Rationalisation of Polypharmacy in the Elderly by the RASP Instrument

Healthy Clinical Trial

— RASP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513265
• Other study ID #: S-53664
• Status: Completed
• Phase: N/A
• First received: December 27, 2011
• Last updated: May 21, 2014
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of actually stopped or adjusted drugs	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.	No
Secondary	Number of potentially inappropriate drug prescriptions as defined by the RASP.		Patients will be followed for the duration of hospital stay, an expected average of 14 days.	Yes
Secondary	Actual drug use		Measured on 30 and 90 days post-discharge.	No
Secondary	Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP		Patients will be followed for the duration of hospital stay, an expected average of 14 days.	No
Secondary	Mortality		Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge.	Yes
Secondary	Number of falls		Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge	Yes
Secondary	Quality of Life (EQ-5D-3L)		Patients will be followed for the duration of hospital stay, an expected average of 14 days.	No
Secondary	Length of stay		Determined at discharge, on average after 14 days	No
Secondary	Rehospitalisation		Within 90 days post-discharge.	No
Secondary	Incidence of delirium		Patients will be followed for the duration of hospital stay, an expected average of 14 days	Yes
Secondary	Number of falls post-discharge		Within 90 days post-discharge	Yes