Rationalisation of Polypharmacy in the Elderly by the RASP Instrument

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01513265
First received: December 27, 2011
Last updated: May 21, 2014
Last verified: December 2011
  Purpose

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.


Condition Intervention
Healthy
Other: Pharmaceutical care plan, mostly based on the RASP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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.

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    At hospital discharge the number of stopped or adjusted drugs will be determined. This variable will be compared between the two arms.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Actual drug use [ Time Frame: Measured on 30 and 90 days post-discharge. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge. ] [ Designated as safety issue: Yes ]
  • Number of falls [ Time Frame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge ] [ Designated as safety issue: Yes ]
  • Quality of Life (EQ-5D-3L) [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days. ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: Determined at discharge, on average after 14 days ] [ Designated as safety issue: No ]
  • Rehospitalisation [ Time Frame: Within 90 days post-discharge. ] [ Designated as safety issue: No ]
  • Incidence of delirium [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days ] [ Designated as safety issue: Yes ]
  • Number of falls post-discharge [ Time Frame: Within 90 days post-discharge ] [ Designated as safety issue: Yes ]

Enrollment: 172
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513265

Locations
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Lorenz Van der Linden, PharmD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01513265     History of Changes
Other Study ID Numbers: S-53664
Study First Received: December 27, 2011
Last Updated: May 21, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
reduction polypharmacy
clinical outcomes
pharmaceutical care
clinical pharmacy
geriatrics
medication review
potentially inappropriate drugs

ClinicalTrials.gov processed this record on October 21, 2014