Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05757765 |
| Other study ID # |
ZuyderlandMC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 27, 2023 |
| Est. completion date |
August 2027 |
Study information
| Verified date |
February 2023 |
| Source |
Zuyderland Medisch Centrum |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare the effects of a deprescribing pharmacotherapy
approach to the STOPP-START approach (usual care) in geriatric patients with sarcopenia and
polypharmacy. The main question it aims to answer is the number and type of medication that
can be stopped in this population without being restarted within 6 months.
After inclusion a medication review is performed by a team consisting of the researcher, a
geriatrician and a hospital pharmacist, according to the protocol within which the patient
was randomised. Participants are follow up at appointments after 1, 3 and 6 months. At these
appointments, questionnaires are administered about the quality of life and complications
related to medication.
Description:
Rationale 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.
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 an control group (CG) of 80 patients
with a SSA.
Study population:
Acutely ill geriatric patients with sarcopenia and polypharmacy admitted to the acute care
geriatric ward of Zuyderland Medical Centre.
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.
Main study parameters/endpoints:
Primary endpoint: the number and type of medication stopped and not restarted during
medication review and number and type of medication restarted within 1, 3 and 6 months.
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
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
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.
