsors
Funding source category [1] 289304 0
Government body
Name [1] 289304 0
NSW Health, Southeast Sydney Local Health Network, Northern District
Address [1] 289304 0
District Executive Unit, Level 4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah NSW 2229

Country [1] 289304 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 287974 0
None
Name [1] 287974 0
Address [1] 287974 0
Country [1] 287974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291068 0
NSW Health, South Eastern Sydney Local Health District, Human Research Ethics Committee
Ethics committee address [1] 291068 0
District Executive Unit, Level 4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah NSW 2229

Ethics committee country [1] 291068 0
Australia
Date submitted for ethics approval [1] 291068 0
Approval date [1] 291068 0
10/05/2013
Ethics approval number [1] 291068 0
HREC Ref 13/034

Summary
Brief summary
Plan EARLY is a randomised trial to assess the impact of Advance Care Planning (ACP) intervention on documentation of ACP, symptom management, healthcare utilisation and concordance with participant wishes in adults with an advanced, progressive life-threatening illness who present to the Emergency Department and who do not require referral for specialist palliative care. The trial will also seek to recruit the participant’s carers if available. Failure to recruit the carer will not result in the patient’s exclusion from the trial. Participants are randomised to one of two treatment groups: advance care planning (ACP) for patients plus Symptom Management and Support (SMS) for their healthcare providers, or Usual Care.

The ACP plus SMS intervention involves: up to 4 face to face visits with a project nurse at the participant’s place of residence to discuss and complete ACP; completion of questionnaires at 9 weekly intervals; in-service style education to ED staff, RACF staff and GPs; individualised education to GPs regarding symptom management; written information regarding ACP, Plan EARLY and referral to specialist palliative care; and follow-up telephone calls to GP and family members at 6 week intervals.

Usual care is the standard clinical care provided by the patient’s regular treating team. As health conditions are expected to vary among participants in the control group, the usual care may differ between participants. Participants randomised to the control group will complete questionnaires regarding their care and symptoms at 9 week intervals over a 6 month period. Furthermore, the SMS education component will be offered to healthcare providers of patients randomised to the intervention group only. However, it is expected that there may be some contamination of the control group with regard to SMS education as inevitably some healthcare providers will care for patients in opposite treatment groups. Participants in the SMS education component will not be asked to withhold the skills they may have acquired from patients randomised to the control group.

Project staff will collect health care utilisation data from hospital records for participants in both the intervention and control groups.

During the course of the study referral to specialist palliative care will be offered if care needs, such as symptom burden greater than 3/10 on SAS or distress requiring multidisciplinary specialist care, are identified.

Finally, health care providers who participate in the SMS education component will be asked to complete an evaluation of the training received.
Trial website
Trial related presentations / publications
Sands, M.B., Rogalski, E., Norris, C., Forerro, R., Gallego-Luxan, B., Caplan, G. Plan EARLY: a randomised control trial for Advanced care planning and symptom
management for patients identified in the emergency department and followed up at home. EAPC RN & PRC pre-congress seminar Lleida, Spain, 2-3 June 2014: Planning and conducting clinical and public health research in palliative care.
Public notes

Contacts
Principal investigator
Name 48774 0
Dr Megan Sands
Address 48774 0
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 48774 0
Australia
Phone 48774 0
+61 2 93824020
Fax 48774 0
+61 2 93821579
Email 48774 0
Meg.Sands@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 48775 0
Dr Megan Sands
Address 48775 0
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 48775 0
Australia
Phone 48775 0
+61 2 93824020
Fax 48775 0
+61 2 93821579
Email 48775 0
Meg.Sands@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 48776 0
Dr Megan Sands
Address 48776 0
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 48776 0
Australia
Phone 48776 0
+61 2 93824020
Fax 48776 0
+61 2 93821579
Email 48776 0
Meg.Sands@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results