A Randomised Control Trial for Advance Care Planning and Symptom Management for patients identified in the emergency department and followed up at home
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.
Prince of Wales Hospital
500 participants
Mar 20, 2014
Interventional
Conditions
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.
Eligibility
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Interventions
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.
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ACTRN12614000590662