Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (RASP)
|ClinicalTrials.gov Identifier: NCT01513265|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : May 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Pharmaceutical care plan, mostly based on the RASP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||December 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||October 2012|
|Active Comparator: RASP||
Other: Pharmaceutical care plan, mostly based on the RASP
Drug use of subjects enrolled in this arm will be systematically evaluated by a clinical pharmacist, using the RASP list. Potentially inappropriate drug use will be pointed out to the treating physician. The pharmaceutical advice is not limited to the RASP list. Any actual change in drug prescription will be decided by the treating physician based upon comprehensive medical evaluations in each individual patient.
No Intervention: Control group
Subjects enrolled in this arm will undergo usual medical and pharmaceutical care with registration of drug use at admission and discharge without interference of RASP or clinical pharmacist.
- Number of actually stopped or adjusted drugs [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days. ]At hospital discharge the number of stopped or adjusted drugs will be determined. This variable will be compared between the two arms.
- Number of potentially inappropriate drug prescriptions as defined by the RASP. [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days. ]
- Actual drug use [ Time Frame: Measured on 30 and 90 days post-discharge. ]
- Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days. ]
- Mortality [ Time Frame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge. ]
- Number of falls [ Time Frame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge ]
- Quality of Life (EQ-5D-3L) [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days. ]
- Length of stay [ Time Frame: Determined at discharge, on average after 14 days ]
- Rehospitalisation [ Time Frame: Within 90 days post-discharge. ]
- Incidence of delirium [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days ]
- Number of falls post-discharge [ Time Frame: Within 90 days post-discharge ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513265
|Universitaire Ziekenhuizen Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Lorenz Van der Linden, PharmD||Universitaire Ziekenhuizen Leuven|