Rationalisation of Polypharmacy in the Elderly by the RASP Instrument

NCT ID: NCT01513265

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

RASP

Group Type: ACTIVE_COMPARATOR

Pharmaceutical care plan, mostly based on the RASP

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenz Van der Linden, PharmD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 27915457 (View on PubMed)

Other Identifiers

S-53664

Identifier Type: -

Identifier Source: org_study_id