The objective is to examine whether the use of CDSS-OPTIMED, a personalized medication advice to attending physicians of patients in the last phase of life, contributes to patients* quality of life.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
patienten met een levensverwachting van 6 maanden of minder, ongeacht de aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients* quality of life four weeks after baseline assessment as measured by
the EORTC QLQ-C15-PAL questionnaire, quality of life question.
Secondary outcome
Secondary endpoints:
- Symptoms (ESAS, four weeks after baseline assessment);
- Health-related quality of life (EORTC QLQ-C15-PAL quality of life question
and EQ-5D, four weeks after baseline assessment);
- Use of medication four weeks after baseline assessment (medical file data and
pharmacist*s information system);
- Use of medical interventions and costs of medical care (retrospective medical
file data check about/of the last week of life);
- Patient survival;
- Satisfaction of the patient with medication (TSQM-9, four weeks after
baseline assessment);
- Satisfaction of the relative with medication (TSQM-9, adapted for relatives,
four weeks after baseline assessment);
- Satisfaction of the attending physician with the medicationadvices, generated
by CDSS-OPTIMED (questionnaire, four weeks after baseline assessment);
- Episodes of (retrospective medical file data, all between baseline assessment
and death):
o Symptomatic hypertension,
o symptomatic hypotension,
o symptomatic hypoglycaemia
o symptomatic hyperglycaemia,
o thrombo-embolic complications,
o bleeding events
Other study parameters
- Health economic analysis and cost-effectiveness ratio of:
o Patients and relatives at baseline and four weeks after baseline
assessment (self-reported HRQoL, capabilities, resource use, employment and
patient activities/informal care needs from patients based on the EQ-5D-5L,
ICECAP-SCM or CPM, HEQ, partial IVICQ, CIIQ)
o Intervention: development and training costs, operational costs (including
time spent on discussing medication alerts with the pharmacist and
patient/relative)
For the subgroup of patients who will be included in the Netherlands extra
endpoints will be measured:
- Health economic analysis and cost-effectiveness ratio of patients every four
weeks after baseline assessment (self-reported HRQoL, capabilities, resource
use, employment and patient activities/informal care needs from patients based
on the EQ-5D-5L, ICECAP-SCM, HEQ)
Background summary
Adequate use of medication is a crucial aspect of care for patients in the last
phase of life. Many patients experience multiple distressing symptoms,
especially in the last weeks of life. Inadequate control of symptoms has been
documented in patients with advanced and end-stage disease and has a huge
impact on patients* quality of life. At the same time, many patients continue
to receive unnecessary medication in the last phase of life, without beneficial
outcomes. Scientific evidence on the safety of stopping medications is scarce.
We have designed a study to evaluate the effect of a personalized medication
advice on the quality of life in the last phase of life. The medication advice,
which will contain alerts, is given by using a Clinical Decision Support System
(CDSS). This guidance is based on a broad set of clinical decision rules using
knowledge about medication interactions, individual results of blood tests and
patient characteristics. The alerts will be adapted for patients who are in the
last phase of their lives, i.e. with a life expectancy of maximal 6 months. The
aim is to see whether a personalized medication advice contributes to the
quality of life in patients in the last phase of life.
Study objective
The objective is to examine whether the use of CDSS-OPTIMED, a personalized
medication advice to attending physicians of patients in the last phase of
life, contributes to patients* quality of life.
Study design
The iLIVE medication optimisation study will be performed in three countries:
the Netherlands, Sweden and Switzerland. In total, there are 10 different sites
(clusters) (5 from the Netherlands, 3 from Switzerland, and 3 from Sweden).
We will examine the effect of a personalized medication advice provided by a
CDSS to support physicians in adequately prescribing and deprescribing
medication, based on available evidence, pharmacological/medical knowledge and
on known patient*s symptom load. The effect of this personalized advice will be
evaluated in a before-after study, with the different study sites being the
clusters. The study sites will switch from control to intervention after
approximately 12 to 18 months. All study sites will start as control sites,
where care is provided as usual. After approximately 12 to18 months the study
sites will switch from control to intervention. There will be 2 observation
periods in 122 weeks. Within two weeks before and ultimately two weeks after
starting the crossover, researchers will visit the study sites. Physicians will
then be trained by the researchers to use the tool in a 2 hour session or by a
trainingsvideo. Both the training and the video includes advice on how to
communicate about medication management at the end of life with patients and
their families. Within these four weeks of training there will be a period of
non-inclusion.
The attending physicians in the intervention group will receive a medication
review within 1 week after inclusion. The medication review will be sent to the
physician*s email address. The physician is free to follow or ignore the advice
in the alert.
