The effects of DPA compared to STOPP-START approach (SSA) prescribing on adverse drug reactions, medical complications, hospital readmission, quality of life in hospitalized geriatric patients with sarcopenia
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal haemorrhages NEC
- Vascular haemorrhagic disorders
Synonym
Health condition
stoppen/ starten/ dosisaanpassing van medicatie bij acuut zieke sarcopene geriatrische patienten met polyfarmacy en diverse uitgebreide co-morbiditeit waarbij de betrokken aandoeningen heel divers kunnen zijn en de reden van de medicatie wijziging ook verschillend kan zijn.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
number and type of medication stopped during medication review and not
restarted within 1, 3 and 6 months
Secondary outcome
Secondary endpoints: number and severity of Adverse Drug Reactions (ADR) and
complications due to medication (e.g. delirium or falls), hospital readmission,
quality of life (QoL) and mortality
Background summary
Acutely ill hospitalized geriatric patients have co-morbid disease and
polypharmacy and 2/3 have low muscle strength and low muscle mass, called
sarcopenic. Although all efforts are done by the multidisciplinary team to
combat health problems and negative sequalae of sarcopenia, 80% of the
(severely) sarcopenic patients will be deceased within 2 years. Optimalization
medication is part of this multidisciplinary treatment strategy. The
STOPP-START criteria are applied to optimize the polypharmacy. However, it is
not known whether this strategy actually results in a better or worse outcome
for these patients. The question that arises is whether it is even better to
minimize pharmacotherapy in these patients and only apply it if the aim is to
combat symptoms and complaints and to stop (preventive) medication as much as
possible. The latter is called a deprescribing pharmacotherapy approach (DPA)
and seemed to be successful in a previous study concerning older frail
patients.
Study objective
The effects of DPA compared to STOPP-START approach (SSA) prescribing on
adverse drug reactions, medical complications, hospital readmission, quality of
life in hospitalized geriatric patients with sarcopenia
Study design
Prospective randomised intervention study. Patients will be randomised in two
groups: intervention group (IG) with a DPA of 80 patients and a control group
(CG) of 80 patients with a SSA.
Medication review in patients randomised to the IG group will be performed
according to the principles of DPA and in the CG this will be performed
following the SSA approach.
Intervention
Medication review in patients randomised to the IG group will be performed
according to the principles of DPA and in the CG this will be performed
following the SSA approach.
Study burden and risks
In either of the two strategies of reviewing medication (SSA or DPA) there are
risks for the sarcopenic patients with polypharmacy as part of the usual care.
Applying the SSA, which is actually the usual care in the Dutch geriatric ward,
there is serious risk of overtreatment with a risk of ADR and complications
with holding off benefit because of a necessary time until benefit compared to
the limited life expectancy. Although the risk for a ADR is low, a ADR with
different kinds of impact can be expected however when starting e.g. preventive
medication. But withholding preventative medication as part of DPA can cause a
new health problem with minor to major impact if the life expectancy seems
longer than predicted and exceeds the time until benefit. Overall, the aim of
DPA is to optimize pharmacotherapy and reduce ADR, medication related
complications and improve quality of life.
Dr. H. Van der Hoffplein 1
Sittard-Geleen 6162BG
NL
Dr. H. Van der Hoffplein 1
Sittard-Geleen 6162BG
NL
Listed location countries
Age
Inclusion criteria
frail older adults, 70 Y and older with sarcopenia and polypharmacy admitted to
the acute care hospital ward because of an acute medical problem
Exclusion criteria
If a patient is not instructable. If a patient has an implantable cardioverter
defibrillator (ICD) or no informed consent or if there is no (legal)
representative with informed consent if the patient is (temporary)
incapacitated.
Patients in a palliative phase will be excluded from this study, since most
medication will be stopped in a palliative setting.
Finally, patients with an expected admission time of less than 48 hours will be
excluded due to logistic reasons (48 hours are needed to screen for
suitability, minimum of 24 hours to consider participation).
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 | NL82636.096.22 |