Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (RASP)

May 21, 2014 updated by: Universitaire Ziekenhuizen KU Leuven

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patients will be followed for the duration of hospital stay, an expected average of 14 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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
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.
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
Determined at discharge, on average after 14 days
Rehospitalisation
Time Frame: Within 90 days post-discharge.
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
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
Within 90 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Lorenz Van der Linden, PharmD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

January 16, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-53664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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