To evaluate whether the DBI can be used as a tool to identify patients with anticholinergic and/ or sedative medication in need of a medication review.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
polyfarmacie, anticholinerge- en sedatieve bijwerkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference in proportion of patients having a
decrease of the DBI >=0.5 between the intervention and control group at follow
up. After a medication review it is expected that the proportion of patients
with a decrease of DBI >=0.5 in the intervention group is significantly higher
in comparison to the control group.
Secondary outcome
Secondary outcomes are:
a) Anticholinergic side effects, measured by the UKU side effect rating scale
b) Sedating side effects, measured by a validated patient-reported adverse
drug event questionnaire
c) Risk of falls, measured by patients reports fall incidents and the *Up & Go*
test
d) Cognitive function, measured by the Seven Minute Screen, the Trailmaking
Test A & B and the Digit Symbol Coding Test
e) Loss of self-reliance, measured by the Groningen Activiteiten Restrictie
Schaal
f) Quality of life: measured with the EQ-5D-3L questionnaire
g) Hospitalization
h) Mortality
i) Proportion of patients having a DBI <1 between the intervention and
control group at follow up
Background summary
Older people often use medications with anticholinergic or sedative side
effects which increase the risk of falling, fractures caused by falls and
cognitive impairment. In the Netherlands medication reviews are done by
pharmacists in collaboration with the general practitioner to optimize the
medication use and reduce these adverse drug events. To maximize the benefits
of medication reviews it is helpful to identify patients with high risk
medication, yet there are few tools to identify patients in need of a
medication review. The Drug Burden Index (DBI) is a tool, designed in
Australia, that calculates the burden of anticholinergic and sedative
medications, taking into account a patient's dose. The DBI could be a useful
tool to identify high risk patients with anticholinergic and/ or sedative
medication, who could benefit from medication reviews.
Study objective
To evaluate whether the DBI can be used as a tool to identify patients with
anticholinergic and/ or sedative medication in need of a medication review.
Study design
Single blinded clustered randomized controlled study. Every pharmacy forms a
cluster and per pharmacy one pharmacist will perform the medication reviews.
Within each pharmacy, patients will be randomly allocated to the control group
(one half) and the intervention group (other half). There are two measurements:
at baseline and at follow-up, 3 months after the medication review has taken
place.
Intervention
A structured 5-step multidisciplinary medication review (STRIP method) as
described in the multidisciplinary guidelines by the Nederlands Huisartsen
Genootschap (2013) including the objective to reduce the DBI, performed by the
pharmacist in collaboration with the general practitioner.
Study burden and risks
Participants will be informed about the study. Informed consent will be asked
from every participant. Data will be encoded. Only the researcher will have
access to the data. If required, the Dutch Inspection of Healthcare will also
be granted access to the data for Inspection. The burden of patients will be
kept at a minimum by trying to retrieve as much information as possible from
patient*s medical records and by using questionnaires and tests that were
specifically developed for this population. In our opinion, participation does
not involve risks. As yearly multidisciplinary systematic medication reviews
are highly recommended for community dwelling elderly with polypharmacy and
risk factors by the multidisciplinary guidelines of the Dutch Society of
General Practitioners (NHG), our intervention can be considered as usual care
with the difference of using the DBI as a screening tool to identify the study
population. Control patients will receive the medication review as soon as
possible after the follow up measurement (delayed intervention) to fulfil the
recommendations of the guideline. Since - comparable to usual care - the
general practitioner is free to adjust medication when symptoms relapse or AEs
occur, study related AEs and SAEs are highly unlikely. The multidisciplinary
multistep medication review is based on expert consensus and the medical
literature. Moreover, the medication reviews will result in high quality
recommendations that are attained by the pharmacist in close collaboration with
the treating general practitioner. Medical specialists will be consulted if
necessary e.g. to verify a diagnosis. The intervention is specifically aimed at
elderly pharmacy patients in an attempt to optimize prescribing, in particular
to reduce both overprescribing and underprescribing. Study results will be
published in peer-reviewed journals and will be distributed through the
professional bodies.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
Patient with age >= 65 years, use of >= 5 medications, DBI >= 1 and written informed consent.
Exclusion criteria
Pharmacy:
Only community pharmacists who are working in close collaboration with the general practitioner will be included. ;Patients:
Patients with palliative care only and a limited life expectancy (< 3 months), patients who urgently need a medication review, patients without Dutch language skills, patients with advanced dementia and patients who received a medication review within 9 months before the study period.
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 |
|---|---|
| CCMO | NL50249.042.14 |