The iLIVE medication optimization study is embedded in a broader international
project, the iLIVE cohort study, which involves a prospective cohort study in
11 countries. Patients with a maximum estimated life expectancy of six months
and their relatives are included and they will be followed up until patients*
death, if that may occur before the end of the data collection, to measure
their concerns, expectations and preferences in the last phase of life.
Intervention
We will evaluate the effect of a personalized medication advice on adequate
medication management in patients in the last phase of life provided by an CDSS
(CDSS-OPTIMED). An CDSS is a software program that provides the physician with
a personalized alert on whether to consider stopping or starting medication for
a specific patient. The CDSS was initially developed to optimize medication
surveillance in older patients using numerous medication. In this study, we
will evaluate a specific set of rules for patients in the last phase of life,
which we refer to as CDSS-OPTIMED. This provides alerts on medication that may
be stopped in patients who are in the last phase of their lives, i.e. with a
life expectancy of maximal 6 months, and on medication that may be prescribed
for symptom control. To make the latter possible, information on patients*
symptom load as assessed with the ESAS questionnaire is added to the original
CDSS system.
All rules are based on evidence from scientific literature and are very
extensively described in several literature reviews. The rules that will be
specifically added to the CDSS-OPTIMED are validated by a currently ongoing
Delphi study among an international panel of around 89 experts.
In order to guarantee adequate use of the CDSS-OPTIMED and of communication
with the patient and relatives about the alerts in each site, physicians will
be trained. In this training the use of the CDSS-OPTIMED will be discussed and
advices on how to communicate about medication optimisation with patients and
their families are given.
Study burden and risks
The iLIVE project involves human beings, in particular patients in the last
phase of life and their relatives. Further, the study collects and processes
personal data, through questionnaires and interviews and through reviews of
patients* medical files.
Use of the CDSS-OPTIMED is expected to result in more well-considered
prescription of medication, which may involve decreased use of potentially
inappropriate medication and increased use of medication to control symptoms.
Improved medication management is hypothesized to improve patients* quality of
life and reduce the burden of potentially inappropriate medications. The
CDSS-OPTIMED is based on available evidence and does not involve experimental
treatment or experimental medication management strategies. The only envisaged
potential risks are therefore the already known side effects of (deprescribing)
specific types of medication. The alerts from the CDSS-OPTIMED are based on
guidelines, a thorough literature search and a currently ongiong Delphi study
among international experts in palliative care and in cardiology and
diabetology.
The study population concerns vulnerable people who often experience
fluctuating symptoms across their disease trajectory. Although this can cause
varying levels of frailty, patients in the last phase of life and their
caregivers have repeatedly been reported to be willing to participate in
research studies, even when they are close to death. Ethical concerns around
patient participation in end-of-life care research are thus not always
justified: patients and their caregivers may feel that taking part in research
contributes to their feeling of being worth living and their satisfaction with
life. They may feel that they are actively participating in their health
care,or they wish to contribute to changing practice, knowing that they will
not experience such change themselves.
Nevertheless, we explicitly acknowledge the potential vulnerability of patients
in the last phase of life and their relatives and the risk of overburdening or
stigmatization. Study participants will as a matter of principle be approached
as people who are in principle fully capable of participating in research and
whose experiences and concerns are of the utmost importance for caregivers to
learn from. If patients feel burdened by their participation, they are
encouraged to indicate that on the questionnaire or to the researcher. Patients
are also encouraged to discuss their issues with relatives or a healthcare
professional.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Patient:
1. Patient is 18 years or over and provides informed consent to participate.
2. The patient is aware that recovering from his/her disease is unlikely, as
assessed by the attending physician.
3. The patient agrees to participate in the iLIVE cohort study.
4. The attending physician would not be surprised if the patient were to die
within 6 months (*Surprise question*).
5. If the physician is uncertain about the surprise question, the patient is
eligible if presenting with at least one SPICT indicator.
Relative:
Relatives of included patients are asked to participate if they are:
1. 18 years or over and provide informed consent to participate; aware that it
is unlikely that the patient will recover from his/her disease;
2. capable of filling in a questionnaire in the country*s main language or in
English.
Exclusion criteria
Patient:
1. The patient is incapable of filling in a questionnaire in the country*s main
language or in English (patients may be supported by relatives when filling in
the questionnaire).
2. The attending physician makes the decision that the patient should not be
included in the study due to e.g. illness burden, fast deterioration or
imminent death, lack of trusting relationship with the physician.
Relative:
Relatives are not eligible if they are incapable of filling in a questionnaire
in the country*s main language or in English. No more than one relative per
patient will be included.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL72473.078.20 |