Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04856202 |
| Other study ID # |
NL72101.078.20 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
January 2022 |
| Source |
Erasmus Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Rationale A recent study into the patient perspective of patients with multiple chronic
conditions in the Netherlands underlines the strain multimorbidity can put on people. Most
patients would appreciate more coordination from and communication with their care providers.
This call for better coordination of needs and preferences ties into the concept of Advance
Care Planning (ACP). ACP is a structured process of communication in which patients and
physicians discuss and, if applicable, document health preferences and goals of patients
regarding their last phase in life. Most ACP studies have been performed amongst older,
terminally ill patients with the main aim of establishing patients' preferences before they
lose capacity. We want to investigate the potential of ACP to increase patient empowerment in
a population of competent patients with multimorbidity, who are not necessarily in their last
phase of life.
The distribution of healthcare expenditure among the population requiring care is skewed. In
the Netherlands the top-10% most cost incurring patients account for 68% of expenditure. Many
of these patients receive unnecessary or ineffective care, with a recent study estimating
preventable spending at 10%. High-Need High-Cost patients comprise a very heterogeneous
group, yet one common denominator explaining high cost is the high prevalence of multiple
chronic conditions. Both overtreatment and conflicting treatment are legitimate concerns
within this population. As multimorbidity and frailty increase with age, the older patient
with multimorbidity is especially at risk. Targeted care programmes have been developed under
the assumption that better coordination will lead to a reduction in healthcare utilization.
However, although care might be identified as preventable or inefficient from a medical point
of view, this is not necessarily the case from a patient perspective. We are interested how
patients experience such care and thereby if better coordination would indeed lead to a
reduction in utilization.
Because ACP supports patients in timely recognition and better expression of their needs and
preferences, we hypothesize that care will address those needs and preferences more
adequately, which will result in improved patient assessment of care. We further hypothesize
that patient empowerment will enable better planning of care and decision making, which can
result in less unwanted or preventable interventions. As a consequence healthcare utilization
might decrease. However, another possibility is that rather than leading to a decrease,
improved empowerment may lead to an increase in utilization because care which is deemed
superfluous from a medical perspective might not be perceived as such by patients.
Objective The primary objective of our pilot study is to assess the feasibility of a formal
Randomized Controlled Trial. Our secondary pilot objectives are to collect data on patient
experience of healthcare, patient engagement, cost-effectiveness, and other data that might
inform the design of a full-scale RCT.
Study design Randomized pilot study
Study population Patients over 65 years of age with polypharmacy, multimorbidity and multiple
hospitalizations and/or ER admissions in the past year
Intervention One of the most well-researched ACP programmes is the Respecting Choices
Programme. In this programme, a trained facilitator encourages patients to reflect on their
goals, values and beliefs, to discuss and document their future choices, and to appoint a
surrogate decision maker. The programme was translated to the Dutch context in previous
studies in the nursing home setting and oncology care. Patients randomized to receive ACP
will have two meetings with a trained facilitator within two months.
Main study parameters/endpoints Primary: trial-feasibility is defined as the successful
inclusion of 50 patients in total, timely administration of the intervention in 25 patients,
adherence to follow-up procedures and identification of problems or barriers during
recruitment, inclusion, intervention administration and follow-up.
Secondary: main outcome for cost-effectiveness is total duration and number of hospital
admissions, as a proxy for both costs and effects (iMCQ). In order to inform a future
cost-effectiveness analysis (CEA), data on health-related quality of life (EQ5D-5L) will also
be collected. Our outcomes for patient assessment of care and patient empowerment are the
PACIC questionnaire, the ACP Engagement Survey and the appointment of a surrogate decision
maker and/or the documentation of advance directives.
Description:
A recent study into the patient perspective of patients with multiple chronic conditions in
the Netherlands underlines the strain multimorbidity can put on people. Conducting
semi-structured, in-depth interviews it was established that besides the burden of disease
itself, patients struggled with managing the logistics such as regular hospital visits.
Another conclusion was that most patients would appreciate more coordination from and
communication with their care providers. This call for better coordination of needs and
preferences ties into the concept of Advance Care Planning (ACP). ACP is a structured process
of communication in which patients and physicians discuss and, if applicable, document health
preferences and goals of patients regarding their last phase in life. Most ACP studies have
been performed amongst older, terminally ill patients with the main aim of establishing
patients' preferences before they lose capacity. We are interested in potential of ACP to
increase patient empowerment in a population of high-need competent patients with
multimorbidity, who are not necessarily in their last phase of life.
When taking a closer look at healthcare expenditure, the distribution among the population
requiring care is skewed. In the Netherlands, the top-1% most cost incurring patients are
responsible for 24% of healthcare expenditure and the top-10% accounts for 68%. These numbers
are in line with international data. Public healthcare expenditure has been rapidly
increasing over the last decades, compromising the economic sustainability of healthcare
systems around the world. In the Netherlands, healthcare expenditure was 40.3 billion euro
(10,35% GDP) in 1998 and has risen to 96.1 billion euro (13,79% GDP) in 2016. The patients
that account for this cost-concentration have become an increasing target for care
management. Studies have shown these High-Need High-Cost patients receive unnecessary or
ineffective care with a recent study estimating preventable spending at 10%. Reducing such
care would not only reduce cost but has the potential to improve quality of care, patient
assessment of care and their quality of life.
