Acute Coronary Syndrome Clinical Trial
Official title:
Randomised Trial of Early Versus Delayed Future Care Planning for Patients and Families Living With Advanced Heart Disease
Patients admitted as an unscheduled hospital admission with either a acute heart failure syndrome (ACF) or acute coronary syndrome (ACS) will be eligible if their 6-12 month mortality risk is estimated to be 20% or greater at the time of discharge. Mortality risk is estimated using GRACE (for ACS) or EFFECT (for AHF) scores. Patients are randomly allocated to receive a holistic care intervention based around the creation of a detailed Future (anticipatory) Care Plan which is agreed with the patient and their family and which is shared with the Family Doctor and Emergency Services including ambulance teams. Primary endpoint is quality of life assessed by questionnaire.
Patients with either acute coronary syndrome(ACS) or acute heart failure (AHF) achieving an
estimated risk of mortality within 12 months of 20% or greater (GRACE score for ACS and
EFFECT score for AHF) will be assigned to early or delayed intervention using a web-based
randomisation system.
Inclusion criteria:
Age > 18 years Unscheduled hospital admission due to congestive heart failure and or acute
coronary syndrome 12 month estimated mortality risk of 20% or greater Optimal tolerated
medical and device therapy
Exclusion criteria:
Expected survival < 28 days Other life limiting non-cardiac condition likely to cause death
within 12 months Moderate or severe dementia Moderate or severe cognitive impairment
Supportive & Palliative Care Planning Intervention The planned intervention will follow the
core principles of holistic palliative care. The detailed content may be adapted following
the baseline qualitative interviews and focus group study outlined above and may evolve
during the pilot phase (see below).
The first component of the intervention will consist of an interview with the patient and
carer within 7 days of enrolment This will be undertaken by the trial consultant
cardiologist and the trial nurse in a quiet room either in the hospital or in the patients
home. This baseline consultation will explore the clinical and social needs of the patient
and their carer, previous and current clinical status and treatment, goals of treatment and
care now and in event of a future clinical deterioration, and cardiopulmonary resuscitation
(CPR) status. The aim will be to develop a patient-centred Future Care Plan (FCP). This
interview will also establish whether the patient and carer are happy to share the FCP with
the community-based care team and out-of-hours emergency care services.
Two further scheduled patient/carer consultations with the nurse specialist will take place
at 6 and 12 weeks following enrolment and will explore issues around cardiac care, physical,
social, psychological, spiritual, cultural and information needs. At each of these meetings
the FCP will be reviewed in detail and any changes will be made to a new document which will
be shared with other organisations as outlined above with the patient's permission.
The second component of the intervention is continuous supportive care delivered by the
trial nurse specialist who will act as professional carer and advocate for the patient
during the 12 week intervention phase. Specifically, the nurse will be available on a mobile
phone Monday to Friday, 0900 to 1700 for the patient or carer to call for advice or support.
This trial nurse will ensure that the patient is placed on the primary care palliative care
register. They will also provide opportunities for the patient and their family to ask for
information about their condition and care, and that their current FCP is available to
primary care, out-of-hours services and on the hospital patient information systems and
updated at no less than 6 weekly intervals. The nurse will review the details of the FCP
with the patient at each follow-up interview focusing on changes in the patient's symptoms,
treatment goals, cardiopulmonary resuscitation status and preferences for place of care
should they deteriorate.
The trial nurse will work closely with the palliative care team, the trial cardiologist and
the patient's general practitioner. In order to document the success of this interface
process, the nurse will document the number, duration and content of each communication with
these healthcare professionals as they arise during the study.
The trial nurse specialist will use an established tool to monitor and document patient and
carer needs at each visit using a Needs Assessment Tool for Palliative Care. The patient's
secondary and primary care teams will be informed of the patient's involvement in the trial.
Since some patients may choose not to take-up the services defined within the intervention
we will carefully document their utilisation of the interventional services offered. Use of
primary care services will be carefully monitored during the study period. All clinical data
including comorbidities will be documented at the time of enrolment in the study.
Summary of the intervention: patients will be randomised while in hospital to either early
intervention for 12 weeks or delayed intervention which will start 12 weeks after discharge,
this too will last for 12 weeks.
