The primary objective of our pilot study is to assess trial feasibility. 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…
ID
Source
Brief title
Condition
- Other condition
- Age related factors
Synonym
Health condition
zorggebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Our 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 possible 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. Other data that will be collected to
describe our population is daily activities (ADL and iADL) and destination at
discharge (if admitted).
Background summary
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.
Study objective
The primary objective of our pilot study is to assess trial feasibility. 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 Controlled Trial feasibility pilot
Intervention
One of the most well-researched ACP programs is the Respecting Choices Program.
In this program, 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 program 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.
Study burden and risks
A possible disadvantage is that participants will be invited to discuss topics
which might make them feel uncomfortable. However, the intervention is very
sensitive to such situations and, moreover, people are not by no means obliged
to participate in the study. This research can deliver useful information on
the experienced quality of care and wishes of patients suffering multimorbidity
as well as informing strategies for cost-reduction.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
patients >= 65 years of age with polypharmacy who gave informed consent and had
2 or more hospitalizations, day clinic admission or individual ER admissions in
the last year
Exclusion criteria
Patients with serious cognitive impairment (MMSE score < 16), patients with a
limited life-expectancy (<6mo) and/or who are not fluent in Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL72101.078.20 |