The High-Need High-Cost patient population is very heterogeneous, yet one common denominator
explaining high cost is the high prevalence of multiple chronic conditions. Both
overtreatment and conflicting treatment are legitimate concerns within this population. As
multimorbidity and frailty increase with age, the older patient with multimorbidity is
especially at risk. Targeted care programmes have been developed under the assumption that
better coordination will lead to a reduction in healthcare utilization. But although care
might be identified as preventable or inefficient from a medical point of view, this is not
necessarily the case from a patient perspective. We are interested how patients experience
such care and thereby if better coordination would indeed lead to a reduction in utilization.
In the United States, the Patient Self Determination Act (1991) embodied the use of advance
directives to promote adequate communication. An advance directive (increasingly being
replaced by the term advance decision) must relate to a refusal of specific medical treatment
and can specify circumstances. It will come into effect when the individual has lost capacity
to give or refuse consent to treatment. Careful assessment of the validity and applicability
of an advance decision is essential before it is used in clinical practice. Valid advance
decisions, which are refusals of treatment, are legally binding. However, studies
demonstrated important limitations of advance directives such as the limited use of advance
directives despite many promotional efforts and the absence of positive effects on the
quality of care, quality of life (QOL) or satisfaction of patients and relatives. From the
mid-nineties, advance directives evolved to ACP, a more comprehensive approach where filling
in an advance directive or decision is only one part of a process of wider communication.
ACP is a formalized process of communication between patients, relatives and professional
caregivers. It has been defined as "a voluntary process of discussion and review enabling
individuals to express, and, if they wish, record views, values and specific treatment
choices to inform their future care". ACP promotes the documentation of patients' preferences
in their medical file, the communication of these preferences to family and friends, the
periodic review of preferences as circumstances change and the nomination of a health care
proxy. Modern ACP programmes aim at informing and empowering patients to express their
preferences about their current and future treatment.
Studies addressing the effects of ACP programmes on end of life care are still rather scarce
which is probably due to their challenging nature. The few studies that have been performed
were mainly small scale with an observational design, often North American and predominantly
performed in a geriatric context. A review of the literature shows that ACP programmes have
the potential to improve communication between patients and healthcare professionals,
increase the quality of life and well-being of patients and their relatives, reduce futile
treatments and unnecessary hospitalizations, enhance provision of care consistent with
patient goals and increase satisfaction with care. Other studies also show ACP has reduced
costs. There are no studies to date that look at ACP in the wider context of multimorbidity
alone.
The process of ACP can be formalized through a complex ACP intervention such as the Let Me
Decide advance directive programme, the Respecting Choices Programme and the Making Advance
Care Planning a Priority (MAPP) Programme. In considering these programmes we looked at
(international) experience with the programme and their evidence-based effects. Let Me Decide
had potential as this decreased emergency calls to the ambulance service and both
hospitalisation and length of stay. However there was no difference in effect on patient
satisfaction. MAPP showed favourable effects on in-hospital death and hospitalisation but no
effect on hospital length of stay, hospice referral and days of hospice or palliative care.
The Respecting Choices Programme has recently been studied in a large international trial and
has been shown to increase compliance with end-of-life wishes, satisfaction with quality of
death and patients' satisfaction while decreasing depression, anxiety and death in the ICU. A
recent systematic review on interventions guiding ACP found that the main body of evidence
regarding interventions that were evaluated in a controlled trial concerned Respecting
Choices with six trials described in seven papers. This large body of evidence with
demonstrated effects on both healthcare use and patient satisfaction combined with local
experience with the programme led us to select the Respecting Choices Programme for this
pilot study.
The programme was developed in the US and successfully trialled in a geriatric setting in
Australia, showing that end of life care wishes were much more likely to be known and
followed in the intervention group (86%) compared to the control group (30%). In this
programme, a trained facilitator in collaboration with attending physicians encourages
patients to reflect on their goals, values and beliefs, to discuss and document their future
choices, and to appoint a surrogate decision maker.
Most ACP studies have been performed amongst older patients with the main aim of establishing
patients' preferences before they lose capacity. We believe that ACP can also increase
patient empowerment in a population of competent patients with multimorbidity, who are not
necessarily in their last phase of life. Because ACP supports patients in timely recognition
and better expression of their needs and preferences it will enable strategic and effective
planning of care and decision making. Our hypothesis is that as a result care will more
adequately address patients' needs and preferences resulting both in improved patient
assessment of care and receiving less unwanted or preventable interventions. We hypothesize
the latter is due to improved patient empowerment. However, another possible outcome is that
improved empowerment will not lead to a decrease of healthcare utilization (and might even
lead to an increase), as care which is deemed superfluous from a medical perspective might
not be perceived as such by patients. The choice for the Respecting Choices Programme was
made because it is one of the most evidence-based interventions available.
Because there is still some uncertainty about the feasibility of a formal RCT we have opted
to conduct a randomized pilot study. In this pilot we will conduct the intended formal RCT on
a smaller scale to draw lessons on the willingness to participate, response rates to
questionnaires and follow-up rates as well as potential differences in these matters between
the intervention and the control arm.
The objective of this pilot is to assess whether it is feasible to conduct a full-scale
Randomized Controlled Trial studying the cost-effectiveness of ACP within the older
population with multimorbidity. The primary research question of such a trial would be
whether formalised ACP is cost-effective in achieving patient empowerment and improved
patient assessment of care.
