Clinical trial NCT01513265: Rationalisation of Polypharmacy in the Elderly by the RASP Instrument
Official title: Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: reduction polypharmacy
clinical outcomes
pharmaceutical care
clinical pharmacy
geriatrics
medication review
potentially inappropriate drugs
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 172
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.

Detailed description: Older persons take on average multiple drugs. As people age, there is an apparent increase in pharmacodynamic sensitivity to different making the patient more prone to experience side effects. Alterations in body composition and concomitant changes in pharmacokinetic parameters can also result in a higher risk for adverse drug events. All these factors make the older person, notwithstanding the heterogeneity of this population, more vulnerable for the negative consequences of polypharmacy.

Polypharmacy is a cause of negative clinical outcomes but it still remains unclear which intervention or set of interventions should be used to optimize the prescription of pharmacotherapy in the elderly patient. Therefore, the investigators developed the RASP (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions), a list as tool to reduce polypharmacy adapted to Belgian national prescribing tendencies within geriatric wards. Content and reliability of the RASP have been validated and the investigators aim to further study the impact of the systematic implementation of this RASP on geriatric wards in a prospective cluster randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent by the patient or a caregiver if the patient is incompetent to sign
* Consecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department

Exclusion Criteria:

* Patients not admitted to the hospital from home or a nursing home
* Patients unable to communicate in Dutch
* Patients admitted for palliative care
* Patients who do not take any drugs at admission

Primary outcomes:
measure: Number of actually stopped or adjusted drugs
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Secondary outcomes:
measure: Number of potentially inappropriate drug prescriptions as defined by the RASP.
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
measure: Actual drug use
timeFrame: Measured on 30 and 90 days post-discharge.
measure: Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
measure: Mortality
timeFrame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge.
measure: Number of falls
timeFrame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge
measure: Quality of Life (EQ-5D-3L)
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
measure: Length of stay
timeFrame: Determined at discharge, on average after 14 days
measure: Rehospitalisation
timeFrame: Within 90 days post-discharge.
measure: Incidence of delirium
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 14 days
measure: Number of falls post-discharge
timeFrame: Within 90 days post-discharge
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Lorenz Van der Linden, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van der Linden L, Decoutere L, Walgraeve K, Milisen K, Flamaing J, Spriet I, Tournoy J. Combined Use of the Rationalization of Home Medication by an Adjusted STOPP in Older Patients (RASP) List and a Pharmacist-Led Medication Review in Very Old Inpatients: Impact on Quality of Prescribing and Clinical Outcome. Drugs Aging. 2017 Feb;34(2):123-133. doi: 10.1007/s40266-016-0424-8.