INTERVENTION
Baseline interview with trial cardiologist and trial nurse lasting for up to 1 hour Creation
of a Future Care Plan (FCP) document following this baseline interview Sharing of FCP
document with primary care and unscheduled care organisations 6 week interview with trial
nurse lasting for up to 1 hour to review FCP 12 week interview with trial nurse lasting for
up to 1 hour to review FCP Continuous access to trial nurse by mobile telephone 9am - 5pm
Monday-Friday for 12 weeks Trial nurse will - ensure FCP is appropriately shared with
primary and secondary care, patient is registered on primary care palliative care register
and will liaise with specialist PC services and the general practitioner as needed.
During the first 12 weeks of the study, patients randomised to usual care will not
specifically receive these services. Recent audit from our centre suggests that delivery of
such services to Heart Failure patients is inconsistent and generally poor while delivery of
these services to people with coronary heart disease is non-existent.
Outcome-measures of the Phase 2 trial
Since this study is not powered to assess clinical outcomes, we plan to explore a number of
outcomes that could be used in a later phase 3 trial. The following outcomes will be
explored:
1. Patient and carer-centred outcomes:
Outcomes will be assessed using the following questionnaire tools for both patients and
their informer carers: ESAS - Edmonton symptom assessment scale, EQ5D - European
Quality of Health Status, KDS - Kessler Distress Scale, Zarit 6 - caregiver burden
questionnaire All patients will complete a series of questionnaires, addressing
symptoms (Edmonton symptom assessment scale), quality of life (EQ5D) and distress
(Kessler Distress scale) [20] immediately prior to discharge and at 6, 12, 18 and 24
weeks (see figure) and ideally within 7 days of each contact with the trial
professionals. Since the intervention may have some impact on the carers we also plan
to assess quality of life (EQ5D), distress (Kessler) and caregiver burden (Zarit 6)
[21] using validated questionnaires at similar time points. Questionnaires will be
mailed to the patient and carer approximately 2 days after each trial time point and
the respondent will be encouraged to complete it within a further 3 days. The RA will
offer telephone support to assist completion of these questionnaires in all cases to
ensure consistency of response [22]. The RA will be responsible for the mailing,
collection and collation of the outcome measures of the phase 2 trial and will be
blinded to the randomisation status of the patient.
2. System outcomes All-cause unscheduled hospitalisation (including number of days in
hospital), cardiovascular unscheduled hospitalisation, hospice admissions and use of
other specialist palliative care services, achievement of primary care palliative care
Quality Outcomes Framework criteria (placed on PC register, care plan in place and out
of hours handover documented) by 6, 12 and 24 weeks after enrolment, whether the
secondary and primary care case records contain documentation of care planning
discussion and a formal record of CPR status at 6, 12, 18 and 24 weeks after enrolment.
All patients will be followed up for 12 months after enrolment for hospitalisation
outcomes.
3. After -death outcome measures These ill include assessment of time to death from study
enrolment, cause of death, preferred place of care, actual place of death, Carer
experience (VOICES questionnaire [22]). All patients will be followed up for 12 months
following enrolment for mortality.
Data analysis and statistical issues Descriptive statistics (continuous variables: mean,
standard deviation, median, range; categorical variables: number and percentage of
participants) will be presented for the clinical and demographic features of the patients
screened and those finally enrolled in the study. One of the main outcomes of our study
which we will assess carefully is quality of life. The mean differences in EQ-5D
health-related quality of life (QoL) utility between early and delayed intervention groups
will firstly be analysed at the 12 week time point using analysis of covariance, adjusting
for baseline utility score. We will then explore differences in QoL between groups at 24
weeks (t5) by the same method. The multiple measures at baseline, mid-point and end of
intervention will allow analysis of trends in intervention effects on QoL and other
parameters addressed by the distress and symptom assessment tools using repeated measures
analysis of variance. The distribution and variability in EQ-5D values in this cohort of
patients identified as having a poor prognosis will be used to inform the design and sample
size of the future phase 3 trial. An economic evaluation in the phase 3 trial will consider,
using a discrete choice experiment, patient preferences, values and willingness to pay for
end of life care and the components which they value for quality of life. This approach
complements the patient-centred nature of the intervention. Information to guide the design
of the economic evaluation will be gathered using feedback from the qualitative component of
this study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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